Infringement & Validity Study Guide (2024)

Infringement & Validity Study Guide to the

Paten t E xa min a t i o n B o a rd Final Diploma 4 Examination

Philip Barnes

Infringement & Validity Study Guide to the

Patent Examinat i o n B o ard Final Diploma 4 Examination

By Philip Michael Barnes

2024

The moral rights of the author have been asserted.

All rights reserved. No part of this publication may be translated, reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the author. © Philip Michael Barnes, 2024 Published and placed on sale by: The Chartered Institute of Patent Attorneys 2nd Floor Viaro House 20 – 23 Holborn London EC1N 2JD United Kingdom Tel: +44 20 7405 9450 Fax: +44 20 7430 0471 Website: www.cipa.org.uk

ISBN 978-0-903932-85-1 Printed and bound by Hobbs – www.hobbs.uk.com

FOREWORD It has been a while since the CIPA FD4 Study Guide was updated, for which I apologise!

A bit of history: in 2018, I was asked by CIPA to update their FD4 Study Guide but only had time to edit what had previously been written and updated for several years by Nigel Frankland. If I had had more time, I would have rewritten the whole book in my own style. I had always intended to re-write the whole book shortly thereafter, as a future edition.

Since then, there have been many incremental changes to the FD4 examination.

Every year, these changes increasingly make me think that FD4 Study Guide needs updating, as they move the exam further and further away from the position in the book. I am pleased to report that I have finally done so. My attempt at a complete re-write started in 2020 during lockdown and has taken (much) longer than expected, but I hope you think the results are worth it.

I am no longer an examiner for FD4, but actively tutor candidates for the exam both in my firm and on revision courses. This has helped me test what works for candidates to pass the exam.

I now plan to update this study guide annually to avoid the incremental changes to the examination building up between updates of the study guide. Hopefully, by declaring this publicly, here, I will be kept honest and actually review and update the study guide each year shortly after the exam results are published (which will allow me to update the book having reviewed the previous year’s exam, marking schedule and examiner’s comments).

Philip Barnes Windsor, May 2024

CONTENTS

1. Introduction to FD4................................................................................... 1 2. The Legislation.......................................................................................... 7 3. The Case Law.......................................................................................... 37 4. The FD4 Examination.............................................................................75 5. Interpretating Patent Claims .............................................................. 83 6. Assessing Infringement........................................................................ 91 7. Assessing Novelty.................................................................................. 97 8. Assessing Inventive Step.................................................................... 101 9. Assessing Sufficiency......................................................................... 107 10. Identifying Amendments.................................................................... 111 11. Preparing Advice.................................................................................. 115 12. Preparing For FD4................................................................................ 119 13. Conclusions..........................................................................................121

CHAPTER 1

INTRODUCTION TO FD4

FD4 in a nutshell The ‘Final Diploma 4: Infringement & Validity’ (usually referred to as ‘FD4’ and previously known as, and still commonly referred to in the profession as, ‘P6’) examination seeks to test a candidate’s ability to prepare an infringement and validity opinion for a set of (typically granted) patent claims for (at least) one potentially infringing article and in view of (at least) one piece of prior art.

Different variations on this theme are possible, for example where the patent is still pending or where there are more than one potentially infringing articles or more than one pieces of prior art. I will go into some of the possible permutations later in this book.

To answer the question paper, candidates need to attempt to prepare a summary of key points of interpretation for the claims being considered, assess the likelihood of infringement by any potentially infringing articles and then assess the likely validity of the claims being considered; following which candidates should prepare a short analysis of whether there are any sufficiency issues worth f lagging, and propose any potential amendments that might potentially fix any issues with the validity of the claims being considered while maintaining that infringement is likely; and then finally some advice is prepared to summarise the situation and both pro-actively offer relevant advice to the ‘client’ and reactively advise the ‘client’ in response to a set of questions posed in a letter from the ‘client’.

In just over five hours.

People who have previously sat this paper will probably tell you that one of the top challenges about this paper is either the amount of work to do, or the time available (essentially variations of the same theme, as you will appreciate: time). This isn’t true for everyone, as some people can complete the paper in the time available once

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INTRODUCTION TO FD4

they understand what is being tested. For those that can’t ‘naturally’ complete the paper in time, a structured approach combined with time discipline should allow you to be able to obtain sufficient marks to be able to pass safely.

Why is FD4 a good test I want to start with what might be taken to be a bit of a controversial statement: FD4 Is a Good Test. Hear me out on this one!

Now, I am willing to bet money that most other patent attorneys and trainees don’t share this opinion (in a profession where many people are scarred by their experience in securing a pass for this paper!), but I don’t say this to incite rebellion – merely to try to point the finger at what I think is really the problem...

My view on the examination is this: I think that the FD4 examination is a very good test of the competence of aspiring patent attorneys, at least in principle, as it tests a wide variety of the skill and knowledge that you should find are applied in a patent attorney’s day-to-day practice, and this is tested in a very practical way in order to determine and assess how a candidate works through the ‘puzzle’ and concludes with appropriate advice for a theoretical client (admittedly, based on a slightly contrived situation).

I particularly like that the ‘output’ from all of the analysis performed during the examination is advice for a client. This, as I see it, is one of the key skills of the job of a patent attorney – distilling a typically highly complex situation into an easy to follow summary and actionable advice for our clients. However, sadly, the advice section of the paper is generally the section attempted at the end of the exam and thus the section for which candidates experience the most acute time pressure.

In summary: this set of tasks encompasses, I think, the core activities of a UK-based patent attorney in day-to-day practice (pulled together in one compressed exercise).

Hence I think that passing this exam is a good sign that those who pass will make a good patent attorney!

Let’s look at what I think the real problem is here.

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Why do candidates struggle?

The limited time available has always been at least a gripe if not a complaint among candidates for not years, but decades!

This time limit means that it is, of course, impossible to do a ‘good job’ (by which people mean a normal job, i.e. as would be expected when preparing real-world advice for an actual client). However, practically, an exam probably can’t realistically last for more than around five hours in one sitting and so I feel that we must be in a situation where the maximum realistic time has already been allocated for sitting this exam and we are stuck with it taking around five hours as a maximum.

Bear in mind that some candidates get some extra time on top of this and there is now extra time for printing the paper and then scanning and uploading your answer to enable the exam to be sat remotely.

Thus, we find ourselves in a contrived position where the paper has to be short enough to be consumed in a realistic maximum amount of time of just over five hours, but complex enough to pose a real test to candidates so that the examiners can assess their answer against what skills and knowledge the exam is testing.

Personally, I think that the contrived nature of the exam is an advantage to candidates, and I will go into more detail about this later in the book.

There is also a general reputation of the exam as being one that is hard to pass. To be entirely fair, the data on pass rates means that it is hard to argue with this: the pass rates for this exam are relatively low and consistently so.

However, the reputation doesn’t help, as it results in candidates approaching the exam in either a negative way or with per-conceptions that are mostly unhelpful.

Based on what I have seen over the time I have been tutoring FD4, I believe that it is actually the information on preparation for the examination that seems to have gone ‘wrong’ and if candidates were able to understand the exam better, and what was needed to pass the exam, both the reputation of the examination would improve, as well as the pass rate. Hopefully this book will chip away at this problem and provide useful instruction to those planning to sit the exam in future.

Anecdotally, I also think that, as a profession, in our day-to-day practice there seem to be far fewer infringement and validity opinions being prepared – possibly due to the high cost of preparing these – and this means that trainees do not get

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INTRODUCTION TO FD4

the experience in assisting with their preparation and therefore have more limited exposure to the knowledge and skills involved. Many trainees are fed a ‘diet’ of European Patent prosecution, with the occasional draft patent specification to either assist with or draft, and rarely get the opportunity to take part in advisory, dispute or litigation work except possibly assisting with oral proceedings at the EPO. This is just the way of the world, but I would recommend jumping at the chance if you ever get the opportunity as a trainee to assist with litigation or advisory work!

How not to struggle From my decade of active FD4 tutoring, courses, and training, I have gathered empirical ‘data’ on what seems to work in this exam (i.e. what training, advice and preparation actually gets my tutees/trainees/course attendees to pass).

I have done this by giving courses/tutoring, then looking at the papers of some of those who failed after attending my course or who I tutored to figure out why they failed and then either adapted my approach or developed it further to try to mitigate against the same mistakes causing people to fail.

The first point I would make, based on this experience, is that it is vital to understand the exam: i.e. what do papers look like; what does a good answer look like and why; what knowledge is needed; what skills are needed; practically what does one need for the actual exam and what preparation is required.

This book will help you with this, but in addition you will need to do some background reading to cement what this book tells you. Doing some mock papers (to time and in exam conditions please!) will round out what you need to address this point.

The second point is to develop a way to answer the paper that works for each candidate: to do this candidates need to attempt past papers to time and iterate their answer technique based on assessment of/feedback on their answer.

I recommend writing down a plan prior to sitting each mock paper, e.g. planned order and timings for reading/writing/sections, and adjusting this each time a mock paper is sat until a reliable plan is arrived at (this then needs to be practiced so that it is tested in advance of the exam).

This book can only help so much with this second point, as each candidate will need to put in the time and effort to sit multiple mock papers – I generally advise trying to do at least one paper a month from May until the exam in October.

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My approach (in this book) I have structured this book to attempt to provide: (1) a simplified summary of some of the key legislation and case law that needs to be used to prepare a solid answer to the examination (obviously this doesn’t substitute for more detailed reading of the source cases, discussion of the case law with study partners, reading of commentary on these cases, and also following the development of case law as it evolves – this I leave up to you) with a view to showing those preparing for the FD4 examination how the various principles from legislation and case law are derived and how these interact; (2) an overview of the exam itself; (3) explanations of some techniques and considerations for each section of the paper, i.e. for construction, infringement, novelty, inventive step, sufficiency, amendment and advice; and (4) some tips for how to prepare for, and then revise for, the exam.

I will finish with some conclusions that I want to make sure candidates take away from reading this book, to highlight some of my key tips on taking this exam.

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THE LEGISLATION

At first glance, this exam should seem easy in terms of theoretical knowledge: you need to understand the law on (a) validity and (b) infringement. However, this isn’t the whole story. There are also the matters of sufficiency and amendment, which are two separate sections of the paper each of which score marks for an answer.

You will also need to know a little bit about a lot of patenting issues in order to be able to give a solid answer to the advice section. In the advice section, the fictitious client will either need answers to their questions (set out in the client letter in the exam paper) or they will raise issues somehow, in their letter or by virtue of the situation they find themselves in, that need to be f lagged to them and/or on which they might need some more concrete advice.

Throwaway comments in the client letter (in the exam paper) are rarely able to be dismissed completely. Typically, these are cues from the examiners to advise on a particular legal point, like inventorship or ownership to pick some example issues that might be raised (and have been in the past).

Consequently, it is useful to have done the FD1 exam recently, or to be doing it at the same time as doing the FD4 exam, as this will provide most if not all of the legal knowledge needed to advise in a typical FD4 exam.

To assist with preparation for the FD4 examination, I have put together a brief guide to the relevant sections of the legislation that you should study in relation to each section of the paper. I have also prepared summaries of some of the relevant case law.

All sections mentioned are those of the Patents Act (as amended) at the time of writing so do be careful to check in case any updates have been made!

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THE LEGISLATION

CONSTRUCTION It is worth noting that I don’t think there is much that is helpful in the legislation about construction, but there certainly is in case law which we will address in later portions of this book.

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INFRINGEMENT The relevant sections of the Patents Act (as amended) are sections 60 & 61. All sections mentioned are those of the Patents Act (as amended) at the time of writing so do be careful to check in case any updates have been made!

Section 60 deals with the definition of infringement and Section 61 deals with infringement proceedings.

To summarise, there are a few different headings of infringement that you must be aware of and apply when sitting the FD4 paper:

1. Direct infringement There are, in essence, two components to direct infringement: (a) an assessment of whether all of the claim features are present in the infringement; in combination with (b) an infringing act.

Lots of candidates taking the exam forget the infringing act! There are (usually) marks for stating what this is, or possibly you will only get the mark(s) for direct infringement if you state this.

There are a few more conditions: (i) the patent has to be in force; (ii) the act must be done in the United Kingdom; and (iii) permission has not been obtained from the patent holder (or authorised delegate thereof).

These conditions are sometimes subjects on which you need to advise in the Advice section of your answer.

1a. Direct infringement – products Section 60(1)(a) sets out the infringing actions for products, which are usually remembered by the initials ‘MUDOIK’: •

M: making;

•

U: using;

•

D: disposing;

•

O: offering to dispose;

•

I: importing;

•

K: keep.

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THE LEGISLATION

In most FD4 papers that I can think of, the infringement is usually a product.

However, there has been at least one method/process paper in the last five years, so don’t assume that the paper will always have only product claims.

1b. Direct infringement – processes Infringing actions for processes are a bit simpler, and defined in section 60(1) (b), where either use or offers to use would be the infringing acts – but there is a caveat that this use or offer to use was done with the knowledge (or that it would be obvious to a reasonable person – otherwise this would potentially become a trivial or at least arguable condition to try to escape liability) that it would be an infringement.

1c. Direct infringement – product by process The circumstance of selling a product using a patented process is also explicitly dealt with in the legislation, in section 60(1)(c).

The acts are very much similar to with straightforward products.

2. Indirect infringement Section 60(2) deals with another way of infringing: indirect infringement (also known as contributory infringement).

Candidates should note that this type of infringement comes up regularly in FD4, and there will be a decent amount of marks if you can apply this test comprehensively in exams where this comes up – which will be the case if there is any indirect infringement situation set up by the examiners in the exam paper. It is well worth knowing the requirements for indirect infringement in detail.

This concept tries to prevent infringers avoiding infringement by deliberately omitting certain features of the claimed invention in their otherwise infringing product or process but in the knowledge that the end user will then almost immediately add the missed feature that was deliberately omitted.

Again there are a few of the same conditions as for direct infringement: (i) the patent needs to be in force; (ii) the infringer doesn’t have the permission of the patent owner (or their delegates).

Then we have something commonly termed the ‘double territoriality requirement’:

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first, as with direct infringement (see above), the (1) supply or (2) offer to supply needs to happen in the United Kingdom and, second, what is supplied or offered to be supplied needs to be intended to be put into use in the United Kingdom (or it would be obvious to a reasonable person that this was the case).

The key and more complicated element of the test is whether what is supplied (or offered to be supplied) is the means relating to an ‘essential element of the invention, for putting the invention into effect’. In the examination, candidates will need to set out their reasoning and conclusions on this point.

3. Infringement under the Actavis case There is another heading of infringement which will be set out in the case law section of this book and explained in more detail in the Infringement Section of the exam paper guidance later in this book.

Other points There are some other points worth being aware of, specifically there are some exceptions to infringement that very occasionally come up, usually in the advice section. These are set out in Section 60(5) of the Act.

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THE LEGISLATION

QUICK REFERENCE: SECTION 60 Meaning of infringement (1) Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say (a) where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise; (b) where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent; (c) where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise (2) Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom.

(3) Subsection (2) above shall not apply to the supply or offer of a staple commercial product unless the supply or the offer is made for the purpose of inducing the person supplied or, as the case may be, the person to whom the offer is made to do an act which constitutes an infringement of the patent by virtue of subsection (1) above.

(4) [repealed] (5) An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if – (a) it is done privately and for purposes which are not commercial;

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(b) it is done for experimental purposes relating to the subject matter of the invention; (c) it consists of the extemporaneous preparation in a pharmacy of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner or consists of dealing with a medicine so prepared; (d) it consists of the use, exclusively for the needs of a relevant ship, of a product or process in the body of such a ship or in its machinery, tackle, apparatus or other accessories, in a case where the ship has temporarily or accidentally entered the internal or territorial waters of the United Kingdom; (e) it consists of the use of a product or process in the body or operation of a relevant aircraft, hovercraft or vehicle which has temporarily or accidentally entered or is crossing the United Kingdom(including the air space above it and its territorial waters) or the use of accessories for such a relevant aircraft, hovercraft or Vehicle; (f) it consists of the use of an exempted aircraft which has lawfully entered or is lawfully crossing the United Kingdom as aforesaid or of the importation into the United Kingdom, or the use or storage there, of any part or accessory for such an aircraft. (g) it consists of the use by a farmer of the product of his harvest for propagation or multiplication by him on his own holding, where there has been a sale of plant propagating material to the farmer by the proprietor of the patent or with his consent for agricultural use; (h) it consists of the use of an animal or animal reproductive material by a farmer for an agricultural purpose following a sale to the farmer, by the proprietor of the patent or with his consent, of breeding stock or other animal reproductive material which constitutes or contains the patented invention (i) it consists of (i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, or (ii) any other act which is required for the purpose of the application of those paragraphs..

(6) For the purposes of subsection (2) above a person who does an act in relation to an invention which is prevented only by virtue of paragraph (a), (b) or (c) of subsection (5) above from constituting an infringement of a patent for the invention shall not be treated as a person entitled to work the invention, but – (a) the reference in that subsection to a person entitled to work an invention includes a reference to a person so entitled by virtue of section 55 above, and

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(6A) Schedule A1 contains – (a) provisions restricting the circumstances in which subsection (5)(g) applies; and (b) provisions which apply where an act would constitute an infringement of a patent but for subsection (5)(g).

(6B) For the purposes of subsection (5)(h), use for an agricultural purpose – (a) includes making an animal or animal reproductive material available for the purposes of pursuing the farmer’s agricultural activity; but (b) does not include sale within the framework, or for the purposes, of a commercial reproduction activity.

(6C) In paragraphs (g) and (h) of subsection (5) ‘sale’ includes any other form of commercialisation.

(6D) For the purposes of subsection (5)(b), anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject-matter of the invention.

(6E) In subsection (6D), ‘medicinal product assessment’ means any testing, course of testing or other activity undertaken with a view to providing data for any of the following purposes – (a) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere); (b) complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation; (c) enabling a government or public authority (whether in the United Kingdom or elsewhere), or a person (whether in the United Kingdom or elsewhere) with functions of – (i) providing health care on behalf of such a government or public authority, or (ii) providing advice to, or on behalf of, such a government or public authority about the provision of health care, to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care.

(6F) In subsection (6E) and this subsection-– ‘medicinal product’ means a medicinal product for human use or a veterinary medicinal product; ‘medicinal product for human use’ has the meaning given by article 1 of Directive

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2001/83/EC(2); ‘veterinary medicinal product’ has the meaning given by article 1 of Directive 2001/82/EC(3).

(6G) Nothing in subsections (6D) to (6F) is to be read as affecting the application of subsection (5)(b) in relation to any act of a kind not falling within subsection (6D).

(7) In this section – ‘relevant ship’ and ‘relevant aircraft, hovercraft or vehicle’ mean respectively a ship and an aircraft, hovercraft or vehicle registered in, or belonging to, any country, other than the United Kingdom, which is a party to the Convention for the Protection of Industrial Property signed at Paris on 20th March 1883 or which is a member of the World Trade Organisation; and ‘exempted aircraft’ means an aircraft to which section 89 of the Civil Aviation Act 1982 (aircraft exempted from seizure in respect of patent claims) applies ‘Directive 2001/82/EC’ means Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products as amended by Directive 2004/28/EC of the European Parliament and of the Council; ‘Directive 2001/83/EC’ means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by Directive 2002/98/EC of the European Parliament and of the Council, by Commission Directive 2003/63/EC, and by Directives 2004/24/EC and 2004/27/EC of the European Parliament and of the Council.

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THE LEGISLATION

QUICK REFERENCE: SECTION 61 Proceedings for infringement of patent (1) Subject to the following provisions of this Part of this Act, civil proceedings may be brought in the court by the proprietor of a patent in respect of any act alleged to infringe the patent and (without prejudice to any other jurisdiction of the court) in those proceedings a claim may be made – (a) for an injunction or interdict restraining the defendant or defender from any apprehended act of infringement; (b) for an order for him to deliver up or destroy any patented product in relation to which the patent is infringed or any article in which that product is inextricably comprised; (c) for damages in respect of the Infringement; (d) for an account of the profits derived by him from the infringement; (e) for a declaration or declarator that the patent is valid and has been infringed by him.

(2) The court shall not, in respect of the same infringement, both award the proprietor of a patent damages and order that he shall be given an account of the profits.

(3) The proprietor of a patent and any other person may by agreement with each other refer to the comptroller the question whether that other person has infringed the patent and on the reference the proprietor of the patent may make any claim mentioned in subsection (1)(c) or (e) above.

(4) Except so far as the context requires, in the following provisions of this Act – (a) any reference to proceedings for infringement and the bringing of such proceedings includes a reference to a reference under subsection (3) above and the making of such a reference; (b) any reference to a claimant or pursuer includes a reference to the proprietor of the patent; and (c) any reference to a defendant or defender includes a reference to any other party to the reference.

(5) If it appears to the comptroller on a reference under subsection (3) above that the question referred to him would more properly be determined by the court, he

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may decline to deal with it and the court shall have jurisdiction to determine the question as if the reference were proceedings brought in the court.

(6) Subject to the following provisions of this Part of this Act, in determining whether or not to grant any kind of relief claimed under this section and the extent of the relief granted the court or the comptroller shall apply the principles applied by the court in relation to that kind of relief immediately before the appointed day.

(7) If the comptroller awards any sum by way of damages on a reference under subsection (3) above, then – (a) in England and Wales, the sum shall be recoverable, if the county court so orders, by execution issued from t he county court or otherwise as if it were payable under an order of that court; (b) in Scotland, payment of the sum may be enforced in like manner as an extract registered decree arbitral bearing a warrant for execution issued by the sheriff court of any sheriffdom in Scotland; (c) in Northern Ireland, payment of the sum may be enforced as if it were a money judgment. .

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THE LEGISLATION

VALIDITY The relevant sections of the Patents Act 1977 (as amended) are: •

Section 2: Novelty

•

Section 3: Inventive Step

All sections mentioned are those of the Patents Act (as amended) at the time of writing so do be careful to check in case any updates have been made!

Looking at each of these sections in turn:

Novelty Section 2 of the Act sets out how novelty is assessed.

I am assuming that all candidates understand the basics of novelty: the claimed invention must be new over the prior art; and prior art is anything published before the priority date of the patent/patent application.

The other thing to watch out for is the novelty test under Section 2(3) of the Act, where prior art also includes patent publications made after the priority date of the claimed invention but the prior art itself having an earlier priority date than the priority date of the claimed invention. A common ruse of the examiners is to include this type of prior art in a paper to check that candidates do not also use it for assessment of inventive step (which is incorrect as it is ‘novelty-only’ prior art).

The techniques used to assess this will be set out in more detail in the chapter on assessing novelty later in this book.

There are a couple of sub-sections in Section 2 of the Act that are generally dealt with in advice if they come up: breaches of confidence and international exhibitions.

Inventive step Section 3 of the Act sets out how inventive step is assessed in theory, but not in practice.

This section makes clear that novelty-only prior art need not be considered to assess

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inventive step, but that the assessment is generically whether a ‘person skilled in the art’ would consider the claimed invention to be ‘obvious’ taking consideration of the prior art. See the information about about ‘novelty-only’ prior art.

The techniques used to choose a notional ‘person skilled in the art’ and how to assess whether this notional person (or persons!) would assess whether something was ‘obvious’ will be set out in more detail in the chapter on assessing inventive step later in this book.

Also, later in this book, the relevant case law on assessing inventive step will be summarised as this sets out how the tests for inventive step have been developed over time and understanding this will help candidates apply the techniques needed for assessing inventive step in the exam.

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THE LEGISLATION

QUICK REFERENCE: SECTION 2 Novelty (1) An invention shall be taken to be new if it does not form part of the state of the art.

(2) The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way.

(3) The state of the art in the case of an invention to which an application for a patent or a patent relates shall be taken also to which was published on or after the priority date of that invention, if the following conditions are satisfied, that is to say – (a) that matter was contained in the application for that other patent both as filed and as published; and (b) the priority date of that matter is earlier than that of the invention.

(4) For the purposes of this section the disclosure of matter constituting an invention shall be disregarded in the case of a patent or an application for a patent if occurring later than the beginning of the period of six months immediately preceding the date of filing the application for the patent and either – (a) the disclosure was due to, or made in consequence of, the matter having been obtained unlawfully or in breach of confidence by any person – (i) from the inventor or from any other person to whom the matter was made available in confidence by the inventor or who obtained it from the inventor because he or the inventor believed that he was entitled to obtain it; or (ii) from any other person to whom the matter was made available in confidence by any person mentioned in sub-paragraph (i) above or in this sub-paragraph or who obtained it from any person so mentioned because he or the person from whom he obtained it believed that he was entitled to obtain it; (b) the disclosure was made in breach of confidence by any person who obtained the matter in confidence from the inventor or from any other person to whom it was made available, or who obtained it, from the inventor; or (c the disclosure was due to, or made in consequence of the inventor displaying the invention at an international exhibition and the applicant states, on filing

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the application, that the invention has been so displayed and also, within the prescribed period, files written evidence in support of the statement complying with any prescribed conditions.

(5) In this section references to the inventor include references to any proprietor of the invention for the time being.

(6) [repealed]

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QUICK REFERENCE: SECTION 3 Inventive step An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (and disregarding section 2(3) above).

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SUFFICIENCY The relevant sections of the Patents Act 1977 (as amended) are: •

Section 14(3) and 14(5)(c)

•

Section 72(1)

Looking at each of these sections in turn:

Section 14 There are two requirements set out: (a) that the specification disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art; and (b) that the claims be supported by the description.

How this is applied in case law can be seen in the Warner-Lambert case discussed later in this book.

Section 72 Section 72 sets out that patents may be revoked if the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.

Concepts The courts appear to have two categories of insufficiency (see the summary in Warner-Lambert case paragraph 25) notably: (1) ‘classical insufficiency’; and (2) ‘Biogen insufficiency’.

Classical insufficiency is said to be where the skilled person is unable to perform the invention from the information disclosed in the specification.

‘Biogen’ insufficiency is said to be where the claim is said to be too broad, because it exceeds the disclosed contribution to the art. The ‘Biogen’ refers to the case Biogen Inc v Medeva Plc [1997] RPC 1, which is summarised in the case law section of this book.

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QUICK REFERENCE: SECTION 14 Making of application (1) Every application for a patent (a) shall be made in the prescribed form and shall be filed at the Patent Office in the prescribed manner; (b) [repealed] (1A) Where an application for a patent is made, the fee prescribed for the purposes of this subsection (‘the application fee’) shall be paid not later than the end of the period prescribed for the purposes of section 15(10)(c) below.

(2) Every application for a patent shall contain (a) a request for the grant of a patent; (b) a specification containing a description of the invention, a claim or claims and any drawing referred to in the description or any claim; and (c) an abstract; but the foregoing provision shall not prevent an application being initiated by documents complying with section 15(1) below.

(3) The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.

(4) [repealed] (5) The claim or claims shall (a) define the matter for which the applicant seeks protection; (b) be clear and concise; (c) be supported by the description; and (d) relate to one invention or to a group of inventions which are so linked as to form a single inventive concept.

(6) Without prejudice to the generality of subsection (5)(d) above, rules may provide for treating two or more inventions as being so linked as to form a single inventive concept for the purposes of this Act.

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(7) The purpose of the abstract is to give technical information and on publication it shall not form part of the state of the art by virtue of section 2(3) above, and the comptroller may determine whether the abstract adequately fulfils its purpose and, if it does not, may reframe it so that it does.

(8) [repealed] (9) An application for a patent may be withdrawn at any time before the patent is granted and any withdrawal of such an application may not be revoked.

(10) Subsection (9) above does not affect the power of the comptroller under section 117(1) below to correct an error or mistake in a withdrawal of an application for a patent.

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QUICK REFERENCE: SECTION 72 Power to revoke patents on application (1) Subject to the following provisions of this Act, the court or the comptroller may by order revoke a patent for an invention on the application of any person (including the proprietor of the patent) on (but only on) any of the following grounds, that is to say – (a) the invention is not a patentable invention; (b) that the patent was granted to a person who was not entitled to be granted that patent; (c) the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art; (d) the matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent, as filed, or, if the patent was granted on a new application filed under section 8(3), 12 or 37(4) above or as mentioned in section 15(9) above, in the earlier application, as filed; (e) the protection conferred by the patent has been extended by an amendment which should not have been allowed.

(2) An application for the revocation of a patent on the ground mentioned in subsection (1)(b) above – (a) may only be made by a person found by the court in an action for a declaration or declarator, or found by the court or the comptroller on a reference under section 37 above, to be entitled to be granted that patent or to be granted a patent for part of the matter comprised in the specification of the patent sought to be revoked; and (b) may not be made if that action was commenced or that reference was made after the second anniversary of the date of the grant of the patent sought to be revoked, unless it is shown that any person registered as a proprietor of the patent knew at the time of the grant or of the transfer of the patent to him that he was not entitled to the patent.

(3) [repealed] (4) An order under this section may be an order for the unconditional revocation of the patent or, where the court or the comptroller determines that one of the grounds mentioned in subsection (1) above has been established, but only so as to invalidate the patent to a limited extent, an order that the patent should be revoked unless

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within a specified time the specification is amended to the satisfaction of the court or the comptroller, as the case may be.

(4A) The reference in subsection (4) above to the specification being amended is to its being amended under section 75 below and also, in the case of a European Patent (UK), to its being amended under any provision of the European Patent Convention under which the claims of the patent may be limited by amendment at the request of the proprietor.

(5) A decision of the comptroller or on appeal from the comptroller shall not estop any party to civil proceedings in which infringement of a patent is in issue from alleging invalidity of the patent on any of the grounds referred to in subsection (1) above, whether or not any of the issues involved were decided in the said decision.

(6) Where the comptroller refuses to grant an application made to him by any person under this section, no application (otherwise than by way of appeal or by way of putting validity in issue in proceedings for infringement) may be made to the court by that person under this section in relation to the patent concerned, without the leave of the court.

(7) Where the comptroller has not disposed of an application made to him under this section, the applicant may not apply to the court under this section in respect of the patent concerned unless either – (a) the proprietor of the patent agrees that the applicant may so apply, or (b) the comptroller certifies in writing that it appears to him that the question whether the patent should be revoked is one which would more properly be determined by the court.

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AMENDMENT The relevant sections of the Patents Act 1977 (as amended) are: •

Section 27

•

Section 75

All sections mentioned are those of the Patents Act (as amended) at the time of writing so do be careful to check in case any updates have been made!

Looking at each of these sections in turn:

Section 27 This section deals with post-grant amendments. Essentially, the proprietor of a patent is allowed to request to make a post-grant amendment at any time after the grant of their patent EXCEPT if there are any validity proceedings either before the Comptroller or a Court.

The application to amend will be published, and can be opposed by third parties – any opposition being considered by the Comptroller before any amendment is allowed.

Section 75 This section deals with post-grant amendments where there are proceedings relating to validity, either before the Comptroller or a Court. The proprietor needs to apply to amend the patent, to the relevant person (i.e. Comptroller or Court) but if applying to a Court, they must also notify the Comptroller. Again, third parties may oppose any such amendment application from the proprietor.

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QUICK REFERENCE: SECTION 27 General power to amend specification after grant (1) Subject to the following provisions of this section and to section 76 below, the comptroller may, on an application made by the proprietor of a patent, allow the specification of the patent to be amended subject to such conditions, if any, as he thinks fit.

(2) No such amendment shall be allowed under this section where there are pending before the court or the comptroller proceedings in which the validity of the patent may be put in issue.

(3) An amendment of a specification of a patent under this section shall have effect and be deemed always to have had effect from the grant of the patent.

(4) The comptroller may, without an application being made to him for the purpose, amend the specification of a patent so as to acknowledge a registered trade-mark.

(5) A person may give notice to the comptroller of his opposition to an application under this section by the proprietor of a patent, and if he does so the comptroller shall notify the proprietor and consider the opposition in deciding whether to grant the application.

(6) In considering whether or not to allow an application under this section, the comptroller shall have regard to any relevant principles under the European Patent Convention.

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QUICK REFERENCE: SECTION 75 Amendment of patent in infringement or revocation proceedings (1) In any proceedings before the court or the comptroller in which the validity of a patent may be put in issue the court or, as the case may be, the comptroller may, subject to section 76 below, allow the proprietor of the patent to amend the specification of the patent in such manner, and subject to such terms as to advertising the proposed amendment and as to costs, expenses or otherwise, as the court or comptroller thinks fit.

(2) A person may give notice to the court or the comptroller of his opposition to an amendment proposed by the proprietor of the patent under this section, and if he does so the court or the comptroller shall notify the proprietor and consider the opposition in deciding whether the amendment or any amendment should be allowed.

(3) An amendment of a specification of a patent under this section shall have effect and be deemed always to have had effect from the grant of the patent.

(4) Where an application for an order under this section is made to the court, the applicant shall notify the comptroller, who shall be entitled to appear and be heard and shall appear if so directed by the court.

(5) In considering whether or not to allow an amendment proposed under this section, the court or the comptroller shall have regard to any relevant principles applicable under the European Patent Convention.

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Advice A variety of issues come up in each paper, but certainly not all of the following!

However, this does mean you need to be prepared for at least some incidental issues to come up on which you can offer some condensed advice as a compartmentalised issue (for each issue you spot) and move on.

The key thing to do is to answer any questions posed by the client, usually in the client letter, and some of the answers require detailed analysis of the paper while others require legal knowledge (I will try to highlight some particularly useful topics below) or a mix or legal knowledge and an analysis of the paper.

The sections that you might want to be aware of and have read can be grouped into a few categories, I would expect (in no particular order and not guaranteed to be an exhaustive list – because the examiners keep finding new topics to include – but I will do my best to catch everything as I update each edition of this book): (1) Entitlement (2) Inventorship (3) Threats (4) Priority Date (5) Joint Applicants (6) Restoration (7) Prior Use (8) Patent Office Opinions (9) Declaration of Non-Infringement (10) European Patents Going into a bit more detail about most of the above:

Entitlement For this you probably need to read and look into Sections 7 and 8.

Typical issues here include a lack of concrete chain of title, which means that the purported patent owner either doesn’t have the documentation to prove their ownership of the patent rights or this documentation doesn’t exist and therefore the purported owner is not entitled to ownership of the patent rights. In most cases, all of the inventors are employees and therefore all patent rights transfer automatically

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to their employer. However, in some cases either the situation is not clear or not documented (e.g. company directors) or specific agreements are necessary and either omit key IP provisions, don’t exist or are unwritten (e.g. contractors; collaborations between companies and/or people). Most of these types of problems can be addressed by following the chain of title from each inventor to purported patent rights owner and being logical.

Inventorship For this you probably need to read and look into Sections 7 and 13. While Section 7 sets out who is entitled to apply for a patent, Section 13 sets out that inventors are entitled to be so named and that applicants are obliged to name the inventors (and how the rights in the invention passed to the applicant from the inventors ) with penalty for not doing so being that the application is deemed withdrawn. Inventors not named can apply under Section 13 to have their names added as inventors to patents/patent applications via the Comptroller.

Typical issues here include that one or more of the inventors perhaps weren’t employed by the applicant at the time the invention was made, or their engagement by the applicant wasn’t clear (e.g. verbal agreement that is later disputed) or is nonexistent (e.g. because there was never any intention of this). Also see my note on joint applicants below – i.e. if there is no agreement otherwise, inventors will end up as a joint applicant and gain certain rights that make life more complex!

Threats For this you will need to read and look into Sections 70 to 70d and note that this law was updated fairly recently and so some of the historic papers might not having marking schemes that fit with the updated law.

Essentially what you need to advise on is whether any statement made by the patentee is an actionable threat. Specifically, Section 70A defines that ‘a threat of infringement proceedings made by any person is actionable by any person aggrieved by the threat’.

Section 70 helpfully defines if a communication contains a ‘threat of infringement proceedings’: if a reasonable person in the position of a recipient would understand from the communication that (a) a patent exists, and (b) a person intends to bring proceedings (whether in a court in the United Kingdom or elsewhere) against

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another person for infringement of the patent by (i) an act done in the United Kingdom, or (ii) an act which, if done, would be done in the United Kingdom.

These sections of the Act then set out various carve outs from what is an actionable threat, including that threats are not actionable if made to manufacturers or importers or to users of a patented process (but NB that this is only the case if the threat relates to manufacture, import or use – threatening any other infringing acts would still be actionable – you need to study these sections carefully). These sections also set out ‘permitted communications’ that are essentially white-listed by the legislation so it is clear that these communications are not actionable threats; as well as the remedies relating to actionable threats; and when professional advisers (e.g. patent attorneys) are shielded from actionable threats litigation (and when they are not!).

The concepts and legislation are worth understanding well as actionable threats come up regularly in this exam.

Priority date For this you will need to understand how priority works, and also read and look into Section 5 of the Act. Generally priority doesn’t come up as an issue regularly in this exam, but when it does it should be fairly obvious that you will need to take it into account as there will either be a big hint in the client letter or there will be documents you need to analyse in comparison to the patent in suit. The major reason that the examiners will introduce a priority issue is to adjust the validity analysis of the patent in suit, so be aware of this prior to making your validity assessment. If there are only vague hints that there might be a priority problem, then this is likely to be an issue that will attract marks in the advice section for f lagging the potential problem and advising on the consequences of any loss of priority.

Joint applicants Joint applicants/owners in practice are a difficult situation, so it is worth understanding the problems of having joint applicants and also having read and understood Sections 10 and 36.

In short, joint owners (unless there is an agreement to the contrary, which is a good

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recommendation in the advice section!) obtain the default right to exploit the patent for their own benefit (with no need to consult/pay/etc any other joint owners).

Further, and problematically in quite a few cases, joint owners can’t agree to license, assign, mortgage, amend or apply to revoke the patent without agreement from all other joint owners!

Agreements to the contrary can be specific joint ownership agreements or can be included within other agreements between the joint owners such as collaboration agreements or other commercial agreements – it helps to agree things such as which joint owner can do what in relation to the issues mentioned above but also in relation to practical points such as who pays the renewal fees and how to deal with any future litigation.

Restoration Restoration I don’t think has come up for a very long time, if ever, but in case it does please be aware of Section 28 of the Act (and possibly, for applications, Section 20A of the Act. Section 28A deals with the consequences of such a restoration).

If renewal fee payments are missed, Section 28 allows applicants to apply to the Comptroller to restore a lapsed patent if missing the renewal fee payment (including late payment with a surcharge!) is unintentional. Section 28A, however, allows those who did anything that would have been an infringement during the period in which the patent was lapsed to escape any sanction AND allows anyone who started doing something (or made serious and effective preparations to do so) to carry on doing that even if it would infringe the restored patent.

This, as you will probably see, might be an area ripe for advice if the examiners manage to craft a situation in which the proprietor of the patent restores the patent but an infringer has started making an otherwise infringing product while the patent was lapsed.

Prior use This is something that comes up from time to time, perhaps not that regularly, but is worth being aware of and it is worth knowing about Section 64 of the Act. This is sometimes called ‘prior secret use’, as typically if there was prior ‘public’

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use then essentially there would be something public that could be used as prior art against any subsequent patent filing.

This provision of the Act allows those who were doing something (or making ‘serious and effective preparations’ to do something) to carry on doing that in spite of a patent application being filed/a patent being granted that would then make this an infringement of the granted patent.

There are some limits on this right – for example, the (otherwise) infringer can only really continue their activities at the level that they were or had prepared for when the patent application was filed and the (otherwise) infringer can’t license others to do the (otherwise) infringing act. This section is worth reading and considering this section of the Act in detail to understand the minutiae.

Patent Office Opinions These are a popular topic in the FD4 paper so are worth remembering as an option for your advice section, as the examiners like this suggested (especially when they have given you clues that the client either can’t, shouldn’t or won’t spend significant sums on litigation). You will need to review and look into Sections 74a and 74b of the Act. At the time of writing there are in effect two branches of opinion that can be requested: infringement and/or validity. Validity drills down into a number of validity issues.

Personally, I have always thought of patent office opinions as a bit like guerrilla warfare because these can be prepared and filed and then left to the patent office and the proprietor to sort out – with the potential for the patent to be invalidated or significantly amended to save it.

These are good options to suggest to clients that perhaps don’t have significant funds to bring full litigation for example, or who have time to allow the patent office process to play out potentially in their favour by resulting in invalidation or significant amendment of the patent, or a declaration of non-infringement.

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Declaration of non-infringement This doesn’t seem to have come up that often in recent papers, but certainly should be a tool of which you are aware. You will need to know about and research Section 71 of the Act. This provision allows third parties to write to patent proprietors with full details of what they are doing and with a formal request for the patent proprietor to confirm in writing that this is accepted as non-infringement of their patent. If the patent proprietor fails to reply or refuses to give such a declaration, then the court or the comptroller can be requested to make such a declaration.

The third party does need to give the patent proprietor sufficient time to consider the request. There have been some examples where third parties have written to the patent proprietor requesting a declaration of non-infringement and either on the same day or the next day brought proceedings for non-infringement at the Court, which was viewed dimly by the Court!

When going to the Court or Comptroller with a request for a declaration of noninfringement, the third party needs to show that they have complied with the details of Section 71 and show copies of any relevant correspondence with the proprietor and evidence that they have sent the proprietor the required evidence etc.

European Patents Where the patent is an EP(UK), bear in mind that the parent European patent may still be within the nine-month opposition period, so check this and it might be worth offering up as advice the option to challenge the European patent centrally via filing an opposition.

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THE CASE LAW

List of cases Actavis UK Ltd v Eli Lilly and Co [2017] UKSC 48...................................... 57 Adhesive Dry Mounting v Trapp (1910) 27 RPC 341.................................. 39 Aerotel Ltd v Telco Holdings Ltd and Macrossan’s Patent Application [2006] EWCA Civ 1371 ......................... 67 Ancon Limited v ACS Stainless Steel Fixings Limited [2009] EWCA Civ 498............................ 49 Astron Clinica Ltd & Others [2008] EWHC 85 (Pat)........................... 69

BOS GmbH & Co KG v Cobra UK Automotive Products Division Ltd [2012] EWPCC 38 ..............................53 Catnic v Hill & Smith Ltd [1982] RPC 183....................................... 41 Conor Medsystems Inc (Respondents) v Angiotech Pharmaceuticals Inc and others (Appellants) [2008] UKHL 49..................................... 71 Improver Corp v Remington Consumer Products Ltd [1990] FSR 181........................................ 43

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Kirin-Amgen Inc and others (Appellants) v Hoechst Marion Roussel Limited and others (Respondents); Kirin-Amgen Inc and others (Respondents) v Hoechst Marion Roussel Limited and others [2004] UKHL 46..................................47 Lubrizol v Esso BL C/110/96 and [1998] RPC 727.................................................. 45 Napp Pharmaceutical Holdings v Dr Reddy’s Laboratories (UK) [2017] EWHC 1517 (Pat)........................ 61 Pozzoli SPA v BDMO SA & Other’s [2007] EWCA Civ 588............................ 65 Smith & Nephew Plc v ConvaTec Technologies Inc [2015] EWCA Civ 607............................ 55

Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062.......................51 Warner-Lambert v Generics [2018] UKSC 56...................................... 73 Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59......................................... 63

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The case law for the FD4 examination feels, to me, like a quasi ‘who’s who’ or ‘hall of fame’ list of UK patent cases. I would hope that most trainees will be aware of most of the names of the cases listed in this book, but some of the cases I include might be less familiar depending on your practice area and on your particular experience in the profession thus far.

I am also hoping that either you have read some of these cases or are inspired to do so once you read my summary of each case. Always go back to the primary source where possible – my summary might miss something that helps you remember what was decided in the case and is likely to be more useful as a reminder of a case you have already read in full, and considered, rather than as the only information you have obtained about a case. Incidental discussions in the case report might be an interesting background to some of the issues raised.

For each case, I have explained what happened in the circumstances that gave rise to the litigation and I link the case to the relevant section of the FD4 examination and, brief ly, discuss and attempt to summarise the key points of the case and how these are relevant to how candidates should approach the FD4 examination.

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1910 – Adhesive Dry Mounting [Construction]

Full case name: Adhesive Dry Mounting v Trapp (1910) 27 RPC 341 Available online: https://academic.oup.com/rpc/article/27/14/341/1586879 Most relevant FD4 section: Construction TL, DR: defined that ‘for’ meant ‘suitable for’ in claim language and that this allowed products to be defined in claims in respect of their intended use but did not limit their use only to the specified process for which they were suitable for use.

Background to litigation: The patentee took ownership of a patent to ‘dry mounting’ for photographs etc, which allowed a more optimal mounting than using a wet mount, which sometimes caused wrinkles or bubbles, and sued to prevent others using this technique.

The patent: The patent was granted for an improved ‘dry’ process for mounting photographs, etc on board by interposing the photograph and board with a thin layer of material that became adhesive under heat and applying heat and pressure to perform the mounting operation. A further claim was directed to the specific configuration of the sheet covered with a film of adhesive, again ‘for mounting photographs...’.

What did the alleged infringer do? The alleged infringer was accused of infringing both claims by selling the sheet/film of adhesive, and also because their allegedly infringing product was intended for use in the claimed process.

Legal point at issue: Whether the use of ‘for’ in the claim language allows a patentee (a) to prevent the use of a product (in this case the thin film of adhesive), whatever the purpose for which it might be used, or (b) whether the patentees can only restrain others from using the product in any process substantially the same as the process referred to after the word ‘for’.

Arguments for/against: The alleged infringer argued that the claims were anticipated by various prior art that they cited, or that they didn’t infringe the product claim if it wasn’t anticipated by the prior art. Specifically, they claimed to be selling products that were well known prior to the patent and should therefore either not infringe (as the patent was new and directed to something else) or the

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patent should be invalid (as the patent covered products already on sale prior to it being filed and thereby was not novel). Arguments were proposed that purchase of a product but not use would thereby not be an infringement, as it would only become an infringement once used thus purchase alone would not infringe. Arguments were also proposed that sale coupled with advice to use the product in a certain way would need to be proven, and that both seller and buyer would be joint tortfeasors in equity. Most critically, the argument proposed was ‘the patentees cannot claim the article for the purpose, it is a claim either for the article itself or for the purpose’.

Decision on legal point: The patent was held to be invalid in view of the cited prior art and so the case was dismissed. The Court noted that the only relief that could be granted was an injunction to prevent the sale of the product for use for mounting purposes, but that it was doubtful such an injunction could be granted.

Reasons for the decision: The Judge decided that by specifying that the product was ‘for’ something, the patent was not limited to preventing others from selling that product only for the specified use, but instead defined the product as being able to be used in that process (but also able to be used in other processes). Thus, because the product was known but not specifically for the use claimed, it was anticipated and therefore the claims were not novel.

Legal test proposed from this case: For is to be construed as ‘suitable for’.

Further reading: n/a

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1982 – Catnic [Construction]

Full case name: Catnic v Hill & Smith Ltd [1982] RPC 183 Available online: n/a Most relevant FD4 section: Construction TL, DR: Formalised the concept of ‘purposive construction’, i.e. that there can be infringement that is not literal infringement of the claims.

Background to litigation: The alleged infringer needed to justify their investment in galvanising equipment for their steel products having won business making motorway crash barriers, so investigated what other products they could make and decided to start making lintels for the building industry.

The patent: The patent related to steel lintels that were novel and proved to be a commercial success. Lintels are used to support courses of bricks or building blocks over an aperture/apertures in a wall during construction, or when making an aperture in an existing wall. Lintels or beams made from heavy timber were known and used for many years, but the claimed invention provided a lighter, inexpensive, and easier to handle lintel.

What did the alleged infringer do? The alleged infringer intended to enter the market for galvanised steel lintels, so examined the brochures issued by various manufacturers and decided that the patentee’s lintel was the best, so copied it and manufactured a number of these lintels. Upon being sued for infringement, the alleged infringer starting producing a new lintel that had a rear support member that was inclined at 6 or 8 degrees from the vertical – instead of being perpendicular to the base (which reduced the load bearing capacity by 0.6 to 1.2 %, i.e. negligibly) in order to avoid the patent which required that the rear member should ‘extend vertically’.

Legal point at issue: Whether a support member that is six or eight degrees from the geometric vertical ‘extends vertically’ as required by the claims.

Arguments for/against: The alleged infringer argued that because the claims required the read member to ‘extend vertically’ and their product was designed to be six or eight degrees from the geometric vertical, there was no literal infringement.

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The patentee argued that this minor difference in design made no substantial difference to the operation of the allegedly infringing product and therefore should still be an infringement of the claims.

Decision on legal point: The patent was found to be infringed by the original copy of the lintel and the modified lintel.

Reasons for the decision: No plausible reason was advanced as to why a limitation should have been intended excluding a back plate not positioned at precisely 90 degrees to both horizontal plates yet close enough to make no material difference to the working of the lintel. ‘Extending vertically’ was in context capable of meaning ‘near enough to vertical to enable the back plate to perform satisfactorily all the functions that it could perform if it were precisely vertical’.

Legal test proposed from this case: A patent specification should be given a purposive rather than a purely literal construction. The question in each case was whether persons of relevant practical knowledge and experience would understand that strict compliance with a particular descriptive word or phrase was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked. Such a question would only be answered in the negative when it would be apparent to a reader skilled in the art that such a descriptive word or phrase could not have been intended to exclude minor variants which would have no material effect upon the working of the invention.

Further reading: The decision also discusses whether copying/using the drawings of a patent constitutes copyright infringement. The Actavis judgment also refers to this case.

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1990 – Improver v Remington [Construction]

Full case name: Improver Corp v Remington Consumer Products Ltd [1990] FSR 181 Available online: n/a Most relevant FD4 section: Construction TL, DR: the construction of a term in a claim can read on to non-literal infringements in some cases, depending on what the skilled person would consider to fall within the meaning of the term in the claim.

Background to litigation: The patentee was granted a patent for their depilatory device (using a helical spring as described below), which they sold as the ‘Epilady’ and which enjoyed substantial commercial success. The alleged infringer produced a rival device that, instead of a helical spring, used a cylindrical rod with radial slits.

The patent: The patent related to a device that worked using a helical steel spring held by its ends and stiffened by a guide wire to form a loop, powered by an electric motor. Due to how the spring was held in place, one side of the spring was held open and the other side held closed – such that, when the spring was rotated and held close to the skin, the open side of the spring would allow hairs to enter the gaps and the closed side of the spring would pluck the hair from the skin.

What did the alleged infringer do? The rival device produced by the alleged infringer, instead of a helical spring, used a cylindrical rod configured in essentially the same way: the rod had multiple radial slits along its length and the way the rod was held within the device caused the slits on one side of the rod to be held open and the slits on the other side of the rod to be pressed together.

Legal point at issue: Whether the features in the alleged infringement which ‘fell outside the primary, literal or acontextual meaning of a descriptive word or phrase in the claim (‘a variant’) was nevertheless within its language as properly interpreted.’

Arguments for/against: The alleged infringer stated that their product was developed due to disadvantages with the patentees product, which in their opinion pulled out too many hairs at once – by replacing the spring with a rubber rod, it was possible to cut fewer slits in the rubber rod in order that fewer hairs were

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removed. In addition, the literal wording of the claim required a spring whereas the alleged infringement instead used a rubber rod, and therefore there could be no infringement of the patent. The patentee argued that the same effect was achieved by this substitution, and the skilled person would consider this within the meaning of the claim and therefore an infringement thereof.

Decision on legal point: The patent was decided to be valid, but not infringed.

Reasons for the decision: A degree of leeway can be applied to what is meant by the wording of the claim, but only so much. As the wording of the claim specified a spring and the alleged infringement did not include a spring, the court decided that this could not fall within the construction of the term spring and therefore there was no infringement.

Legal test proposed from this case: Lord Diplock proposed three questions to assess these types of cases in future: (i) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no: – (ii) Would this (i.e.: that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes: – (iii) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.

Further reading: n/a

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1998 – Lubrizol v Esso [Construction]

Full case name: Lubrizol v Esso BL C/110/96 and [1998] RPC 727 Available online: n/a Most relevant FD4 section: Construction TL, DR: You can’t read into claim terms limitations from specific examples in the specification, you must still take a purposive construction of claim terms. Where a value is specified in a claim, the number of decimal points is significant in that this should be taken as the level of accuracy considered important by the patentee.

Background to litigation: The patentee developed a lubricating oil and tested small samples of it in the UK market before filing a patent. Various prior art also existed but it was unclear whether the prior art documents relating to lubricating oils disclosed exactly the same properties as the claimed invention.

The patent: The patent related to a lubricating oil, having an additive made with ‘over-succination’ (more than one ‘succinate’ is added) from a polyisobutene of relatively high Mn (the number-average molecular weight) with the ‘polydispersity’ kept within specified limits.

What did the alleged infringer do? Sold a competing lubricating oil.

Legal point at issue: The construction of ‘succination ratio’; the construction of ‘acylating agent’ and the Mn value.

Arguments for/against: The alleged infringer argued about what was covered by the claimed term ‘acylating agent’ and whether this included the unreacted polyisobutene in the reaction product. The alleged infringer also argued that if the succination ratio was less than exactly 1.3, their product did not infringe.

The alleged infringer also argued that it was not possible to decide upon a way of determining Mn which would give one value (from the specification or claim) and therefore the patent was invalid for ambiguity.

Decision on legal point: The Court held that the patent wasn’t ambigous and was fairly based on the specification. However, the patent was ruled to be invalid for obviousness and prior use.

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Reasons for the decision: Using purposive construction, the claims had to be construed in light of the whole specification, however, ‘it was not permissible to put a gloss on a claim using a statement in the specification. To seek to alter the clear meaning of a claim by words used to describe preferred methods of implementing the invention... could not be right’. The court also stated that ‘it was incorrect to rely on evidence that some people who were skilled in the art would use a certain procedure and some would not’. The meaning of ‘acylating agent’ was considered clear and did not include unreacted polyisobutene. The court also stated that ‘in giving a ratio to two figures, the patentee had been indicating that only those two figures were significant’ and the ‘patent did not call for precise readings or absolute values. It was sufficient that the Mn was somewhere between 1300 and 5000 as measured by the normal routine method’.

Legal test proposed from this case: n/a Further reading: n/a

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2004 – Kirin-Amgen [Construction] Full case name: Kirin-Amgen Inc and others (Appellants) v Hoechst Marion Roussel Limited and others (Respondents); Kirin-Amgen Inc and others (Respondents) v Hoechst Marion Roussel Limited and others [2004] UKHL 46 Available online: https://www.bailii.org/uk/cases/UKHL/2004/46.html Most relevant FD4 section: Construction TL, DR: Consideration of what the invention defined by the claims covered, and how broad the protection for the invention can be in light of the claims and the specification (and the interplay with validity and sufficiency). Concluded that a reasonable interpretation of the claims should be made in light of the specification, but if a very broad interpretation is made then there is a higher likelihood of a lack of validity or sufficiency.

Background to litigation: The patentee discovered a method of artificially making a hormone known as ‘EPO’ (the full name is erythropoietin) for use as a drug, which was a significant advance in the treatment of anemia (which is associated with kidney failure) and very profitably marketed it in under the name ‘Epogen’. The alleged infringer (Transkaryotic Therapies or ‘TKT’) developed a method of making what it called ‘GA-EPO’ made using a process called ‘gene activation’ and Hoechst Marion Roussel proposed to import GA-EPO into the UK. The patent: The patent related to a method of production of the EPO hormone using recombinant DNA technology (EPO is naturally made in the kidney and stimulates the production of red blood cells by the bone marrow). The patented method was to use the DNA sequence coding for EPO introduced into a suitable host cell which then produces EPO according to the DNA sequence. The relevant independent claim was to the DNA sequence for use in securing the expression of EPO in a host cell.

What did the alleged infringer do? The alleged infringement was to produce EPO using a human cell into which the required regulator was provided to control the cell to produce EPO. Legal point at issue: The construction of the claims, and how to apply Catnic/ Improver and the Protocol on the Interpretation of Article 69 EPC. Specifically, whether ‘host cell’ in the claims covers human cells (which already have the

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requisite DNA) or a non-human cell into which the relevant DNA has been introduced.

Arguments for/against: The arguments presented turned on whether the invention should be (a) the discovery of the DNA sequence which codes for EPO; (b) a way of making EPO; or (c) a new artificial form of EPO. In respect of (a) it was argued that this was a discovery and incapable of patenting. There was significant discussion of (c) in the judgement as it was noted that the new artificial form of EPO was indistinguishable from natural EPO and thus could not be novel in and of itself. In respect of (b) there were arguments as to whether all methods of making EPO were covered or some more specific method. Further to the question of infringement, the questions of validity and sufficiency also turned on what the invention should be.

Decision on legal point: The invention was limited to the use of a non-human or ‘host’ cell, thus there was no infringement and some of the claims were not valid but the valid claims were sufficient.

Reasons for the decision: The Court repeated that there is only one compulsory question set by Article 69 and its Protocol: what would a person skilled in the art have understood the patentee to have used the language of the claim to mean? The Judge stated that the invention should normally be taken as having been claimed at the same level of generality as that at which it is defined in the claims. The judge decided that the answer to the compulsory question was that the claim meant a non-human host cell to which a relevant portion of human DNA was introduced in order to trigger the non-human cell to produce EPO and therefore there was no infringement as the alleged infringer used a human cell and another technique to trigger the human cell to produce EPO. Legal test proposed from this case: n/a Further reading: n/a

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2009 Ancon [Construction]

Full case name: Ancon Limited v ACS Stainless Steel Fixings Limited [2009] EWCA Civ 498 Available online: www.bailii.org/ew/cases/EWCA/Civ/2009/498.pdf Most relevant FD4 section: Construction TL, DR: The wording ‘generally elliptical cone shape’ was construed as any rounded non-circular form, in spite of arguments that the wording should be restricted to the shapes described in the description or shown in the Figures.

Background to litigation: Previous litigation found that the patent in suit was valid but not infringed, and the finding of non-infringement was appealed by the patentee. The alleged infringer didn’t appeal the finding that the patent was valid so the Supreme Court only considered the question of infringement.

The patent: In the construction industry, channel assemblies are used to fix components on to a building, such as brackets (to support masonry) or cladding. The patent related to a different shape of channel assembly having two complementary components: a channel portion and one or more ‘elliptical coneshaped’ fixings that fit within the channel portion. Both are shaped to mate together, so the channel portion has sides that are tapered/inclined at the same angle as the shape of the fixings, which when slotted together reduce the amount of ‘play’ between the fixings and the channel and allows a higher load capacity and less metal needs to be used to manufacture the channel assembly. The channel assembly can then be used to fix materials/cladding/etc upon.

What did the alleged infringer do? The alleged infringer produced a similar product that wasn’t exactly the same shape as the described or illustrated examples of the claimed invention in the patent specification.

Legal point at issue: The correct construction of the claim, and whether the equivalents language in EPC 2000 meant there was still infringement even if the construction didn’t provide direct infringement. Specifically, what was meant by ‘elliptical cone shape’.

Arguments for/against: The patentee argued that the judge in the previous litigation

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construed the patent too narrowly, whereas the alleged infringer argued that the judge in the previous litigation was correct on construction. The alleged infringer argued that the meaning of the claims should be derived from the drawings, which show oval shaped fixings, and that claim wording didn’t seem to match the shapes described in the patent nor did the advantages of ‘smooth camming’ derive from being ‘generally elliptical’. The alleged infringer also presented arguments about what the skilled man would have understood about the figures and that this didn’t match the ‘generally elliptical’ language of the claims. Finally, the patentee argued that the words chosen in the claim had to have a reason for their choice, and that it was possible to claim less than what is taught in the patent – thus an ellipse of some sort needs to be present in any infringement.

Decision on legal point: The Court decided that claim 1 was infringed and allowed the appeal.

Reasons for the decision: The Court decided that claim 1 was infringed because the wording of the claim, specifically the ‘elliptical cone shape’ wording, was construed to cover any rounded non-circular form and thus the alleged infringement.

Legal test proposed from this case: n/a Further reading: n/a

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2009 Virgin [Construction] Full case name: Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062 Available nline: Yes Most relevant FD4 section: Construction TL, DR: The patentee invented a new style of aircraft seat that folded the back of the seat down to form a fully-f lat bed, and arranged these in a herringbone layout, so diagonally rather than facing forwards in the cabin, to fit in almost as many as would fit if using standard business class seats, thereby allowing fully f lat beds in business class. The patent in this litigation was a divisional that focused on protecting the herringbone arrangement. The alleged infringer alleged either non-infringement or that the patent was invalid. The court ruled that the patent was valid and infringed, and covered seats other than just the f lap down seats (that included all of the features of the claims – i.e. not the prior art examples).

Background to litigation: Virgin created a new type of seat that f lipped over so that the back of the seat formed a f lat bed. By arranging these in a ‘herringbone’ layout, it was possible to fit almost the same number of seats in a business class area of a plane as was possible in a normal configuration, thus allowing f lat beds in business class. The herringbone arrangement allowed the otherwise lost space to be used by the f lat bed.

The patent: The patent in suit was a divisional patent filed to try to protect the herringbone arrangement rather than the f lip-over seat that remained the subject of the parent application.

What did the alleged infringer do? The alleged infringer sought a declaration from the Court that either it didn’t infringe or, if it did infringe then the claims were invalid.

Legal point at issue: The alleged infringer argued on a contingent basis that if the patent was wide enough to cover its system then, and only then, the patent was invalid. The Court considered that the issues to be decided were first whether claim 1 of the patent was limited to systems which employ ‘f lip-over’ seats and, if not limited, was the patent invalid either for added matter or for lack of novelty or

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inventive step over two prior art documents.

Arguments for/against: The alleged infringer argued that the reference numerals in the claims indicated their narrow interpretation of the claims was the correct one, i.e. that the patent required f lip-over seating as per the only described embodiment in the patent.

Decision on legal point: It was decided that the patent was valid and infringed.

Reasons for the decision: The problem of lost space caused by the herringbone configuration was decided to be clearly identified in connection with the prior art, and the Court decided that the skilled person would appreciate that the idea of using the ‘lost space’ by extending the f lat bed arrangement into this lost space would be ‘wholly unrelated to whether the bed f lips over or not. So the skilled reader would have no reason to suppose that the patentee intended to limit his claim to f lip over beds/seats.’ The word ‘f lat’ in the claim was decided not to mean a ‘f lip over’ arrangement. The reference numerals and characterising portion of the claims were deemed to make no limitation on the claim interpretation.

Legal test proposed from this case: No new test – just repeating from previous case law that the construction of the claim will rely on what a skilled person would understand in light of the specification as a whole.

Further reading: The judgment refers to the Kirin-Amgen case among others.

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2012 BOS [Construction] Full case name: BOS GmbH & Co KG v Cobra UK Automotive Products Division Ltd [2012] EWPCC 38 Available online: www.bailii.org/ew/cases/EWPCC/2012/38.html Most relevant FD4 section: Construction TL, DR: Various terms of the claim needed to be construed in order to determine infringement, and a key term of the claim could not be discarded as the wording was present in the claim, thus it needed to be construed and present in any infringement.

Background to litigation: BOS alleged that Cobra made infringing security nets that were installed in Volvo cars and sued for infringement. Security nets are usually installed between the row of back seats and the luggage area to prevent luggage f lying forward in a crash by catching the f lying luggage.

The patent: The patent related to a ‘security net installation’ for security nets used in cars. The general idea of security/luggage nets for cars was known at the priority date, but there were a number of problems with prior art nets such as manufacturing problems, rattling when installed and the use of an energy absorbing means in the bar. The claimed invention provided improvements in the upper bar fixings and an energy absorbing means, however, the energy absorbing means was only present in claim 2 (which was not subject of the proceedings).

What did the alleged infringer do? Cobra made a very similar net for Volvo cars, but modified it upon being accused of infringement to ensure it was not infringing and stopped selling the existing net.

Legal point at issue: The construction of the claims and whether they therefore were infringed by the alleged infringement.

Arguments for/against: It was argued that one of the expert witnesses should not be considered able to speak for a skilled person as they had several patents to their name and were therefore ‘too inventive’ (this was taken into account by the Judge but dismissed as an objection to the expert witness). Cobra accepted that their product falls within the scope of claim 1 subject to some caveats that needed to be decided by the Court on whether the top support was ‘bar-like’ as required by the

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claims, whether the insert was ‘tubular’ (as there had been a mistranslation and the correct translations was considered to be ‘pipe-like’); and whether the fixing arrangement was ‘in the region of this edge’. The patentee argued that the feature ‘in the region of this edge’ should not be read too narrowly as the feature was relatively unimportant to the inventive heart of the invention.

Decision on legal point: The Judge decided that the alleged infringement was ‘barlike’ and ‘tubular’, but that it did not connect to the car into which it was fixed ‘in the region of this edge’ – therefore there was no infringement of the patent.

Reasons for the decision: The feature ‘in the region of the edge’ was not disregarded by the Court, as it was present in the claim and the Judge considered that as a result it could not be disregarded. A construction was applied to this term based on what the Court considered a skilled person would understand by the term and this construction did not read on to the alleged infringement, therefore this feature was ruled not present in the alleged infringement.

Legal test proposed from this case: n/a Further reading: The case Select Healthcare v Cromptons Healthcare defined CGK as follows: ‘The common general knowledge is all the knowledge which is generally known and generally regarded as a good basis for further action by the bulk of those engaged in the art to which the invention relates. It also includes all that material in the field in which the skilled person is working which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art.’

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2015 – Smith & Nephew [Construction]

Smith & Nephew Plc v ConvaTec Technologies Inc [2013] EWHC 3955 (Pat) reversed

by Smith & Nephew Plc v ConvaTec Technologies Inc [2015] EWCA Civ 607 (also see Goldschmidt v EOC Belgium BL/83/99 and Lubrizol v Esso BL C/110/96 and [1998] RPC 717 (CA)) Full case name: Smith & Nephew Plc v ConvaTec Technologies Inc [2015] EWCA Civ 607 Available online: Yes Most relevant FD4 section: Construction TL, DR: Concerned the scope of a patent claim which contains a numerical range.

Background to litigation: The patentee owned an EP(UK) patent concerning a process ‘for the silverisation of gel-forming fibres used in wound dressings’. The alleged infringer tried to design around the patent and brought proceedings for a declaration of non-infringement to confirm their design around was not an infringement.

The patent: Silver is a known antimicrobial agent but there is a problem with silver-containing materials because they often dis-colour on exposure to light, so the patented invention was said to solve this by provided a method to make lightstabilised ‘silverised’ anti-microbial materials using three steps. First, a solution of an organic solvent and a source of silver is prepared. Second, gel-forming fibres that use a particular polymer are subjected to the silver solution. Third, the gel-forming fibres are subjected to an agent such as a chloride salt that facilitates the binding of the silver to the polymers. In particular, the patent claim recites that the agent must be present in a concentration of ‘between 1% and 25% of the total volume of treatment’.

What did the alleged infringer do? The alleged infringer, Smith & Nephew, designed a new process that they thought would not infringe the patent – specifically by using a concentration of binding agent that was no more than 0.77% and began proceedings for a declaration of non-infringement.

Legal point at issue: Did the range specified in the claim (of between 1% and 25%)

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cover the potential infringement with a concentration of 0.77%?

Arguments for/against: The patentee argued that the range should encompass values that would round up to the values specified in the claim, so therefore 0.5% to 25.5% would be within scope. The alleged infringer argued that the significant figures were important and therefore the range within scope should be 0.95% to 25.5% (or 25.49%).

Decision on legal point: The Court decided that the range within the scope of the claim was between 0.5% and 25.5%.

Reasons for the decision: The Court viewed it important to consider the precision with which a number is written, rather than the number of significant figures.

Hence the argument about rounding applied, so the range can be extended to the extent that the values would round to the specified range.

Legal test proposed from this case: Ranges specified in claims can be extended to values that would round to the level of precision specified in the claim.

Further reading: The Court referred to how numerical values/ranges were dealt with in (a) PLG Research Ltd v Ardon International Ltd [1993] FSR 197; (b) Auchincloss and anor v Agricultural & Veterinary Supplies Ltd and ors [1997] RPC 649; (c) Lubrizol Corporation v Esso Petroleum Co Ltd and ors (13 November 1996 and reported at [1997] RPC 195 then ([1998] RPC 727)); (d) TH Goldschmidt AG v EOC Belgium NV (25 January 2000); (e) Halliburton Energy Services Inc v Smith International (North Sea) Ltd [2005] EWHC 1623 (Pat), [2006] RPC 2; (f) FNM Corporation Ltd v Drammock International Ltd [2009] EWHC 1294 (Pat); and (g) Zeno Corporation and anor v BSM-Bionic Solutions Management and anor [2009] EWHC 1829 (Pat). Some EPO case law was also referred to.

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2017 – Actavis [Infringement]

Full case name: Actavis UK Ltd v Eli Lilly and Co [2017] UKSC 48 Available online: www.supremecourt.uk/cases/docs/uksc-2015-0181-judgment.pdf Most relevant FD4 section: Infringement (but NB that this case discussed Construction too) TL, DR: Formalised the concept of infringement by equivalence.

Background to litigation: Three products manufactured by the Actavis group of companies were alleged to infringe a EP(UK) patent owned by Eli Lilly & Company.

Specifically, a chemical named ‘Pemetrexed’ was known for some time to have therapeutic effects on cancerous tumours however, when used for that purpose along it could often have seriously damaging and sometimes fatal side-effects – the Eli Lilly patent essentially disclosed that the damaging side-effects could be avoided if a compound called ‘Pemetrexed Di-sodium’ was administered together with vitamin B12, enabling the use for treatment under the brand name ‘Alimta’ by Eli Lilly since 2004.

The patent: The patent claimed the use of ‘Pemetrexed Di-sodium’ in the manufacture of a medicament for use in combination with vitamin B12 (and optionally folic acid) for the treatment of cancer. Although the actual invention could have been characterised as a disclosure that ‘Pemetrexed’ could be administered safely if it was combined in a medicament with vitamin B12, the claimed invention was actually the manufacture of such a medicament (as this was the requirement under the EPC at the time, which prohibited the patentability of any method of treatment of humans). To get around this restriction in the EPC, patentees at the time used this form of claim – known as a ‘Swiss form’ claim – to protect their inventions using manufacturing claims.

What did the alleged infringer do? Actavis’ proposed products involved ‘Pemetrexed’ compounds being used together with vitamin B12 for cancer treatment – however, rather than using ‘Pemetrexed Di-Sodium’ as per the Eli Lilly patent, Actavis instead used three alternative active ingredients: ‘Pemetrexed Di-Acid’; ‘Pemetrexed Di-Potassium’; and ‘Pemetrexed Di-Tro-Methamine’.

Legal point at issue: The prohibition on treatments for humans or animals was

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amended with the passage of EPC 2000 (too late for the patent in suit) but EPC 2000 also introduced the concept of taking into account ‘equivalents’. The Court wanted to consider to what extent ‘equivalents’ have to be taken into account. The Court also wanted to consider the extent to which it is permissible to take into account the prosecution history of a patent when determining its scope (NB worth comparing to the US concept of ‘file wrapper estoppel’).

Arguments for/against: Actavis argued that, as its products didn’t include any ‘Pemetrexed Di-Sodium’, there was no infringement because the claims of the patent were limited to a specific ‘Pemetrexed’ salt and all of the Actavis products contained either ‘Pemetrexed Di-Acid’ (i.e. the active ingredient as a free acid rather than as a Di-sodium salt) or different ‘Pemetrexed’ salts. Eli Lilly countered that there was both direct infringement but also indirect infringement (as ‘Pemetrexed Di-Sodium’ would be involved in the preparation of the Actavis products before they were administered) – specifically, Eli Lilly contended that the Actavis products infringed the patent because they were medicaments to be used as a treatment for cancer consisting of ‘Pemetrexed Di-Acid’, or a ‘Pemetrexed’ salt, with vitamin B12, which represented the essence of the teaching of the patent and the claimed invention.

Decision on legal point: The Supreme Court decided that Actavis’ products directly infringed Eli Lilly’s patent in the UK and confirmed the Court of Appeal’s decision that Actavis’ products indirectly infringed the same patent in the UK. Reasons for the decision: The Court noted that UK law is specifically noted (in section 130(7) of the UK Patents Act 1977 as amended) to be ‘framed as to have, as nearly as practicable, the same effects in the United Kingdom as the corresponding provisions of the European Patent Convention... have in the territories to which [that Convention applies]’ and therefore it should be accepted as common ground that EPC 2000 applies – and then the Court specifically highlighted Article 69(1) of EPC 2000 which provides that the ‘extent of the protection conferred by a European patent... shall be determined by the claims... nevertheless, the description and drawings shall be used to interpret the claims’. The Court also referred to the Protocol on the Interpretation of Article 69 which was amended in 2000 and this amendment introduced the concept of ‘equivalents’: specifically the amended protocol allowed that the patentee’s scope of protection is not to be limited by the literal meaning of the claims, and that equivalents must be taken into account to determine the extend of protection. Thus the Court ended up in a position where it made what it considered the first determination on precisely what constitutes an infringing equivalent or how equivalents are to be taken into account based on the EPC 2000 amendments. The Court noted the previous cases on whether the literal scope of protection was all that was afforded to a patent

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in Catnic, Improver and Kirin-Amgen (which considered what the concept of equivalents meant for construction but conf lated this with infringement rather than considering infringement separately) – these cases are all discussed elsewhere in this book. Under the normal principles of interpreting patent documents, the Court considered that there would be no direct infringement (i.e. under Catnic), and considering whether the variations made were ‘immaterial’ (i.e. under Improver) the Court considered that it would be too difficult to assess whether the variations made would have no material effect on the way the invention works but concluded that there didn’t seem be direct infringement under the Improver test (even when modified). The Court then proceeded to create a new legal test, and concluded that as (i) the allegedly infringement products work in the same way as the invention; (ii) the notional addressee of the patent would appreciate (NB at the priority date) that each of the Actavis products would work in precisely the same way as the ‘Pemetrexed Di-Sodium’ when included in a medicament with vitamin B12 (and investigating this would be a purely routine exercise); (iii) as there is no teaching in the specification which relates to the relevance or importance of the sodium cation and the specification teaching that there are other anti-folate drugs which have a similar effect to ‘Pemetrexed Di-Sodium’ (the Court noting that it was generally known that cations other than sodium could be successfully used with anti-folates), thus the Court concluded that the patentee did not intend to exclude salts other than ‘Pemetrexed Di-Sodium’ or the free acid from the scope of protection. The Court also considered the prosecution history and whether it should take this into account, noting prior judgements stating that this was not the custom in the UK courts but didn’t modify its findings on infringement as a result. Indirect infringement was confirmed as pharmacists would mix the Actavis product in saline solution and cause ‘Pemetrexed Di-Sodium’ to be created, albeit in dissolved form.

Legal test proposed from this case: (i) Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent? (ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention? (iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?

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Further reading: (1) If you would like to learn more about ‘Swiss form’ claims, then these are discussed in detail in Ranbaxy (UK) Ltd v AstraZeneca AB [2011] FSR 45, paras 42 to 60. (2) The prohibition on patentability of methods of treatment for humans or animals was substantially modified in European Patent Convention 2000 (‘EPC 2000’).

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2017 – Napp [Infringement]

Full case name: Napp Pharmaceutical Holdings v Dr Reddy’s Laboratories (UK) [2017] EWHC 1517 (Pat) Available online: Yes Most relevant FD4 section: Infringement TL, DR: The case decided that de minimis infringement, i.e. by a small fraction of total products put on sale by a potential infringer (due to manufacturing variance), did not constitute infringement and did not allow the patentee the remedies for infringement.

Background to litigation: The patentee alleged infringement by the two defendants as they were marketing branded generic seven-day patches which they proposed to launch. The two defendants claimed to have worked around the patent and Dr Reddy’s had written to the patentee to seek an acknowledgment that their marketing would not infringe. One of the defendants had already received marketing authorisation for their product and the other was seeking it.

The patent: The patent related to a ‘buprenorphine transdermal patch for use in the treatment of pain for a dosing interval of at least seven days’. The patent was one of a family of one parent and eight divisional patents and applications, some of which had been revoked. Buprenorphine is an opioid ‘used for the treatment of nonmalignant pain of moderate intensity’, for example used for treatment of chronic back pain and osteoarthritis. The patches lasting for seven days makes them more convenient and cost-effective than patches which last a shorter period.

What did the alleged infringer do? Both alleged infringers intended to start selling generic versions of the patentees product that they claimed were not infringements, and they planned to do so around two years prior to expiry of the patent.

Legal point at issue: The way that the potentially infringing products were proposed to be manufactured meant that the chemical composition thereof varied in each manufactured product. As a result, there was a probability that at least some of the patches were infringements of the claim. As a result, there was a question as to whether the infringement was ‘de minimis’, i.e. whether the proportion of infringing products within the total number of products manufactured was

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sufficient to be considered infringement. This was especially the case since manufacture had not yet commenced so it was theoretical as to what proportion fell within the claims, as it couldn’t be tested. Following this, there was the question of bringing the ‘quia timet’ (i.e. action on the basis of a threat to infringe rather than demonstrable infringement) and whether this was fair in light of potential de minimis infringement and whether an injunction should be granted for infringement where only a small proportion of the potentially infringing products were genuine infringements.

Arguments for/against: Statistics were presented on the likely percentage of infringements likely to be present in the total alleged infringing articles. One of the potential infringers set out a testing regime they were proposing to follow for all batches of their product to ensure that they stayed outside of the range of values that would infringe the patent.

Decision on legal point: The Court decided that neither potential infringer would infringe the claims as any infringement would be on a de minimis basis, and the testing regime proposed by one of the defendants was suitable to ensure this.

Reasons for the decision: The statistics presented and statistical methods accepted by the Court indicated an extremely low probability that a such a small number of products proposed for manufacture by the alleged infringers would infringe that this constituted de minimis infringement and therefore there was no threat to infringe the patent by either alleged infringer.

Legal test proposed from this case: n/a Further reading: There is a good summary of the law on de minimis infringement and quia timet actions in this judgment.

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1985 – Windsurfer [Inventive step]

Full case name: Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59 Available online: No Most relevant FD4 section: Inventive step TL, DR: Proposed a test to assess inventive step, now modified by the newer Pozzoli case (see later in this section).

Background to litigation: the patentee invented a windsurfer and patented it, and this was challenged by a third party as lacking novelty and/or inventive step in light of an individual teenager creating a very similar water craft and using it in public for a couple of years off the south coast of England.

The patent: The patent in suit claimed a ‘wind propelled vehicle having an unstayed spar connected through a universal joint and a sail attached along one edge to the spar and held taut between a pair of arcuate booms mounted on the spar at one end and joined together at the other’ – i.e. a windsurfer.

What did the alleged infringer do? The defendant alleged that the patent was invalid both through lack of novelty and lack of inventive step.

Legal point at issue: The patentee appealed a decision that their patent lacked novelty and was obvious.

Arguments for/against: In the High Court, the defendants counter-claimed for revocation of the patent on the grounds that it lacked novelty over a prior user and was obvious in view either of the prior use or due to a printed publication cited as prior art (that was an article entitled ‘Sailboarding – Exciting New Water Sport’ which described the same basic concept as the patent where the board was fitted with a square-rigged sail). The cited prior user was by a 12-year old boy, ten years previous to the date of the patent, who had built their own sailboard and used it on the UK coast for two consecutive seasons, visible to anyone in the vicinity. The patentee argued that it was necessary to show that a person interested in the field of the invention would be likely to have come upon what was known and to have appreciated its significance and utility – and a man skilled in the art would have

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dismissed the published prior art as describing a not very practical toy which it would not have been obvious to develop and that the isolated prior use could not be relied on for obviousness. The patent also argued that the prior use was not an anticipation due to the different boom, which was not arcuate at rest.

Decision on legal point: In the High Court, the patent was found invalid, being anticipated by the prior use and obvious in light of the prior art publication. In the Appeal, the Court dismissed the patentee’s arguments.

Reasons for the decision: The Court ruled that the philosophy behind obviousness must take into account the same concept as anticipation, namely that it would be wrong to prevent a man from doing something that was merely an obvious extension of what he had been doing, or what was known in the art, before the priority date.

The Court also ruled that it could not matter that a prior use was non-commercial and of relatively short duration if it was not accidental and was exposed to public view. The question of obviousness should be answered by hyphothesising what would have been obvious at the priority date to a person skilled in the art who had access to what was known at that date (and not whether it would have appeared commercially worthwhile to exploit). The Court went on to say that the man skilled in the art must be assumed to be sufficiently interested to address his mind to the subject and consider the practical application of the information which he was deemed to have.

Using the test proposed in this case (reproduced below), they assessed the claimed invention to lack inventive step over the prior use and published article.

Legal test proposed from this case: The Court set out a four-step test to assess inventive step: ‘Answering the question on obviousness required four steps to be taken: (i) identifying the inventive concept embodied in the patent; (ii) imputing to a normally skilled but unimaginative addressee what was common general knowledge in the art at the priority date; (iii) identifying the differences if any between the matter cited and the alleged invention; and (iv) deciding whether those differences, viewed without any knowledge of the alleged invention, constituted steps which would have been obvious to the skilled man or whether they required any degree of invention.’

Further reading: Pozzoli case (see later in this section).

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2007 – Pozzoli [Inventive step]

Full case name: Pozzoli SPA v BDMO SA & Other’s [2007] EWCA Civ 588 Available online: No Most relevant FD4 section: Inventive step TL, DR: This case established the current test for inventive step.

Background to litigation: The parties to proceeding both sold cases for discs such as CDs and the defendant started selling a similar product to the patentee.

The patent: The patent related to a container for a plurality of discs (e.g. CDs) that allowed two or more discs to be accommodated in an overlapping arrangement so that they are held separately to prevent damage to each disc but also to be removed individually, while the external dimensions of the container allowed it to be a convenient size to be stored/easier to use/more aesthetically pleasing. In particular, the container wasn’t simply the height of two discs, which apparently didn’t fit into standard bookshelves.

What did the alleged infringer do? The defendants sold a case that held the discs at the edges rather than in the central hole.

Legal point at issue: Was the patent obvious in light of an array of prior art disc cases.

Arguments for/against: The patentee argued that it was a prejudice in the art against trying to make a case that held multiple discs in a single case without some barrier to prevent damage by one disc to the other.

Decision on legal point: The Court decided to restate the test from Windsurfing.

Following this, the court decided that by identifying the problem of needing a case that fit into a standard bookshelf, a skilled person when considering the art would be able to arrive at the solution of the claimed invention.

Reasons for the decision: The court disagreed their was a technical prejudice.

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Legal test proposed from this case: (1)(a)Identify the notional ‘person skilled in the art’ (1)(b) Identify the relevant common general knowledge of that person; (2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it; (3) Identify what, if any, differences exist between the matter cited as forming part of the ‘state of the art’ and the inventive concept of the claim or the claim as construed; (4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?

Further reading: Windsurfing International case

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2006 – Aerotel Macrossan [Inventive step]

Full case name: Aerotel Ltd v Telco Holdings Ltd and Macrossan’s Patent Application [2006] EWCA Civ 1371 Available Online: www.bailii.org/ew/cases/EWCA/Civ/2006/1371.html Most relevant FD4 section: Inventive step TL, DR: Sets out the current test for excluded matter in the UK Background to litigation: By virtue of what seems to be a slightly complicated interlocking sets of litigation (some of which were settled) and revocation of a patent that was appealed (but on which the Comptroller of the UK Patent Office sought guidance on patentability from the Court), the Court was asked to assess whether the invention at issue was patentable or not.

The patent: there were two patents being considered, the ‘Aerotel’ patent which related to a method and telephone system for making telephone calls with a pre-paid code (stored in a telephone exchange and drawing down the pre-paid credit when used) and the ‘Macrossan’ patent related to an automated method of acquiring the documents necessary to incorporate a company (using a remote server where the user answers a sequence of questions).

What did the alleged infringer do? n/a (the Patent Office needed guidance on how to assess non-patentable subject matter).

Legal point at issue: What is the correct test for determining whether a claimed invention is excluded from patentability.

Arguments for/against: (1) The ‘Aerotel’ patent was originally found to be excluded as the evidence presented suggested that it could have been implemented using known components (but this evidence was assumed to mean that the hardware arrangement wasn’t new), but the Court adopted a test proposed by the UK Patent Office (recited below) and determined that the proposed system as a whole was new (as a new telephone exchange was required to make the invention work, and while this could have been constructed with known components the new telephone exchange itself was not known) and thus the invention was ‘clear(ly)… more than a method of doing business as such’ and ‘clearly technical in nature’. (2) The

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‘Macrossan’ patent had been previously rejected as unpatentable for being a mental act as such and a computer program as such but not a method of doing business, however, the UK Patent Office considered the decision of the claimed invention being a mental act to be incorrect.

Decision on legal point: The ‘Aerotel’ patent was found to be patentable (i.e. not excluded matter). The ‘Macrossan’ patent was found not to be patentable as it was a method for doing business as such and a computer program as such.

Reasons for the decision: The ‘Aerotel’ patent was found not to relate to excluded matter and therefore to be patentable, as the system configuration in the system proposed was new, even if its constituent hardware was not, and thus the method was also patentable. The ‘Macrossan’ patent was found to be a method for doing business as such and a computer program as such because the inventor did not claim to have invented any new kind of hardware, and so the ‘interactive system which will do the job which otherwise would have been done by a solicitor or company formation agent’ was the contribution and thus the claimed invention was not to a free-standing business tool (e.g. fax machine or telephone etc) but to the very business itself – i.e. the business of advising and upon and creating appropriate company formation documents – and therefore there was nothing technical about this. Considering that the invention was run as a computer program, the Court decided that this was excluded as a computer program as such as running a website to pose questions and receive answer data from users, and then complete template documents with/based on the answers was considered standard knowledge and so the only contribution was the business method which had already been considered and dismissed.

Legal test proposed from this case: The test as to whether a claimed invention is excluded from patentability should be approached with four steps: (1) properly construe the claim (2) identify the actual contribution; (3) ask whether it falls solely within the excluded subject matter; (4) check whether the actual or alleged contribution is actually technical in nature.

Further reading: This decision includes an appendix that summarises the case law on excluded matter up to the date of this case in 2006, which is an interesting read should you be interested in further detail.

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2008 Astron Clinica [Inventive step]

Full case name: Astron Clinica Ltd & Others [2008] EWHC 85 (Pat) Available online: www.bailii.org/ew/cases/EWHC/Patents/2008/85.html Most relevant FD4 section: Inventive step TL, DR: Computer program product claims are permitted, but will not confer patentability merely by their formatting as a computer program product claim (i.e. the corresponding method and apparatus claims will need not to be deemed excluded).

Background to litigation: Six different patent applications by five different applicants had claims to methods and apparatus that had been allowed by the UK Patent Office, but claims in the same applications to computer programs rejected.

The applicants collectively appealed these decisions.

The patent: The six different patent applications covered a range of different technologies but all included a computer program that conferred the technical advance.

What did the alleged infringer do? n/a (this was an appeal regarding a decision of the UK Patent Office) Legal point at issue: Can a claim to a computer program itself be patentable?

Arguments for/against: The patentees collectively argued (as they shared the same representative) that the inventions relied on a computer program to confer the technical advance, so commercially it was very important to protect the computer program itself with a claim, rather than rely on a method/apparatus claim. The UK Patent Office simply argued that computer program claims were not allowable.

Decision on legal point: The Court decided to allow the claims to the computer program, on condition that these were effectively covering the same inventions as per the method and apparatus claims but in a different claim format in order to protect the computer program product per se.

Reasons for the decision: The Judge saw no reason in any of the previous case law on computer-implemented inventions to prohibit the claiming of a computer

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program product claim as long as the method/apparatus claims were deemed to be patentable.

Legal test proposed from this case: n/a Further reading: The case provides a very good summary of the case law to date on the patentability of computer programs at both the EPO and in the UK Courts.

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2008 – Conor v Angiotech [Inventive step]

Full case name: Conor Medsystems Inc (Respondents) v Angiotech Pharmaceuticals Inc and others (Appellants) [2008] UKHL 49 Available online: https://publications.parliament.uk/pa/ld200708/ldjudgmt/ jd080709/conor.pdf Most relevant FD4 section: Inventive step TL, DR: A patent wasn’t obvious in spite of prior art suggesting to try the claimed device with an array of possible drugs, that technically included the claimed drug used to coat the device, because there was no reason to try the claimed drug specifically, nor did separate prior art relating to the claimed drug suggest its use in the manner of the claimed invention.

Background to litigation: It was a known problem that inserting stents into arteries to improve blood f low through constricted arteries caused the artery walls to regrow and this regrowth again blocking the f low through the stent. Various options to overcome this problem were proposed in academic papers, but a researcher in Canada who was researching angiogenesis (the process by which capillary blood vessels grow) proposed using an anti-angiogenic agent to prevent this regrowth and tested several possible drugs for this purpose, and these experiments resulting in finding a drug called taxol was effective to prevent regrowth. A very broad patent application was originally filed to the use of anti-angiogenics, but also included a claim to coating stents and provided details of the use of taxol specifically. The stent coated with taxol was a great commercial success for the company (Angiotech) that was set up to commercialise the invention.

The patent: The granted patent related to a stent (a tubular metal scaffold to be inserted into an artery to keep it open) coated with taxol for ‘treating or preventing recurrent stenosis’ (i.e. to prevent the walls of the artery re-growing and again blocking the artery where the stent was inserted).

What did the alleged infringer do? Conor originally opposed the patent at the EPO (resulting in the claim being narrowed to a stent coated with taxol), then brought an action for revocation in the UK courts in 2005 Legal point at issue: Whether the patent was valid for being obvious.

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Arguments for/against: Taxol was a highly publicised new drug for cancer treatment at the time of filing of the original patent application, so Conor argued that the patent should be revoked as it would have been obvious to coat a stent with it at the time of filing of the original patent application, as it would have been an obvious choice for a suitable anti-proliferative drug to coat a stent seeking to prevent artery regrowth. Angiotech, however, argued that there would be no reason to select taxol out of the huge variety of possible solutions then under consideration and on account of its toxic properties it more likely would have been discounted from consideration to coat a stent. Conor then submitted the argument that the specification only taught to try taxol, not that it would work, and that there was no information in the specification about tests showing that it would work nor information about doses to enable the skilled person to work the invention.

Decision on legal point: The patent was decided to be inventive by the Court, as the prior art did not suggest the coating of stents with taxol, instead referring to a vast array of possible drugs to try as coatings, and the prior art relating to taxol itself did not suggest its use in the same way as the present invention.

Reasons for the decision: The Court dismissed the argument that the specification only taught to try taxol and therefore the invention should be limited to this teaching, and confirmed that the claimed invention was the only thing being assessed and this was defined in the claim. The Court then went on to clarify that the question being answered was whether the claimed invention was inventive or not, and specifically whether it was inventive to use the claimed product to prevent or treat restenosis. The Court also dismissed the argument that there was no information on experiments on explanation why the invention would work, as there was no requirement for this in patent specifications under the EPC or UK statutes.

The Court noted that the patentee might be at risk of a finding of insufficiency, but the invention did work so it did not matter why.

Legal test proposed from this case: n/a Further reading: n/a

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2018 – Warner-Lambert [Sufficiency]

Full case name: Warner-Lambert v Generics [2018] UKSC 56 Available online: Yes Most relevant FD4 section: Sufficiency TL, DR: Sufficiency requirement in law establishes an underlying principle to prohibit claims that exceed the disclosed contribution to the art, the purpose being to prevent ‘armchair inventors’ making speculative claims but who had not done anything new or inventive but simply sought to patent abstract possibilities.

Background to litigation: Warner-Lambert is a division of Pfizer that held a second medical use (or ‘Swiss Claim’) patent to a drug for use to treat a specific type of pain.

The patent: The patent covered the second medical use of a drug called Isobutylgaba (originally used for the treatment of seizure disorders) for the treatment of pain. The dependent claims set out fall back positions to specific types of pain.

What did the alleged infringer do? The alleged infringers were generics companies that wished to market the no-longer patented drug for the second medical use claimed.

Legal point at issue: The generics companies claimed that the patent was invalid due to lack of inventive step and insufficiency, but their inventive step arguments failed. The remaining issue was whether the patent was sufficient.

Arguments for/against: The generics companies argued that the specification supported the use of the drug for inf lammatory pain but not for any other type of pain, and as the claims weren’t limited to inf lammatory pain therefore the claims weren’t sufficiently supported by the description.

Decision on legal point: The Court agreed with the point that inf lammatory pain was supported by the description but not any other type of pain, therefore the description was insufficient for the claim scope.

Reasons for the decision: Based on Sections 14 and 72, but also the 1778 case Liardet v Johnson (and the EPO case T409/91 from 1994), it was noted by the Court that

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second medical use patents shouldn’t be allowed for speculative use cases but that the patentee should be required to disclose some reason for regarding the assertion of a second medical use as plausible (but that it seemed generally accepted that the threshold for this plausibility test was low in order only to prevent speculative claims).

Legal test proposed from this case: The claims must be supported by the description.

Further reading: n/a

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THE FD4 EXAM

Introduction It is always worth reviewing the syllabus for FD4 each year, especially to note any changes from previous syllabi as this can give you an indication of any planned shift in the ‘direction’ of the examination that will manifest in this year’s paper.

The current version of the syllabus is the 2024 edition at the time of writing and is unchanged from the 2023 edition.

It is divided into several sections: (i) some guidance for candidates; (ii) the syllabus in table format; (iii) a reading list; and (iv) an overview of the structure of the paper.

Guidance In the guidance section, there is some general information on what the final diplomas are versus the foundation level examinations and in particular that the difference between the two sets of exams is primarily that the final diploma examinations test the core competencies expected of a patent attorney.

The guidance section also sets out what candidates need to demonstrate and what is being tested.

Specifically, the following are listed as things candidates need to demonstrate: – a thorough knowledge and understanding of the law; – application of this knowledge in a manner that is appropriate to the facts and the client’s needs; and – providing advice expressed in a clear and consistent manner.

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Specifically the following are listed as being tested by the examinations: – seeing the overall picture; – assimilating and making use of data/information/themes/ideas provided; – extracting & identifying the key issues and considering how best to present these in the context of the situation; – writing logically, cohesively and clearly; – providing outcomes/proposals that (i) ref lect client needs/priorities; (ii) are based on the analysis of information available and risks/costs if appropriate; (iii) are practicable/achievable; (iv) meet the requirements of relevant law and are good practice/take into account commercial realities.

I think the key things to take away from this is that (A) it is assumed that candidates have a decent knowledge of the law – so if you are sitting FD1 in parallel with FD4 this should be covered; (B) you need to apply the law to the facts – this has consistently been something rewarded in the mark scheme over the years in FD4; and (C) consistent advice (and analysis) is very important and inconsistency in a candidate’s answer tends to result in no marks being awarded for any inconsistent answers. The two bonus things I would highlight are (D) seeing the overall picture is critical to at least some candidates, as it is very easy to get ‘lost’ and make unforced errors in your answer if you don’t see the whole situation clearly; and (E) the examiners tend to reward commercial insight generously when candidates spot commercial issues or give good commercial advice.

Syllabus The guidance section sets out that the syllabus tests candidates’ abilities to (i) analyse and prepare advice on UK infringement and validity issues that are appropriate to the facts provided and the client’s needs; (ii) reach an informed opinion on a finely balanced point; and (iii) use information provided to support the opinion reached.

The syllabus then sets out that ‘to complete this examination successfully, you will need to demonstrate a full understanding of the law and practice of patent infringement and validity issues in the UK. You will also need to demonstrate an ability to advise lay clients on their best course of action in matters related to patent infringement and validity.’

For those of you that have a general understanding of the exam, this isn’t news,

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but this is where it is set out for the world to see. The table that is presented in this section is the source of more detailed information.

The table goes on to set out exactly what law candidates are expected to know and exactly what advice candidates are expected to be able to provide.

The law/knowledge that is expected is the more comprehensive section of the table and sets out that candidates need to know about (i) patentable inventions; (ii) amendment; (iii) infringement; (iv) challenging validity. Each of these sections plus the advice section sets out the actions that candidates are expected to be able to demonstrate in the exam (a.k.a. ‘learning outcomes’) and the relevant law pertaining to each of the headings.

To assist, I have summarised what I consider to be the key legislation for each of the areas of the paper in the ‘Legislation’ section of this book and recited the relevant sections for ease of reference, but I recommend reading the syllabus and the remaining sections of the Patents Act listed therein prior to the exam.

Reading list The reading list gives you some reference works that you can refer to, including the Black Book (which is a great place to dip in to when you want more detail on specific sections of the Patents Act but which I don’t recommend reading cover to cover!), Terrell, and, very kindly, the previous version of this book.

Structure This section repeats the wording found on the front of each exam paper and sets out the pass mark, the time allowed and the task to be performed.

Scenarios There are a variety of possible scenarios that the examiners may present in the paper, most of which we have seen in previous examinations.

I think that the most common scenario you are likely to face in the examination is to be presented with a recently granted patent and some form of marketing document outlining at least one potentially infringing product, which a client will write to you about asking for you, as their attorney, to advise ‘what to do next’. The

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client will then usually f lag two prior art documents to you, potentially that they have apparently found themselves or potentially that have been provided to them by the third party marketing the potentially infringing product.

Typically, the examiners aren’t aiming to assess your reading or writing speed, and so will try to limit the documents you need to assess to a reasonable number and/or length. This aim isn’t always achieved, and a criticism levelled at the examination is that there is too much reading/understanding/assimilation required in the time available. However, this aim generally means that you will typically be presented with three documents, so in the above scenario I would expect one ‘infringement’ document and two ‘prior art’ documents to be included in the examination for you to read and analyse. This allows candidates to get used to processing this number of documents when revising for the examination by answering the previous papers as mock papers in preparation for the exam.

However, the number of documents does not tell the full story of what you need to analyse: what you as the candidate should be more interested to determine is the number of infringing articles and the number of prior art embodiments.

Thus a single ‘infringement’ document may contain more than one infringing article, both of which will need to be analysed separately. Alternatively, the ‘infringement’ document may describe a single infringing article but the client letter may state that there is some form of variation to this infringing article (e.g. being planned for launch soon, or they heard about the variant at a trade show, etc), again resulting in more than one infringing article to analyse (again separately).

Prior art documents may contain multiple embodiments, each of which may need to be analysed separately for the purposes of assessing novelty and inventive step.

Equally, the patent specification may contain a background section that provides enough detail to be considered a prior art embodiment that needs to be analysed.

Variations to the possible scenarios could therefore be (note that I have omitted listing any specific example past papers to prevent ‘spoilers’ for those of you planning to use the past papers for mock papers as revision): •

The patent may be granted or may still be pending.

•

The patent may be owned by the client or may be owned by a third party and your client is concerned about potential infringement of the patent – i.e. your client may be either the patentee or the potential infringer.

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•

The technology of the patent will typically be something that is simple and mechanical, and preferably something about which most candidates will have at least a vague understanding. However, sometimes very simple chemical or electronics may be involved, and on rare occasions more complex mechanical systems form the subject matter.

•

The claims will typically contain a handful of key words or phrases that provide the basis for any ‘tipping points’ or ‘finely balanced points’ that will heavily inf luence a candidate’s answer to the paper.

•

There may be only one infringing article or multiple infringing articles, which may or may not yet be in production/on sale.

•

There may be one or multiple prior art documents. Some prior art documents may not be relevant and the examiners expect you to perform minimal analysis to conclude this lack of relevance. Some prior art documents may contain only a single embodiment and some may contain multiple embodiments, some of which may or may not be relevant and require respectively full or little/no analysis. The patent may contain a prior art embodiment requiring full analysis or little/no analysis, or may not contain any prior art embodiment to consider at all. Some of the prior art may be prior art for the purposes of only novelty analysis and some of the prior art will be full prior art for the purposes of both novelty and inventive step analysis.

•

There is, quite commonly, no sufficiency issues to f lag in your answer.

Sometimes, however, there is one or more sufficiency issues and these need to be explained.

•

Most of the time there are potential amendments that can be made to the claims, some of which might assist the patentee. It is extremely unlikely but possible that no amendments will be possible. Typically, amendments are possible through a combination of independent and dependent claim features and/or using material present in the patent description that is not present in the claims.

•

The advice sought by the client can vary, and is set out in the client letter. There are typically some specific questions posed by the client to which it is expected that the candidate should prepare some advice in response. There is also a more general request from the client, sometimes a very broad request simply to advise them what to do in light of the situation presented but sometimes more specific – such as ‘what can I do to stop these people infringing my patent’ which will focus what type of advice is expected from the candidates. The client letter may also

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include some irrelevant information, to test whether candidates can sift out the important content from that which is irrelevant.

•

The paper as a whole may also omit to include one or more critical pieces of information, in response to which candidates are expected to note this omission and advise accordingly/request this information (typically in the advice section).

Throughout all of your preparation for the examination, and when taking the examination, please focus on the core tasks tested in the paper and try to remain focused, even if some of the above variations in scenario are presented, as these do not change what is being tested and are mostly distractions from the core tasks tested in the paper.

Examiners’ comments Every year the examiners write some comments on the paper generally, as well on each section of the paper. Until 2014, these comments served partially as a hint towards the marking schedule as this wasn’t published prior to 2014, but now these offer the examiners a way to provide some insight into what the paper was intended to test and also a way to comment on how well the various aspects and sections of the paper were answered in the exam.

The examiners, in the general section of the examiners’ comments, will typically let candidates know how the cohort of candidates performed in the paper and in each section.

Reviewing the examiners comments is a useful exercise once you have attempted the relevant paper but is unwise before you attempt the paper as it will influence your answer, as it contains too many spoilers. To assist with getting the general feel for the information from the examiner’s comments I have collected the general points that tend to repeat each year without revealing too much about each paper in case you want to use some of the more recent papers for mock papers to revise prior to the exam.

Some useful general points from the examiners include: 1. The examiners, when relevant, will remind candidates that all of the technical information necessary for the paper will be contained in the paper.

2. The examiners, in a related point to point 1 above, will also remind candidates that, where a paper doesn’t contain all of the information needed to address all of

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the issues thoroughly, they expect candidates to identify the missing information and how it might affect their advice OR candidates may speculate on this missing information as long as they clearly show what of their answer is speculation.

3. The examiners will usually remind candidates that marks are not available for unsupported conclusions.

4. The examiners are happy to confirm that it is possible to pass with good marks in the construction, infringement and novelty sections and ‘indifferent performance’ in the rest of the paper.

5. The examiners tend to report that they find that those who fail in the high 40s tended to miss relatively easy marks in the latter half of the paper (i.e. inventive step, amendment, sufficiency and advice) that would have taken them over 50%.

The examiners also say that even superficial answers to parts of the paper can allow candidates to pick up marks.

6. The examiners are also happy to confirm that candidates do not need to give the expected conclusions (e.g. exactly as listed in the marking schedule) as what matters most is that answers show how and why each candidate comes to their particular conclusion as much as what the conclusion is (and that full marks are available for any reasonable conclusions so supported). The examiners go on to say that several possible conclusions are usually expected.

7. The examiners tend to repeatedly remind candidates that the questions in the client letter are expected to be answered by candidates.

8. The examiners have now said a few times that candidates who reformat the Word document used for their answer make their answers very hard to read for the examiners.

9. Candidates who copy and paste large amounts of text into their answers but who didn’t use this information are potentially obscuring their answers, and the examiners have warned that this risks candidates losing marks by making it too hard for the examiners to find marks to award.

10. When candidates run out of time, the examiners say that they generally can’t tell if the candidates had an answer and simply ran out of time to record it, and remind candidates that they are happy to accept answers in note form provided the support and reasoning can be followed.

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INTERPRETATING PATENT CLAIMS

Claim interpretation – introduction Claim interpretation is a complicated area of law, but it is a learnable skill. It is probably best learned by experience, both through prosecution and drafting of patent specifications.

There is a need to practice how to interpret claims before taking the exam. In particular, in the exam the time you will realistically have to write your answer to the construction section in the paper means that you need to practise an efficient way to produce your answer to the section.

This section takes a significant amount of time for most candidates, but is generally done well as a result. A good construction section should, in theory, make the rest of the paper straightforward to answer as it should reduce the thinking time required if candidates follow their construction.

What do the examiners say?

Candidates generally score quite highly in the construction section, and the examiners tend to report that most provide reasonable constructions, providing concrete limitations to the scope of the claims and relating this to the disclosure of the patent. Almost all candidates are reported to demonstrate that they understood and can apply the process for construing a claim.

The examiners repeatedly warn candidates that while many candidates go to great lengths to discuss the claims, there are always some who then did not use their conclusions in the rest of the answers (and thereby lose marks for lack of consistency).

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To gain full marks for construction, the examiners repeatedly remind in their comments that support and reasoning for the meaning of the terms in the claims is required.

The examiners have stated that where there are a number of different examples of a feature of a claim in the patent, a meaning for the term/feature needs to be found that encompasses these multiple examples. Further, some features are not explicit in the patent and need to be construed from the context of the invention. The examiners have also previously reminded candidates that relative terms are expected to be construed.

An example that the examiners have given previously is that, where for example a feature is said to be configured ‘at an angle’, candidates are expected to look at the reason for the angle in order to determine what should be in scope for this phrase.

The examiners have also said that some terms in the claims might be able to be assessed as non-limiting but the examiners prefer giving a meaning to these terms that can be justified with reference to the rest of the paper.

The examiners have further said that where terms are defined explicitly in the specification, it is expected that candidates use this explicit definition as their construction where no other (sensible) meaning can be derived from the patent.

In respect of dependencies, the examiners point out that where there are inconsistencies, candidates still need to construe the claim in light of this inconsistency.

The theory As you will appreciate, if you have read the case law section of this book or if you are aware of the case law on interpretation and construction of claims, infringement/ validity cases can turn on a single word or phrase. This is therefore something that is tested in the FD4 examination (and more advice on how to approach this in the examination is provided below in the next section of the book).

For examples relating to infringement turning on a single word or phrase: the KirinAmgen case (see the case law section of this book) turned on whether or not the alleged infringement used a ‘host cell’; while the Catnic case turned on the meaning of ‘extending vertically’; and the Improver case turned on the meaning of ‘a helical spring’.

Similarly, validity can also turn on single words or phrases.

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In the exam however, there tends to be a few ‘tipping points’ or ‘finely balanced points’ that candidates need to construe with care and then apply consistently. These more important points are typically allocated more marks in the marking schedule to allow candidates to discuss the points in detail and conclude with a reasoned answer.

Practical construction points In practice, you will need to interpret a handful of key word or phrases (upon which the answer to the exam will most likely turn). These will potentially be unclear terms or phrases, or terms or phrases that don’t necessarily mean what candidates might assume to be their normal meaning (for example, the context provided by the specification allows a broader or narrower interpretation than when the word or phrase is taken alone).

For unclear terms or phrases, there may be no clarification possible from the specification of the patent and so a fairly ‘robust’ approach to choosing a reasonable interpretation must be made (simply because of the limited time available in the exam). Where the specification does provide some clarification, then this can be used to provide an interpretation for what was intended by the word/phrase in the claim.

For terms or phrases having a specific meaning defined by the specification, these should take a reasonable interpretation in light of the description. Such terms or phrases can only be interpreted in light of the specification as a whole, so careful reading of the description is required to locate and correlate any material that is required to interpret specific words and phrases intended to take a certain meaning by the patentee.

The construction of the terms/phrases used in the claims should be arrived at independently of an analysis of, or from comparison to, the contents of the prior art. Thus care must be taken not to construe the claims transparently in light of any potential infringement or prior art documents. That said, it being an examination (and one suspects that many judgments have been formed in real-life cases on interpretation of claims only in light of the prior art), it is a known technique used by some to construe the claims having considered the prior art documents and the infringing article(s) to assess which words/phrases in the claim map neatly on to the infringing article(s) and prior art and which don’t (and thus the terms that don’t map neatly on to the language of the documents describing the infringing article(s) and the prior art documents need to be interpreted so that they do map on neatly).

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Errors Sometimes there are errors in the claim that need to be interpreted. For example, an incorrect term may be used or an incorrect dependency may be used.

The ‘nuts and bolts’ of claims In practice, there are various techniques that typically need interpretation in the construction section (and for which there will be a least ½ to 1 mark per point):

Claim structure (independent & dependent claims) It is usually necessary to understand the claim structure of the claims of the patent, in particular to identify any independent claims and the specific combinations that are possible between claims based on the dependency structure.

Repercussive effect Where a feature is defined in a later dependent claim to be more specific, the earlier feature can be interpreted to be at least broader than the more specific definition in the later claim.

So, for example, if claim 1 recites ‘An apparatus comprising a widget’ and claim 2 recites ‘The apparatus of claim 1 wherein the widget comprises a blue widget’ one can infer from the repercussive effect that the widget in claim 1 can be any colour or that at the very least the widget in claim 1 can be blue and other colours.

Optional features Optional features in the claim can be denoted using a variety of language, most obviously ‘optionally’. For example, claim 1 might recite ‘An apparatus comprising a widget optionally wherein the widget is blue’. For the purposes of construction, this should be noted (and it follows for the purposes of both infringement and novelty/ inventive step that the optional features are not needed for there to be respectively infringement/anticipation of the claim).

Other words that denote (or might denote) an optional feature can include: particularly; preferably; sometimes; can; may; for example; in some cases. Others might be possible – leave it to the examiners setting the FD4 paper to think up new variants!

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‘For’ and ‘suitable for’ The words ‘for’ or more correctly ‘suitable for’ (it is pretty much always useful to set this out, that ‘for’ = ‘suitable for’ when recording your interpretation of a claim in writing) indicate that a feature in a claim must be suitable for a particular purpose but need not be limited to only being used for that purpose. We know this from the Adhesive Dry Mounting v Trapp (1910) 27 RPC 341 case that is summarised earlier in the book in the case law section.

For example, a claim might recite ‘A handle for use on a door’ but when interpreting this claim it is useful to note that the handle need only be usable on a door rather than the claim covering handles only on doors – thus a handle on for example a window would fall in the scope of this claim wording (as long as it was in theory transferable to a door to function as a handle on a door).

Apparatus, method and system claims Apparatus and method claims should be well understood – apparatus claims relate to a physical object of some sort and will define at least the physical characteristics of the object; while method claims will set out a series of steps to be performed.

System claims can be categorised as either apparatus or method claims, or can be a mix of both apparatus and method features, or sometimes can be used to for example cover a plurality of related apparatus. Sometimes it is clear what is intended, but worth recording in writing the interpretation to be taken. Sometimes more analysis will need to be made to assess what is intended to be covered by a system claim.

Operable features/‘in use’ In some apparatus claims, method features will be included to clarify the purpose of apparatus features. These can be interpreted either as a refinement of the apparatus feature or as a feature that is only present when the apparatus is being used.

For example, a claim might recite ‘a widget operable to conduct electricity’ which would typically be interpreted as a feature that is only observed in use. Thus, infringement of this feature is most likely intended/desired whether or not the apparatus is in use, and an interpretation needs to set this out.

Another example might be where a claim recites ‘An apparatus comprising a widget and a gasket, the widget operable to communicate with the gasket’ which would

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most likely be interpreted as indicating that two apparatus features are in some way connected – perhaps to transfer data, or perhaps to transfer something physical like electricity, signals, or f luids.

Ranges Ranges are generally interpreted in line with case law in Smith & Nephew (see the case law section of this book for more detail). The degree of precision used by the patentee indicates how to interpret the range, so a range between 1% and 25% indicates the relevant range within scope is 0.5% (as this would round up to 1%) to 25.5% (as this is just beyond the maximum that would round down to 25%).

Interpretation approach The general approach in the construction section is to pick out key phrases or words in the claims of the patent and provide an interpretation for each of these key phrases or words. To be absolutely clear, the examiners are not expecting you to provide a construction for every single word in the claims – there are marks only for discussing the key phrases or words in the claims and providing an interpretation of these key phrases or words.

Your answer to the construction section should serve as a ‘dictionary’ of sorts to help you answer the remainder of the paper (i.e. is the patent seemingly infringed and is it seemingly valid).

A good rule of thumb when considering what the key words or phrases in the claim are is: for the word or phrase you are considering, is the interpretation you are considering simply ‘takes its normal meaning’ or ‘see dictionary definition’ or just rearranging the words in the phrase being considered? If so, then you aren’t really adding any value by providing this as your interpretation and thus you are unlikely to score any marks (even if marks are available).

Of particular interest you will want to identify any ‘tipping points’ or ‘finely balanced points’ in the claim, and for these you should consider the multiple ways that these points can be interpreted and then make a reasoned decision about which way these points are to be interpreted.

There are some overarching principles in forming your construction of the claims that are worth flagging here:

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Try to avoid jumping to an extreme construction. Doing so will typically allow you to reach a conclusion more quickly but will probably lose you some of the marks available as your reasoning for choosing that construction will likely be less rigorous (not always) and you will be unable to access some of the later marks for having less to debate (i.e. the answer will be too clear cut to allow any debate – you may potentially negate one of the ‘tipping points’ or ‘finely balanced points’).

Remember that you are not meant to be acting aggressively for or against the patentee, regardless of who your client is supposed to be. Your ‘job’ in the paper is to prepare a neutral opinion, i.e., what is most likely to be the construction once all views/possibilities are considered. You could ask yourself the question: ‘what would the judge conclude if this ever went to court?’ to check yourself when concluding any construction point.

Finally, it seems that as of the 2023 examination, the examiners expect you to give page and line references to the specification as basis for any construction points you make.

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ASSESSING INFRINGEMENT

Introduction The infringement section is in theory much more straightforward than the construction section and a section that candidates can score high marks in if they don’t omit to assess all infringing articles and if they show the required attention to detail desired by the examiners and mandated by the marking schedule (and if they give answers to each section clearly allowing the examiners to allocate them marks).

What do the examiners say?

Candidates generally perform well in the infringement section, according to the examiners in the examiners’ reports.

Level of detail The examiners tend to repeat that no marks are available for simply stating that a feature of the described process was within the scope of the claim. The examiners also tend to repeat that candidates lose marks by failing to address which features were present and which features are not present, i.e. that the details matter in this section of an answer.

The examiners have specifically reported in the past that candidates must identify the corresponding features of each infringement that match each feature of the claim in order to score marks for analysis. I cannot emphasise enough how important it is to find correct page and line references and to provide these as basis for finding a claim feature to be present or not.

The examiners have also specifically stated that a lack of reasoning will lose candidates marks – simply saying that a feature is present will not score any marks.

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Whether something is an infringement The examiners have previously noted that where two processes have been disclosed in the paper (in the infringement document for example), most candidates will analyse both of these even if one was not intended to be analysed – e.g. because a major feature was missing from one of the potentially infringing articles/examples or because the described potentially infringing article/example was stated to have been in use for a long period of time that pre-dates the filing of the patent (i.e. the examiners intended this to be discussed in the advice section as prior use). This is my preferred approach too, as missing an embodiment will lose in the region of ten marks and so I would err on the side of caution and analyse each embodiment I spot.

Actavis The examiners in the more recent papers have started to remind candidates that where a conclusion of no (direct) infringement is reached, they expect candidates to see it as appropriate to consider whether or not Actavis (i.e. equivalence) should be considered and that they have noticed that many candidates do not address this issue at all.

The examiners occasionally remind candidates that there will even be marks available for statements that Actavis is not applicable. This links to their general comment that even addressing some of the issues brief ly will score marks across the paper that might result in a candidate scraping a pass.

However, the examiners have also said that when assessing infringement under Actavis, candidates sometimes appear to present the test without applying it to the facts of the situation thus losing marks.

More worryingly, the examiners have in the past had to state in their comments that some candidates seemed to confuse ‘normal’ direct infringement with infringement under Actavis and they noted that Actavis infringement should only be considered when no direct infringement is found.

Questions The examiners, in papers where it is relevant, generally find and therefore report that candidates don’t always spot or f lag in their answers where further information is needed to reach a conclusion and that information is and why it is important.

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Method claims The examiners tend to report that, when the paper includes method claims (or where use is important), some candidates do not explain how a particular apparatus disclosed relates to the method of use when considering infringement (especially where alternative uses of the apparatus might be possible).

Defences to infringement Where the paper has included claims directed to for example methods of treatment, the examiners note that some candidates have assessed/concluded that there is no infringement rather than the correct answer which is that there is a defence to infringement as the claim was excluded from patentability.

The theory In general, looking at the case law and the statute, it can be said that once you have made an assessment of construction, infringement is straightforward in that it can be analysed and decided fairly objectively.

For each feature recited in the claims, an analysis needs to be made of whether or not that feature is present in the infringement. This is important to do for every feature of the claim, without missing any detail, so this aspect of the examination is very much a test of consistent attention to detail.

The major theory aspect of the infringement section is to remember to assess the three veins of infringement: direct infringement (see the legislation section earlier); indirect/contributory infringement (see the legislation section earlier) and Actavis infringement (see the Actavis case in the case law section earlier).

Direct infringement in practice requires you to assess each feature/phrase/word of the claim in turn and analyse whether, based on any interpretation made in your construction section, each of these respective features/phrases/words are present in the potentially infringing article you are assessing. If all of the features/phrases/ words are present in the infringing article, and there is an infringing act performed, then there is direct infringement.

Indirect infringement in practice requires the same detailed analysis as set out above in relation to direct infringement, but, after making your assessment of direct infringement and answering that there is no direct infringement, consideration

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needs to be made of whether the combination of features/phrases/words present in the infringing article constitute the essential element of the invention (for example, one element may be deliberately omitted by the potential infringer in order to avoid direct infringement but in full knowledge that the end user will immediately add back in the omitted feature in order to gain the full benefit of the invention).

Finally, after considering direct and indirect infringement and if no direct infringement has been found, an assessment should be made as to whether the missing feature of the claim in the infringing article is substituted with an equivalent feature – if so then there is infringement under the Actavis test proposed in the Actavis case (see the case law section earlier).

Approach One of the common errors in assessing infringement that candidates tend to repeat each year is that candidates assess their construction of the claims against the potential infringing article or articles.

What do I mean by this? Well, as explained earlier in relation to the construction section of the paper, in the construction section the (seemingly) most important phrases or words in the claim are given an interpretation as to the scope of that respective phrase or word. This, by necessity, is not done for every word in the claim. As a result, if candidates only assess whether their construed features are present, they will end up missing making an assessment of all of the features recited in the claim as all non-construed features will be missed or the focus of any assessment will be on the construed features and thus detail will be missed and either marks will be lost (i.e. not gained for the detailed points) or the whole answer will be wrong (i.e. the crux of the answer is wrong as a result of missed or omitted detail).

The other thing that is important in this section is to actually give an answer. This a source of great frustration to the examiners, who are happy to give marks but need candidates to actually give them an answer to do so according to the marking schedule!

What do I mean by giving an answer? There are two categories here: the first is to remember to give answers to each point of analysis in your infringements section – i.e. is this claim feature/word/phrase present or not present in the potential infringing article being analysed. The second category is giving a final answer: i.e. is claim 1 infringed or not (and all of the other claims). Further marks are available

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for being specific as to the type of infringement – direct, indirect/contributory, or infringement under Actavis/equivalents.

Most candidates use a table format to record/present their analysis, and I think it is safe to say that the examiners favour this answer format too as it is much easier to see what each candidate has recorded as their answer (and if they have in fact given a conclusion!).

A major failing that still continues to happen each year is that at least some candidates will omit to present answers for all of the infringing articles for which there are marks available. Before starting your infringement section, please make sure you have identified all potentially infringing articles and, if using a table format, allocate a column to each potentially infringing article. Sometimes the infringing articles are explicit, but sometimes there is a paragraph in either the infringement document or perhaps the client letter where it is mentioned that there is some variant/improvement of the infringing article descriwbed in the infringement document – this needs separate assessment.

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ASSESSING NOVELTY

Introduction The novelty section is very similar to the infringement section in that what needs to be done is very similar to the infringement section. It is in theory also more straightforward than the construction section, and a section that candidates can score high marks in if they don’t omit to assess all of the separate prior art embodiments and if they show the required attention to detail desired by the examiners and mandated by the marking schedule (and if they give answers to each section clearly allowing the examiners to allocate them marks).

What do the examiners say?

The examiners tend to report in most papers that candidates generally perform well in the novelty section.

The examiners will remind candidates from time to time that they are expected to conduct a full novelty assessment of the prior art for all claims. Specifically, the examiners regularly report that it is insufficient to say only that the features are absent to score all of the marks available.

The examiners will also regularly remind candidates that their conclusions need to be consistent with their construction and properly supported by the documents/ paper in order to gain the allocated marks.

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Novelty assessment date The examiners have in the past reported that the date for assessing novelty is sometimes not stated by candidates and that this is useful thing to do in most papers, as in at least some papers it is important to be clear about this as it is relevant to some of the potential prior art documents.

What is a prior art document/embodiment In a recent paper where there was a non-infringing article in the infringement section that had been in use prior to the patent being filed, no candidates spotted that this could be used as a prior art embodiment in their novelty section. Be careful that you assess each document provided in the examination as to whether it (or a portion of it) might be prior art.

Where it is the case (which it is every now and then) that the introduction of the patent serves as a prior art embodiment in its own right, the examiners will usually report that only some candidates spot this (and sometimes report that the candidates who do spot this tend to score high marks). There are always some candidates that miss this type of prior art, even thought it is a ‘trick’ used by the examiners regularly in this exam to hide prior art from unsuspecting candidates.

What isn’t a prior art document/embodiment that is worth assessing in papers where one of the potential prior art documents/embodiments does not include sufficient detail to assess novelty, the examiners typically report that they allocated no (or very few marks) for assessing the non-enabled document/ embodiment and that some candidates still performed a full prior art analysis (and thus wasted time and scored no marks).

The theory In general, looking at the case law and the statute, it can be said that once you have made an assessment of construction, novelty (like infringement) is straightforward in that it can be analysed and decided fairly objectively.

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For each feature recited in the claims, an analysis needs to be made of whether or not that feature is present in each prior art embodiment/document. This is important to do for every feature of the claim, without missing any detail, so this aspect of the examination is very much a test of consistent attention to detail (again, like for infringement).

The major theoretical aspect of the novelty section is to remember to assess the relevant date for the prior art and also what type of prior art each document/ embodiment is: i.e. is it ‘full’ prior art for the purposes of both novelty and inventive step; or is it ‘novelty-only’ prior art only to be used for the assessment of novelty.

Finally, after considering whether all of the features of each claim are present or if any are missing, a conclusion needs to be made as to whether each claim is novel or anticipated in light of each prior art embodiment/document.

Approach There are two common errors in assessing novelty that candidates tend to repeat each year, which are: (1) candidates assess their construction of the claims against the potential prior art document/embodiment rather than every feature of the claims; and (2) candidates miss or ignore a prior art embodiment.

What do I mean by (1)? Well, as explained earlier in relation to the infringement section of the paper, in the construction section the (seemingly) most important phrases or words in the claim are given an interpretation as to the scope of that respective phrase or word. This, by necessity, is not done for every word in the claim.

As a result, if candidates only assess whether their construed features are present, they will end up missing making an assessment of all of the features recited in the claim as all non-construed features will be missed or the focus of any assessment will be on the construed features and thus detail will be missed and either marks will be lost (i.e. not gained for the detailed points) or the whole answer will be wrong (i.e. the crux of the answer is wrong as a result of missed or omitted detail).

For (2), candidates need to be careful to identify ALL possible prior art in the paper.

This can be hidden in the client letter (or more likely hinted at in the client letter), in the infringement document, in the background section of the patent, or there might be multiple embodiments in one of the prior art documents that need to be assessed separately. Candidates need to be careful not to miss a piece of prior art.

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Again, as with infringement, it is important in this section to actually give an answer – at the end of the analysis of each claim vs each piece of prior art, candidates need to remember to conclude whether each claim is novel or not in light of each piece of prior art.

Most candidates use a table format to record/present their analysis, which I think the examiners favour as it is much easier to see what each candidate has recorded as their answer.

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ASSESSING INVENTIVE STEP

Introduction The inventive step section is where things tend to go downhill for most candidates, I think mainly because the time pressure at this point in most candidates’ answers means that there simply isn’t sufficient time to do an excellent piece of work and as a result candidates panic or simply don’t have time to do enough, or write enough, to give an answer that scores well.

Mixed with this time pressure point, I think it is also possible that candidates aren’t as well versed in UK inventive step analysis to be able to answer this section as they would in their day-to-day practice (which, for most trainees, tends to be mainly EPO-based prosecution).

That all said, those candidates who (a) either have a very time-efficient way to answer this section or who have reached this section of their answer with sufficient time, and (b) who are suitably versed in how to conduct UK inventive step analysis, tend to score very well in this section and achieve an ‘easy’ pass of the paper. Even a very quick but well-done answer to this section can score a surprising fraction of the marks available for candidates who know what needs to be done but are short on time to prepare an entire answer.

What do the examiners say?

The examiners will regularly state a warning that candidates in each examination do not analyse inventive step well. Sometimes the examiners will add that those candidates who did well in the inventive step section usually achieved good marks overall.

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Sometimes the examiners will acknowledge that candidates are able to set out the Pozzoli analysis in general terms but that the answers to specific claims are typically not well presented.

The examiners will regularly remind candidates that ALL claims need to be assessed.

UK vs EPO law In the more recent examinations, the examiners have moved to a more concrete position on what is permitted when answering the inventive step section in the FD4 exam. Previously, the examiners had allowed the use of the problem-solution approach but had generally advised that candidates using the problem-solution approach might not score as many marks as those who used the UK law to assess inventive step. This evolved into more explicit warnings against the use of the problem-solution approach and candidates were warned that using the problemsolution approach would result in them scoring fewer marks. In the 2023 marking schedule, the examiners explicitly stated that the relevant UK test must be used (i.e.

Pozzoli) and that the EPO-style problem and solution approach is not appropriate.

Claims that lack novelty The examiners will repeat regularly that, should a claim be found to lack novelty, inventive step analysis still needs to be performed.

Also, the examiners (fairly regularly) will point out that just saying that ‘the claims lacks novelty so can’t be inventive’ also doesn’t score any marks. At least a simple analysis is needed. The examiners tend to expand on this by saying that marks are still available, even if claims lack novelty, for identification of the inventive concept and the state of the art.

I will point out at this point that the marking scheme will have an allocated number of marks for assessing inventive step for each claim. Just answering with a single line statement that the claim lacks novelty will not give candidates the opportunity to access most of these marks. Thus candidates need to assume that a full Pozzoli analysis is required for each claim and that there are marks for doing this for each claim.

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Argumentation The examiners also regularly repeat that arguments and conclusions need to be supported by reference to the information provided in the paper - just SAYING something is obvious won’t score any marks. The examiners will complain from time to time that candidates just present superficial statements - i.e. superficial statements will score low marks or no marks.

Consistency Another point the examiners make regularly is that consistency with one’s construction section is required. There will be occasional admonitions from the examiners that candidates were inconsistent with their construction/infringement/novelty sections.

Person skilled in the art The examiners have previously f lagged that the person skilled in the art needs to be defined in a way that covers all embodiments, even if the embodiments span different technology areas (where this is applicable).

Inventive concept The examiners have previously f lagged that candidates sometimes struggle to define the inventive concepts of each claim or that the inventive concepts chosen don’t match the breadth of the claim.

In one paper where the inventive concept came from two (different) fields of art, it was necessary to argue why the skilled person would look elsewhere (i.e. into the other field) to address the inventive concept.

The theory The key case law that applies to the inventive step section is the Pozzoli case (see the case law section of this book for more details).

This sets out a sequence of steps that form the analysis you need to perform using the test set out in this case. The steps are broadly as follows:

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1. Person skilled in the art The first assessment you need to make is who is the notional person skilled in the art, from whose perspective you need to assess whether each claim is inventive in light of the prior art.

The person skilled in the art may be a team of people, or just one person.

This assessment needs to be made for each claim, but in reality the assessment mostly remains the same for the dependent claims so needs to be repeated for at least each independent claim.

2. Common general knowledge The second assessment you need to make is what is the common general knowledge for your chosen skilled person.

3. Inventive concept For each claim, you need to set out the inventive concept of the claim - this is the core technical advance or innovation that distinguishes the invention from the prior art. It is the essence of what makes the invention non-obvious (from the perspective of the skilled person reading the patent).

4. Starting (prior art) document For each claim, you need to choose the prior art embodiment from which you are starting your analysis.

5. Differences between claimed invention and starting document Using your novelty analysis from the novelty section, then you need to set out the differences between the claimed invention and the starting document.

6. Argumentation and conclusion In light of the differences between the claimed invention and the starting document, you then need to set out arguments as to whether and why the inventive concept is truly inventive when considering this from the perspective of the skilled person and the common general knowledge.

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Approach As set out in the theory section, candidates need to follow the Pozzoli analysis and set this out for the examiners in the expected order.

Independent claims Generally, the person skilled in the art and common general knowledge is set out for each independent claim and not repeated for each dependent claim. So for the independent claims you follow the following approach: 1. Person skilled in the art Your first choice needs to be whether you need one skilled person or a team of skilled people - then you need to explicitly state the jobs of the people you choose.

So for example you might choose a ‘water storage apparatus designer’ as your skilled person.

2. Common general knowledge Generally, you need to identify the common general knowledge that has been provided in the paper and list it here, taking into account who you have chosen as your skilled person to make sure that the common general knowledge is appropriate for that skilled person choice.

Dependent claims 3. Inventive concept For each claim, you need to set out an inventive concept of the claim that explains what the skilled person reading the patent would consider as the core technical advance or innovation. Typically, candidates will be well served to set out for the dependent claims that distinguish the invention according to how it is presented in the patent specification. This may not stand up to scrutiny in your analysis, but you need to extract what the patent specification seems to present as the key concept/ advance and distill this into a statement to describe the inventive concept. Most of the time, candidates will get a strong hint as to what would work as an inventive concept by considering the features of the dependent claim against the prior art.

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4. Starting (prior art) document For each claim, you need to chose the prior art embodiment from which you are starting your analysis. This will tend to be the starting point that you consider to most likely result in the claimed invention lacking an inventive step - i.e. what you would call the closest prior art before the EPO, but note the different nomenclature.

5. Differences between claimed invention and starting document Using your novelty analysis from the novelty section, then you need to set out the differences between the claimed invention and the starting document. This is straightforward but it is generally recommended to spell this out in a single sentence rather than copying and pasting the claim elements that are missing from your novelty section as this is overkill.

6. Argumentation and conclusion In light of the differences between the claimed invention and the starting document, you then need to set out arguments as to whether and why the inventive concept is truly inventive when considering this from the perspective of the skilled person and the common general knowledge.

Generally, candidates are advised to f lag what of the common general knowledge is relevant here first.

Then candidates should probably test whether any of this prior art provides the missing features that are recited above as a summary of your novelty analysis. This should be f lagged to the examiners - either some or all of the features are present or obvious from the common general knowledge or not.

Based on this analysis, an assessment then needs to be made as to whether the still missing features are in any way derivable from the starting document or the common general knowledge.

Finally, a conclusion needs to be presented on whether the candidate believes this means the claimed invention is obvious or inventive.

This needs to be repeated for each claim in turn.

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ASSESSING SUFFICIENCY

Introduction The sufficiency section tends to be pretty short, and very short if there are no real issues to discuss (which happens regularly).

If there are no sufficiency issues, there tends to be a mark for explicitly stating ‘There are no sufficiency issues.’ and moving on to the next section - saying nothing will not score you this mark.

If there are sufficiency issues, there tends to be around four marks available and the clues tend to be that (a) a feature described as (or implicitly) essential to the invention is missing from the claims; or (b) the claimed invention scope covers a broad range of possible elements that have been poorly described or not described well enough that a skilled person would be able to satisfactorily reproduce the invention across the scope of the claims.

What do the examiners say?

When there are no sufficiency issues in a paper, the examiners tend not to say much other than that there was a single mark (or half a mark) available for stating this explicitly (and that marks were only available for explicit statement).

Where there are sufficiency issues, the examiners usually report that the marks were generally poor as few candidates provide acceptable analysis of the sufficiency issues. The examiners usually put a hint that there is a sufficiency issue to assess into the paper, so will highlight this in their feedback on the examination.

Sometimes the examiners will set out in detail what they are testing with the sufficiency issues in the paper in question, and will explain what the sufficiency issues were and how they expected candidates to deal with these.

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The examiners have previously said that candidates who discuss any sufficiency points for which there were marks in another section, typically the advice section, will still be given the marks for the sufficiency points even if in the ‘wrong’ section of their answer.

The theory There are a few ways that there can be sufficiency issues in a patent application, and candidates are directed to the case law section of this book for more detail on this specifically the Biogen and Warner-Lambert cases.

The first issue that the examiners want f lagged is whether there is sufficiency across the scope of the claim (or ‘Biogen sufficiency’). What needs to be considered is whether the invention would ONLY WORK in for example certain conditions or with a particular feature. If the claims are not limited to these certain conditions or by including the feature, then there is probably a sufficiency issue.

The second issue is a question of reasonable trial and error (i.e. is it ‘relatively easy to determine with a few practical tests’ that the claimed invention can be replicated) if the skilled person would be able to replicate the invention and make it work, without needing to do undue levels of experimentation, then there should be no issue with sufficiency. If this isn’t the case, then there is probably a sufficiency issue.

Approach Candidates should first look at whether there are any hints in the paper that there might be a sufficiency issue, as the examiners tend to drop major hints if they have included something that needs to be discussed. Knowing the marks in advance for the paper should also indicate whether there are marks for sufficiency and therefore that there is an issue.

The key things to look for is whether there are seemingly essential elements that are missing from the claims, or if the claims are very broad but there are either limited specific examples in the specification or vague implementation details in the specification that might make it difficult for a skilled person to put the invention into practice using the specification and their common general knowledge.

An example of a ‘Biogen sufficiency’ would be where a process claim is described as only working within a specific temperature range but the claims are not so limited

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to this range. Candidates would be expected to f lag this and then suggest that the claims could be fixed by amendment to include a limitation to the process working within this range (assuming this is described in the specification). If for example the letter tells you that the process only works within this range but that this isn’t disclosed in the specification, then candidates should probably f lag this to the examiners as a sufficiency issue that might be problematic and unable to be fixed due to a lack of basis for this amendment in the specification.

An example of sufficiency issues that require an assessment of reasonable trial and error (i.e. is it ‘relatively easy to determine with a few practical tests’ that the claimed invention can be replicated) will probably include some hints from the examiners in the client letter that the invention couldn’t be replicated or something along these lines, else candidates would be expected to set this out and then dismiss this as not being a sufficiency issue.

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CHAPTER 10

IDENTIFYING AMENDMENTS

Introduction The amendment section also tends to be pretty short. Depending on each candidate’s answer up to this point in the examination, candidates sometimes find themselves having very little to say, or very different amendment source material to consider compared to what the examiners were expecting.

Generally, what the examiners want is either for candidates to propose sensible options for amendment, or they want candidates to propose the best available amendment (preferably one that both is infringed and valid, but at the very least restores validity if this is an issue).

The amendment section has changed over time (in the exam papers), in my opinion, between rewarding finding ‘THE amendment’ and rewarding finding a selection of useful amendments.

Over the last ten years of papers from 2013 to 2023, initially the examiners seemed to be looking for one amendment that restored validity and infringement but over this time the examiners seemed to accept that there were multiple options for amendment and that candidates didn’t always reach the same conclusions as the examiners in order to then reach the same one amendment that the examiners had in their marking schedule.

As a result, the examiners moved to a more flexible position where they awarded marks for a range of possible amendment that candidates could flag for consideration, nominally by the client.

The more recent papers (2020 onwards) seem again to concentrate on rewarding finding ‘the’ amendment (i.e. one that restores validity and maintains infringement) but, interestingly, also introduces the (potentially more realistic) possibility that there is no useful amendment to be found as the possible amendments might restore validity

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but remove infringement, or solidify infringement but weaken validity (or, at least, not strengthen it).

What do the examiners say?

Regularly, the examiners note that few candidates propose sensible amendments. The examiners will also regularly put on record that a detailed analysis of the amendment and its justification was not needed as long as the main features (of the amendment proposed) were identified. The examiners have also said in the past that candidates are not expected to do more than identify the subject matter that could form the basis for their proposed amendment (to achieve the single mark available, in some papers!) – i.e. candidates do not need to prepare the wording of an amended claim in this section.

More recently, the examiners have acknowledged a couple of key things: first, in a recent exam the examiners accepted that there was no amendment expected that would provide novelty, inventive step and infringement; second, in the most recent exam, the examiners have made clear that they considered there to be a number of possible amendments and that the discussion of these depended on each candidate’s conclusions for infringement and validity. This is useful for candidates, who tend to worry if they can’t find a useful amendment or have a variety of options for amendment and struggle to select one that they think the examiners are looking for.

Where there is no fixing amendment possible (i.e. an amendment that restores validity and which is infringement) the examiners have gone on to say that they expected candidates to attempt to improve the validity of the patent, for example by cancelling the invalid claims at the very least.

Where there are sufficiency issues in papers, the examiners have previously said that amendments to address any sufficiency issues were expected in the amendment section (e.g. to introduce a limitation described as essential into the claims).

Where there is a problem with non-patentable subject matter, the examiners have previously said that amendments to fix this issue (or to delete the claims) are expected.

The theory As hopefully all prospective candidates for this exam will know, patents cannot be amended to make them broader than when granted, so post-grant amendments must only narrow the scope of protection. In almost all FD4 papers, the patent at issue is

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granted so this needs to be taken into account, but candidates should be mindful of whether in a future paper there is (a) a patent application rather than a patent and (b) whether there are options in other jurisdictions or the possibility for a divisional filing.

Amendments will either be possible using the claim wording (e.g. introducing part or all of the features of one or more dependent claims) or using wording from the description – i.e. the amendment must be supported.

Amendments can also delete matter from the patent application, and for the purposes of the exam it is most likely to be one or more claims that might need to be deleted.

In previous papers, another source of amendments are to correct errors – here you will need an obvious error with an obvious solution and would be wise to state this.

Amendments Generally, the amendment section can only be answered once a candidate has completed their analysis and therefore has conclusions for their infringement, novelty and inventive step sections.

In light of the examiner comments from more recent examinations, it is relatively safe to say that an amendment that is both infringed and valid is desired if possible to find this.

If a candidate’s analysis indicated that at least one claim is valid and infringed, then it seems that amendments to improve the claims are probably expected – e.g. any errors in the claims amended so that they are corrected, and non-patentable subject matter deleted or amended/non-valid claims deleted or amended.

If a candidate’s analysis indicates a lack of validity, then amendments should be presented to restore novelty.

If there is a lack of infringement, this is typically harder to fix without broadening the claims – typically, a narrowing amendment that is still infringed tends to mean that a narrowing feature is present in the description that needs to be added to claim 1 (based on previous exam papers).

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CHAPTER 11

PREPARING ADVICE

Introduction The advice section is probably one of the worst-answered sections of the FD4 exam purely because it is the last section most candidates reach when writing their answer and therefore the section that is most time-pressured. Some candidates either don’t reach this section because they have already run out of time, while others reach this section with very little time remaining and aren’t able to write very much in the time they have remaining in the examination.

This section requires relatively little writing to score the points available, as the examiners have always made it clear that they are able to accept ‘note-form’ answers rather than fully written out detailed pages of writing per point of advice.

Typically, the advice expected is driven by the conclusions reached by the candidate combined with the question(s) asked by the client in the client letter. Some of the advice expected is reactive to the conclusions reached while other advice is expected in reaction to the questions posed in the client letter by the client.

What do the examiners say? the examiner will, pretty much every year, say something along the lines that ‘few candidates provided anything other than superficial advice to the client’ or ‘the advice from most candidates was superficial at best’.

As a more general statement, the examiners have also previously reminded candidates that ultimately the problem presented in this paper is one of advice for the client and while credit is given for the underlying work, the advice itself is important but in most cases an afterthought. I completely agree with this general statement but personally note that the marks allocated to the advice section are typically 10% of the total marks

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available and so the incentive for candidates is to answer the rest of the paper well enough rather than to present a brilliant advice section answer.

Generic advice The examiners have previously stated, explicitly, that general comments not related to the scenario presented in the paper scored very few marks.

Client questions The examiners usually remind candidates to provide explicit answers to the specific questions asked in the client letter.

The examiners have also noted in the past that the questions in the client letter should direct candidates to the areas of general advice that may be relevant.

Bad advice In previous papers, the examiners have said that some candidates offered very bad advice that would put the client in a worse position, such as seeking interim relief or trying to enforce a patent without amendment to ensure validity.

In situations (for example) where the conclusions of the candidate indicate that the client is infringing, the examiners have stated that advice to proceed to launch a product where that candidate’s analysis indicated that the claims were infringed cannot be awarded marks.

Amendments In papers where there is no satisfactory amendment possible, the examiners advised candidates that they expected advice to the client that the claim could not validly cover the infringement process and that there was no saving amendment, and that this should be presented in terms the client could understand.

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Missing information The examiners have also advised that candidates were expected to outline what further information was needed in order to give advice.

The theory There is much theory that is needed in order to answer the advice section, and this theory can vary widely between papers.

The core of the theory is advising in relation to infringement and validity, which is covered in detail in the previous sections and tends to need minimal summary in the advice section unless there are issues that need further advice following the conclusion reached on each of these issues.

Infringement advice tends to be in relation to what actions the client needs to know about and their options/next steps. For example, candidates might want to advise on interim injunctions, bringing proceedings, sending letters before action, etc.

Validity advice tends to be advice on whether any of the claims are valid, and if any amendment is needed to restore validity.

Sufficiency advice is only relevant if any issues have been identified with a lack of sufficiency, and needs to include any fix to these issues if available or the consequences of a sufficiency issues that can’t be fixed.

Amendment advice tends to focus on the procedural issues of how and where to amendment (e.g. the patent office vs the Courts).

Other issues tend to be raised in the client letter or as a result of the analysis of the claims or sufficiency. For example, in recent examinations, the following have been issues about which some advice has been necessary: entitlement; inventorship; threats; the priority date; joint applicants; restoration; prior use (and other defences to infringement); patent office opinions; declarations of non-infringement; European patents.

Details about at least some of these issues are included in the earlier sections of this book.

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Approach – advice section the thing candidates need to do is to present both (a) their proactive advice and (b) their reactive advice.

Their proactive advice will relate to their conclusions on infringement, validity, amendment and sufficiency. Taking the conclusions on each of these topics, candidates need to present their conclusions alongside options for the client as to why these conclusions are important and what the client’s options are and/or what the client should do next.

Their reactive advice will predominantly answer the questions posed by the client in the client letter, generally flowing from some further information provided in the client letter. For example, there might be some information on a coinventor and a question about whether there might be an inventorship issue or entitlement issue, about which candidates then need to prepare some advice.

All of these advice points should be able to be presented as a bullet point list, but candidates are free to present their advice as they wish.

Some candidates have provided this advice as a formal letter, but this is not recommended as it takes longer and scores no additional marks.

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PREPARING FOR FD4

Theory Candidates are recommended to review the theory section of this book and then do some further reading of the relevant legislation and case law to ensure they have a decent grounding in the relevant theory.

It is likely that candidates for the FD4 exam are either taking FD1 in parallel or have passed the FD1 exam already, in which case it is likely that they will be aware of all of the relevant legislation and case law.

Mock papers Whenever I have tutored FD4, I recommend trying to do at least one previous exam paper as a mock paper per month from around May until the exam.

From 2014, the marking schedules have been released and so enable candidates to assess their own answers or to get someone else to assess their answers in order to get a rough idea of their mark for each mock paper. They will also be able to identify points that they have missed and advice that didn’t match what the examiners expected.

It is key to refine your approach to the paper, including deciding how long you plan to read the material provided and in what order, and to get used to preparing the answer to the paper (e.g. whether you plan to use tables to set out your answer to the infringement and novelty section).

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Revision Having done roughly one paper a month up until the exam, candidates might not have the time to do many more papers close to the examination date – something I recommend doing is to practice at least the construction section of the exam in the time leading up to the examination, as this takes less time than sitting an entire mock paper.

Specifically, I recommend using the very old papers available on the CIPA website and either just highlighting the terms that you would construe (if very limited for time) or highlighting the terms and then writing a construction answer (if you have more time), as this sharpens your skills running up to the exam and increases the chance that you start the exam well.

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CONCLUSIONS

Final points As I have said elsewhere in this book, the FD4 paper is a pretty complete test of being a patent attorney and one that can be passed by candidates that are prepared.

The key thing to remember is that this paper is a very practical test, and so is generally prepared for by doing mock papers to time and in close to exam conditions. Once you have done a few papers, and (hopefully) as you improve your approach each time, you will appreciate the constraints of the time allowed for the exam but also you should be able to hone your approach to provide a decent answer in time available across each section of the paper.

Good luck!

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The ‘Final Diploma 4: Infringement & Validity’ examination seeks to test a candidate’s ability to prepare an infringement and validity opinion for a set of patent claims for at least one potentially infringing article and in view of the prior art.

This study guide by Philip Barnes is structured this book to attempt to provide: • A simplified summary of some of the key legislation and case law that needs to be used to prepare a solid answer to the examination with a view to showing those preparing for the FD4 examination how the various principles from legislation and case law are derived and how these interact.

• An overview of the exam itself.

• Explanations of some techniques and considerations for each section of the paper, i.e. for construction, infringement, novelty, inventive step, sufficiency, amendment and advice; and • Some tips for how to prepare for, and then revise for, the exam.

Price: £40