CIPA Journal, December 2016 by CIPA Journal

CIPA JOURNAL Incorporating the transactions of the Chartered Institute of Patent Attorneys

December 2016 / Volume 45 / Number 12

Unintended consequences? Pregabalin: CA could make more pain for pharmacists

Human embryonic stem cells Alex Bajjon and George Schlich

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Six things we love about EPO Oppositions Gwilym Roberts

Management Skills: a business survival kit Marks & Clerk

Report on the uptake of the UK's Patent Box Michael D. Jaeger

The not-so-secret diary of a CIPA President Andrea Brewster

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CIPA JOURNAL

CIPA CONTACTS

Editor Editorial Panel

Alasdair Poore David Barron, Paul Cole, Kristina Cornish, Tibor Gold, Alan White Publications Committee William Jones (Chairman) Production Iain Ross, 020 3289 6445 and advertising (iain@ross-limbe.co.uk) Design Neil Lampert Cover design Jonathan Briggs Contact editor@cipa.org.uk Published on behalf of CIPA by Ross-Limbe Communications. The Institute as a body is not responsible either for the statements made, or for the opinions expressed in this Journal. No papers read before the Institute or extracts from its Proceedings may be published without the express permission of the Council and without the simultaneous acknowledgement of their source. CIPA Journal is sent to all members of the Institute as part of the benefits of membership. It is also available on subscription at £130 per annum (plus postage for overseas addresses: Europe £35, Other £70). Individual copies may be purchased at £14 (plus postage for overseas addresses: Europe £4, Other £6). The Editor welcomes the submission of articles, news and correspondence for possible publications including photographs, tables, charts, etc, when appropriate, and any contributions should be sent by email to editor@cipa.org.uk. Iain Ross (iain@ross-limbe.co.uk) will be pleased to discuss any queries regarding submissions and advertising. Copyright in material submitted for publication Material submitted to the CIPA Journal will be accepted for publication on condition that the author, or each of them, grants the Chartered Institute a non-exclusive licence to publish the material: i. in paper form first; and ii. after paper publication, also on its website www.cipa.org.uk, in the members’ area with the ability for members to download them. When sending material, the author(s) should confirm acceptance of this condition and also that the submission is free of any third party rights or other encumbrances. Past contributors The Institute is in the process of putting on its website past articles not covered by an express agreement as set out above. Any contributor wishing to object to their work being treated in this way should write to the editor at editor@cipa.org.uk. Editorial deadline dates for receiving submissions are on the 10th of the preceding month. Please contact editor@cipa.org.uk to discuss any ideas for articles or submissions.

Tony Rollins President

Stephen Jones Vice-President

Andrea Brewster Immediate Past-President

Chris Mercer Honorary Secretary

Committee Chairs Administrators Vicky Maynard; Business Practice (joint with ITMA) Matt Dixon; Computer Technology Simon Davies; Congress Steering John Brown; Constitutional Alasdair Poore; Designs and Copyright David Musker; Education and Professional Standards Simone Ferrara; Exploitation Catriona Hammer; Informals Ben Charig; Internal Governance Bobby Mukherjee; International Liaison Richard Mair; Life Sciences Simon Wright; Litigation Vicki Salmon; PEB Rob Taylor; Patents Tim Jackson; Protected Titles Lee Davies; Media and Public Relations Jerry Bridge-Butler; Regulatory Affairs Chris Mercer; Textbooks & publications Bill Jones; Trade Marks Keith Howick. Membership Team Leader: Dwaine Hamilton Events Coordinators: Kirsty Burls; Johanna Lynch Membership and Events Coordinator: Charlotte Russell Membership Finance Coordinator: Frances Bleach Chief Executive Lee Davies Executive Assistant Gary McFly Head of Media and Public Affairs Neil Lampert Communications Officer Isabelle Wilton Policy Officer Rebecca Gulbul Head of Education Georgina Sear Education Projects Co-ordinator: Angelina Smith Finance Manager Spurgeon Manuel Finance Administrator Andrew Hewitt General enquiries: 020 7405 9450; mail@cipa.org.uk; www.cipa.org.uk

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Contents 15 24

UP FRONT

ARTICLES

EDUCATION

50 53

Institute events Women in IP group

Update on SPCs

IP Enforcement

Editorial

Alasdair Poore 5

Council Minutes

Lee Davies

Management Skills

Daniel Talbot-Ponsonby, Darren Mossemenear 15

The A Words

Cathy Mack

Alison Madgwick 18

Patent Box

Alexis Harper

Michael D. Jaeger

NEWS

Alexis Harper

Human embryonic stem cells

Alex Bajjon and George Schlich

Future US information disclosure practice EU Pharmaceuticals Guidance

Registration of professional training and activities

Six things we love about Oppositions

A Business and IP Degree in the EU

DECISIONS

Announcements

THE PINKS

EQE update 10

Gwilym Roberts

Kerry Tomlinson

Intellectual Property (Unjustified Threats) Bill

Rebecca Gulbul

Patent decisions

Unified Patent Court Agreement

IPO decisions

Beck Greener

IPO press release Double-sided printing

Going Remote

Heather Lane

IP Pro Bono scheme

Sean Dennehey

PERSONAL

The not-so-secret diary

Andrea Brewster

CIPA's Life Sciences Committee 9

Pregabalin litigation

Maeve Lynch, Rebecca Lawrence

Barker Brettell 33

IPO update

EPO decisions

Bristows 37

59 61 62

Courses and events Recruitment International

Trade marks and other IP

Bird & Bird

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From threats to (hospital) theatres: practitioners in the firing line Alasdair Poore

t is easy when faced with another consultation to suffer from consultation fatigue – and wonder, does it matter if we see bad legislation; will it just mean more work for attorneys? This month’s Journal draws together two apparently disparate issues – unjustified threats and second medical use, which are examples of the impact, and duration, of unintended consequences. “Threats” (the reforming legislation on which is mentioned at page 11) have been a thorn in the side of practitioners for nearly 40 years. Warner Lambert v Generics (discussed at page 26) has caused intense intellectual pain over the last 18 months, but this is a culmination

Unjustified threats The threats issue: in relation to patents, the current form of law on unjustified threats was first introduced in 19781. A claim could be made by a person aggrieved by a threat made to bring proceedings for infringement of a patent. The aim was to address the problem that a distributor or retailer might think it was easier to submit to a threat than run the risk of further argument2; but if the distributor or retailer dropped the product the manufacturer or importer could be damaged, often without any real recourse. The threat could be justified of course if there were found to be an infringement

CIPA should take a role in scrutinising and reviewing initial and amended legislative proposals in order to minimize unintended consequences. of many years of working through the impact of wording around second medical use protection, which still leaves medical practitioners in the firing line. And ironically, at the last turn, could expose them to threats (which are excluded from being actionable). Both illustrate why getting the right legislation matters – a rather critical question with Brexit meaning that, even to keep the laws the same (as most anticipate) will not be straightforward. The currently proposed ratification by the UK of the Unified Patent Court Agreement is an excellent example [see IPO press release on page 32]. 2

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– not so far the case so far in Warner Lambert v Generics3. In addition section 70(4) provided that: “Proceedings may not be brought for threat to bring proceedings for an infringement alleged to consist of making or importing a product for disposal or of using a process”. Note that the wording, probably after careful consideration, did not say “a threat made against the manufacturer or importer” – perhaps this was because it was (correctly)

seen that it might not be clear who the manufacturer or importer was. That choice has itself caused much pain. It would seem sensible that, if a threat – such as a letter before action – was made against a manufacturer or importer, it would never be actionable. That was not the effect of section 74 (nor will it be under the proposed reforms). Under the original section 74, a threat even against a manufacturer or importer was still actionable if it was one to bring infringement proceedings in respect of that person selling the goods they were manufacturing. So you could tell the manufacturer to stop manufacturing, but not to stop selling what they had manufactured – an invitation one might think to get rid of the stock as quickly as possible. That alone might have had a limited impact. However, another consequence of section 70 was that, if a professional advisor wrote that letter, even an innocuous but firm letter before action, a claim could be made against them personally. And claims were made against lawyers; and in more cases, claims were threatened against the professional advisors. An amusing turning of the tables, one might think. But that also could mean that the professional advisor was placed in a position of conflict, where they could not fully advise their client, because their own interest in defending the threats claim might differ from that of their client. And even if the letter before action was formally restricted to “making or importing”, the court would assess how a reasonable person (in the overall context) would perceive it. A threat limited to manufacture could still be seen as implicitly covering much more, especially if the client had already been heavy handed. www.cipa.org.uk

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UP FRONT

In the large majority of cases professional advisors were not threatened, and in those where it did happen, the issue could be resolved. However, it had a lasting impact on the approach taken to writing to a potential infringing party in relation to infringement. This included justifying not complying with the Practice Direction on Pre-action Conduct – ironic as the purpose of that Practice Direction was to encourage settlement of disputes. CIPA has worked for many years for reforms to the patents unjustified threats legislation, and corresponding provisions in relation to trade marks and registered designs. The first reform, in relation to patents, added an additional proviso that “a threat, made to a person who has made or imported a product for disposal or used a process, to bring proceedings for an infringement alleged to consist of doing anything else in relation to that product or process,”4 was not actionable. This (partially) solved one problem – but left others. The reform, also provided that it was not a threat “to make enquiries of the other person for the sole purpose of discovering whether, or by whom, the patent has been infringed [by making or importing a product]”, or to assert infringement for that purpose and protected them where they had used their best endeavours to find out the manufacturer or importer5. This again did not resolve the issue. Making these enquiries could often result in letters which did not make the recipient feel compelled to do more than throw the letter in the waste bin. More reforms were needed6. Now, nearly 40 years after that simple legislation caused lasting issues, the Law Commission reviewed the law. CIPA has actively commented, and Vicki Salmon (Chair of the CIPA Litigation Committee), has worked with the Law Commission in her personal capacity to address some of these issues. The Intellectual Property (Unjustified Threats) Bill has been subject to review in the House of Lords. In October 2016, CIPA made comments to the House of Lords Committee, and Vicki Salmon gave evidence. The result has been some positive changes being put forward, including Volume 45, number 12

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lowering the threshold of enquiry which should be made to identify the manufacturer or importer and (in relation to trade marks)7 to confirm as a note to the proposed Act that “applying a trade mark” to a product (an issue raised by CIPA and the BBC) can include doing so electronically – e.g. on a web site8. In addition, if enacted, the reform will mean that a representative (any representative who is subject to regulatory oversight) who is acting on the instructions of their client will not be liable for such threats.9 The client may still have a liability, but that change removes a significant obstacle to clients’ legal advisors writing letters before action in IPR infringement matters. A warning word, however. The Committee questioned whether, amongst patent and trade mark attorneys and solicitors, the regulatory oversight was known to have had any impact in relation to threats made by lawyers. There were even suggestions in discussions that perhaps lawyers were some of the worst offenders in overstepping the mark when threatening potential infringers. We will have to wait and see whether these reforms will eventually relegate the unintended consequences of the section 70, Patents Act 1977 to the back seat. But practitioners could still remain in the firing line.

Second medical use It is perhaps ironic that, while this has been occurring, another “difficult” piece of legislation has been centre stage; and that case has resulted in a finding of unjustifiable threats on what could potentially have been a breathtaking scale10; and also an opinion which shows that practitioners in another field, one much more sensitive than the legal profession, could be the subject of perfectly justifiable threats. Those are pharmacist11 and doctors. The case in question is of course the ongoing story of pregabalin, and Swiss-form claims. Swiss-form claims were invented to provide protection for second medical uses. They were necessary because a method of treatment of the human or animal body for surgery, therapy or diagnosis was not patentable in accordance with EPC 1973. The rationale

behind this exclusion of, effectively, new methods of use or treatment using, for example, an existing pharmaceutically active component, was apparently that practitioners should be protected from the possibility of proceedings being brought which would have a direct impact on their immediate treatment of a patient. But it was still highly desirable to provide incentives for pharmaceutical companies to invest in finding new uses for existing drugs. Indeed, such uses provide real opportunities to find new relatively safe treatments, bearing in mind that, often the drug in questions will already have passed its Phase I clinical trials, one of the greatest obstacles for successful new drugs. And the Convention provided an exclusion of: “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; [but] this provision shall not apply to products, in particular substances or compositions, for use in any of these methods”12. Thus was born the second medical use claim – the use of a pharmaceutically active ingredient in the process for the production of a composition for use for treatment of a particular ailment or medical indication. And also a rich line of hearings last year exploring what was meant by the word “for” in such a claim. The details of this case (and its implications for fields outside the pharmaceutical field) have been well discussed in this Journal. In summary, the Court of Appeal in Warner Lambert v Actavis (28 May 2015)13 held (obiter) that “for” meant that it the composition was intended for or that it was a reasonably foreseeable consequence that it would be used for treatment of the indication in question. While not agreeing with their obiter opinion, Arnold J respected it in the substantive trial on infringement and found that there was no infringement. That decision was then appealed to the Court of Appeal again, and the Court of Appeal (Floyd LJ) had the opportunity now to confirm its earlier opinion DECEMBER 2016

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UP FRONT

– which it did, with a slight twist. It expressed the view that it was possible to avoid infringement by taking steps to avoid the composition being used for the specifically patented indication14 – as had been held in analogous proceedings concerning pregabalin in France. That is interesting as it has some relevance to other areas such as the whole law on contributory infringement. What is of particular interest, however, in the context of this editorial is the discussion and implications of the conclusions on infringement. Firstly, the impact of both Arnold J’s initial approach to interpretation of “for” and that of the Court of Appeal: if it were determined that the composition had been prepared for use for treatment of the particular indication (in this case pain) its supply and use would infringe. That would be the case even if in a particular instance the composition was used for treatment of the non-patented indication. Likewise, if the

Notes and references 1. Section 70 Patents Act 1977 2. And at least one major retailer, Marks & Spencer, some years ago was said to do so, as were some mail order catalogues – now online retail sites fill a similar role, and the notice and take down procedures for stopping offers of allegedly infringing products have been under intermittent and interim scrutiny both in the courts (e.g. Cassie Creations Limited v Blackmore and Another [2014] EWHC 2941 (Ch) – www.bailii.org/ew/cases/EWHC/ Ch/2014/2941.html) and before the HL Unjustified Threats Bill proceedings. 3. It will be interesting to see whether the other subject of this editorial develops any further law on this, Arnold J having found that Warner-Lambert/Pfizer had been responsible for “threats” – and keeping pregabalin out of the pain treatment market for many months (Generics (UK) Limited v WarnerLambert [2015] EWHC 2548 (Pat), paras 690 to 721 – www.bailii.org/ew/cases/EWHC/ Patents/2015/2548.html#para721) 4. Patents Act 1977 section 70(4)(b) 5. Patents Act section 70(5)(b), 70(6) 6. Eloquently explained by Mark Anderson and

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intention of the manufacturer was not that it be used for treatment of the patented indication, any use of that composition, even for use of the patented indication, would not infringe. This was recognized in the Court of Appeal15. So the practical implication is that, in fact, the specific exclusion which was put in place to prevent practitioners being the subject of infringement proceedings has meant, not only that they remain exposed, but that is the case even if they are not doing the very thing that was patented. A further twist was the opinion in the Court of Appeal, perhaps based on concessions made by Counsel, that it was perfectly possible to conceive that a pharmacist, in taking actions relating to preparation of the drug for dispensing (including applying a label to the packaging) could be said to be preparing the composition for use for the treatment of patented indication16. This means that a pharmacist could be a primary infringer

Vicki Salmon in opening statements to the HL Committee (Proceedings 24 October 2016 – http://parliamentlive.tv/Event/Index/ 3414c82e-854f-4db0-9f60-678797ec14e4, at 15.42 to 15.47) 7. 23 November 2016: proposed amendments to the Bill adopted by the House of Lords http://publications.parliament.uk/pa/ld201617/ minutes/161124/ldordpap.htm#minproc and the amended Bill www.publications.parliament. uk/pa/bills/lbill/2016-2017/0078/17078.pdf 8. “I think that the principles of the bill cover Internet trading as well as physical trading” (HL Committee Proceedings, 16 October 2016, 16.12.30); “something that could quite usefully be explained in the explanatory notes” (16.13) 9. E.g. Clause 1, introducing section 70D to the Patents Act 1977, and corresponding provisions for trade marks and designs. 10. See above, footnote 3 11. Warner-Lambert v Generics (UK), [2016] EWCA Civ 1006, para 224 12. Article 52(4) (as it then was) 13. Warner Lambert v Actavis [2015] EWCA Civ 556, para 127: “He would understand that the manufacturer who knows (and for this purpose constructive knowledge is enough) or

in relation to the composition – one of the very questions raised by the generics drug companies17. Of course the second medical use provisions were also reformed in EPC 200018 so that maybe some of that unintended consequence has been eliminated for the system – but not until the last of the pre-EPC 2000 second medical use patents has run through the system. And there will remain a question over the position in relation to EPC 2000 second medical use patents. So, the lesson? It is all too easy to create a law, with the best of intentions, with unintended consequences. What is more, reforming those laws is far from straightforward. That makes it all the more important that CIPA should take a role in scrutinising and reviewing initial and amended legislative proposals in order to minimize unintended consequences. Let’s hope that CIPA is taking the correct approach on the Unified Patents Court.

could reasonably foresee that some of his drug will intentionally be used for pain is making use of the patentee’s inventive contribution” 14. Court of Appeal, 2016 para 208: “The intention will be negatived where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring. In such circumstances his true objective is a lawful one, and one would be entitled to say that the foreseen consequences were not intended, but were an unintended incident of his otherwise lawful activity” 15. para 202, 203, addressing Adrian Speck QC’s arguments 16. para 224 17. Question put by the Association of Manufacturers of Generics Medicines to the House of Lords Committee (Proceedings: 13 October 2016 at 16.07) – “the threat should be made to the person prescribing the medicines and not to the dispenser”, “the dispenser is the secondary infringer”. 18. Article 54(5) “Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.”

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NEWS

COUNCIL

Council Minutes Minutes of the Council meeting held on Wednesday 7 September 2016 at 14:30. Item 1: Welcome and apologies Present: A.J. Rollins (President, in the Chair), S.F. Jones (Vice-President), A.R. Brewster (Immediate Past President, by phone), R. Ackroyd, J.P. Asquith, J.D. Brown, J.A. Florence, C.M. Hammer, A.C. Instone, J.T. Jackson, R.D. Mair, B.N.C. Ouzman (by phone), A.D. Poore (by phone) and T.W. Roberts (by phone). Lee Davies (Chief Executive) and Neil Lampert (Head of Media and PR) were in attendance. Apologies: C.P. Mercer (Honorary Secretary), R.J. Burt, P.G. Cole, M.P. Dixon, S. Ferrara, S. Harte, G.J. Iceton, R.P. Jackson, A. Mukherjee, G.V. Roberts, V.B. Salmon and S.M. Wright.

Item 2: Minutes 231/16: The Minutes of the meeting held on Wednesday 3 August 2016 were approved with the proviso that minute 227/16 be redrafted to better reflect the outcome of the discussion on membership of the International Liaison Committee. Stephen Jones proposed that, following the recommendation of Richard Mair, Chair of the International Liaison Committee, Carin Burchell be appointed as a member of the Committee. The proposal received the unanimous support of Council.

Item 3: Conflicts of interest 232/16: There were no reported conflicts of interest.

information on CIPA’s position for members who are invited to speak at conferences. Neil added that a response written by the Chair of the Media & PR Committee, Jerry BridgeButler, to the claims made by Dennemeyer had been published in the Patent Lawyer. Council supported a proposal that CIPA commissions a leading economics research agency to produce a report to inform/ support Council policy decisions relating to Brexit. The aims of the project will be to gather evidence and statistical data on the positives and negatives of the UK’s participation in the UPC and UP in the light of Brexit; to provide an overview of how markets may develop in Europe after Brexit; and to gain a clearer understanding of how Brexit will effect patent attorney workloads and IP filing and litigation. Tony Rollins informed Council that a number of meetings had been arranged with partner organisations to discuss the implications of Brexit. A meeting with the German Patentanwaltskammer is scheduled for 15 September 2016, with Stephen Jones, Tim Jackson, Chris Mercer and Lee Davies representing CIPA. Tony Rollins will lead a CIPA delegation to Japan in mid-October to meet with theJapan Patent Attorneys Association and the Japan Intellectual Property Association. Lee Davies provided Tony Rollins with a copy of a letter sent by the Japanese government to the UK and the EU, setting out its concerns over Brexit.

Item 4: Brexit 233/16: Neil Lampert informed Council that CIPA had published a briefing paper, authored by a number of contributors from key committees, on the implications for IP rights as a consequence of the UK leaving the EU. The paper had been distributed internationally and had been covered by media outlets including Bloomberg and Managing IP. It was suggested that the paper would provide useful background Volume 45, number 12

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the moderator, with Stephen Jones speaking on CIPA’s position on Brexit. The second speaker will be an officer from ITMA. Tony added that he had replied accepting the invitation and had asked if it would be possible to meet separately with AIPLA’s Executive Committee. Tony added that he has asked the UK IPO to help facilitate a meeting with the USPTO. Tony Rollins advised Council that he would arrange a meeting with the UK IPO once CIPA had possession of Counsel’s opinion on the legal case for the UK remaining in the Unitary Patent and UPC post-Brexit. Tony confirmed that there was a meeting scheduled with Counsel on 9 September 2016, with Vicki Salmon representing CIPA, and that Counsel’s opinion was expected on or before 16 September, in time for the meeting with the Patentanwaltskammer. Tony Rollins informed Council that CIPA continued to work in partnership with other representative bodies, for example with ITMA, on responding to questions raised by AIPLA and with the IP Federation and Intellectual Property Lawyers’ Association (IPLA) on procuring Counsel’s opinion on the Unitary Patent and UPC. Lee Davies added that the mock trial being held at Aldgate Tower on 14 October 2016, in partnership with EPLIT, was going ahead as scheduled. Tony Rollins said that he had been invited to speak at the Global IP Network in Milan on 21 September 2016, following the AIPPI meeting there.

Action: Lee Davies to forward the letter from the Japanese government to Council members.

Item 5: Promoting the professions abroad

Tony Rollins advised Council that he had received an invitation for a moderator and two speakers to participate in a Brexit session at the American Intellectual Property Law Association’s (AIPLA) annual meeting in October. Tony said that he would act as

234/16: Catriona Hammer advised Council that the trade delegation to China, organised by the IP Minister, went very well. Catriona said that a follow-up teleconference between the delegates had been arranged to ensure that all of the resulting actions were carried out. DECEMBER 2016

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NEWS

Item 6: Regulatory issues 235/16: Council received a report from the Regulatory Affairs Committee following the Committee’s consideration of a complaint received from a client of a patent attorney. The complainant raised concerns about a complaint made to IPReg about a patent attorney which was rejected on the grounds that the patent attorney’s registration with IPReg had lapsed on 1 January 2016, despite the fact that the complaint related to work undertaken during 2015, when the patent attorney was registered with IPReg. Council supported the Committee decision to ask Lee Davies to write to Ann Wright and express CIPA’s concerns that IPReg’s decision not to investigate the complaint reduced the public’s confidence in the regulation of IP professionals. Action: Lee Davies to write to Ann Wright setting out CIPA’s concerns and seeking an assurance that IPReg would investigate the complaint. 236/16: Tony Rollins advised Council that he had raised the other matters identified in the Regulatory Affairs Committee’s report with Caroline Corby, setting these out in a letter sent shortly before the meeting. Tony reported that very little progress had been made at the Approved Regulators' Forum as there was an expectation that matters should be raised at least a week before the meeting, this despite the fact that amendments to the minutes were made shortly before the meeting and were not made clear to the participants. Tony advised Council that he was waiting for a written response from Caroline Corby to the issues he raised in his letter. 237/16: Council considered the Regulatory Affairs Committee’s comments on IPReg’s consultation on its business plan and budget and agreed with the Committee’s concerns that, as in previous years, the budget did not include a year-on-year comparison and that IPReg had failed to take on board CIPA’s previous observation that the budget should include a detailed analysis of income. Council noted the Committee’s observation that IPReg had budgeted for a £40,000 surplus and that, whilst the decision to not raise practice fees 6

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should be welcomed, there was the question about passing this on to registrants through a reduction in the practice fee. Council granted the Committee the power to act on its behalf in submitting a response to the consultation by 16 September 2016.

be confirmed. Council members were asked to forward any suggestions for invitations to Gary McFly. [See page 10.]

Action: Lee Davies to liaise with the Chair of the Regulatory Affairs Committee, Chris Mercer, and prepare a response to the budget for submission to IPReg by 16 September 2016.

Item 11: Chief Executive’s Report

Item 7: Unitary Patent and UPC 238/16: This Unitary Patent and UPC were discussed under item 4.

Item 8: IPO and EPO matters 239/16: Tim Jackson advised Council that, whilst CIPA had not been asked to respond, the Patents Committee will consider the EPO’s proposals for the online payment of fees at its next meeting and prepare a position paper. Council granted the Patents Committee the power to act on its behalf and make the response.

Item 9: Committees and committee reports 240/16: Congress Steering Committee Council noted the report from the Congress Steering Committee and was pleased to hear that delegate numbers were significantly up on the same time last year. John Brown advised Council that the programme was complete, although the Committee was waiting for the UK IPO to confirm who would replace John Alty.

Item 10: Officers’ reports 243/16: Council noted the Officers’ reports.

244/16: Council noted the Chief Executive’s report.

Item 12: Applications for election 245/16: Fellows Council approved the following first time Fellow applications: Kirwin Lee; Alistair George Alan Holzhauer-Barrie; Catrin Petty; Ritchie Lewis Daniel; Sebastian Mooser; Rachel Sarah Mercer; Edward Osmond Leslie. Council approved the following second time Fellow applications: Jessica Smart; Harry Simon Harden; Daniel Wolstenholme; Anthony Smee; Sinead Lucy. 246/16: Associate members Council approved the following first time Associate membership application: Tim Mount. Council approved the following second time Associate membership applications: Michael Conway; Andrea Kallides. 247/16: Students Council approved the following Student membership applications: Elliot Lewis Stephens; Jacob Willey; Lionel Newton; Aaron Lucas; Andrew Caulfield; Matthew Blindt.

Item 13: Resignations, etc 241/16: Education and Professional Standards Committee Council members were asked to send any comments on the draft professional standards to the Chair of the Education and Professional Standards Committee in advance of the document coming to the October Council meeting for approval. 242/16: Pro Bono Sub-Committee Council was advised that the IP Pro Bono initiative would be launched on 17 October 2016 at an event hosted by Baroness NevilleRolfe and His Honour Judge Hacon, venue to

248/16: Council noted the report on resignations and expressed its sadness on hearing that Gerald Kosmin, a Fellow of CIPA, had passed away.

Item 14: Any other business 249/16: Council approved the appointment of Guy Robinson as Rosa Wilkinson’s successor on the Exploitation Committee.

Item 15: Date of next meeting 250/16: Wednesday 5 October, 2016. The President closed the meeting at 17:12. www.cipa.org.uk

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COMMITTEE NEWS

LIFE SCIENCES

EU Pharmaceuticals Guidance Comments by CIPA’s Life Science Committee (10 November 2016) in response to the EU Guidance document for the pharmaceutical sector (3 October 2016)

IPA is grateful for the opportunity to comment on the draft guidance document for the Pharmaceutical sector. CIPA members frequently file patent applications on inventions related to genetic resources, many with medical uses. We regard it as part of our job to help ensure that the research involved in such inventions is in full accordance with the law. We also see it as our task to try to ensure that the law governing such research is interpreted and administered in a way that fulfils its objectives, as clearly and as simply as possible. The sector-specific guidance on the pharmaceutical sector is exceptionally important. Pharmaceutical research and development is vital to the economy of the European Union. Still more importantly, the work done by the sector provides new drugs to relieve suffering in diseases of all types, as well as vaccines against infections both old and new. This work is of benefit to the whole world community. It must not be impeded unnecessarily. We have comments of two types, general and specific. The former relate to the interaction of the Nagoya Protocol with public health policy under EU regulation 511/14: the latter to the detailed proposals set forth in the draft Guidance. We consider the former first. The Nagoya Protocol is a protocol to the Convention on Biological Diversity (CBD). The objectives of the CBD are three-fold (paraphrased): 1. preservation of genetic resources (GR) 2. wider (sustainable) use of GR 3. fairer sharing of the benefits of such use. Volume 45 number 12

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The Nagoya Protocol emphasises the third, seen as neglected. But this emphasis must not be allowed to prejudice the first two – in particular the second. Unnecessarily strict, complex or uncertain rules to ensure sharing benefits can easily inhibit wider use. All three objectives must be held in balance. Further, the Protocol must not be applied in such a way as to detract from other important policy goals, such as public health. The Protocol recognises the need to take into account other policy goals. In Article 8 (‘Special Considerations’), parties are required to take into account ‘emergencies’ that ‘threaten or damage human, animal or plant health’ and the need for ‘expeditious access’ – to GR and the benefits resulting – including ‘affordable treatments for those in need, especially in developing countries’ – Article 8(b). Special treatment for GR for food and agriculture (‘food security’) is also proposed – Article 8(c). However, with regard to public health at least, the provisions of Regulation 511/14 are totally unsuitable. Influenza pandemics are specifically excluded from the Regulation (see Recital 16) as covered by a special agreement (the ‘PIP Framework’). Seasonal influenza strains are not. They (and other infectious agents – Ebola? Zika virus?), are covered (if at all) by Article 4(8). This allows research on such agents to begin immediately, without permission from the source country. However, unless arrangements for use and benefit-sharing are finalised with the source country within three months, research must stop. How could a company start work to defeat a threat like Ebola, if there were a real risk that after three months’ work, and before they had developed a useful product, they must stop? Some fear Article 4(8) means it may

no longer be possible to prepare annual vaccines against seasonal influenza strains. The provisions of Article 4(8) are barely credible. They take no account of practicalities. Infectious agents carry no stamp revealing their country of origin. Sometimes this is known, because it is where the sample has been collected. But then there is the problem of finding out who in the country of origin has the right to grant consent to the research. To help to find the answer, the CBD Secretariat has set up a website on which countries are to list ‘focal points’ to deal with such matters. Some countries have done so, others not yet. Even when ‘focal points’ are listed, early experience shows that replies to enquiries are often not received within three months (or at all). Perhaps this may improve with time. But even if prompt replies are received, three months is a quite inadequate period for negotiating an important agreement of this kind. It seems likely that if a serious public health emergency arises, the provisions of Article 4.8 will simply be ignored. That in itself indicates that Regulation 511/14, at least insofar as it applies to public health, is unfit for purpose, and must be amended. Meanwhile, the draft Guidance is proposed to deal with the position under the Regulation in its current form. We have two general comments on this. Firstly, ‘guidance’ should be (to the extent possible) clear and definite. To say (as the Guidance does, in several places) “it could be argued that” is not helpful. Users want to know what they may do. If officially advised that an action ‘could be argued’ to be illegal, they will not do it. The Regulation is after all backed by criminal sanctions, in some countries at least. If the Commission feels that DECEMBER 2016

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COMMITTEE NEWS

the argument is unsound, and may be disregarded, it should say so. That would not prevent a court subsequently deciding differently. However, if in such a case an action were subsequently found to be illegal, the ‘user’ would be able to argue that following the Commission’s advice constituted ‘due diligence’. Secondly (and related to the first point), what is to constitute ‘due diligence’ is not made sufficiently clear.

PATENTS

Research into genetic resources is to be encouraged, by as wide a range of users as possible, including academic researchers and SMEs. Such smaller entities, in particular, need the clearest possible instructions as to how to fulfil the legal requirements, so that they can have the confidence to invest time and money in risky projects. We are told by SMEs that the draft guidance does not meet that standard. We have no doubt

that universities, which are generally riskaverse, will be of the same mind. We hope that the draft guidance will be reconsidered in the light of the above comments. We also hope (while recognising that this is beyond the scope of the present consultation) that the Commission will give prompt and serious consideration to considering how Regulation 511/14 might be amended to respect important public health goals.

Future US information disclosure practice The United States Patent and Trademark Office (USPTO) has requested comments1 on a proposal to automate the citation of prior art from corresponding applications in other countries, by leveraging electronic resources such as the Global Dossier. This would relieve applicants of a significant burden. CIPA's Patents Committee strongly welcomes this, and has sent the following response (28 October 2016).

he Chartered Institute of Patent Attorneys (CIPA) is the professional body which represents over 2000 patent attorneys in the United Kingdom. Our members act on behalf of large corporations, small and medium entities, universities, public bodies and individual inventors. CIPA members are very commonly responsible for the parallel prosecution of patent applications in multiple countries, including the US. Ensuring compliance with the duty to disclose prior art cited elsewhere to the USPTO examiner is a major burden. We therefore strongly welcome USPTO plans to automate the process, which we believe will benefit both applicants and examiners. By reducing the possibility of inadvertent omission of prior art cited elsewhere, it should also improve the quality of patents and reduce litigation about whether such omission amounts to inequitable conduct. 8

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1. In balancing the goals of examination quality and efficiency, should the USPTO monitor other applications, besides domestic parent and counterpart foreign applications, for relevant information located therein for consideration in the instant US application? If so, which other applications should be monitored (e.g., siblings, applications involving the same or related technology, etc.)? As a precaution against allegations of inequitable conduct in subsequent litigation, we believe that most applicants already cite references automatically if they are cited in either domestic or foreign sibling applications (continuations or divisionals). It will therefore be a significant benefit to applicants for the USPTO to monitor for such information itself. Moreover, usually it will not result in examiners being burdened with significant extra information, since it is information which they already receive in IDSs.

On the contrary, if examiners are provided with tools and training which enable easy access to foreign file wrappers in the Global Dossier, it should assist them to deal with the burden they already experience. It should then be easier for examiners to understand why a foreign examiner cited a particular document, and for example whether it was seen as particularly relevant or merely as background information. Please note that the information in the Global Dossier is continually updated by other patent offices. The USPTO must therefore continue to monitor it in order to provide updated information at the time most suited to the US examiner’s needs, e.g. when an office action is in preparation, an applicant’s response is being considered, and also before issuance of a Notice of Allowance. Rules 56, 97 and/or 98 should be amended to relieve the applicant of the need to provide this information in a timely fashion. www.cipa.org.uk

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2. What is the most convenient way to bring an application to the USPTO’s attention that should be monitored for information during the examination of a US application (e.g., automated system, applicant notifies the USPTO, etc.)? For domestic and foreign siblings, it should be straightforward to provide an automated system. For other applications relating to similar technology, we suggest that the applicant should notify the USPTO. 3. How should the USPTO determine which information from the monitored applications to provide examiners while ensuring they are not overburdened with immaterial and marginally relevant information? As noted above, we believe that most applicants already provide this information,

PATENTS • EQES

so it should not result in an extra burden on examiners. In fact, it will reduce the burden if examiners are provided with tools giving easy access to Global Dossier information which shows why foreign examiners cited it. It should be noted that at present, most applicants feel unable to assist the US examiner in this way, since that in itself could lead to an allegation of inequitable conduct, questioning whether guidance supplied by the applicant was misleading. It would be counter-productive to attempt to filter the information, providing examiners with only some of the references cited in the domestic and foreign counterparts. Fearing allegations of inequitable conduct, applicants would likely file the missing information in an IDS, as at present. There would be no benefit to the examiner, and the need to check and supply missing information

EQEs – Registration of professional training and activities On 24 November 2016, the Examination Secretariat for the EQEs at the EPO circulated a notice on the Obligatory Registration for Candidates of the European qualifying examination. It is now compulsory for EQE candidates to register at the beginning of their professional activities and training. Candidates who have not registered will not be able to enrol next year to the pre-examination 2018.

Transitional period Candidates who register during the transitional period, which expires on 31 March 2017, will benefit from: • •

registration free of charge; and the possibility to register all past periods of relevant training (without limitation).

As of 1 April 2017 there will be a registration fee and only training which occurred two months immediately before registration will be taken into consideration. It will no longer be possible to have professional training and activities taken into account retroactively. The EPO urges candidates to register for the EQE without delay using the web portal which can be accessed from the EQE website – see www.epo.org/learningevents/eqe.html. Further information can be found in the FAQs – see www.epo.org/learning-events/eqe/faq.html.

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would frustrate the major benefit to applicants. Providing US examiners with the suggested tools to aid their understanding of why the foreign examiner cited a reference is much preferable. 4. If the USPTO were to import information from applicant’s other applications, how should the USPTO document the information imported into the image file wrapper of the instant US application? For example, should the record reflect which domestic parent or counterpart foreign application the information was imported from, the date that the information was imported, and whether the examiner considered the imported information? Most applicants (or their attorneys) currently check that the US examiner has initialled their IDSs to show that all information has been considered. It is therefore extremely important that there should be a record of what has been considered, and that this should be sent to the applicant. Ideally, this should be a simple statement that all information from the Global Dossier at a specific date has been considered (and the USPTO should automatically check the Global Dossier again at the time of the Notice of Allowance). 5. Taking into consideration the information that is publicly available in PAIR, what information should be part of a patent? For example, should prior art references and classification information still be listed on the front page of a patent? All information should be available in one place, to make it easy to find. If it is provided in Public PAIR, rather than on the front page of the patent, then PAIR should have a specific tab for the purpose, and the front page of the patent should include a reference to it. We would not wish to have to wade through all the documents in the image file wrapper looking for it (in the way that IDSs are currently interspersed with all the other application documents). 1. See https://www.federalregister.gov/ documents/2016/08/29/2016-20703/request-forcomments-and-notice-of-roundtable-event-onleveraging-electronic-resources-to-retrieve DECEMBER 2016

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IP PRO BONO

IP Pro Bono scheme IP Pro Bono launch, Monday, 17 October 2016. Opening remarks by Sean Dennehey (Acting Chief Executive, Intellectual Property Office)

am delighted to be here this evening to celebrate the launch of “IP Pro Bono”. This new initiative is a very welcome and important addition to the support available for innovative businesses and individuals. Through it they will have access to high-quality pro-bono; or, as most lay people would say, no-cost legal advice when they find themselves caught up in the IP legal system, particularly when needing to use the Intellectual Property Enterprise Court (IPEC).

These aim to promote greater understanding of IP amongst businesses and to assist them in maximising the revenue and potential growth from their IP assets. We work not only to help businesses recognise, understand, protect and exploit their IP, but to enforce and defend their IP rights. In particular, it is crucial that businesses can cost effectively resolve their IP disputes if they are to have the confidence to innovate.

Why does this matter? Because it is essential in promoting innovation and growth. Innovation is at the heart of a vibrant and creative economy. It brings new ideas that challenge the status quo, solutions to difficult problems, new goods and services to market and drives new ways of working that spur productivity. It is a critical building block for our economic well-being. For all of these reasons, the IPO and wider government work to encourage innovation across the UK. In the latest Taylor Wessing Global IP Index1, the UK’s intellectual property regime retained its very strong reputation, being ranked for patents first in the world. This is among other things testimony to the government’s commitment to make the UK the best place to patent. Innovation can be expensive and risky though and the IP regime plays an essential role in managing that risk and providing support and incentives for businesses to innovate. Many of you here tonight have worked with the IPO to develop other initiatives to support businesses on their IP journey. An excellent example of this collaboration is the range of tools, resources and outreach activities which we offer.

So where have we collaborated with you in this area of enforcement? Let me begin with IPEC. For many years IP dispute resolution was a problem for businesses – the Court set up and intended for small businesses, the ‘Patents County Court’ (PCC), was not in practice considered fit for purpose. Legal costs were often disproportionately high in relation to what was at stake, among other things.

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In 2009, the IP judges, through the IP Court Users Committee, instigated work to address this problem. In 2012, with the support of the IPO and Ministry of Justice, their commitment culminated in the ‘Intellectual Property Enterprise Court’. The reform of the PCC included streamlining court procedures and introducing a fixed capped scale of recoverable costs. This gave potential litigants clarity and some certainty around the process, their own costs and in particular, their maximum exposure to the other sides’ costs were they to lose the case. In 2001, there were virtually no PCC cases, but in 2010, following the early reforms, this grew to 89 cases. By 2012 there were 202 cases at the court of which around 70% were filed by SMEs. These reforms have been a big success, and undoubtedly improved ‘access to justice at proportionate cost’ for businesses seeking to resolve their IP disputes.

Sean Dennehey, Acting Chief Executive of the Intellectual Property Office

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The government has also shown that it is committed to helping parties resolve their issues by means other than litigation, for all types of dispute, IP or otherwise. Litigation should always be a last resort. Yes, the IPEC has seen a rise in cases but evidence suggests that its mere existence is helping to bring parties to the table, particularly for the very lowest value disputes on the small claims track. Where negotiation fails, the IPO has ensured businesses have a cost-effective alternative to litigation. The IPO reviewed and modernised its Mediation Service in 2012-13 to coincide with completion of the court reforms. For disputes around all the IPRs, businesses have access to a range of mediation options, including telephone mediation, at a cost which is again proportionate to what is at stake. We

IP PRO BONO • IP BILL

also ensure businesses can enjoy a wide choice of mediator by providing access to a comprehensive list of other mediation services. But all this would be redundant if our outstanding IP judges were not pro-active in “encouraging” litigants to consider alternative dispute resolution. Their support for ADR is crucial if businesses are to properly recognise and take advantage of the benefits and opportunities from resolving their disputes through mediation. The IP Pro Bono scheme is yet another example of successful working together, this time in response to a challenge set by His Honour Judge Hacon. The IPO has played only a small part in the process and this new initiative is all to the credit of the UK’s IP legal services providers. It is you who have successfully come together to meet

the challenge of providing much-needed advice and legal support for parties in IP disputes who cannot afford to meet the costs of professional representation. It is crucial for small businesses and individual innovators to have access to high-quality legal advice when they find themselves caught up in the IP legal system, particularly where it could involve the IPEC. This service will now make that advice available when it is most needed and on a pro bono basis. I welcome this important initiative and congratulate the Chartered Institute of Patent Attorneys, the Institute of Trade Mark Attorneys and the Law Society on successfully launching ‘IP Pro Bono’. I wish it every success in the future. 1.

https://united-kingdom.taylorwessing.com/ global-ip-index/

Intellectual Property (Unjustified Threats) Bill Vicki Salmon, on behalf of CIPA, was invited to give oral evidence to the Special Bill Committee of the House of Lords on 24 October 2016.

he Intellectual Property (Unjustified Threats) Bill was proposed by the Law Commission and seeks to amend existing law relating to unjustified threats to sue for infringement of IP rights. The Bill aims to reduce legal costs and complexity and encourages parties to negotiate a settlement rather than issue litigation. It distinguishes between legitimate threats and those used to cause commercial damage to a business rival. The Bill also seeks to remove liability for unjustified threats from professional advisers acting on behalf of clients. Various questions were raised by the Lords. Ms Salmon provided views on the Bill and its impact. Mark Anderson and Matthew Harris from the Law Society also gave evidence.

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The discussion started with the shortcomings of the current law on unjustified threats and how serious the problem was. It then moved onto whether the Bill was a good way forward and whether it would simplify the law. The issue of costs and the reduction of cases litigated were also raised. Baroness Neville-Rolfe asked whether the Bill would make it easier for SMEs to contact alleged infringers or help SMEs subject to unjustified threats. The consensus was that it would be. The protection of professional advisers, regulated by a regulatory body, from personal liability for making threats when they act for their clients was then discussed. The last item on the agenda was the amendments to the Bill which were proposed by the Law Society and CIPA.

Vicki Salmon, chair of CIPA's Litigation Committee, provided views on the Bill and its impact

A full transcript of the session can be found on the parliament website [see https://goo.gl/zmA2H8]. Additionally, you can find all of CIPA’s previous submissions on the Intellectual Property (Unjustified Threats) Bill on our website. [Also see the Litigation Committee’s response to the call for evidence reported at November [2016] CIPA 10.] Rebecca Gulbul, Policy Officer at CIPA DECEMBER 2016

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Management Skills They’re not “soft skills”; they’re your business survival kit. By Daniel Talbot-Ponsonby (Fellow) and Darren Mossemenear

An unpleasant Monday morning Before you left the office on Friday you drew up a neat, reassuring to-do list of client work for the coming week. Over the weekend you received two emails: one, asking you to take responsibility for risk and compliance for the firm; the other apologising for the late notice but requiring your urgent input on the office budget for the coming year. On Monday, on your way to work, you decide that you really need to have that conversation giving difficult feedback to a work colleague – you have been putting it off for too long. You arrive at work to find that the IT server is down, the office manager and both the secretaries are off with the flu, there is a new hire attorney arriving in 15 minutes for their first day – and everyone is looking at you. So much for the reassuring to-do list!

The “producing manager” dilemma As your career develops in a private practice firm you will increasingly face the “producing manager” dilemma – taking on management or leadership responsibilities whilst maintaining the day job of being a patent attorney. The producing manager dilemma was first explored by Jay Lorsch and Peter Mathias in the 1980s – “When Professionals Have to Manage” Harvard Business Review. Producer activity (the stuff we are comfortable with) includes our technical work, client service, building a professional practice and business development; manager activity (the scary stuff that we do not have a manual for) includes people management, strategic planning, administration and compliance, and many other miscellaneous duties. The themes Lorsch and Mathias first articulated have been further developed by various business thinkers; but the fact remains that it can be extremely challenging to juggle these variable, and sometimes conflicting, responsibilities. Referring back to your old notes from P6 and the drafting exam will not help you here! The larger your firm, the more likely you are to have capable support teams, professionals in their own fields (HR, 12

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marketing, finance, IT, etc), to help with the management burden. But the nature of our industry is such that most qualified patent attorneys will have some management or leadership responsibilities, which will only increase with seniority. Your best strategy is to acquire practical management and business skills as essential CPD from an early stage. Some of these skills can be learned from business literature and training courses, some more likely from hard earned practical experience.

Everyday planning and project management New joiners to the world of intellectual property often comment that it is surprising how a profession so precisely regulated and driven by immovable deadlines in its client facing duties, can often leave its own business-related activity to the last minute, or beyond! Prioritisation is critical in our work and it is appropriate that client matters almost always come first. However, the more experience we accrue and the wider our responsibilities become, the more essential it is to develop strong prioritisation, time and project management skills. In the realm of client work, systems and support staff teams are in place to ensure we never miss a critical deadline and to help identify what needs doing now and what can wait a couple of weeks. In general business and administration matters we have significantly fewer safety nets. Therefore this requires your diligent and focused efforts. There are many mechanisms of organising your time – prioritised to-do list; devising miniproject plans for key management duties; allocating blocks of time for distinct duties whilst planning your day; setting aside mornings for client work and being open to practice management requirements and ad-hoc “interruptions” in the afternoon. Diligence in planning and execution is just as important with internal firm matters as client work, and as rewarding. It almost always helps to break down large tasks and project activity into manageable chunks, set yourself deadlines and make sure you treat them seriously. www.cipa.org.uk

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It is also crucial not to forget communication. There are few management duties that require you to operate in a vacuum. Always consider the communication requirements of business and project activities. You may need to consult others for input, delegate tasks, and as a minimum, let others know what you are planning and what is required of them. The most common failing in the execution of project work and managing business change is poor communication. For a quick refresher on many business topics – designed for professionals with limited time – the Harvard Pocket Mentor Series is an excellent distillation of knowledge, guidance and tools (for example, Managing Projects: Expert Solutions to Everyday Challenges – Harvard Pocket Mentor Series).

Developing teams Working as part of a team does not come naturally to everyone but it is part of the day job. Managing a team is a responsibility you will probably pick up as your career develops; developing a truly and consistently highperforming team requires skill and dedication but is immensely worthwhile for you, the team members, your clients and your firm. In our experience, effective team management has a number of key elements: the team leader must understand the relative strengths and weaknesses of team members; the team needs a clear sense of purpose;

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performance expectations should be clearly defined and periodically reviewed; successes should be celebrated; and failures and problems dealt with in a constructive manner. Leaders of truly high-performing teams usually have a (flexible and realistic) plan, devote adequate time to management and communication, and lead from the front. Really good team leaders are well aware of, but do not necessarily feel the need to control, all aspects of the team’s work. They share their knowledge and experience with other team members. Knowing that team members are informed and capable of good work, they empower others to make decisions at an appropriate level. In the fee-earning context, the client has the reassurance of a senior fee-earner overseeing the relationship and the work outputs, but they know and have trust in other team members too. The team leader is still instrumental in a high-performing team, but in a way which does not hamper the development of other team members. Developing “people management skills” from an early stage of your career is advisable. These skills can be useful in a surprisingly wide range of circumstances – as any parent who has applied Landsberger’s Hawthorn Effect1 to encourage their kids to tidy their rooms can attest. Devote time to team engagement, communication and constructive feedback. Make sure this is not the last thing on your to-do list for the day. Do this well and all parties reap the rewards.

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Coaching and managing people Whole books could be, and have been, written on this subject. We believe that achieving a good balance of support and challenge for any colleagues you coach or manage is an important starting point. You should offer adequate support so that your colleagues are able to push boundaries and make mistakes from time to time on the road to doing a great job; but also challenge them to grow and improve their work outputs. Managers who offer neither support nor challenge find their colleagues tend not to take pride in the quality of their work. If you focus too much on challenge, without adequate support, this can engender anxiety, risk aversion and low morale. Too much support without enough challenge can engender low energy and innovation levels, complacency and boredom. Sensitively balancing high levels of both support and challenge engenders innovation, growth, collegiality, high morale and high achievement levels. To gauge the appropriate levels of support and challenge requires frequent – but not necessarily lengthy – interactions with your colleagues. Furthermore, if you see a problem which needs to be addressed, do not put it off. It is almost always easier to have a potentially difficult conversation, or to give difficult feedback to a colleague, sooner rather than later. Dealt with quickly, problems will be easier to put right, opinions and inappropriate behaviours less entrenched. The anticipation of a difficult conversation, so long as you are well prepared and reasonable in your approach, is almost always worse than the conversation itself.

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Sensitively balancing high levels of both support and challenge engenders innovation, growth, collegiality, high morale and high achievement levels.

In conclusion We believe that developing management and general business skills from an early stage and throughout your career should not be viewed as optional – it is essential. You do not need to be an expert: you can utilise and work with professional support teams around you in your firm. Taking the time to apply your business skills – whilst it requires time and discipline on your part – will pay dividends for you, your colleagues and your clients in the long run. Treat your own business duties, and your colleagues, with the same professional diligence as you treat your clients. Daniel Talbot-Ponsonby was Oxford office managing partner from 2012-2016 and is currently a member of the Marks & Clerk LLP management board. Darren Mossemenear is Director of Human Resources for Marks & Clerk. 1. Henry A. Landsberger studied productivity in Chicago factories in the 1950s, and found that people work harder and perform better when their work efforts are observed. This was arguably the start of the movement advocating regular feedback and recognition for good effort. Also useful for pre-schoolers.

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The A Words Some definitions, tips and suggestions for employers and colleagues of people on the Autistic Spectrum, told from the personal point of view of a trainee with Asperger’s Syndrome. By Alison Madgwick

his article comes in three parts. First, in case you’ve no idea what I am on about, a short summary section of Autistic Spectrum Disorders with some useful definitions. Second, if you’ll allow me, a section of self-indulgence in which I will attempt to explain to you my own relationship with my Asperger’s Syndrome in the hope that this personal experience will put this article into context. Last but not least, I shall end with an important summary of what can be done in the workplace to help people with Autistic Spectrum Disorders do their jobs whilst benefitting from the same respect, tolerance and understanding as their neurotypical colleagues.

Some definitions

Autistic Spectrum Disorder (ASD) is the umbrella category for a group of conditions which very broadly include the symptoms of difficulties with social interaction and communication, repetitive behaviours, restricted interests and sensory issues. Autism is the most common and well-known of the above conditions and is often used as an umbrella term itself, including synonymously with ASD. Asperger’s Syndrome (AS) was, at the time I was diagnosed, classified as a separate condition to autism. Since then, however, it has been redefined as one of the conditions covered by the umbrella term of ASD. Some people also use AS synonymously with high-functioning autism. Others, myself included, find the latter term unhelpful and offensive to those not classed as “high-functioning” and would prefer it if it were not used. Aspie is a word which some people with Asperger’s Syndrome, including myself, have reclaimed for themselves. It is wise not to use this term for other people unless they have explicitly said that it is ok to do so. Volume 45, number 12

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In the following paragraphs I shall try to use the above terms as consistently and coherently as possible. If, however, I slip up and am less than clear please do accept my apologies. You will hopefully be able to work out what I meant to say.

My Asperger’s Syndrome Right, time for the self-indulgence. Growing up I knew I was different to the other kids at school in the ways in which I thought about things, a knowledge which often bordered on arrogance when I knew that my way was the more correct way of thinking, if not the most useful. Probably partly because of this arrogance, along with little desire to mix with those whom I didn’t understand, I never had many friends growing up. It wasn’t that I didn’t want friends, I often craved social contact most desperately, it was just that my peers didn’t make any sense to me whatsoever and interacting with people whom I couldn’t understand frustrated me. The only person at school whom I understood at all was a boy whom I knew had something called Asperger’s Syndrome. I could talk to him without feeling nervous, stupid, inferior, superior, dumbfounded, annoyed, perplexed, ashamed, offended, awkward or any other of the myriad of confusing feelings that interactions with “normal” children made me experience. I did wonder a few times if there may be a straightforward reason for why I would find this child’s view of the world made so much more sense than other people’s and I even asked my parents on occasion whether I might have this Asperger’s Syndrome as well. They dismissed my queries because they didn’t understand the need to “label” children. Fast forward to my eighteenth year of life and I had successfully gained a place at Cambridge University reading biological Natural Sciences. I found my first year at university hard and in more ways than one. Upon immersing myself into Cambridge life, the social problems which I had experienced my whole life and had just about learned to cope with were turned on their head once again and shaken about a bit. And as if that wasn’t enough, there was the work. I very quickly found DECEMBER 2016

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myself floundering in a mire of unfinished essays, untouched example sheets, loud parties next door which I had not been invited to and a growing sense of “What on earth am I doing here?”, I think it is called Imposter Syndrome. That was when I decided to pursue the line of thought I had had earlier on in my life, to find out if I could be “labelled” with another sort of syndrome. From that point on, everything was a lot simpler. Not simple by a long way, but simpler. It is important to point out here that, as with anything, my experience is not the same as other people’s. Just because I found my life so much more bearable after being diagnosed with Asperger’s Syndrome does not mean that anyone with Aspie tendencies should immediately seek a diagnosis. Nor do I agree with my parents’ not “labelling” view. It very much depends on each individual person what they are likely to find most helpful. For my part, I am glad to have collected my label. Once I knew why I was different I started thinking of myself as such. Different, not strange or weird or odd, just different. This change in attitude towards myself was probably the most important effect of my diagnosis. Where previously I was floundering in a sea of confusion, I could now mostly step back, realise that I was confused, realise what was confusing me and why and in many cases actually do something about it. That is not to say that I had immediately solved all my social and communication problems, but I was from that point on a lot more able to deal with them. The practical outcomes of my diagnosis were of course also useful. At university I received extra time in exams

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and was able to sit them in another room. This was also more recently allowed when I did the PG Certificate in IP at Bournemouth University. Supervisors were made aware that I may find it difficult working with other people and that I may need more time finishing off practicals or handing in essays. Once I was able to work to my full potential, or at least nearer my full potential, I was able to start tackling the confusion that was the social side of my life. At first I was paranoid about mentioning my Asperger’s, assuming that it was not possible to do so without it seeming like an excuse. With time, however, I got used to casually mentioning it in conversation and explaining certain behaviours with neat little phrases like, “I’m sorry, my Asperger’s Syndrome causes me to take things literally sometimes” or “Can we please schedule when we’re going to meet in advance? I have Asperger’s and don’t deal well with uncertainty and changes in routine”. Once I felt more comfortable with myself and my interactions with the world, I was able to start helping others. Whilst at Cambridge I helped the Disability Resource Centre there with various access initiatives, as well as being Disabled Students’ Officer at my college. I was also facilitator for the AS Social Group for a fair while. This not only helped me to explain a lot of my own behaviours through chatting to other people on the Autistic Spectrum, but if I don’t sound too much like I am blowing my own trumpet in saying so, I think I helped the other people at the group as well. The main reason for this though was simply that their previous

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facilitator did not have an Autistic Spectrum Disorder! This in my opinion is an example of one of the least helpful ways for neuro-typical people to help neuro-atypicals, make a space for them and then sit in it. By all means make the space and we will thank you, but then get out of it! It is almost true of any group that if you are not a part of that group and you want to help the best thing to do is give the people who are in that group the space to help themselves, with support from you only when they ask for it.

ASD in the workplace Onto the third and probably most relevant part of this article for you, the reader. Some advice on what to do if you have a colleague with ASD. Since starting down the route of training as a patent attorney after my degree, I have had positive experiences and negative ones related to my Asperger’s. I shall not go into great detail here about these experiences, but rather sum them up in the form of take-home does and don’ts for employers and colleagues of someone on the Autistic Spectrum. It is important to point out that the following list is by no means complete. It is simply a list of the most important points which I am aware of from my own experiences, which will of course be different from other peoples’. I hope you will find it helpful nonetheless. 1. Do give clear instructions. People on the Autistic Spectrum often cannot infer meaning or “read between the lines”, so if given unclear instructions can find it difficult to carry out the required task. This not only means the job does not get done adequately, but it can cause the person with Autism significant stress. It is often useful to provide instructions in writing rather than orally and can be helpful to ask the person to repeat back instructions to be sure they have understood. 2. Do allow for routines and give adequate notice when these change. People on the Autistic spectrum often find routines very helpful and can get upset and stressed when these are not in place or are changed without notice. Clarification of working hours and break times can be useful, as can timetables for when there are multiple tasks to be completed in the same time period. 3. Do give feedback and make it clear that it is not criticism. Clear feedback can be very important to someone with Autism so that they can be sure that they are doing work correctly, or alter how they are doing it if not. It is, however, often important when dealing with people with ASD to make sure that this feedback is constructive and not interpreted as criticism. Autistic people are often perfectionists, so perceived failure can hit them hard. Many have also experienced bullying in the past, so can be more sensitive than others to negative remarks. Volume 45, number 12

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4. Do not expect them to be super-good at teamwork. As described above, people on the Autistic Spectrum often have social and communication difficulties. They are therefore probably not the wisest people to expect to do large amounts of teamwork! If they are needed in a team, then just be aware of their needs and maybe make sure that the others in the team are as well, of course with the Autistic person’s consent. 5. Do not expect them to join in social stuff. It varies from firm to firm and office to office of course, but socialising can be an important part of working in IP. As with teamwork, it is important to remain aware of an Autistic co-worker’s needs and not pressure them into going to the pub after work. If they do decide to join in social activities, be respectful of boundaries, possible sensory issues and the fact that they may need to take some time out at any point to recover from the social interaction. 6. Do not make assumptions based on stereotypes. Not everyone on the Autistic Spectrum is like Rain Man. As the name suggests it is a Spectrum and many people have learned tricks to make their Autism invisible most of the time. Avoid saying things such as “You can’t possibly be autistic” or “Does that mean that you do X?”. Such things can be very upsetting or frustrating for someone who has put a lot of effort into learning how to appear “normal”. 7. Do listen to the person with Autism. This is possibly the most important take-home message of this article. Of course, self-education is good and I whole-heartedly encourage you to go home and read up on ASD (the National Autistic Society website is good). At the same time, I would like to stress one last time that everyone is different. So, in deciding what reasonable accommodations to make in your office or how to socially interact with an Autistic colleague, the person who best knows the answers to your questions about their autism is the colleague themselves! Of course, don’t think from the above that I believe the entire impetus is on other people for making sure that a person with ASD gets on ok in the workplace. I believe that it is of course important for the Autistic person to make an effort as well. If the above points are followed, however, it should hopefully be a lot easier for the Autistic person to work together with their colleagues to find ways of working that benefit all. Alison Madgwick, Trainee Patent Attorney This article was written for IP Inclusive and first appeared on its blog at www.ipinclusive.org.uk/blog/ autistic-spectrum-disorders-in-the-workplace DECEMBER 2016

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Patent Box Michael D. Jaeger (Fellow) unpacks HMRC’s report on the initial uptake of the UK’s Patent Box.

he UK’s Patent Box came into effect on 1 April 2013. Under the scheme UK companies are able to pay a reduced rate of Corporation Tax on certain profits derived from patented technology. HM Revenue & Customs (HMRC) published its first report1 on the uptake of the scheme on 14 September 2016, and that report includes a number of notable statistics, which are discussed below. This article considers the published figures and considers their relevance in the wider context of Corporation Tax revenue.

It has taken a while The report details the number of companies benefiting from Patent Box and the extent to which they have done so in the first year of the scheme, namely the fiscal year 2013-142. More than two years have passed since the end of the fiscal year under consideration. Why has it taken HMRC such a long time to compile a report on the take-up of the scheme? The reason for the delay in reporting on that year’s Patent Box claims is as follows. Companies are able to notify HMRC that they wish to benefit from Patent Box within two years after the end of the accounting period in which the relevant profits arise3. This means that where a company’s fiscal year ended on 31 March 2014, it can file a Patent Box claim by 31 March 2016, which makes the delay understandable. However, if a company’s accounting year runs in parallel with the calendar year then for the year 2014, the first three months of which coincide with the last three months of the first year of Patent Box’s implementation, the company would be able to claim Patent Box relief until the end of 2016. For such companies it appears that the HMRC’s report may be premature, rather than late. One must conclude from the release of the report that HMRC believes that the majority of companies who intend to claim Patent Box relief for the 2013-14 fiscal year had done so by the time that the report was compiled. 18

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Timeline for the next report The report states4 that HMRC is considering if it will be feasible to publish provisional statistics gathered only one year after the end of the relevant fiscal year. This would mean that by autumn 2017 we should have sight of full figures for the 2014-15 fiscal year as well as provisional figures for the 201516 fiscal year. Presumably HMRC is confident that the bulk of the Patent Box claims will have been made within 12 months of the accounting period in which the relevant profits and income arise, reinforcing the final point made in the previous paragraph.

A drop in the ocean The total amount of Patent Box relief claimed by companies in 2013-14 was £342.9 million5. To put this into perspective, Corporation Tax receipts in 2013/14 were £39.6 billion6. This equates to around 115 times the value of the Patent Box relief. Of this £39.6 billion, £3.3 billion came from North Sea companies7, leaving £36.3 billion coming from other companies, equivalent to a multiple of 105 times the Patent Box relief.

A disappointing take-up When the scheme was first proposed, the Government undertook an impact assessment, in which it forecast that the fiscal impact of Patent Box would be £500m in the 2013-14 fiscal year8. Since the actual figure for claims was only 69% of the anticipated figure, this shows that take-up was lower than expected. In a similar vein, a mere 700 companies9 claimed Patent Box relief. This is a drop in the ocean when considering that 1,117,780 companies10 paid Corporation Tax in 2013/14. This means that only 1 in every 1,600 of the Corporation Tax paying companies took advantage of the Patent Box scheme. www.cipa.org.uk

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PATENT BOX

Company size and Patent Box Companies

Relief claimed under Patent Box

Company size

Number

Number as a percentage of total

Amount (£ million)

Amount as a percentage of total

Large

225

32.1%

327.2

95.4%

Medium

175

25.0%

11.8

3.4%

Small

170

24.3%

3.0

0.9%

Micro

120

17.1%

0.9

0.3%

Unknown

0.7%

0.1

0.0%

All

70011

100%

342.912

100%

Patent Box relief by industry sector Companies

Relief claimed under Patent Box

Industry Sector

Number

Number as a percentage of total

Amount (£ million)17

Amount as a percentage of total

Manufacturing

445

63.6%

216.9

63.3%

Construction

2.1%

–

Wholesale & Retail and Transport

115

16.4%

34.7

10.1%

Information & Communication, Financial & Insurance and Real Estate

3.6%

58.5

17.1%

Professional, Scientific & Technical

9.3%

21.6

6.3%

Admin & Support Services, Education, Health and Other

5.0%

–

All

700

100%

342.9

100%

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Whilst there is no doubt that the bulk of UK companies do not set out to be innovative are consequently unlikely to be eligible for the scheme, this nevertheless represents a further indicator of disappointing take-up.

Company size and Patent Box Below is a table showing the Patent Box relief data by company size. One eye-catching figure highlighted in the second Key Point13 of the report is that 95.4% (£327.2m) of the total Patent Box relief was claimed by 225 ‘large’ companies14 who made up 32.1% of the total number of Patent Box claiming companies. On the face of it this statistic looks surprisingly high, however, looks can sometimes be deceiving and one should not be taken aback by this figure. Simply put, larger companies have a higher revenue and pay more Corporation Tax than smaller companies. This

Breakdown of industries claiming Patent Box relief (number of companies19)

    

Manufacturing – 445 Wholesale & Retail and Transport – 115 Professional, Scientific & Technical – 65 Other – 50 Information & Communication, Financial & Insurance and Real Estate – 25

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PATENT BOX

can be seen from the Corporation Tax receipt figures for 2013/14 where the top 35.7% of liable companies paid 93.6% of Corporation Tax15. Hence in this respect the Patent Box figures are very much in line with the general Corporation Tax receipts16. In light of these figures and returning to the question of the amount of Patent Box relief claimed compared to the amount initially forecast by the Government, it is clear that the lower than anticipated overall claimed Patent Box relief came from fewer large companies making claims, or their claims being smaller than originally anticipated. Whilst around one-third of the companies claiming Patent Box relief were ‘large’, around one sixth of the companies (120 companies) were ‘micro’ entities, i.e., had nine or less employees. It is encouraging that the benefits of Patent Box are being enjoyed by companies of such a small size.

Amount claimed by each industry (£ million)

    

Manufacturing – £216.9m Wholesale & Retail and Transport – £34.7m Professional, Scientific & Technical – £21.6m Other – £10.9m Information & Communication, Financial & Insurance and Real Estate – £58.5m

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PATENT BOX

Break-even point for claiming Patent Box relief?

Patent Box relief by Industry Sector

The average amount of Patent Box relief claimed by small and micro-sized companies was £17.6k and £7.5k respectively. There is a direct cost involved in qualifying for Patent Box relief, namely the cost of applying for, obtaining and maintaining a patent. An argument presented in favour of pursuing Patent Box relief is that if the benefit received over the life of the patent is greater than the cost of obtaining and maintaining a qualifying patent then it makes financial sense to take advantage of the scheme. Since on a simple level an annual benefit of £7.5k equates to a benefit of £75k if the patented product has a life of ten years and double that if it is maintained for its full term, it can be surmised that the threshold for choosing to pursue Patent Box relief requires a clear financial benefit beyond the argument referred to above.

Section 3.2 of the report provides a breakdown of how companies in different industries have claimed patent box relief, as shown in the table “Patent Box relief by Industry Sector “ on page 19. Some industry sectors have been combined together to avoid disclosure of confidential information, but the way in which these industries have been combined is arguably unsatisfactory. In addition, the grouping of industries makes it difficult to compare the Patent Box relief data with a breakdown of Corporation Tax data available for these sectors18. In the future if more companies claim Patent Box relief then this should reduce the need to anonymise data and allow a finer breakdown of industry sectors. The industry data can be shown graphically, where the Construction and Admin & Support Services, etc. industries have been combined as ‘other’.

Company size and Patent Box Companies Region

Number19

Relief claimed under Patent Box

Number as a percentage of total

Amount (£ million)

Amount as a percentage of total

North East

2.9%

1.6

0.5%

North West

7.9%

3.3

1.0%

Yorkshire & Humberside

10.7%

28.6

8.3%

East Midlands

7.9%

22.4

6.5%

West Midlands

11.4%

14.2

4.1%

East of England

12.9%

28.82

8.4%

London

10.0%

196.8

57.4%

South East

115

16.4%

18.6

5.4%

South West

9.3%

12.0

3.5%

Scotland

5.0%

9.7

2.8%

Wales

2.9%

4.8

1.4%

Northern Ireland

2.1%

2.0

0.6%

700

100%

342.9

All

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PATENT BOX

Patent Box relief by region Number of companies19 and amount claimed by region (with the amount as the percentage of the total)

Scotland

companies: 35 (5.0%) amount: £9.7m (2.8%)

North East Northern Ireland

companies: 20 (2.9%) amount: £1.6m (0.5%)

companies: 15 (2.1%) amount: £2.0m (0.6%)

Yorkshire & Humberside

companies: 75 (10.7%) amount: £28.6m (8.3%)

North West

companies: 55 (7.9%) amount: £3.3m (1.0%)

West Midlands

companies: 80 (11.4%) amount: £14.2m (4.1%)

Wales

companies: 20 (2.9%) amount: £4.8m (1.4%)

South West

companies: 65 (9.3%) amount: £12.0m (3.5%)

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East Midlands

companies: 55 (7.9%) amount: £22.4m (6.5%)

East of England

companies: 90 (12.9%) amount: £28.8m (8.4%)

London

companies: 70 (10.0%) amount: £196.8m (57.4%)

South East

companies: 115 (16.4%) amount: £18.6m (5.4%)

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The charts on pages 20 and 21 show the amount claimed by each industry. When comparing these charts one striking feature is the relatively larger amount of Patent Box relief claimed by companies in the Information & Communication, Financial & Insurance and Real Estate industries sectors. This equates to an average Patent Box relief of £218k per company in this sector.

Patent Box relief by region Section 3.3 of the report provides a breakdown of how companies in different regions claimed patent box relief. This regional data is shown in the table on page 21 and opposite. The regional data can be shown graphically as set out on page 20. What is apparent from these graphs and figures is that the amount claimed by the 70 London-based companies makes up the majority (57.4%) of the claimed Patent Box relief. In this regard the report notes that the regional distribution data is skewed, since companies can have a single address for tax purposes (for example, a headquarters’ location) even though they may have operations across the UK.

Notes and references

PATENT BOX

It is of note that across the North East, Scotland, Wales and Northern Ireland only around 90 companies claimed Patent Box relief.

Conclusion The report provides a window onto the take-up of Patent Box relief in the first year of its introduction. However the need to anonymise some data has made that window more obscure than would be desirable. One thing that is clear from the report is the number of companies benefitting from Patent Box is disappointing. Whilst it is natural for there to be a slow adoption of a new tax scheme, factors such as the drop in the main Corporation Tax rate20 and the introduction of a more restrictive revised Patent Box scheme21 are disincentives to the uptake of the scheme which should be countered by increased Government action to encourage the uptake of Patent Box. Michael D. Jaeger (Fellow) is a partner at Withers & Rogers LLP.

14. Company size is based on the EU Enterprise Size Classification as follows: Size Turnover Classification (€ million)

Total assets (€ million)

Number of employees

Micro

2. The period from 1 April 2013 to 31 March 2014.

Small

3. “Statistics on uptake of the Patent Box” (see footnote 1), s.2 (page 4)

Medium

249

4. ibid.

Large

> 50

> 43

250+

1. “Statistics on uptake of the Patent Box”, https://www.gov.uk/government/ uploads/system/uploads/attachment_data/file/552641/Sep2016_201314_ PB_Official_Statistics.pdf

5. ibid. s.2.1, key point 2 6. “Corporation Tax Statistics”, HMRC, Released 31 August 2016, page 11 https://www.gov.uk/government/uploads/system/uploads/attachment_ data/file/548398/Corporation_Tax_Statistics_August_2016_FINAL.pdf 7. ibid. Table 11.1B (page 22) 8. Budget 2011, HM Treasury, Table 2.2, line bu (page 46) http://webarchive. nationalarchives.gov.uk/20130129110402/http:/cdn.hm-treasury.gov. uk/2011budget_complete.pdf 9. “Statistics on uptake of the Patent Box” (see footnote 1), s.2.1, key point 1 (page 4) 10. “Corporation Tax Statistics” (see footnote 6), Table 11.6 (page 35) 11. The total number of companies in the cells above the ‘All’ row comes to 695, not 700. This is because the numbers of companies claiming the relief have been rounded to the nearest five.

To be classified as a certain size, a company must meet the Employee limit and one or other of the Turnover and Total assets limits. 15. “Corporation Tax Statistics” (see footnote 6), Table 11.6 (page 35). Considering companies paying Corporation Tax in excess of £10k. 16. Note that there is not a direct equivalence between the figures in the two reports, since the “Statistics on uptake of the Patent Box” figures are based on company size as defined in Footnote 14 and the figures taken from the “Corporation Tax Statistics” report are based on the amount of tax paid by companies. Nevertheless, the principle of the bulk of Corporation Tax is paid by a minority of companies is still true. 17. The amount of relief claimed by the Construction and Admin & Support industries has not be disclosed in order to meet confidentiality requirements. However, it can be derived that the 50 companies claiming relief in this sector claimed a total of £10.9 million. 18. Table 11.7 (page 38) of “Corporation Tax Statistics” (see footnote 6).

12. The total amount of relief claimed in the cells above the ‘All’ row comes to £343 million, not £342.9. This is because the relief has been rounded to the nearest £100,000.

19. Rounded to the nearest five.

13. “Statistics on uptake of the Patent Box” (see footnote 1), s.2.1, key point 2 (page 4)

21. https://hansard.parliament.uk/lords/2016-09-15/debates/16091542000344/ RoyalAssent

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Human embryonic stem cells EPO Practice Update: Inventions Concerning Human Embryonic Stem Cells. By Alex Bajjon and George Schlich

he EPO has recently updated their Internal Guidance to Examiners regarding the patentability of inventions relating to the use of human embryonic stem cells. There has been and will be, however, no formal announcement. Subtle media releases are not new, of course. Tech giant Google® is well known for ‘soft’ launch of its products: there is no fanfare heralding release of its latest app, it just arrives and news gets around; you pick it up on social media or second hand from your 11-year old child. Enlightened by this tech vernacular the EPO stem cell practice change has just happened and the news is gently disseminating: a new, morally acceptable source of human embryonic stem cells has now been identified, and can be referred to in patent applications relating to this subject-matter with an effective filing date on or after 5 June 2003 to avoid an objection of lack of morality under Article 53(a) EPC.

Background Article 6(2) of the EU Biotech Directive excludes uses of human embryos for industrial or commercial purposes from patentability1. This exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it (Recital 42 of that Directive). The boundaries of the subject-matter falling within the scope of this article and the definition of ‘human embryos’ have, however, been widely debated. In December 2014, the CJEU decided that human parthenotes (non-fertilised human ova stimulated by parthenogenesis) are not human embryos within the meaning of Article 6(2) of the EU Biotech Directive because they are incapable of commencing the process of development into a human being2. Obtaining human embryonic stem cells from these parthenotes necessarily avoids destruction of a human embryo. 24 CIPA JOURNAL

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In a previous article3, we noted that a source of morally acceptable pluripotent stem cells was therefore arguably disclosed as early as November 2005 by Mina Alikani4. We anticipated that European patent applications relating to human embryonic stem cells with an effective filing date of November 2005 or later would not be excluded from patentability under Article 53(a) EPC.

Updated practice As noted above, following Decision C-364/13 the EPO has updated their Internal Guidance to Examiners relating to inventions concerning human embryonic stem cells, although this guidance does not appear to have been formally publicised to applicants and representatives. Thus, if the news has not yet reached you: patent applications relating to human embryonic stem cells with an effective filing date of 5 June 2003 or later should no longer be excluded from patentability under Article 53(a) EPC. This means that some applications which have struggled to overcome Article 53(a) objections, provided they were filed on or after 5 June 2003, may now proceed to allowance. The updated EPO approach can be seen in T 2365/13 (31 May 2016) relating to European Patent Application No. 0688713.9. In this case, the Board referred the case back to the Examining Division to order a Rule 71(3) communication be issued in light of the new practice. The Examining Division acknowledged International application WO 2003/046141, which has a publication date of 5 June 2003, as the earliest public enabling disclosure of human parthenote-derived pluripotent stem cells. As production of these cells does not involve the use of human embryos, according to CJEU judgement C 364/13, this publication was accepted as the earliest enabling disclosure of human pluripotent stem cells acceptable under Article 53(a) EPC. The patent application www.cipa.org.uk

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the subject of T 2365/13 had a priority date of 30 November 2005 and hence the objection under Article 53(a) EPC was withdrawn.

Conclusions For those who have been prosecuting applications before the EPO relating to human embryonic stem cells, or cells derived therefrom, this will be a welcome development and may mean that the fight for the patentability of those cases is over. This earlier date of 5 June 2003 for the availability of morally acceptable sources of human embryonic stem cells means that the Article 53(a) objections can no longer be raised against any stem cell applications cells that our firm is handling. If any readers have, nevertheless, human embryonic stem cell cases which predate 5 June 2003, we would be happy to discuss possible approaches for dealing with any Article 53(a) issues. There is the possibility, for example, that an even earlier date could be established if it can be shown that parthenotes

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could be obtained without using human embryos before June 2003. As discussed in our January 2015 article, it is arguable that there was a source of human embryonic stem cells acceptable within the provisions of the EU Biotech Directive that was available as early as September 2001. Alex Bajjon (Student) and George Schlich (Fellow), Schlich Ltd – www.schlich.co.uk

References 1. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions 2. CJEU Decision C-364/13 (18 December 2014) 3. January [2015] CIPA 27, “Parthenotes are an acceptable source of human embryonic stem cells” 4. Alikani and Munné, Stem Cell Rev. 2005 Dec; 1(4):337–43.

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Swiss-form claims A step nearer to construction infringement and relief?

On 13 October 2016 the Court of Appeal handed down the latest judgment in the long and hard-fought battle between Warner-Lambert and Actavis (and others) in connection with Warner-Lambert’s second medical use patent protection for its blockbuster drug, Lyrica (pregabalin) [2016] EWCA Civ 1006. Maeve Lynch and Rebecca Lawrence of Redd examine the infringement aspects of the Court of Appeal’s judgment, which arguably sets a low bar for infringement of Swiss-form claims in the UK and suggests the need for a new approach to damages in these cases.

he Court of Appeal took the opportunity to issue further guidance on the infringement of Swiss-form claims, following reservations expressed by Arnold J about the Court of Appeal’s interim judgment on the infringement issues in these proceedings. It reiterated that the infringement test is an objective one which primarily concerns what a manufacturer can foresee about the intentional use by others of its product, adding that any objective intent on the part of a manufacturer to infringe a Swiss-form claim can be ‘negatived’ by taking “all reasonable steps within [its] power to prevent the consequences occurring”. Further, contrary to what Arnold J held at first instance, the Court of Appeal held that a pharmacist could be liable for indirect infringement if his or her preparation of the medicament is done with the necessary intention. Finally, obiter comments made by the Court of Appeal suggest that in cases such as these, the balance between protecting a patentee’s rights and the right of a generic to supply a non-patented market may require a novel approach to damages for infringement.

The story so far Although this case is likely to be familiar to many readers, we start with a quick reminder of the case to date. Pregabalin is made and sold by Warner-Lambert under the brand name ‘Lyrica’ and is licensed for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder. Patent protection for the pregabalin compound expired on 13 May 2013. However, another of Warner-Lambert’s European patents (EP (UK) 0 934 061) has Swiss-form claims to the use of pregabalin for the preparation of a pharmaceutical composition for treating pain, neuropathic pain and a number of other pain sub-types. On 8 December 2014, Warner-Lambert applied for an interim injunction prohibiting Actavis’ planned launch of its pregabalin product, which omitted the neuropathic pain indication from 26 CIPA JOURNAL

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its product information leaflet – a so-called ‘skinny label’ product. One of the key questions in these proceedings has been how generics can supply the non-patented market, as they should be entitled to do, whilst avoiding infringement of Swiss-form claims covering the patented market. The prescribing system in the UK discourages doctors from prescribing by brand name and pharmacists generally do not know what indication a drug is prescribed for. Consequently, unless doctors are given specific guidance to prescribe by brand name for a patented indication, so that the brand name appears on a prescription and must therefore be dispensed by the pharmacist, it is inevitable that a generic drug which is intended to be supplied to a non-patented market will also supplied to the patented market, even if that is not what the generic company intends. Warner-Lambert’s injunction application was refused, although Arnold J recognised that this case presented unusual difficulties. Arnold J granted a novel form of interim relief, in the form of an order instructing the NHS to issue guidance to doctors that Warner-Lambert’s Lyrica (rather than generic pregabalin) should be prescribed for the treatment of neuropathic pain. The guidance was intended to preserve Warner-Lambert’s position in the market whilst the infringement issues were determined at trial. Warner-Lambert appealed against Arnold J’s refusal to grant an interim injunction. In its judgment (the “Interim Court of Appeal Judgment”), the Court of Appeal disagreed (obiter) with Arnold J’s approach to direct and indirect infringement, prescribing an objective infringement test. At the subsequent trial, Arnold J struggled to apply the Court of Appeal’s obiter guidance, particularly in the case of indirect infringement, and reached a finding of non-infringement.

The Court of Appeal judgment Although it was not necessary for the Court of Appeal to make a ruling on infringement in its latest judgment (due to a finding of invalidity), it nevertheless took the opportunity to clarify the position on the construction of Swiss-form claims and the infringement tests to be applied, in the light of reservations expressed by Arnold J about the Interim Court of Appeal judgment and further developments in other jurisdictions. Floyd LJ noted that a uniform approach to the construction of Swiss-form claims had not yet emerged amongst EPC member states. The Spanish courts look for an express authorisation or encouragement to use the drug in question to treat the patented indication. Similarly, the German courts require there to be some express reference to the patented indication on the product packaging itself (but not advertising) in order to fall within the scope of such a claim. Floyd LJ considered that although this approach benefited from simplicity, it did not afford the Volume 45, number 12

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patentee adequate protection. Floyd LJ favoured the opposite approach, as taken by the French tribunal de grande instance (in the Sandoz case), where in order to escape liability for infringement, a generic manufacturer marketing a ‘skinny label’ product must take positive steps to discourage use of that product to treat a patented indication. Floyd LJ rejected Actavis’ submissions that a subjective test, requiring the generic to “aim” for or “target” the patented indication, should apply. He reiterated that the objective test that he set out in the Interim Court of Appeal Judgment was correct and the question is whether it is known or foreseeable that the drug will intentionally be used for the patented indication. However, drawing on the approach of the French courts, Floyd LJ elaborated on this test and held that an objective intention on the part of a generic could be ‘negatived’ where the manufacturer has: “taken all reasonable steps within his power to prevent the consequences occurring”. In such circumstances, a generic could say that: “the foreseen consequences were not intended, but were an unintended incident of [its] otherwise lawful activity”. Although Floyd LJ made it clear that marketing a drug under a ‘skinny label’ would not, of itself, be enough to negative an objective intention to infringe a Swiss-form claim, he did not provide guidance on what positive steps a ‘skinny label’ manufacturer should take in order to avoid infringement. The ‘objective’ infringement test set out in the Interim Court of Appeal judgment required assessment of the intention of the generic manufacturer by reference to what it could foresee about the intention of other participants in the relevant process, namely doctors and pharmacists. As regards the intention of those participants, Arnold J held at first instance that: 1. As a doctor would not know whether a pharmacist would dispense a particular generic manufacturer’s drug (as opposed to Warner-Lambert’s Lyrica or some other generic manufacturer’s pregabalin) there could be no infringement because the intention of the generic manufacturer had to relate to its particular product. 2. Ordinarily, pharmacists do not know which indication pregabalin has been prescribed for, in which case they cannot intend to dispense generic pregabalin for a patented indication (save for a small number of cases in which a pharmacist dispenses pregabalin in the knowledge that it will be used to treat pain, which Arnold J regarded as de minimis). On this basis, Arnold J decided that had claims 1 and 3 been valid, Actavis would not have infringed them because Actavis could not foresee intentional use of its own pregabalin product by doctors and pharmacists. Floyd LJ held that Arnold J should not have dissected the requirement for the intentional treatment of pain in the DECEMBER 2016

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way that he did. The key question is whether the manufacturer foresees intentional use of at least some of its product for the patented indication. This seems to be quite a low bar. Interestingly, Floyd LJ went on to say that: “intentional use is to be distinguished from use where the drug is prescribed for a different indication and, without it in any sensae being the intention of the treatment, a pain condition is in fact treated”. On the question of indirect infringement, in the Interim Court of Appeal Judgment Floyd LJ decided that it was arguable that indirect infringement may arise where pregabalin is manufactured by one person and supplied to another who intentionally uses it to treat pain. When the matter came to trial, Arnold J disagreed with Floyd LJ’s reasoning and decided that because Swiss-form claims are claims to processes of manufacture, there can be no indirect infringement in the circumstances of the case because there is no act of ‘downstream’ manufacturing by any person other than the generic manufacturer. In the latest Court of Appeal judgment, Floyd LJ cautioned against the “danger in translating section 60(2) into a requirement for a ‘downstream act of manufacture’”. He agreed with Warner-Lambert’s submission that a pharmacist could be liable for indirect infringement by applying a label to a product which refers to pain, although “this was not the only way” of putting the claimed process into effect and he was:

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The Court of Appeal held that a pharmacist could be liable for indirect infringement if his or her preparation of the medicament is done with the necessary intention.

“unable to understand why other acts of the pharmacist in preparing the composition for delivery to the patient cannot also be regarded as relevant acts of preparation, if done with the necessary intention”.

Discussion The Court of Appeal was seeking to achieve a fair balance between protecting the rights of the patentee and facilitating the supply of the non-patented market by third parties. However, the Court of Appeal’s broad brush guidance does not give generics any certainty that they can avoid infringement in circumstances identical or similar to this case. Aside from stating that marketing under a skinny label is not, of itself, enough to avoid infringement, the Court of Appeal did not provide any specific guidance on what positive steps might be enough to ‘negative’ an objective intention to infringe. For example, would writing to clinicians be sufficient or must a generic, for example, state on its label that a product is not to be used to treat the patented indication(s)? Similarly, if the NHS is under an obligation to advise doctors to prescribe a branded product for a patented indication (as it was in this case), what positive steps, if any, is it necessary for a generic to take in these circumstances? Does it depend on whether the guidance

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is effective and, if so, how effective does it need to be? Unless more detailed guidance is issued by the Supreme Court, these questions will remain unresolved for the time being. In any event, even with guidance, future cases may turn on very specific facts making it very difficult for generics to assess what (if anything) they can do to avoid infringement. Interestingly, Floyd LJ stated that: “The solution adopted by this court in Warner-Lambert CoA was an attempt to strike the right balance by not placing insuperable obstacles in the path of the patentee, whilst at the same time recognising in very clear terms that the remedies available for infringement will have to be moulded so as to achieve fair and proportionate relief tailored to the very special circumstances of this type of case”. This may be an acknowledgement that in cases such as these, it is very difficult for a generic to avoid a finding of infringement. As Actavis argued in these proceedings, a finding of infringement has the consequence that all of the products supplied by the generic are technically infringing despite the fact that only a subset of those products are ultimately used to treat the patented indication. In these circumstances, it would seem unfair to calculate damages based on all sales of the infringing product. However, if the Court of Appeal is advocating an approach where the balance between protecting the patentee’s rights and a generic’s right to supply a non-patented market is achieved by formulating a novel approach to damages, it is not at all clear how that approach would work. Presumably, the generic company would need to account to the patentee for a certain proportion of its sales, but it is impossible to say at present how that would be assessed. This, of course, creates further uncertainty for generics, and makes it impossible for them to gauge the potential damages exposure associated with the launch of a ‘skinny label’ product. The Court of Appeal finding that the scope of a Swissform claim includes acts of “preparation” of a medicament, if done with the necessary intention, exposes pharmacists to a risk of indirect infringement. However, in practice, it may be difficult for a patentee to show that a pharmacist had the relevant intention to infringe. Interestingly, Floyd LJ did not mention the position of doctors. Since the claims alleged to be infringed covered the “preparation of a pharmaceutical composition for treating pain”, it is difficult to see how a doctor, who merely issues a prescription for a drug, could be involved in such an act of preparation. Nonetheless, the position is not entirely clear and doctors may have reason for concern. It will be interesting to see whether the perceived risk brings about any cautionary change in prescribing and dispensing practices. For example, in the case of patients Volume 45, number 12

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suffering from both pain and generalised anxiety disorder or epilepsy, to avoid the risk of indirect infringement (if such a risk exists), should a doctor expressly record the fact that the medicament is primarily being used to treat a non-patented indication and any treatment of the patented indication is unintended? Changes in prescribing and dispensing practices could also have an impact on the assessment of the damages due to their potential effect on how much generic pregabalin might be dispensed for a patented indication. If the Supreme Court declines to hear an appeal in this case, these particular proceedings will be final and we will need to await further proceedings before any further clarity can be obtained. In any event, perhaps the most satisfactory solution would be a legislative change – one which has been thoroughly debated by Parliament and which has taken into account the interests of all of the relevant players, including patentees, generic companies, the NHS, doctors, pharmacists and patients. However, it would be surprising if these issues reached the top of the UK government’s list in these politically tumultuous times. Maeve Lynch is a solicitor and senior associate and Rebecca Lawrence is a solicitor and consultant at Redd Solicitors LLP (see-redd.com)

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Patent decisions Sufficiency | Abuse of process | Infringement Warner-Lambert Company LLC v (1) Generics (UK) Limited (trading as Mylan), (2) Actavis Group PTC EHF, (3) Actavis UK Limited, (4) Caduceus Pharma Limited [2016] EWCA Civ 1006 13 October 2016 Patten LJ, Kitchin LJ and Floyd LJ [Also see pages 2 and 26.]

This is a decision from the Court of Appeal following various appeals against the judgments of Arnold J of 10 September 2016 ([2015] EWHC 2548 (Pat)), reported November [2015] CIPA 41 (“the main judgment”) and 25 November 2015 ([2015] EWHC 3370 (Pat)), reported January [2016] CIPA 38 (“the abuse judgment”). The lead judgment was given by Floyd LJ, with the other judges being in agreement. The judgments related to European Patent (UK) No. 0934061, which was directed towards the use of pregabalin for the treatment of pain. At first instance in the main judgment, Arnold J found that claims 1, 3, 4, 6, 13 and 14 were invalid for lack of sufficiency. The judge also found that even if claims 1 and 3 had been valid, Actavis would not have infringed those claims under section 60(1)(c) or section 60(2) of the 1977 Patents Act. The judge did find that the claims were inventive and this aspect of the judgment was not appealed. Warner-Lambert subsequently made a conditional application to amend the patent. However, Arnold J decided that this application constituted an abuse of procedure in the abuse judgment. Both Mylan and Actavis on the one hand and WarnerLambert on the other appealed against the decision on insufficiency. Warner-Lambert additionally appealed against the decision on infringement and the subsequent abuse of procedure point.

Insufficiency The claims were in the “Swiss form” of second medical use claims. Claim 1 was directed towards the treatment of pain, with the dependent claims being directed towards specific types of pain. Claim 3 was directed towards the treatment of neuropathic pain. At first instance, Arnold J considered that the claim covered both peripheral neuropathic pain 30 CIPA JOURNAL

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and central neuropathic pain and that whilst the data in the specification made it plausible that pregabalin would be effective to treat peripheral neuropathic pain, it was not plausible that it would be effective to treat neuropathic pain. Warner-Lambert raised objections to the judge’s finding of insufficiency for claim 3 in a number of ways. Warner-Lambert argued that Arnold J had erred in his findings in relation to common general knowledge. In particular, Warner-Lambert objected to the judge’s division of neuropathic pain into peripheral and central neuropathic pain when considering central sensitisation. However, Floyd LJ did not find any reason to depart from Arnold J’s view on common general knowledge. Warner-Lambert also objected to the construction of the claims. In particular, objection was raised against the construction of claim 3 as covering both peripheral and central neuropathic pain and not just peripheral neuropathic pain. Floyd LJ considered that it was unlikely that the skilled reader would adopt a narrow interpretation of neuropathic pain to exclude central neuropathic pain, noting that the skilled person would observe that the patentee was making very broad claims as to the efficacy of pregabalin for treating pain of all kinds. Warner-Lambert argued that claim 3 was sufficient for a variety of reasons. Of note was the argument that if the judge had looked at the claims from the perspective of the clinician, he would have seen a unifying principle across the whole of the claim from hyperalgesia and allodynia (types of sensitivity to pain). However, Floyd LJ considered that the argument of the unifying principle was not made part of Warner-Lambert’s case at a sufficiently early stage. Floyd LJ therefore rejected Warner-Lambert’s challenge to claim 3 being found insufficient. Mylan and Actavis argued that the patent made no plausible claim that pregabalin was effective to treat neuropathic pain at all. However, agreeing with Arnold J that there was a sufficient unifying principle between inflammatory pain and peripheral neuropathic pain, Floyd J considered that the skilled person would understand that pregabalin might be effective for peripheral neuropathic pain. Therefore, he also rejected this challenge to the judge’s reasoning.

Abuse of process Floyd LJ considered whether the judge was correct to deny Warner-Lambert the opportunity to amend claim 3 to subject-matter that the judge considered inventive and rendered plausible. Warner-Lambert raised a number of reasons why the judge was incorrect in the first instance. Floyd LJ considered that only two made the case a potential candidate for allowing post-judgment amendment, namely: www.cipa.org.uk

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a. the fact that the subject-matter of the proposed claim is or may be already the subject of a finding in the main judgment; or b. the extent to which the procedural history hampered Warner-Lambert from formulating the amendment earlier. Floyd LJ considered that the amendment gave WarnerLambert an alternative route to a successful outcome which was not dependent on winning the construction argument. It was unfair to Mylan and Actavis to treat a case where only the construction point was in play to one in which an amendment was also in play, the judge noting that Mylan and Actavis may have refocused their attacks in the latter case. Therefore, Floyd LJ considered the amendment sought involved an abuse of process unless Warner-Lambert could demonstrate a good reason for not raising it at trial. The judge then considered that although WarnerLambert were slow to appreciate the significance of Mylan and Actavis’ point on central neuropathic pain: “What was plainly necessary was for Warner-Lambert to indicate, no later than the commencement of the trial, that in the event of an adverse finding on the sufficiency of claim 3, it would seek to amend. They plainly could have done so. If they had done so it would have been necessary for the court to decide how to case manage the situation which then arose. There would have been a range of options open, but the court is in the highest degree unlikely to have countenanced the possibility of a second trial raising issues of sufficiency and requiring the same witnesses to be recalled. I therefore do not consider that there is any basis for this court to interfere with the judge’s evaluation on the issue of abuse of process.”

Infringement Warner-Lambert relied on claims 1 and 3 for the purposes of its claim of infringement. As these claims were found invalid and Arnold J’s ruling that Waner-Lambert should not be permitted to apply for a validating amendment of claim 3, Floyd J also found the infringement claim to fail. However, he considered that it was necessary to look further at the issue. This followed Arnold J’s reservations

PATENTS: UK

of the conclusion reached in relation to interpretation of Swiss-form claims in the earlier appeal decision in these proceedings ([2015] EWCA Civ 556), reported July [2015] CIPA 42 (“Warner-Lambert CoA”). Floyd LJ considered the construction of Swiss-form claims following Arnold J’s reservations and the further developments in the law of other states and the EPO. He also dealt with the arguments of the Secretary of State for Health, present as an intervener. He further considered the complaint of Warner-Lambert that Arnold J has not correctly applied the law of WarnerLambert CoA and the issue of indirect infringement. The judge noted that the issue was one of great complexity and the solution adopted by the court in Warner-Lambert CoA was: “an attempt to strike the right balance by not placing insuperable obstacles in the path of the patentee, whilst at the same time recognising in very clear terms that the remedies available for infringement will have to be moulded so as to achieve fair and proportionate relief tailored to the very special circumstances of this type of case.” On consideration of Arnold J’s reservations, the submissions of the Secretary of State and the relevant additional law, he considered that the test proposed in Warner-Lambert CoA was correct, requiring the manufacturer to take all reasonable steps within its power to prevent use of a compound for the patented treatment. On that basis, Floyd LJ considered that Arnold J fell into error in the manner in which he dissected the requirement for intentional treatment pain into the state of mind of each of the doctor, the pharmacist and the patient. In addition, Floyd LJ disagreed with Arnold J’s reasoning in relation to indirect infringement. He took the view that the process of preparation of a pharmaceutical composition can continue through any packaging step, including the labelling step performed by the pharmacist. Therefore, he considered that there were acts of pharmacists which could be relevant downstream acts under section 60(2). However, he did not comment on whether in this case the judge was correct to reach the conclusion of non-infringement. The appeals of both parties were therefore dismissed.

The UK patent court case reports are prepared by Jonathan Markham, Anna Hatt, Matthew Ng and Sarah-Jane Poingdestre of Beck Greener. All the court decisions listed in this section are available on the free-to-use website www.bailii.org.

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IPO decisions Correction of irregularities – Rule 107 Fisher-Rosemount Systems, Inc. BL O/490/16 21 October 2016 During examination of two related applications, the examiner maintained that the claimed inventions were excluded from patentability under section 1(2) as a program for a computer and/or the presentation of information. At the subsequent hearing, the hearing officer noted an issue with the compliance date of one of the applications, which had expired prior to the hearing. The applicant was warned by the IPO that an as-ofright two-month extension could be obtained retrospectively under rule 108(2) by filing a Form 52. An email was later sent by the IPO advising that the period for requesting the extension had expired, but that a late filing of the form would be accepted providing adequate reasons were provided, such as the forthcoming hearing. A Form 52 and letter setting out the reasons were received from the applicant the same day.

PATENTS: UK IPO

The hearing officer considered that the offer by the IPO to accept a late filing was made in error and was ultra vires, following the decision in BL O/238/12 in relation to the same applicant. However, since the case had not been flagged as an urgent case nearing the end of its compliance period as it ought to have been, this was an irregularity that could have resulted in late filing of a Form 52. The hearing officer therefore authorised the compliance period to be extended under rule 107 to allow the request for an extension under rule 108 to have been made in time. The hearing officer considered the question of whether the inventions were patentable and determined that both inventions were excluded under section 1(2). The applications were refused.

Patent decisions of the comptroller can be found on the IPO website via http://bit.ly/ipodecisions, and opinions issued under section 74A via http://bit.ly/opinion-requests. This month’s contributors were David Pearce and Callum Docherty of Barker Brettell LLP.

UK signals green light to Unified Patent Court Agreement IPO press release – 28 November 2016. See https://www.gov.uk/government/news/uk-signals-green-light-to-unified-patent-court-agreement

The UK Government has confirmed it is proceeding with preparations to ratify the Unified Patent Court Agreement (UPCA). This is part of the process needed to realise the Unitary Patent and Unified Patent Court. Under the new regime, businesses will be able to protect and enforce their patent rights across Europe in a more streamlined way – with a single patent and through a single patent court. The court will make it easier for British businesses to protect their ideas and inventions from being illegally copied by companies in other countries. UK Minister of State for Intellectual Property, Baroness Neville Rolfe said:

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"The new system will provide an option for businesses that need to protect their inventions across Europe. The UK has been working with partners in Europe to develop this option. As the Prime Minister has said, for as long as we are members of the EU, the UK will continue to play a full and active role. We will seek the best deal possible as we negotiate a new agreement with the European Union. We want that deal to reflect the kind of mature, cooperative relationship that close friends and allies enjoy. We want it to involve free trade, in goods and services. We want it to give British companies the

maximum freedom to trade with and operate in the Single Market – and let European businesses do the same in the UK. But the decision to proceed with ratification should not be seen as pre-empting the UK's objectives or position in the forthcoming negotiations with the EU." Following the announcement today, the UK will continue with preparations for ratification over the coming months. It will be working with the Preparatory Committee to bring the UPC into operation as soon as possible.

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EPO decisions Partiality – Article 24 T 1647/15: Nooteboom Group B.V. / Trailer having pivoted axles and a central recess TBA decision of 24 June 2016 Chairman: G. Pricolo Members: Y. Lemblé and P. Guntz This was an appeal by the patentee and the three opponents following the Opposition Division’s decision to maintain a patent, concerned with a trailer having pivoted axles and a central recess, in its amended form. The most significant point arising from the decision relates to the question of partiality on the part of the Chairman of the Opposition Division. In the oral hearing at the first instance, upon repeated interruption by the representative of opponent III, the Chairman said to the representative “Shut your mouth” and “Don’t talk anymore”. All three opponents requested that the decision of the Opposition Division be set aside due to bias shown by the Chairman against the representative for Opponent III. The Opponents further argued that, under Article 24(3) EPC, there had been a fundamental procedural violation by the Opposition Division in rejecting the partiality objection at the oral hearing. In addition, the opponents alleged a violation of their right to be heard regarding the Opposition Division’s rejection of their request to inspect the objects of the prior use argument in the case. The opponents requested the remittance of the case back to the Opposition Division. The TBA agreed with the opponents that the outburst of the Chairman was such that, to the mind of an objective observer, the Chairman’s ability to assess the arguments of Opponent III’s representative without partiality may be affected. The TBA therefore set aside the decision. However, the TBA did not think that the Opposition Division had committed a substantial procedural violation in rejecting the opponents’ objection. Article 24(3) EPC applies only to the members of the Board of Appeal and the Enlarged Board of Appeal (G 5/91). Since the proceedings in front of the Opposition Division are not judicial in nature, but rather administrative, and in line with the decision in T 1028/96, the original board composition (including the Chairman about whom the complaint was made) was competent to decide on the partiality objection. Additionally, the TBA did not think the case should be remitted to the first instance as the Opposition Division had already decided on a large number of the points in issue before the Chairman’s outburst. The TBA used its powers under Article 111(1) EPC together with Article 11 RPBA to decide the case itself. Arguments were also made in relation to admissibility of an auxiliary request (numbered 5A), added matter, clarity, novelty and inventive step. The TBA considered each of the Volume 45, number 12

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arguments set out by the parties and decided to remit the case to the department of the first instance with the order to maintain the patent in its amended form as set out in auxiliary request 5A, and with an addition to the description. The TBA did, however, reimburse the appeal fees of the opponents.

Inventive step – Article 56 EPC T 2517/11: Orange / Codage / decodage par transformee, a fenetres adaptives TBA decision of 12 October 2016 Chairman: G. Assi Members: P. Fontenay and J. Geschwind This was an appeal by the applicant following the Examining Division’s refusal to grant a patent concerned with coding/ decoding a digital signal using a transform with adaptative windows. The Examining Division considered that the subjectmatter of the independent claims of the main and auxiliary requests lacked of inventive step pursuant to Article 56 EPC. An interesting point arising from the decision concerns the existence of a “hidden feature”, defined by the TBA as a technical feature implicitly included in a prior art document, the existence of which could not be established by the mere reading of such a document. According to the appellant, the Examining Division’s refusal to grant the patent based on the identification of a hidden feature in a prior art document was erroneous, as such a hidden feature could only be revealed by a mathematical analysis and the person skilled in the art did not have any objective reason to establish the existence of such a feature. The TBA disagreed with the appellant, considering that the Examining Division’s mathematical reasoning established that the feature was indeed available to the person skilled in the art. The TBA referred to the Enlarged Board of Appeal’s decision of 18 December 1992 (G 1/92), which ruled that according to Article 54(2) EPC, the state of the art comprises everything made available to the public and that specific information is considered available when it is directly and unambiguously available – whether or not there is any reason to look for such specific information is therefore irrelevant. The TBA further specified that according to the problem-solution approach developed by the EPO, all technical features of a prior art document should be considered, including features that can be directly identified as well as features that are hidden, provided those hidden features are nevertheless available. After reviewing the prior art, the TBA considered that the coding method sought to be patented was inventive pursuant to Article 56 EPC as it would not have been obvious to the person skilled in the art. The TBA overruled the Examining Division’s decision and referred the case back to the Examining Division in order for the patent to be granted. DECEMBER 2016

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Disclaimers | Added matter – Article 123(2) T 437/14: Trustees of Princeton University / Complexes of form L2IrX. TBA decision of 17 October 2016 Chairman: W. Sieber Members: M.O. Müller and F. Blumer The Technical Board of Appeal (TBA) has referred questions to the Enlarged Board of Appeal (EBA) regarding the standards to be applied to the assessment of undisclosed disclaimers under Article 123(2) EPC. This will become case G 1/16, and is expected to be heard by the EBA during the course of next year. The case concerned a patent application related to organic light-emitting diodes (OLEDs), co-owned by the Princeton and Southern California Universities. Claim 1 covered a range of compounds with phosphorescent properties. During prosecution, the applicant had introduced two “undisclosed” disclaimers (i.e. without basis in the application as filed) in claim 1 in order to restore novelty by limiting the claim to exclude from its scope certain compounds in the prior art. The excluded compounds had been previously disclosed in the context of completely different uses, and therefore only properties irrelevant to the present invention were known. The TBA was satisfied that these were “accidental anticipations”, i.e. so unrelated and remote that the skilled person would never have taken them into consideration when working on the invention. When considering whether the addition of undisclosed disclaimers to claim 1 added matter under Article 123(2) EPC, the TBA came across an apparent inconsistency between two decisions of the EBA. Firstly, in G 1/03 and G 2/03 (jointly referred to as G 1/03) the EBA considered undisclosed disclaimers to be allowable under Article 123(2) in certain cases, which the TBA described as “exceptions” to the rule. Among these exceptions is the addition of undisclosed disclaimers for the purposes of restoring novelty against an accidental anticipation. Later, in G 2/10, the EBA defined the “gold standard” to be applied to the assessment of “disclosed” disclaimers, namely whether the skilled person would, using

PATENTS: EPO

common general knowledge, regard the remaining claimed subject-matter as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed. As the TBA notes, since G 2/10 dealt primarily with disclosed disclaimers, its ruling may seem not to apply to undisclosed disclaimers. However, the Board identified several passages in G 2/10 suggesting that the gold standard must be applied to the assessment of any amendment, including the addition of undisclosed disclaimers. Nonetheless, the EBA in G 2/10 had extensively considered the ruling in G 1/03, but failed to explicitly set aside the exceptions it set out in relation to undisclosed disclaimers. Applying the gold standard to the addition of an undisclosed disclaimer would result, almost by definition, in the amendment not being allowable. As the TBA put it: “if a whole is reduced by an undisclosed first part, the present board fails to see how the remaining second part could ever be regarded as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed”. The TBA reviewed the case law of the Boards of Appeal dealing with undisclosed disclaimers since G 2/10 and found a tendency towards trying to accommodate the gold standard (by its modification) so as not to contradict the ratio decidendi behind the exceptions in G 1/03. The TBA concluded that the conflicting standards in G 1/03 and G 2/10 raised fundamental questions of law, and sought to reconcile these rulings by referring the following questions to the EBA: 1. Is the standard referred to in G 2/10 for the allowability of disclosed disclaimers under Article 123(2) EPC, i.e. whether the skilled person would, using common general knowledge, regard the subject-matter remaining in the claim after the introduction of the disclaimer as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed, also to be applied to claims containing undisclosed disclaimers?

Legal Board of Appeal (LBA) and Technical Board of Appeal (TBA) decisions are available on the EPO website at https://www.epo.org/law-practice/case-law-appeals/recent.html and similarly decisions of the Enlarged Board of Appeal (EBA) can be downloaded from https://www.epo.org/law-practice/case-law-appeals/eba/number.html. A list of the matters pending before the Enlarged Board is included at https://www.epo.org/law-practice/case-law-appeals/eba/pending.html. Recent notices and press releases of the EPO are published at http://www.epo.org/service-support/updates.html and http://www.epo.org/news-issues/press/releases.html respectively, and recent issues of the Official Journal can be downloaded from https://www.epo.org/law-practice/legal-texts/official-journal.html. This issue’s contributors from Bristows were Rachael Barraclough, Vanessa Rieu, Manuel Rey-Alvite Villar, Lucie Fortune and Tom Hendicott.

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2. If the answer to the first question is yes, is G 1/03 set aside as regards the exceptions relating to undisclosed disclaimers defined in its answer 2.1? 3. If the answer to the second question is no, i.e. if the exceptions relating to undisclosed disclaimers defined in answer 2.1 of G 1/03 apply in addition to the gold standard, may this standard be modified in view of these exceptions?

Admissibility of late-filed evidence and standard of proof – Article 13(1) RPBA T 0971/11: Toyobo Co.Ltd / Heat-shrinkable polyester film roll and process for producing the same TBA decision of 4 March 2016 Chairman: M. Poock Members: P. Lanz and G. Weiss This was an appeal by the opponent from a decision of the Opposition Division (“OD”), which rejected the opposition filed against a patent for a heat-shrinkable polyester film roll and a process for producing the same. The decision offers interesting guidance on the admissibility of late-filed evidence and the standard of proof for supporting evidence.

Admissibility of late-filed evidence The opponent submitted that document B1 (which had not been admitted by the OD) and supporting documents B2 to B7 and B10 to B13 (which were not submitted to the OD by the opponent), were prima facie relevant to the issues of novelty and inventive step and should be admitted into the appeal proceedings. The opponent submitted that one further document (B14) was particularly relevant for proving that a precise temperature control of +/- 0.5°C during the process steps of pre-heating, drawing and heat-setting belonged to the common general knowledge (“CGK”) and thus was not inventive. Although the document was only filed after the arrangement of the Board of Appeal oral proceedings, the opponent argued that the document should be admitted as it was being filed in response to an assertion made by the patentee during the examination proceedings some eight years before and it could not be retrieved earlier. The TBA admitted documents B1 to B7 and B10 to B13 into the proceedings. The TBA first considered the discretionary power conferred on the OD by Article 114(2) EPC 1973 to disregard late-filed evidence. The TBA held that it saw no reason to overrule the way in which the OD had exercised that discretion in refusing to admit document B1 to the first instance proceedings (it was filed just two days before the OD oral hearing). However, the TBA went on to consider the further discretion granted to it under Article 12(4) of the Rules of Procedure of the Boards of Volume 45, number 12

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Appeal (“RPBA”) regarding admissibility of evidence, finding that this applied equally to: i. documents that were submitted to the OD but were not admitted (B1); and ii. documents that could have been submitted to the OD but were not (B2 to B7 and B10 to B13). The TBA exercised this discretion in favour of the opponent, finding that the filing of the documents was indeed an immediate and appropriate reaction to developments in the last phase of the opposition proceedings (where it appeared that the OD had provisionally assessed that the subject-matter of claim 1 was not novel and changed its view during the course of the oral proceedings). As such, the TBA decided to admit the documents into the TBA proceedings. However, the TBA reached a different conclusion with respect to document B14, filed approximately one month before the TBA oral hearing. The TBA considered Article 13(1) RPBA regarding its discretion to admit any amendments to a party’s case after it has filed its grounds of appeal. The TBA considered that the appellant’s submission of this document was an attempt to present a new line of attack against the inventive merits of the contested claims at a very late stage of the appeal proceedings, which was not compatible with the principles of procedural economy and fairness. Document B14 was therefore not admitted into the appeal proceedings.

Novelty and inventive step – evidence The opponent argued that there was a public prior use of a glycol-modified polyester film in the form of shrink sleeves on “Nesquik” bottles as of April 1999. The opponent also claimed that the polyester material used for shrinkage tests in document B1 had all the properties specified in the contested claim. Finally, the opponent submitted that in May 2000 it had delivered to a customer 6505 kg of “E749/01” films and that this constituted a novelty-destroying prior sale. The TBA held that none of the evidence submitted by the opponent proved these objections according to the standard of proof required by the case law of the Boards of Appeal. In relation to the first two objections, because the patentee and opponent both had access to the evidence in support, the standard of proof applicable is the balance of probabilities. However, in cases where all the supporting evidence lies within the power and knowledge of the opponent, as it did for the third objection relating to the opponent’s own allegedly novelty-destroying prior sale, the standard of proof was more stringent (“up to the hilt” or “beyond any reasonable doubt”). The TBA concluded that the evidence on file did not prove the objections to the required standards of proof. DECEMBER 2016

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Amendment – Rule 80, Article 123(2) EPC T2129/14: KCI Licensing, Inc / Vacuum assisted tissue treatment system TBA decision of 1 June 2016 Chairman: E.Dufrasne Members: D.Ceccarelli and C.Körber This was an appeal by Smith & Nephew against the Opposition Division’s decision that an amendment made during opposition to KCI’s patent complied with the EPC having been opposed on the basis of insufficiency of disclosure and lack of inventive step. The invention relating to a system to stimulate the healing of tissue at a wound site of a patient by applying negative pressure and the arguments focused on the manner in which an odour vapour filter was positioned in relation to a pair of hydrophobic filters. The decision is notable for providing an example of an exception to the principle of prohibition of reformatio in peius (i.e. an exception to the rule that the appellant should not be put in a worse position by the appeal decision than if the appeal had not been made). The TBA allowed the appeal, agreeing with Smith & Nephew that the amendment was not allowable, but went on to remit the patent to the first instance department with an order to maintain the patent on the basis of an auxiliary request. The auxiliary request was challenged by the appellant for lack of inventive step in relation to four new pieces of prior art – using their discretion under Article 12(4) RPBA – but the TBA was not convinced by the arguments made by the appellant. The TBA also considered a main request and two auxiliary requests made by the respondent as set out below. The main request concerned the addition of a requirement that the odour filter be attached to the hydrophobic filters. The respondent requested such an amendment on the basis of a schematic diagram (Fig. 1) in the application which showed the filters’ respective proximity within the system. The Board agreed with KCI that Fig.1 could, in theory, directly and unambiguously disclose the feature as set out in a request in accordance with Article 123(2) EPC. However, in this case, the skilled person would, having approached the amended claim with a willingness to understand its meaning, see that something more than that disclosed by the drawing was required. The Board considered that the addition of the term “attached” must, when read in the context of the patent which previously defined the relative positions of other elements in the claim, imply a “special relationship” in the form of a direct or permanent fastening between the filters. This could not be unambiguously derived from the figure. Accordingly, the Board dismissed the main request as it did not comply with Article 123(2) EPC (and the first auxiliary request as it contained the same feature). The Board held the second auxiliary request admissible as, despite being filed during the oral proceedings, the amendment did not raise any issues which the Board 36 CIPA JOURNAL

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or the appellant could not reasonably deal with in accordance with Article 13(3) RPBA. The second auxiliary request defined the hydrophobic filters as an integral part of the system, specified the odour vapour filter as interposed between the hydrophobic filters and removed the requirement for the filters to be attached. Such an amendment complied with Article 123(2) EPC on the basis of a further embodiment of the invention described in the patent differing only from previously described embodiments to the extent specifically described (and therefore inheriting the characteristics of the former embodiments unless specifically stated otherwise). The appellant argued that the amendment in the second auxiliary request did not comply with the principle of prohibition of reformatio in peius as set out in G1/99 in that the amended claim should not put the appellant in a worse position than if it has not pursued the appeal. The appellant argued that the deletion of the requirement for the filters to be attached broadened the scope of the claim. However, the Board noted that G1/99 also provided an exception to this principle, namely that the amendment should be allowed if to do otherwise would lead to the revocation of the patent. The Board held that the present case falls within the exception to reformatio in peius. In accordance with the stepwise conditions set out by the Enlarged Board in G1/99, the TBA went through the process of considering the four elements (two hydrophobic filters, the odour vapour filter and the canister) and the relationship between them which had been required by the inadmissible amendment now deleted from the second auxiliary request. For each lost requirement the Board checked that the amendment either: i. introduced an originally disclosed feature which was limiting (e.g. a more specific form of attachment between the components); ii. introduced an originally disclosed feature which extended the scope but within the limits of Article 123(3) EPC; or iii. was a deletion of the inadmissible amendment within the limits of Article 123(3) EPC. Having done so the Board was satisfied that the exception applied and the amendment in the second auxiliary request was allowable. The Board rejected an argument by the appellant that an amendment referring directly to Fig. 1 would have been less bad insofar as the claim scope would have been extended by a smaller amount. Apart from the shortcomings with its disclosure mentioned earlier, a claim with reference to the “arrangement of Fig 1” would suffer difficulties with lack of clarity under Article 84 EPC owing to the schematic nature of the drawing. www.cipa.org.uk

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TRADE MARKS

Trade marks Decisions of the CJ and GC Ref no.

Application (and where applicable, earlier mark)

CJ C-442/15 P

Pensa Pharma SA v EUIPO; Ferring BV and Ots 22 September 2016

– pharmaceutical and veterinary preparations; dietetic substances adapted for medical use, food for babies; plasters; fungicides, herbicides (5) – medical services and consultancy in the field of pharmacy (44)

Reg 207/2009 PENTASA

– pharmaceutical preparations (5) (various national registrations)

LUVO LUVOWORLD

T-449/15 T-450/15

– mobile phones; tablets; computers; portable communication devices (9) – telecommunications services; providing user access to the Internet (38)

Satkirit v EUIPO; Advanced Mailing Solutions Ltd

LUVO

27 September 2016 Reg 207/2009

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– design and development of computer hardware and software (42)

Comment

In invalidity proceedings, the CJ upheld the GC’s decision that there was a likelihood of confusion between the marks under Article 8(1)(b). The CJ confirmed that it was for Pensa Pharma to file evidence to support its submission that two of the earlier PENTASA registrations had expired prior to the BoA hearing – the GC was not under a duty to examine the status of registrations relied on within the invalidity application of its own motion. The GC had erred in dismissing Pensa Pharma’s submission that Ferring BV’s arguments before the GC attempted to revise the factual and legal context of the proceedings as inadmissible. The error, however, did not have an impact on the operative part of the judgment. The CJ dismissed the submission that the GC had found a likelihood of confusion between the marks under Article 8(1)(b) on the basis of an artificial division of the mark and confirmed that Pensa Pharma was not entitled to obtain a re-examination of the factual assessment by the GC on appeal, which was necessarily limited to points of law.

The GC upheld the BoA’s decision that there was a likelihood of confusion between the marks under Article 8(1)(b). The BoA correctly assessed the relevant public as comprising the general public and professionals, whose degree of attention fluctuated between normal and higher-than-average. The GC endorsed the BoA’s assessment of similarity of the class 9 goods and class 42 services at issue, and confirmed they were functionally complementary, targeted at the same relevant public and shared distribution channels, as both were frequently provided in the same specialist physical/online retail outlets. The BoA was therefore correct to find a likelihood of confusion, taking into account the normal level of distinctive character of the earlier mark, the weak distinctive character of the additional ‘world’ element and the identity/high levels of similarity between the marks.

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Ref no.

GC T-400/15

Ana Isabel Pinto Eliseu Baptista Lopes Canhoto v EUIPO; University College London

Application (and where applicable, earlier mark)

CITRUS SATURDAY

– clothing; headgear; footwear; t-shirts; polo shirts; shirts; blouses; sweatshirts; jumpers; hooded jumpers; aprons; caps; hats; wrist bands; headbands; socks; jackets; scarves (25) CITRUS

28 September 2016

– clothing; footwear; headgear; belts (25)

Reg 207/2009

(Portuguese mark)

FITNESS

T-476/15

European Food v EUIPO; Société des produits Nestlé 28 September 2016 Reg 207/2009

– milk; cream; butter; cheese; yoghurts and other milk-based food preparations; substitutes for dairy products; eggs; jellies; fruit; vegetables; protein preparations for human consumption (25) – cereals and cereal preparations; ready-to-eat cereals; breakfast cereals; foodstuffs based on rice or flour (30) – still water; aerated or carbonated water; spring water; mineral water; fruit drinks; fruit juices; nectars; lemonades; sodas and other nonalcoholic drinks; syrups and other preparations for making syrups and other preparations for making beverages (32)

TRADE MARKS

Comment

The GC dismissed the appeal on the basis that Ms Canhoto had failed to prove the existence, validity and scope of protection of the earlier mark as required under Rule 19 of Regulation 2868/95. The requirements to substantiate the earlier mark were set out precisely and exhaustively under Rule 19(2), (3) and (4) and documents submitted outside the period referred to in Rule 19(1) could only be admitted at the discretion of the BoA, pursuant to Article 76(2). That discretion was to be exercised restrictively and, in the circumstances, there was no legitimate reason for the delay in the submission the documents.

In invalidity proceedings, the GC held that the BoA had erred in finding that evidence submitted for the first time during the appeal was to be regarded as out of time pursuant to Rule 37(b)(iv) of Reg 2868/95. European Food applied to invalidate the mark for all goods in classes 29, 30 and 32 pursuant to Article 7(1)(b) and 7(1)(c). Further evidence concerning the filing date of the mark was submitted for the first time before the BoA. The GC held that neither Rule 37(b)(iv) nor Reg 207/2009 imposed time limits for the submission of evidence in invalidity proceedings based on absolute grounds. An application for a declaration of invalidity needed only to include evidence to support the grounds on which it was based. The BoA had exercised its discretion under Article 76(2) and disregarded the later filed evidence as having been submitted out of time. The GC annulled the decision on the basis that it was not inconceivable that the later filed evidence may have modified the substance of the BoA’s decision.

The reported cases marked * can be found at http://www.bailii.org/databases.html#ew and the CJ and GC decisions can be found at http://curia.europa.eu/jcms/jcms/j_6/home Abbreviations used: A-G=Advocate General; BoA=Board of Appeal; GC=General Court; CJ=Court of Justice of the EU; CTM=Community Trade Mark; EUIPO=European Union Intellectual Property Office; EUTM=European Union trade mark; IPEC=Intellectual Property Enterprise Court This month’s contributors are Katharine Stephens, Hilary Atherton and Emma Green at Bird & Bird LLP. Reporters’ note: We are grateful to our colleagues at Bird & Bird LLP for their assistance with the preparation of this report: Ahalya Nambiar, Sam Triggs, James Fowler, Georgie Hart, Louise O’Hara, Toby Sears, Henry Elliott, George Khouri, Mark Livsey and Rebekah Sellars.

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Ref no.

GC T-593/15

The Art Company B & S, SA v EUIPO; G-Star Raw CV

Application (and where applicable, earlier mark) THE ART OF RAW

– bags; rucksacks; purses; wallets; trunks and travelling bags; umbrellas (18) – clothing; footwear; headgear; belts (25) – retail (store) services in relation to the above goods

28 September 2016 Reg 207/2009 – clothing, footwear (except for orthopaedic shoes), headgear, in particular boots, shoes, sandals and slippers (25) – retailing via global computer networks, retailing of clothing, footwear in relation to the above goods (35)

– clothing, footwear, headgear (25) (EUTM and Spanish marks)

GC T-362/15

The Lacamanda Group Ltd v EUIPO; Nigel Woolley 28 September 2016 Reg 207/2009

HENLEY

– optical apparatus and instruments (9) – precious metals and their alloys and goods in precious metals or coated therewith (14) – leather and imitations of leather and goods made of these materials (18) HENLEYS

– t-shirts, jeans, shirts, skirts, trousers, jackets (25) – the bringing together, for the benefit of others, a variety of T-shirts, jeans, shirts, skirts, trousers and jackets (35)

TRADE MARKS

Comment

The GC upheld the BoA’s decision that there was no likelihood of confusion between the marks pursuant to Article 8(1)(b). The additional word or figurative elements and the length and structure of the marks created only a remote visual similarity notwithstanding the common word ‘art’. There was no phonetic similarity. The GC confirmed that the earlier mark might be understood as a conceptual reference to ‘art’ in general, whereas the mark applied for evoked the idea of a specific art. This difference would be understood by the relevant public, being both English and Spanish general public and business customers with professional knowledge, including those with a below average command of the English language. The BoA was correct to find that ‘art’ was a laudatory term used to promote a characteristic of artistic and pleasurable goods and therefore had weak distinctive character. As such, this element did not constitute the dominant element of the earlier marks nor was it decisive as to the overall impression. The identity and similarity of the goods could not offset the very low degree of similarity between the marks. A likelihood of confusion could not be established.

The GC annulled the BoA’s decision on the basis that it had infringed Article 8(5). In its assessment of whether the earlier mark had a reputation, the BoA restricted its analysis to the existence of injury only and failed to take into account the degree of similarity between marks at issue and the strength of the earlier mark’s reputation. As a result, the BoA neither concluded that the earlier mark had a reputation nor adopted the detailed analysis of the cancellation division. The GC was not entitled to assess the reputation of the mark, so annulled the BoA’s decision in its entirety.

(EUTM and UK national marks)

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Application (and where applicable, earlier mark)

Ref no.

GC T-430/15

Flowil International Lighting (Holding) BV v EUIPO; SC Lorimod Prod Com, Srl

– meat, poultry and game; meat extracts; jellies, jams, compotes; eggs; milk and milk products; edible oils and fats (29) – coffee, tea, cocoa and artificial coffee; rice; tapioca and sago; flour and preparations made from cereals; bread, pastry and confectionery; mustard; vinegar, sauces (condiments); spices; ice (30)

30 September 2016 Reg 207/2009

SYLVANIA

– various goods relating to lighting in classes 7, 9, 10 and 11 – design services and consultation services, all relating to lighting and lighting technology (42)

TRADE MARKS

Comment

The GC upheld the BoA’s decision that there was no likelihood of confusion between the marks at issue pursuant to Article 8(1)(b) and confirmed the mark applied for did not take unfair advantage of the earlier marks under Article 8(5). The BoA was correct to find that the goods in classes 29 and 30 were dissimilar to the goods and services in classes 7, 9, 10, 11 and 42 covered by the earlier marks as they did not share a common nature, purpose or intended use. The goods and services were not in competition with nor complementary to each other as there was no close connection between them. The BoA was also correct to find that the mark applied for did not take unfair advantage of the distinctive character or the repute of the earlier marks. The GC found that although the mark applied for was similar overall to the earlier marks, the earlier marks only had a weak reputation in relation to goods in classes 9, 10 and 11. The BoA was right to conclude that a link between the marks could not be established due to a lack of any similarity between the goods and services. As such, the opposition on the basis of Article 8(5) could not be maintained.

(EUTM and non-registered marks used in the course of trade – Art 6 bis)

ASTEX

Alpex Pharma SA v EUIPO; Astex Pharmaceuticals, Inc.

– drug discovery and development services; biotechnology research; scientific analysis; providing scientific information in the field of pharmaceuticals and clinical trials (42)

30 September 2016

ALPEX

T-355/15

Reg 207/2009

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– scientific and technological services and research and design relating thereto; industrial analysis and research services; design and development of computer hardware and software; legal services (42)

DECEMBER 2016

The GC upheld the BoA’s decision that genuine use of the earlier mark had not been demonstrated pursuant to Article 42 and that, as a result, the opposition based on Article 8(1)(b) could not succeed. The BoA was correct to conclude that whilst the evidence showed use of ALPEX in relation to research on or development of pharmaceutical products or nutritional supplements, it did not prove that Alpex Pharma SA had conducted such work for external clients. The BoA did not err in finding that the evidence was insufficient to establish genuine use of the earlier mark in relation to the class 42 services. It was clear from the BoA’s decision that it had met the requirement to state the reasons for its decision and had met its obligations to examine all the facts, evidence and arguments submitted to it.

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DECISIONS

Ref no.

GC T-549/15

Lidl Stiftung & Co. KG v EUIPO; Horno del Espinar, SL 4 October 2016 Reg 207/2009

Application (and where applicable, earlier mark)

CASTELLO

– baking ingredients; foodstuffs for flavouring (29) – flour and preparations made from cereals, sugar, salt, cocoa, starch for food, decorative chocolate and confectionery, yeast, raising agents for baking, confectionery products (30) – poppy seeds, nuts and almonds of all kinds; fresh fruits (31)

TRADE MARKS

Comment

The GC partially annulled the BoA’s decision that there was a likelihood of confusion in relation to class 29 goods pursuant to Article 8(1)(b). The BoA was correct to find a strong visual and phonetic similarity and no conceptual difference between the marks at issue. However, the BoA erred in finding that frozen fruits and vegetables covered by the mark applied for were similar to ‘sauces (condiments)’ covered by the earlier mark. The GC held that as frozen fruits and vegetables were sold in specific departments or shops and were closer to fresh goods sold in raw form than to cooked goods as a result of the limited/lack of processing used. As such there was no likelihood of confusion in respect of these goods.

– flour and preparations made from cereals; honey; yeast, bakingpowder; salt, mustard; vinegar, sauces (condiments); spices; ice (30) – services of distribution, storage, transport and packaging of food items (39)

– industrial patisserie and confectionery (30) (EUTM and Spanish national marks)

T.G.R. ENERGY DRINK

T-456/15

– non-alcoholic drinks, mineral water, cooling and energy drinks (32)

Foodcare sp. z o.o. v EUIPO;Dariusz Michalczewski

DARIUSZ TIGER MICHAELCZEWSKI

– mineral water, isotonic drinks (32)

5 October 2016 Reg 207/2009

– goods in class 32 (EU and Polish national marks)

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The GC upheld the BoA’s decision that the mark applied for was invalid on the ground of bad faith under Article 52(1)(b). The BoA was correct to take into account an agreement between Foodcare and Dariusz Michalczewski (a former professional boxer) predating the application for the mark, which authorised Foodcare to use the boxer’s image and nickname ‘Tiger’ to promote energy drinks. Taking into account the get-up of the Tiger Energy Drink, the GC confirmed there was a clear intention for Foodcare to circumvent its contractual remuneration obligations arising under the agreement by creating an association between the mark applied for and the Tiger Energy Drink product. Foodcare also intended to benefit from the reputation of the product. The application had therefore been made in bad faith and the GC declared the registration to be invalid pursuant to Article 52(1)(b).

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TRADE MARKS

Application (and where applicable, earlier mark)

Ref no.

GC T-350/15

Perry Ellis International Group Holdings Ltd v EUIPO; CG Verwaltungsgesellschaft mbH

– clothing and accessories, namely, swimsuits, jackets, shorts, leotards, swimsuits, swim trunks, casual shirts, shorts, workout pants, warm-up shirts and suits, cover-ups, socks, sport bras, sweatshirts, sport shirts, T-shirts, underwear; headwear and footwear (25)

11 October 2016 Reg 207/2009

– articles for clothing (25) (German mark)

GC T-753/15

Guccio Gucci SpA v EUIPO; Guess? IP Holder LP

– decorative and protective covers and cases for portable electronic devices, (9)

11 October 2016 Reg 207/2009

– apparatus for recording, transmission or reproduction of sound or images (9) – leather and imitations of leather; animal skins, hides; trunks and travelling bags; umbrellas and parasols (18) – clothing, footwear, headgear (25)

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Comment

The GC upheld the BoA’s decision that there was a likelihood of confusion between the marks pursuant to Article 8(1)(b). The most distinctive and dominant element of the mark applied for was likely to be perceived as the letter ‘p’. The marks were visually similar to an average degree because they were similar in structure and shared stylisation. The marks were phonetically identical if they were perceived and pronounced as a letter ‘p’. A conceptual comparison was not possible. The GC rejected the submission that the earlier mark had weak, rather than average, distinctive character. Taking into account the normal level of attention of the relevant public and the identity or high degree of similarity of the goods, the BoA was correct to find a likelihood of confusion.

The GC upheld the BoA’s decision that there was no likelihood of confusion between the marks pursuant to Article 8(1)(b). The marks at issue created different visual impressions in light of the stylisation and positioning of the elements in the mark applied for. The relevant public would retain the image of the mark applied for as a whole and would not perceive the capital letter G (represented by the earlier marks) independently from the overall impression of an abstract ornamental motif. As the mark applied for was a purely figurative sign, a phonetic comparison could not be carried out. Similarly, a conceptual comparison was not possible – as an abstract ornamental motif the mark applied for had no meaning and the earlier marks did not have any semantic content of their own. Based on the dissimilarity of the marks, it was not necessary to carry out a global assessment for the purposes of likelihood of confusion. The GC dismissed the opposition under Article 8(1)(b) and confirmed that there was no infringement of Article 8(5), given the dissimilarity of the marks.

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DECISIONS

Ref no.

Application (and where applicable, earlier mark)

FRUITFULS

T-367/14

– confectionery, chocolate, chocolate goods, pastry (30)

August Storck KG v EUIPO; Chiquita Brands LLC 18 October 2016 Reg 207/2009

BRAUWELT

T-56/15

– various goods and services in classes 9, 16, 32, 35, 38, 41, 42 and 43

Raimund Schmitt Verpachtungsgesellschaft mbH & Co. KG v EUIPO 18 October 2016 Reg 207/2009

GC T-693/15

Clover Canyon, Inc. v EUIPO; Kaipa Sportswear GmbH

CLOVER CANYON

– tops, bottoms, shirts, pants, sweaters, headwear, shorts, swimwear, lingerie, underwear, jackets, coats, wraps, dresses, skirts, scarves (25) CANYON

20 October 2016

– woven, weft-knitted and warpknitted clothing (25)

Reg 207/2009

(German mark)

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TRADE MARKS

Comment

The GC partially annulled the BoA’s decision to revoke the mark for non-use in respect of confectionery pursuant to Article 51(1)(a). The GC held that hard fruit candies were not an independent subcategory of confectionery. Use in respect of confectionery was therefore sufficient to demonstrate genuine use of the mark in relation to the category as a whole. The BoA had imposed an excessive burden of proof by comparing the sales of hard fruit candies to the whole confectionery market in the EU and was wrong to have compared sales production figures in Slovenia and Germany to the wider EU market. In doing so, the BoA had erred in concluding that the volume of sales was extremely low. It was not necessary for a mark to be used in an extensive geographic location or for its use to be a commercial success for use to be considered genuine. The BoA had not erred in finding that genuine use of the mark had not been demonstrated in relation to chocolate, chocolate products or pastry.

The GC upheld the BoA’s decision that the mark was descriptive within the meaning of Article 7(1)(c) and lacked distinctive character under Article 7(1)(b). The BoA was correct to find that the German word ‘brauwelt’ meant ‘brewers’ world’ or ‘world of brewing’ and referred to a sales location or wide-ranging offer of goods and services linked to brewery activity. The BoA had examined the overall significance of the mark and was correct to find that the mark indicated the subject-matter of the goods and services. The mark was therefore descriptive of all goods and services pursuant to Article 7(1)(c). The BoA was therefore entitled to refuse the registration of the mark as it lacked distinctive character under Article 8(1)(b) without needing to provide a fuller statement of reasons. The GC was not able to restrict the category of ‘magazines’ to ‘specialized magazines in the field of brewing’ as this would change the target public and thus the factual context of the dispute. The GC upheld the BoA’s decision that there was a likelihood of confusion between the marks under Article 8(1)(b). The GC endorsed the BoA’s assessment that the marks were both visually and phonetically similar. Notwithstanding the additional word element ‘CLOVER’, the German-speaking public would largely understand the meaning of ‘canyon’. The inclusion of ‘clover’, although less commonly-understood by that public, did not preclude a finding of conceptual similarity. The parties had not disputed that the relevant public was the general public with an average level attention, and that the goods at issue were identical. DECEMBER 2016

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DECISIONS

Passing off Application to join additional defendants rejected Glaxo Wellcome UK Ltd & Anr v Sandoz Ltd* Judge Hacon; [2016] EWHC 2743 (Ch); 2 November 2016 Judge Hacon dismissed Glaxo’s application to join two of Sandoz’s group companies in its action for passing off. Glaxo brought a claim for trade mark infringement and passing off against Sandoz relating to Sandoz’s AirFluSal inhaler. In June 2016, Sandoz succeeded in an application for summary judgment on its counterclaim that Glaxo’s EU trade mark was invalid ([2016] EWHC 1537 (Ch), reported in August-September [2016] CIPA 43). The trade mark part of the claim was stayed pending an appeal but the passing off claim continued. Glaxo claimed that the AirFluSal inhaler passed off its Accuhaler, each of which is shown below. Glaxo applied to join three further members of the Sandoz group in the proceedings: Sandoz International GmbH, Aeropharm GmbH, and Hexal AG. The first was joined by consent and therefore the Judge was only concerned with Aeropharm and Hexal. Glaxo applied to join the two parties because it claimed there was evidence to indicate that they had taken an active role in the creation of the design of the AirFluSal product and its packaging, and were therefore implicated as primary and/or joint tortfeasors, along with Sandoz, for passing off. In practical terms, Glaxo wanted Aeropharm and Hexal to have to give disclosure of documents relating to the creation of the designs in issue. It was common ground that in order to join a party the court had to be satisfied that the proposed pleaded allegations against it disclosed a sufficiently arguable case.

Joint tortfeasance Citing Unilver plc v Gillette (UK) Ltd [1989] R.P.C. 583 (CA), the Judge was of the view that an act of contributory infringement did not have to take place within the jurisdiction to amount to joint tortfeasorship. The question was whether either party had actively cooperated to bring about the sale

The Accuhaler inhaler and packaging

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or promotion of AirFluSal in England. The Judge found that, if by marketing AirFluSal at a medical conference in Amsterdam, Hexal had contributed anything to Sandoz’s efforts to market AirFluSal in England, it was de minimis. Although he went on to find that Aeropharm and Hexal had, between them, facilitated the sale and promotion of AirFluSal products in England by (i) contributing to the design of the AirFluSal inhaler and its packaging, (ii) obtaining marketing authorisation in the UK through data collection, and (iii) carrying out trials as part of an EU-wide programme, as none of those amounted to actively cooperating in the sale and promotion of the product in England. Finally, the Judge held that this condition was not fulfilled by the companies actively cooperating in the sale of the inhalers in Germany to Sandoz despite the fact that it was done in the knowledge that they were destined for sale in England.

Alleged primary act of passing off The Judge rejected Glaxo’s argument that it was sufficient under this head that Aeropharm or Hexal had supplied the AirFluSal product to Sandoz UK anywhere in the world. He found that such supply had to be in the UK. As there was evidence that only Aeropharm supplied the AirFluSal inhalers to Sandoz UK and that title to those products passed in Germany, the Judge concluded that there was no arguable case that any primary act of passing off had been committed or threatened.

Additional arguments put forward by the Sandoz companies The Judge went on to reject an argument advanced by the defendants that related proceedings in Germany against Aeropharm and Hexal prevented them from being joined in these proceedings under Article 30 of the Recast Brussels I Regulation. He also rejected an argument made by the defendants that acts of joint tortfeasance were time barred under section 2 of the Limitation Act 1980 (but likewise rejected Glaxo’s submission that the Limitation Act never applied to acts of joint tortfeasance). However, having found that there was no arguable case that either Aeropharm or Hexal had committed or threatened primary acts of passing off or joint tortfeasance, the application to join them as defendants was dismissed.

The AirFluSal inhaler and packaging

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DECISIONS

Claim based on goodwill in get-up alone rejected George East Housewares Ltd (“GEH”) v Fackelmann GmbH & Co KG & Anr* Miss Recorder Amanda Michaels; [2016] EWHC 2476 (IPEC); 11 October 2016 Miss Recorder Amanda Michaels (sitting as a Deputy Judge) dismissed GEH’s claim for passing off against Fackelmann and its connected company, Probus Creative Housewares Ltd (“PCH”). She found that GEH did not enjoy the requisite goodwill in the shape or other aspects of the get-up of its conical kitchen measuring cups in the absence of the trade name “Tala”. GEH was the successor in business to a long-established kitchenware manufacturer which had sold conical kitchen measuring cups under the brand name Tala in the UK since 1934. GEH had made and distributed the Tala range including the measuring cups since 1992. The tinplate, conical shape of the cups had been broadly consistent since 1934, with measurements marked in columns on the interior. Although the exterior and interior designs had varied over time, the Tala brand name had always appeared on the exterior – GEH did not complain about the brand name on the exterior of the defendants’ cups, but claimed that Fackelmann and PCH had passed off their own conical measuring cups as GEH’s by the adoption of a similar getup, namely: (i) shape, (ii) stripes, (iii) colours, and (iv) interior design. Although GEH’s main witness referred to it in his evidence, the overall “vintage and retro appearance” of the get-up as a feature of GEH’s goods was not pleaded as a feature of the relevant get-up. The defendants had manufactured and sold different versions of their measuring cups. The Judge found that one, unbranded version was “extremely similar if not identical” to GEH’s cups in shape and size, and that it was clear that the interior had been copied. However, the Judge considered it relevant that another “Dr Oetker” branded version was not complained of by GEH. Examples of the parties’ products are shown below:

GEH’s cups

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The Judge cited the authorities which had established that it was possible – depending on the facts of the case – for features such as shape and decoration to identify a product even when the name by which it was known was missing, and for a competing product to cause passing off even when no confusingly similar name was adopted. However, although she found that GEH had a de facto monopoly in conical measuring cups at the relevant date, she was of the view that the evidence did not show that the public had been educated to recognise the shape of a Tala cup alone as indicative of the origin of the goods. She also went on to find that the aspects of get-up relied up by GEH, either as a whole or in one or more identifiable features, did not have the requisite goodwill. In case she was wrong on the issue of goodwill, the Judge went on to consider whether the defendants’ use of the getup complained of was similar to that of GEH’s product such that it constituted a misrepresentation to consumers or the trade that their goods were those of or otherwise associated with GEH. Taking all the evidence into account, she held that it did not lead to the conclusion that either the trade or the average end-purchaser would be so confused and, if some were, they would be too few in number to satisfy the test established in Neutrogena Corporation v Golden Ltd [1996] RPC 473, i.e. there would be passing off if a substantial number of the claimant’s customers or potential customers were deceived for there to be a real effect on the claimant’s trade or goodwill. Therefore, the defendants’ acts could not have caused any damage to GEH and its claim was dismissed.

Defendants’ unbranded cups

Defendants’ “Dr Oetker” branded cup

DECEMBER 2016

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2015

The not-so-secret diary of a CIPA President

By Andrea Brewster

This time Mr Davies has excelled himself. He has made us a website for our diversity task force, which is henceforth to be known as IP Inclusive on account of that JU LY is our brand name and we have a logo and we have even done a trade mark clearance search. He has put us on Twitter® as well, because Twitter is what Mr Davies does best. Now we have to finish doing the stuff we have been talking about doing, like the diversity charter and the support groups and the training materials and careers videos. We have the added incentive of a launch party to make sure we do. I ask Mr Davies if I can have access to the @IPInclusive Twitter account. He is nervous about this. I have a bit of a reputation when it comes to social media, because I say outrageous things that everyone is glad someone else said, apart from the people who would rather no one had said them at all. It’s OK, I say. Honest. I will not tweet anything outrageous. I will just tweet about launch parties and stuff. Mr Davies replies with something that sounds like a Chinese proverb, and which roughly translates as “If someone else tweet from your Twitter account you in heap big trouble.” Really, I think he is being unduly sensitive.

The VeePee and I go to see some IPO officials. The IPO are making sure to meet up with the CIPA Pee regularly this year, to check what I am up to and whether AUG the government needs to intervene to save the UK’s IP system from disrepute. We talk about my plan to take some CIPA people on a day trip to Newport, which the IPO are very excited about. There will be facilitated discussions; not that patent attorneys generally need a lot of facilitation when it comes to expressing their opinions but the IPO people say the facilitator is more versatile than that and he can do crowd control too.

AUG

I have lunch with the Professional Development Working Group. The Working Group has finished defining its objectives and is now raring to go and planning lots of webinars.

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I am there to provide continuity. So when they look at the list of Webinars We Did Before they can ask me Why did we do these webinars? Unfortunately I cannot remember why we did most of the webinars and I have a sneaking suspicion it was more to do with who volunteered to speak than any clear sense of purpose. So I waffle on about learning outcomes and development matrices, and then I choose the largest sandwich on the lunch plate so as to be unavailable for providing continuity for the rest of the meeting.

On the menu today: biscuits from the EyePeePee, with a meeting of the Congress Steering Committee on the AUG side; lunch with the other Officers, with a discussion about CIPA strategy on the side; coffee with the EyePeePee and two of our new Council members, with a talk about Council on the side. I wish people would stop filling my refreshment breaks with meetings. The two new Council members tell us that although it is sometimes quite fantastic being on Council, it is also sometimes quite hard to get a word in edgeways. They tell me about a system for running meetings which involves having one person to make sure you keep to time, and another person to make sure you keep to the agenda, and a third person to tell participants to shut up if they are carping on and on about something tangential to the issue at hand. I think this is a great idea. I say Bagsy the job of telling participants to shut up. They say You already do that anyway. On which note, we head back for an actual Council meeting. There will be a tube strike later, so I resolve to make it an ultra-short meeting; this will call for some extreme chairing and I am not sure our insurance extends to extreme chairing, but I will give it a whirl anyway. I locate the ceremonial gavel to help me keep order. Near to the ceremonial gavel I find a ceremonial mallet. I do not know why we have a ceremonial mallet, but I guess sometimes a gavel is just not enough to keep 26 patent attorneys on track. I begin by glaring round the table and explaining how it is going to work with the ceremonial gavel and the ceremonial mallet. I remind people about the tube strike and about how I have been away from home for three days and am going to get back to my family tonight if

www.cipa.org.uk

07/12/2016 13:08:34

NOT-SO-SECRET DIARY

it kills me. Some of the more competitive Council members take this as an invitation. But we do indeed have the fastest Council meeting I can remember. This is roughly how it goes: Me: Is everybody here? Good. Me: Does anybody have any conflicts of interest? Good. (We always have to ask this. Nobody actually knows what it means. It is something to do with Governance.) Me: You’ve read the minutes of the last meeting. I presume you approve them. Good. Me: You’ve read the papers for the next item. I presume you’re all OK with them. If not, email your comments to me next week. (I will be on holiday next week.) Me: Good. Next item. Mr Davies: Wait; I haven’t finished writing about the last item yet. Me: Write “ditto”. Me: Next item. You’ve all seen the proposal. Email your comments to Mr Davies. (Mr Davies squeaks.) Me: Good. Next item. Nothing to report. Me: Next item. You’ve read the committee reports. The Business Practice Committee wants us to approve its new member. Anyone have a problem with that? (Fierce look.) Good. Me: Next item. You’ve all read the officers’ reports. Aren’t they exciting? Mr Davies: Wait! Me: Get a move on, man! We haven’t got all day. Me: Date of next meeting. 2 September. See you there. Bye! And in a flurry of straw, I am off. Ten minutes later, Mr Davies finishes writing the minutes.

I am back from what is euphemistically known as a “staycation”. A staycation is what happens when you wanted to go somewhere glamorous on holiday – or at AUG least somewhere sunny – but failed to organise anything in time and couldn’t get familial consensus on The Most Rubbish Place to Drag Reluctant Children Along To. This leaves you, in my case, facing the prospect of a fortnight’s worth of day trips to Wookey Hole, Weston-super-Mare and Ye Olde Cheddar Cheese Shoppe, which are, ironically, pretty much top of the list of The Most Rubbish Places to Drag Anyone Along To. My inbox is full to overflowing. CIPA has been absolutely fine without me, of course, but a lot of people are now duly awaiting my immediate response yours respectfully. I spend the day working through about half of what’s in there and adding things to my to-do list in response. I have to add them to next year as this year is too full.

Part-way through the day, I attend a lunch for retired CIPA members, because we are thinking of setting up a retired members’ Volume 45, number 12

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network. There are not many people there, as most retired members are quite rightly on holiday most of the time. But the retired members who are there look very well on their retirement and they offer to help with various CIPA things. When they are around, that is. I tell them I have a project for them, which is to write up their memoirs before we all forget what CIPA used to be like in The Good Old Days. What was it really like to be self-regulating? Who let women in? Why is there a ceremonial mallet? One of the retirees remembers being on a CIPA float one year, in some kind of parade, and that he was dressed as a fire extinguisher. Nobody’s memory is good enough to counter this outrageous allegation – and the implication it carries that CIPA members have in the past knowingly engaged in undignified floating, in unseemly apparel to boot – so he is charged with going away and finding some evidence. A used fire extinguisher costume, for instance.

The VeePee, the Chief Eggsek and I are talking about how to make the role of CIPA President more manageable. Otherwise there may come a time when the only people AUG we can get to be Pee are those who have nothing better to do, and someone who has nothing better to do than be the CIPA Pee is inherently a little bit suspect. There are some things that would certainly make the President’s life easier: • Not having to chair Council, which is a rubbish job in anyone’s books and really needs to be done by a Fierce Expert such as for example a management consultant or a serial killer. • A nicer swimming gala medal. (I suggest a massive 24-carat gold chain and a diamond-encrusted pedant, sorry I mean pendant.) • A Presidential tractor, with chauffeur, the chauffeur to have a hat full of straw and a belly full of zoidurr. • Three PAs and a Communications Facilitator, who can gracefully accept the criticism from other Institute members, in particular other Council members, and write polite letters back. • Counselling. • Counselling for the President’s spouse. Or at least a bit of company now and then.

3 pm We record a video. The star of the video is me. In the video I am asking people to please take some notice of the Bye-laws review and not regard it as boring old procedural stuff. In this way we are hoping to elicit excitement and delight in the opportunity to help reshape CIPA’s structure and functions. The video does not go viral.

The Not-so-Secret Diary is available in blog form, with additional material and more up-to-date news – http://thenotsosecretdiary.weebly.com/ DECEMBER 2016

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Six things we love about Oppositions This month Gwilym Roberts focuses on what he loves (and hates) about the Opposition process.

Six things we love

“The Pros from Dover”

To understand just how important European patent attorneys are, you first have to watch the original M*A*S*H movie. In the scene where the two army doctors swing a free R&R golfing trip to Japan, they get away with it by swanning through hospitals claiming they are the “pros from Dover”. That’s how you should feel when you do an Opposition. Look at litigation in the UK – on a big case you can have barristers doing the advocacy, witnesses of fact, expert witnesses, and a team of solicitors and patent attorneys beavering away in the background. Multiply that by two and it’s not surprising that we have such big court rooms here. In an opposition, on the other hand, the European patent attorney is everything – advocate, proponent of fact, proponent of technical excellence and strategic mastermind. We whisk through the EPO, briefcase swinging and brain bulging like a pro from Dover. We just don’t get to play golf.

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Preparing with the client

Being a patent attorney can sometimes be a somewhat lonely job, cloistered with the patent application, exam report, the prior art and an email from the client telling you what they want. The opportunity to sit down face-toface with a fully engaged and often pumped client, to get the inside track on the technical detail and, for once, for them to see that the other side does have a case, however weak, is fantastic. You bond and, if you happen to be working out of a Munich hotel, never more so than after one of you has visited the restroom when you can share details of the astonishing things that they sell in toilet vending machines in Germany. Just explain that having two bottles of wine over dinner the night before the hearing isn’t always a great idea for the advocate…

Believing almost anything

By the time you’re at the hearing stage you’ve put your case in, you’ve seen the other side’s case and the EPO’s told everyone what they think. It may not all be rosy, but you have to believe in your case and you have to have an argument that you can run convincingly. What we seem to be able to do, however, is suspend disbelief about the level of convincingness of that argument. The best advocates will make sure they understand every facet of the other side’s, and EPO’s concerns and yet somehow even with all this knowledge, you can persuade yourself that you’re going to win. Of course, often you do even in the face of pretty tricky odds, and this commitment is probably part of that. But manage your expectations and even more importantly your client’s expectations!

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SIX THINGS WE LOVE

Watching the EPO win it for you

You get all kinds of Opposition Divisions. Enthusiastic ones, inquisitorial ones, scary silent ones you would never want to meet in a poker game. Just as you can persuade yourself that your case is infallible, sometimes you see your opposite number doing the same thing and starting to push a line that is perhaps a little outlandish. The temptation is to splutter, plead with the EPO, and cry out: “But can’t you see, this is madness!” But the Opposition Division, like you, has been doing this for years and is not mad. If things go to plan, occasionally something wonderful happens. From an initial phase of the proceedings when the EPO Opposition Division fires out its questions in all directions, like radar looking for a reflection, suddenly they lock on to a dodgy argument like a heat seeking missile. You still need to keep up while they track down their target, but it’s a lovely feeling when you realise that the target’s not you.

OPPOSITIONS

Fake good manners

A triumph of EPO procedure is that an ability to explain and understand technology, apply law accurately and use procedure judiciously means that there is little need or place for ornamental advocacy. In other words, if you understand your case, understand the other side’s case and can speak pretty slowly you’re probably quite good at oppositions. In addition, manners are essential. This is not some US jury trial but a calm discussion of a series of logical points and the EPO, thankfully, does not welcome anything other than courtesy. If your counterpart should depart from these basic rules this is the moment for fake good manners – be the adult and let the Opposition Division deal with bad behaviour. Put another way, lose your temper and risk losing the case. And a shout out here also for the translators – those poor people already have to understand the whole case and interpret in real time; don’t make them dig out idiomatic alternatives to fruity provincial insults amidst all that.

A happy client

We’ve already observed that patenting can be a lonely job. Getting a 71(3) communication, whilst a giant triumph, doesn’t carry quite the same spontaneous excitement and glory as, say, a World Cup Final penalty shootout victory. Even winning ex-parte examination proceedings, whilst a good commercial outcome, doesn’t tend to engage the emotions in the majority of cases. Winning Oppositions, on the other hand, has the extra human element, even when sometimes the case itself doesn’t carry too much commercial weight, of succeeding over an adversary albeit in a strange, intellectual, sciencey version of UFC. But reverting to 5 above, this doesn’t mean that you can roll out your victory roar – be gracious in victory and forgiving in defeat. And bear in mind there is probably an appeal ahead where it could all go the other way.

And the one thing we hate… When

the EPO switches its focus to you

You remember that thing about being able to believe anything? And that thing about the EPO being able to spot lunacy on your behalf? Well sometimes it all goes a bit wrong and the laser spot lands on your forehead. Not even the sweat that instantly gathers can disperse it, your adversary sits back with arms folded and their fake good manners hiding a broad grin, you begin to regret that second bottle of red wine, your client decides he wants the other side’s attorneys next time, the flight of shame beckons and suddenly you wish you really were out playing golf somewhere…

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CPD & EDUCATION

INSTITUTE EVENTS

Institute Events For more information and to book onto any event please see the CIPA website or email cpd@cipa.org.uk

Wednesday, 11 January 2017 Webinar

IP Outside Your Comfort Zone: Trade Marks Time: 12:30–13.30pm

This webinar is aimed at those that do not routinely work in trade marks. It will provide an overview of trade mark law and the law of passing off, and will also look at the overlap between trade mark law and other rights including design rights and copyright. Speakers: Sophie Maughan, Partner Scott & York IP Law

CPD: 1; Prices: £72 (members £48)

the Early Certainty initiatives at the EPO. Further recent developments at the EPO will also be addressed. This event will be followed by drinks and nibbles. Speakers: Heli Pihlajamaa, Director of Patent Law at EPO, John Beatty, director Practices and Procedures Management at the EPO CPD: 2; Prices: £156 (members £102)

Wednesday, 25 January 2017 Webinar

Patentability of Diagnostics in the US – Will the Decline Ever Reverse? Time: 12:30–13.30pm

Thursday, 19 January 2017 Social

Winchester Happy Hour Time: 18.00–19.30pm Location: The Green Man, 53 Southgate Street, Winchester, SO23 9EH

Join us in the South of England for after work drinks and a chance to network with other CIPA members. Please note, booking is mandatory and drinks tokens will be distributed on arrival. FREE for CIPA members, register at www.cipa.org.uk/whats-on/events/

A series of US Supreme Court decisions severely limited the patentability of diagnostics in the United States. This discussion looks at the current patentability of diagnostics with an eye towards maximizing the likelihood of success. Speakers: Brett Nelson & Rachal Winger, Lee & Hayes

CPD: 1; Prices: £72 (members £48)

Thursday, 26 January 2017 Seminar

USPTO – Patentable Subject-Matter

Monday, 23 January 2017 Seminar

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Speakers: Michael Piper, Conley Rose CPD: 1.5; Prices: £97.20 (members £81)

–

Wednesday, 22 February 2017 Thursday, 22 February 2017 Residential Course

Intellectual Property Enterprise Court – Use your rights! And learn skills for the UPC Location: Missenden Abbey, London Road, Great Missenden, Bucks, HP16 0BD For full details on page 51. CPD: 16; Prices: £1,980 (members £1,668) Thursday, 9 March 2017 Seminar

East of England CPD Meeting 2017

Time: 12.30–17.00pm Location: Hilton Cambridge City Centre, 20 Downing Street, CB2 3DT Please see http://www.cipa.org.uk/ whats-on/events/east-of-england-cpdmeeting-2017 for more details. CPD: 3.5; Prices: £234 (members £156)

Time: 15.30–18.30pm Location: CIPA, 95 Chancery Lane, London, WC2A 1DT

Reporters Needed!

ECF Everything

Time: 16.15–19.15pm Location: CIPA, 95 Chancery Lane, London, WC2A 1DT

USPTO’s most recent guidance. Please email cpd@cipa.org.uk for further details.

This seminar provides a practical discussion on the USPTO guidelines and suggestions to help navigate a sound path from disclosure development through to application drafting. It also includes current experience of the

CIPA is looking for volunteers to report on regional CIPA events. If you are interested, please contact cpd@cipa.org.uk.

www.cipa.org.uk

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EDUCATION

INSTITUTE EVENTS

Intellectual Property Enterprise Court Use your rights! And learn skills for the UPC With the growing popularity of the IPEC amongst SMEs, and its more EPOlike procedures, patent attorneys are starting to take the opportunity to offer competitive litigation services. Also there will be opportunities to run revocation and even infringement actions in the Unified Patents Court. The aim of this course is to provide experienced patent attorneys (3+ years PQE) with an understanding of the procedures of the IPEC and the skills required to run litigation (transferable to the UPC) by running a patent case study from issue to trial. This course, which was run successfully in 2011, 2012 and 2015, will give you the tools to conduct proceedings in IPEC, either alone or with a barrister, and skills for the UPC – or at the very least give you the confidence to look after your client through the litigation process. For those interested, we can organise direct experience of the IPEC in action by arranging for at least some attendees to act as marshals in the court after they complete the course. The course starts with an introductory day at CIPA Hall followed by a residential “long weekend” (Thursday lunch time to mid-Saturday pm). This takes place at conveniently situated Missenden Abbey, in the Chiltern Hills. Much of the time will be spent in groups of four or five working on the case study, under the supervision of a tutor. There will also be plenary sessions dealing with procedural law, case management and practical aspects of running a case and preparing for trial. There is nothing like a “long weekend” course, with hands-on experience for delivering the required levels of competency and confidence to act.

Session 1 (non-residential)  Wednesday 22 February 2017  CIPA, London

Member rate: £1,668 (£1390 +VAT) Non-Member rate: £1,980 (£1650 +VAT)

Introductory day: Reading into the case study. Plenary sessions on getting started. Preparation of initial statements of case. Session 2 (residential)  23 to 25 March 2017  Missenden Abbey, Buckinghamshire Preparation for the case management conference. Plenary sessions on getting the case to trial, including disclosure and evidence. Preparation of skeleton arguments. Trial (including cross-

Please note this fee includes payment for the course, accommodation, food and beverage. CPD: 16+ CPD hours

examination of expert witnesses). Judgment. Feedback. The course leaders are Vicki Salmon (IP Asset) and Richard Davis (Hogarth Chambers). The other tutors will be IP barristers, solicitors or PALs. There will be a guest speaker at the introductory day on Wednesday 22 February 2016 (the IPEC judge in previous years). The course is designed for Fellows of CIPA, but there are a limited number of places available for solicitors and barristers. The course is limited to 30 delegates, to ensure that everyone gets the opportunity for hands-on learning.

Important Information: In order to ensure the smooth running of this course, we need to have 16 delegates confirmed, these places will be filled on a first come first served basis.

If you would like to register your interest or find out more information please contact cpd@cipa.org.uk before Friday 16 December 2016

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PERSONAL

Going . . . e ot Rem

hat a difference a month and a few hundred miles can make… swapping the busy streets of Kuala Lumpur for the tropical island paradise of Koh Phangan, it was clear that the second month of Remote Year was going to be nothing like the first. And so it proved… Aside from the obvious slow-down in pace which comes from living on a beach, probably the biggest difference is that, unlike KL, Koh Phangan is one of those places you really don’t feel inclined to leave. It would be quite easy to spend the whole month there, enjoying the views from the sea-front workspace, eating your fill of amazing Phad Thai, trying (and failing) to blend in with all the yoga instructors and never quite tiring of the sunsets. You couldn’t be blamed for “forgetting” there is a whole country to explore. Fortunately, I identified this risk early on, and decided to spend a week travelling around some of mainland Thailand before island life consumed me entirely. And I’m glad that I did, or else I would have missed out on all sorts of unexpected pleasures. We started with the obligatory one night in Bangkok, a stark contrast to our peaceful island home. Apparently this massive, sprawling, sweltering city has more cars than

GOING REMOTE

Thailand: Koh Phangan By Heather Lane (Fellow) people – and after sitting in its traffic jams for many hours I can well believe it. As if to prove the point, the airport car park operated via a version of real-life Jenga in which cars are double parked on purpose (since there is nowhere else for them), leaving the handbrake off and gears in neutral so that you can push them out of the way should you need to retrieve your own car from behind them. Hours of fun! However even within the centre of town, once we escaped the traffic, we found tranquil pockets of calm in the form of the stunning Buddhist temple complexes which dot the city. We were fortunate enough to arrive at the famous Wat Po temple just as the sun was beginning to set, which made the gold-trimmed buildings appear to glow. After spending the evening politely declining interesting offers at Bangkok’s extensive night markets, speeding between them in a series of hair-raising tuk-tuk rides, the next morning we headed further north to the ancient capital of Ayutthaya, which was ransacked by the Burmese in the 17th Century. The result is a beautiful jumble of crumbling ruins, temple spires leaning at unlikely angles and headless Buddha statues. Here, the pace of life is much slower – two of the best ways to get round are by bicycle (especially if your car battery has gone flat…) or by elephant, which seem to know their highway code pretty well. In the evening, we were lucky enough to visit the elephants’ favourite bathing spot and to watch them cool off in the river, which was mesmerising. The next day, we drove west to visit the site of the BurmaSiam railway – better known now as the Death Railway,

Enjoying the views from the sea-front workspace

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www.cipa.org.uk

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PERSONAL

where tens of thousands of Allied prisoners of war were put to work during WW2. For me, there was a particular resonance since my grandfather was one of the fortunate survivors. I’ll admit I was apprehensive about visiting a place with such unhappy associations, but to my surprise I found it to be one of the most beautiful and peaceful places I have been, which feels like a good tribute after what happened there. Finally, we flew to the city of Chiang Mai, full of temples, bazaars – and lots and lots of food. We took a day to scooter round the ancient city centre, getting lost in the stunning temple complexes and soaking up the welcome shade they offered, before driving up to Wat Doi Suthep, perched high on a hill above the city to watch the sun go down. The next day we were lucky enough to spend exploring some of the surrounding area as guests of a local family whom we had

IP INCLUSIVE

met just by chance, ending up with a surreal but wonderful afternoon putting the world to rights with our host, his two young nieces, numerous cats, a dog and two chickens. And then, all too soon, it was back to the office and down to work again. Oh, ok – not office, beach. I forgot that bit. Island brain, you know? Next month: Phnom Penh, Cambodia Heather Lane is a Senior Associate at Gill Jennings & Every LLP To see if Heather has escaped the island, you can follow her adventures on her blog https://expatandtea.wordpress.com/ and on Instagram as @expat.and.tea http://www.gje.com/person-13-heather-lane.html www.remoteyear.com

Women in IP group Report of the launch event for the Women in IP group, attended by 200 people on on 2 November 2016. See more on the IP inclusive website at www.ipinclusive.org.uk/blog.

nder the umbrella of the IP Inclusive initiative, the first Women in IP event was held on 2 November 2016, hosted by IP Inclusive Charter signatory Norton Rose Fulbright LLP. The event featured an interactive panel discussion on: “The power of networking and mentoring in developing your career”. Feeling a bit daunted on arrival at the rapidly filling room confirmed that one of the topics of the event – networking – was going to be a very useful one. The event began with introductions to the group and the IP Inclusive initiative by Women in IP committee members and Andrea Brewster. They outlined the aims of IP Inclusive and explained how the Women in IP committee aims to facilitate the building of a network of women across the IP professions that will enable challenges to be recognised, shared and overcome. I haven’t attended many of these types of events, but it felt very welcoming from the outset as Andrea explained in her introduction that it was open to all members of the IP profession, including patent and trade mark attorneys, solicitors, barristers, trainees, administrators, UK IPO staff and searchers. In fact, as Andrea pointed out, just seeing the large number of women together in one room gave a sense that “prevalence is confidence”. The first part of the event then got underway as the panel (Claire Baldock, Penny Gilbert, Jean Hughes, Parminder Lally, Suzanne Oliver and Kate O’Rourke,

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expertly chaired by Carol Arnold) drew upon their differing experiences of mentoring and networking. The range of experience of the panel members was inspiring, and the discussion highlighted that mentoring and networking have always been necessary skills, but the means to mentor and network have changed and continue to change. (Meeting people for coffee and a chat wasn't always possible, and LinkedIn® has not always existed!) Panel chair, Carol Arnold, defined a mentor as being someone who “talks to you about you”, and as someone having the skills and experience to facilitate learning and career progression. A mentor is someone who can give you the benefit of their hindsight. The definition helped highlight that mentoring is not necessarily a formal process, and can often take the form of what may feel like informal chats (with or without cake!) Having different mentors for different skills or career stages can also be valuable. So, how to go about looking for a mentor if you do not have one already? You will need to: • • •

Determine what you need from a mentor – what skills do you need to develop, what advice do you want? Work out if someone has got the information/experience you are looking for. Ask them to be your mentor! DECEMBER 2016

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The panel talked about not only benefitting from having mentors themselves but also from mentoring others within their firms and organisations, via the CIPA Informals, and via university societies, outreach programmes, and via the Law Society. On the topic of networking, the panellists offered advice and practical tips for building and maintaining a network. The panel stressed that networking is just a way of building relationships and this is not limited to potential clients, but applies to colleagues and other members of the profession too, all of whom could be useful for your career development. Attending events may seem nerve-wracking or even terrifying if you are shy and/or just starting out in the profession, but the panellists reminded us that, in general, everyone is in the same boat. Choosing an event where you have something in common to speak about – maybe a university event or a lecture which has a social element afterwards – can be a good way to build your confidence. Taking a friend along to events can also help you feel less nervous. Do not forget to talk about yourself when meeting new people – this gives them something to remember you by when following-up afterwards. The audience asked the panel for advice on how to follow-up with people after a networking event. They suggested: •

Following-up selectively and personally – do not feel obliged to follow-up with everyone you meet, and do not send the same generic message to everyone!

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•

Follow up promptly – this could be via LinkedIn®, email, or if the connections are within your organisation, dropping by their desk/office.

•

Connecting via LinkedIn® – this can provide an easy way to find out about your contacts’ new qualifications, new ventures/jobs, and interests, and provides you with something to talk about when you follow-up or see them again.

•

Keeping in regular contact, not just when you want something!

And then it was time for drinks! After listening to the discussions on networking, it felt more comfortable than usual to both catch-up with people I know and meet new people at the reception. I chatted with representatives of the UK IPO, which was interesting and gave me some insight into the other side of the patent prosecution process. As the reception went on well past the scheduled end time, it seems that many of the attendees also enjoyed the opportunity to connect and reconnect. I thought the event was expertly organised and enjoyable, and it provided much food for thought and many practical suggestions for building and maintaining a network. I recommend future events to all, and it would especially be nice to meet other paralegals, administrators and practice managers at the next event. Cathy Mack (Fellow), Practice Manager at TLIP Ltd

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ANNOUNCEMENTS

A business and IP degree in the European Union I would like to draw the attention of members to a Master’s degree programme in business management and intellectual property law offered by CEIPI; indeed, to heartily recommend it. The next course runs from 23 January to 24 June 2017 and is open for applications up to early January. CEIPI, attached to the University of Strasbourg in Alsace, France, is the senior European school for intellectual property studies and among many other things provides training for European patent attorneys and UPC judges. The course is formally The Master of Intellectual Property Law and Management (MIPLM) and the content can be simply thought of as an LLM and part of an MBA. The programme is designed especially for patent attorneys, lawyers and other experienced IP professionals, such as technical managers moving up in IP management. It aims to qualify such people to act as IP managers, with the practical skills and knowledge to deal with the new challenges of wealth creation and profit generation in a knowledge-based economy. Participants acquire an understanding of how intellectual property works in business models and the skills to achieve the systematic alignment of IP management and business objectives. More details are on the website www.ceipi.edu/index. php?id=5478&L=2 The business side of the course is taught by Prof. Dr. Alexander Wurzer, a natural scientist who as well as holding academic posts is a consultant in business strategy, IP management and valuation. He is author of numerous publications on these subjects, including textbooks, and chairs

the committee that developed the DIN standard for patent valuation. The law teachers are professors drawn from about 15 of the most distinguished IP law faculties across Europe including the UK. The law content offers a comprehensive study of IP law and its commercial relevance, with a European civil law feel. The business content will equip a lawyer with an understanding of corporate economics and strategy tools, and with the boardroom vocabulary to allow them to collaborate confidently with businesses on strategic management. The format of the course is highly condensed and allows one to continue in one’s normal job to some extent. There are six modules in six months, with lectures one week in four in Strasbourg. I estimated that there were 230 hours of lectures including 3300 slides; there was course work in Strasbourg, home assignments, a written examination and an oral examination. The cost would be about £9000 including travel and accommodation. A great pleasure and advantage of the course is the connections made with fellow students (about 20) who will be in senior roles in IP management. Another pleasure and advantage is to be in receipt of the degree of Master of Laws under the Ministry of Education of the French Republic. This entitles a European patent attorney to represent before the UPC. Kerry Tomlinson (Fellow), MA MIPLM (LLM)

Announcements Marks & Clerk has brought five associates of its member firms into partnership. In the UK, Graham McGlashan (Fellow) and Mike Williams (Fellow), patent attorneys based in the Glasgow and Manchester offices respectively, and Dafydd Bevan, a solicitor based in the London office, have all been promoted to partner. Elsewhere, trade mark attorney Cynthia Houng from the Hong Kong office and patent attorney Upasana Patel (Fellow) from the Singapore office have also been promoted to partner. Hicks & Associates Intellectual Property congratulates its associate, Dr William Murphy (Fellow), on becoming a Registered Canadian Patent Agent. See more details on page 60. IPReg Chair Resignation: CIPA received notification from IPReg that Caroline Corby has resigned her position of Chair with effect from 10 November 2016, due to personal reasons. Steve Gregory, lay Board member, has been appointed Acting Chairman and the Legal Services Board has been advised. Letters for the Editor and announcements should be e-mailed to: editor@cipa.org.uk

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CPD & EDUCATION

Update on SPCs Report of a CIPA webinar, 18 October 2016, 12.30pm

his fascinating and detailed CIPA webinar covering recent supplementary protection certificate (SPC) case law was delivered by Dr Duncan Curley, Director and Head of Patents at Innovate Legal Services Limited, a London-based boutique law practice. The remarkable level of detail and clarity provided by Duncan to this complex area cannot be replicated here, but the main case details are given (and are readily accessible on the Internet), with an indication of relevance to practice.

Background SPCs — available for human and veterinary medicinal, and plant protection products — extend the term of a patent for a period of up to five years, compensating the patent holder for the time-to-market delay resulting from the regulatory

1(a) medicinal product – any substance or combination of substances for treating or preventing disease in human beings or animals … for medical diagnosis or restoring, correcting or modifying physiological functions; 1(b) product – the active ingredient or combination thereof of a medicinal product; 1(c) basic patent – a patent which protects a product, or process or application of a product.

Reference

Issue Date

Overview

Actavis v Sanofi

C-443/12

12/12/13

Medeva

C-322/10

24/11/11

Georgetown I

C-422/10

24/11/11

Georgetown II

C-484/12

12/12/13

Actavis v Boehringer

C-577/13

12/03/15

The courts’ judgments variously covered the subject-matter of the invention, the core inventive advance, single-active claimrelevance to [combination product] MA, and the presence of specific claims alongside, and the innovative nature of the [combination] product.

Merck Sharp & Dohme

[2016] EWHC 1896 (Pat)

29/07/16

Merck Canada

C-555/13

13/02/14

Seattle Genetics

C-471/14

06/10/15

Genzyme

UKIPO BL O/418/13

22/10/13

Hoffman-La Roche

C-572/15

05/10/16

[2013] EWHC 619 (Pat)

21/03/13

C-210/13

14/11/13

Forsgren

C-631/13

15/01/15

Pharmaq AS v Intervet

E-16/14

09/04/15

SPC duration case law from the CJEU and the UK’s Intellectual Property Office (IPO)

Active ingredient case law from the CJEU, the EWHC and the European Free Trade Association Court (equivalent to the CJEU for the European Economic Area)

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Regulation (EC) No. 469/2009 – summary of Articles 1 and 3

Case Combination product case law from the Court of Justice of the European Union (CJEU) and England and Wales High Court (EWHC)

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approval process. The key aspects of the relevant Regulation (EC) No. 469/2009 are the Article 1, Definitions; and Article 3, Conditions for obtaining a certificate, are set out below:

GSK Biologicals

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The courts’ judgments addressed the maximum permissible term of exclusivity, the exact date from which SPC term is calculated (date of notification of MA), and the impact of country EU-accession date alongside MA date.

The courts’ judgments related to the definition of an active ingredient in terms of whether a substance [that forms part of a medicine] has an effect on its own, and the consideration of SPC protection for an active ingredient outside the wording of the MA.

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3(a) The product is protected by a basic patent in force; 3(b) a valid marketing authorisation (MA) for the product has been granted; 3(c) the product has not already been the subject of an SPC; 3(d) the MA is the first authorisation to place the product on the market. The wealth of case law has arisen from pharmaceutical companies’ interpretation of and value-extraction from the Regulation, and has served to help regularise interpretation of the Regulation in EU member states and, sometimes, to highlight differences. Duncan focused his presentation on combination products, calculation of SPC term, and the definition of ‘active ingredient’. [See table opposite.]

Other SPC issues •

There is a proposal for an advanced manufacturing waiver of rights conferred by an SPC for generics to address the perceived disadvantage for generic/biosimilar

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•

manufacturers operating within the EU – compared with those outside the EU, where the exclusive rights which have not been extended by an SPC very likely expire earlier. There is an intention to review the SPC Regulation. A study has been put out to tender to evaluate the requirement for a new Regulation to meet market developments in the EU, and review the legal efficiency and economic aspects of the current SPC framework. The impact of Brexit on SPC regulation will become apparent in due course. Alexis Harper (Associate), Jalcyon Limited

Missed this webinar? A recording is available from CIPA, contact cpd@cipa.org.uk. (Also see Carpmaels & Ransford’s SPC review published in August-September [2016] CIPA 14 and October [2016] CIPA 40.)

IP Enforcement A joint CIPA / ITMA CPD webinar; speaker Huw Watkins (IPO); 5 September 2016.

uw Watkins is Head of the IPO Intelligence Hub, and is also the UK Policy Lead on an Interpol/ Europol initiative, Operation OPSON, which works to ensure the continued safety of the UK food chain. A retired police officer, the majority of Huw’s police service was as a detective. Huw was Head of Force Intelligence Bureau for the Gwent Police, where he managed a team of intelligence professionals in key areas of risk; including kidnap, extortion and online child protection. The IPO Intelligence Hub was created to provide a link between enforcement and intellectual property right (IPR) holders, sharing intelligence on counterfeiting and piracy between public and private enforcement bodies. The Hub provides expert analysis of intelligence, enabling law enforcement and other agencies to take action. So, the scene was set for a fascinating insight into the sharper end of IP enforcement, focusing more on the brand-based IPRs of trade marks, design, copyright and counterfeiting: issues some distance away from paper-based exchanges and formal oral oppositions. Huw did, however, share a ‘sharp-end’ story for the IPO at Newport which, only last month, had to call in bomb disposal experts to evacuate the Office and perform a controlled explosion: an applicant had submitted, together with the application, a device which was intended to kill fish! One of the roles of the Hub is to ‘map’ (monitor)

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organised crime groups in the UK. There are more than 7,500 of these groups, 80 of whose activities are attributable to counterfeited goods. Mapping focuses on intent, capability, and crossover with other similar groups. Traditionally, the lead organisation in IP crime enforcement has been Trading Standards, dealing also with doorstep crime, rogue traders and product safety. Online trading has created additional resource difficulties. The task is to provide co-ordinated enforcement against criminal abuse of copyright and trade marks in difficult financial times, or: ‘how can we do more with less, and in the face of conflicting priorities for budget’. Huw invited the audience to consider the risk-ranking of issues such as child protection, drugs, benefit fraud, IP crime, drink driving, antisocial behaviour and domestic violence. He went on to demonstrate how an issue could move up or down the priority list, depending on severity. For example, child protection would rightly be ranked as high priority. If this related to a historic incident, it might change the risk to medium or low. IP crime involving counterfeit vodka might initially be ranked as low risk, but if use of the product led to death or blindness (as it did, with 38 deaths in the Czech Republic in 2012), it would move to high risk. IP enforcement can be impacted by recession, with resulting cuts in services, availability of resources, job losses and demotivation of staff. Doing more with less DECEMBER 2016

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IP enforcement challenges for the IPO 1.

2. 3.

To reduce the level of illegal online content: in 2013 the Police Intellectual Property Crime Unit (PIPCU) was established, funded by the IPO and run by the City of London Police, with a special focus on offences committed online. To date, thousands of infringing websites have been removed. To tackle the trade in counterfeit goods. To strengthen the legal framework to facilitate easier access to justice: private criminal prosecutions have flourished as rights’ holders take more responsibility. To increase IP education, awareness and respect: in the UK, the public generally have a lenient view of counterfeit goods. To make it easier for UK right holders and businesses to trade internationally: for example the China-Britain Business Council (CBBC); and To improve the evidence-base for IP enforcement policy: better informed research will lead to better informed policy.

is often achieved by working through collaboration and partnership efforts. In May 2016, the IPO published IP Enforcement 2020, a document setting out the government’s IP enforcement strategy for the next four years. The IPO is encouraging contributions and information-sharing to assist with IP enforcement. The IPO may hold information which could assist IP right holders. In the processing of intelligence (which can sound rather ‘secret service’), information is subjected to a system of processing and analysis which reveals accuracy, what is known/not known, source reliability, information access, and the managing of information sharing in a sensitive manner.

INSTITUTE EVENTS

To highlight the effectiveness of multi-agency collaboration, Huw recalled the case of a Brighton restaurateur who bought a substantial quantity of a wellknown sparkling French wine. On closer inspection, the wine appeared to be counterfeit. The collaborative investigation involved the Immigration Office, the IPO, Trading Standards, the Food Standards Agency, and Europol, plus partner agencies in France, Spain, Portugal and Italy; and revealed a supply network that originated in Naples and which was part of a wider criminal activity. The HMRC took the lead in this investigation, which resulted in an £8.5m tax bill for the perpetrators. A Q&A session considered the usefulness of information-sharing between attorneys and the IPO. Details of the issuance of cease-and-desist letters, for example, could be useful intelligence to the IPO. It was acknowledged there could be information sharing issues due to obligations between attorneys and their clients. Alexis Harper (Associate), Jalcyon Limited On 28 September (and therefore three weeks after the webinar), the IPO launched the annual IP Crime Report for 2015-16. The report provides an insight into the scale and scope of counterfeiting and piracy in the UK and an overview of the work being done by law enforcement and IPO stakeholders to tackle these threats. See https://www.gov.uk/government/ uploads/system/uploads/attachment_data/file/555795/ ip-crime-report-2015-16.pdf

Reporters Needed! CIPA is looking for volunteers to report on regional CIPA events. If you are interested, please contact cpd@cipa.org.uk.

IPO update – double-sided printing The IPO Patent Formalities Team processes letters and reports produced by patent examiners and formalities officers. Currently these documents are usually printed on single-sides of paper. This results in Formalities issuing some 14,000 documents every quarter, most of which contain multiple pages. This requires a very large number of sheets of paper. We propose to introduce double-sided printing of all letter and reports, including Certified Office Copies, early in 2017. This will result in no loss of clarity or quality in the documents we produce, but will be a significant saving in terms of paper use. If this results in any questions or comments, these might be best directed to the IPO via the CIPA representatives on the Patent Practice Working Group (PPWG) . Glenn Rose’Meyer (Divisional Head of Administration), IPO

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