LSIPR Newsletter - February

February 2013

newsletter news and intelligence from life sciences Intellectual property review

highlights this issue:

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Australian court backs Myriad in gene patent dispute

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B-MS loses Baraclude patent fight with Teva

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Hub and spoke?

Life sciences in Northern France

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UK patent change paves way for pharma innovation

Page 18

Investigating insects: Oxitec’s novel approach Founding Sponsor:

Other contents >>

The right medicine

A blockbuster team of over 20 biotech and pharma patent specialists www.potterclarkson.com

UK - Patent Prosecution Firm of the year 2011

editor’s letter/contents

LSIPR Newsletter 02:13

Life Sciences IP Review is published by: Newton Media Limited Kingfisher House, 21-23 Elmfield Road, Bromley, BR11LT, United Kingdom +44 203 301 8200 Director Nicholas Lipinski Publisher John Haley Telephone: +44 203 301 8205 Email: jhaley@worldipreview.com Managing Editor Peter Scott Telephone: +44 203 301 8211 Email: pscott@newtonmedia.co.uk Sub-editor Ros Bromwich Journalists Rachael Steven, Ed Conlon, Leonie Mercedes Production and design Fisherman Creative ©Newton Media Limited 2013 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electrical, mechanical, photocopying, recording or otherwise without the prior written permission of the publisher.

The views expressed in LSIPR are not necessarily those shared by the publisher, Newton Media Limited. Wishing to reflect the true nature of the market, we have included articles from a number of sources, and the views expressed are those of the individual contributors. No responsibility or liability is accepted by Newton Media Limited for any loss to any person, legal or physical, as a result of any statement, fact or figure contained in LSIPR. This publication is not a substitute for advice on a specific transaction.

The publication of advertisements does not represent endorsement by the publisher.

Life Sciences IP Review (LSIPR): ISSN 2049-2359 (Print)

Editorial Panel Trevor Cook, partner, Bird & Bird Lars Kellberg, corporate vice president, corporate patents, Novo Nordisk A/S Nathalie Moll, secretary general, EuropaBio Caroline Pallard, partner, Nederlandsch Octrooibureau Jane Wainwright, partner, Potter Clarkson LLP Gordon Wright, partner, Elkington & Fife LLP, on behalf of CIPA

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Starting up Hello, and welcome to the first Life Sciences IP Review monthly newsletter. This new project aims to provide a regular, flexible news resource for professionals active in the life sciences, biotechnology and pharmaceutical industries. While the focus will be on intellectual property in those industries, we also hope to be able to provide a wider look at interesting trends, interesting companies and interesting places that have a part to play. We’ll cover all the key news of the month, but there will also be interviews, case reports by experts, looks at clusters of innovation in the industry, and legislative updates.

In this issue, we cover the recent Myriad case in Australia, generic heroin substitutes in the US, a patent revocation in India, and a UK court decision on a Genetech patent, among others. We also take a look at potential changes to UK and Mexican patent legislation, which could have a big impact on the innovation climate in those countries.

One of the key ways in which governments attempt to stimulate the industry is with the creation of clusters, which bring together companies working in the same broad areas and allow them to feed off each other’s creativity; the theory goes that this kind of interaction leads to better results for everyone. In what we hope will become a regular segment, we visited one of those clusters, in Lille, to see how things work. We report back in this issue.

Finally, we have an interview with Hadyn Parry, CEO of Oxitec, which pioneers insect sterilisation techniques in the fight against dengue fever and malaria, among others. He speaks about the company’s approach to innovation, and has some interesting comments on the importance or otherwise of the company’s IP to its success.

Peter Scott, Managing Editor

Contents 4

News 4 US Appeals Court upholds AstraZeneca’s Seroquel XR Patent 4 Teva faces $2 billion damages for selling generic Protonix 5 Australian court backs Myriad in human gene patent dispute 6 India publishes feedback on draft biotech guidelines 8 Bristol-Myers Squibb loses Baraclude patent fight with Teva 8 Nuvo Research and Apotex reach Pennsaid patent settlement 10 India’s Patent Office revokes Sutent cancer drug patent 10 FDA approves generic heroin substitutes

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Life sciences cluster focus Hub and spoke? Life sciences in Northern France

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Legal update 14 Mexican Senate proposes bill to reduce life term of medicine patents 15 UK patent change paves way for pharma innovation 16 India publishes feedback on draft biotech guidelines

18

Investigating insects: Oxitec’s novel approach

20 Case report—Australia: the Myriad case 22

Case report—India: The Sunitinib case

Life Sciences IP Review

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News

LSIPR Newsletter 02:13

US appeals court upholds AstraZeneca’s Seroquel XR patent formulations. The judge rejected this claim and found in favour of AstraZeneca.

washington DC, US

The US Court of Appeals for the Federal Circuit has affirmed a 2012 ruling that AstraZeneca’s patent for ‘blockbuster’ antipsychotic drug Seroquel XR is valid and has been infringed by companies selling competing generics.

In a one-line judgment published on February 14, the court upheld a ruling delivered by the District Court of New Jersey on March 29 last year, which found pharmaceutical companies Mylan, Torrent and Osmotica liable for infringement for selling generic versions of Seroquel XR in the US before the patent for the drug expired on May 28, 2017.

The New Jersey court also granted an injunction blocking the companies from producing competing generics in the US before this date.

In a statement issued following Thursday’s judgment, AstraZeneca said it was pleased with the court’s decision. Mylan, Torrent and Osmotica did not immediately respond to requests for comment.

Seroquel XR is used to treat depression, bipolar disorder and schizophrenia and is an extended release version of Seroquel.

AstraZeneca has also been defending its Seroquel XR patent in Europe and was successful in Spain and the Netherlands, but unsuccessful in the UK and Germany.

The Federal Circuit.

AstraZeneca’s patent for the original Seroquel expired in 2012 but its follow-up was granted protection from the US Patent and Trademark Office in 1999.

Mylan, Torrent, Osmotica and Anchen Pharmaceuticals (which later paid an outof-court settlement) tried to invalidate the Seroquel XR patent after AstraZeneca sued them for applying to release generic versions of the drug in 2010.

The companies argued that the method of using a gelling agent to create a slow release tablet was obvious to anyone with experience of working in the field of sustained release pharmaceutical

Ira Levy, partner at Goodwin Procter LLP in New York, said the appeal court’s decision is no great surprise given the detailed nature of the district court ruling last year, but added: “It is slightly unusual that the court issued a one-line affirmance rather than addressing the merits of the decision.

“This decision will keep the US market for Seroquel XR closed until at least late 2016, when at least one company, Intellipharmaceutics International, may enter through settlement. But the rulings in Germany and the UK may allow generics companies to move their inventory to markets where they can sell,” he said.

Levy also said that the divergence in opinion between EU courts is unusual given the similar patent standards applied across Europe. “If this continues, it could lead to calls for greater harmonisation in courts’ approaches to similar or related global patents,” he added. n

Teva faces $2 billion damages for selling generic Protonix In December 2007—more than three years before the patent’s expiry date—Teva launched its generic in what is known as an ‘at risk’ launch (a launch during continuing patent litigation), expecting Nycomed and Pfizer’s patent to be invalidated.

patau tikva, israel

Israeli company Teva Pharmaceuticals could be forced to pay more than $2 billion in damages for selling a generic version of Nycomed’s and Pfizer’s heartburn reliever pantoprazole (sold as Protonix) before the drug’s patent exclusivity expired in the US.

A jury upheld the pantoprazole patent’s validity in April 2010, however, and found Teva liable for infringement. The decision was upheld by a judge in New Jersey, and a jury trial to determine the damages that should be awarded to Nycomed and Pfizer is scheduled for July this year.

Teva announced last year that it expected to pay around $670 million in damages for infringing the pantoprazole patent, which is owned by European pharmaceutical company Nycomed and licensed to US drugs maker Pfizer.

But in an annual report filed in the US on February 12, the company said that “ultimate resolution of this matter could result in a further loss of up to $1.4 billion in excess of the amount accrued”.

Teva asked the US Food and Drug Administration (FDA) to approve its generic version of pantoprazole in 2004. Nycomed

Generic damages.

and Pfizer sued Teva for patent infringement, attempting to block its generic from being released; Teva claimed the pantoprazole patent is obvious and attempted to have the patent invalidated.

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Howard Hogan, a partner at Gibson, Dunn & Crutcher LLP in Washington, DC, said that $2 billion would not be an unusually large settlement for a case concerning a blockbuster drug, but added: “This should serve as a warning to generics companies about the dangers of at risk launches.” n

News

LSIPR Newsletter 02:13

Australian court backs Myriad in human gene patent dispute A judge at Australia’s Federal Court has upheld Myriad Genetics’ patent covering a human gene mutation linked to breast cancer, in the country’s first court ruling on whether isolated genes can be patented.

Intellectual property law firm Marks and Clerk has opened a new office in Edinburgh’s BioQuarter.

Marks and Clerk will share its new office in laboratory building Nine with Scottish law firm Maclay Murray & Spens.

Myriad was granted a patent covering the isolated nucleic acid coding for a mutation known as BRCA1 in 1996. In 2010, the patent was challenged by not-for-profit organisation Cancer Voices Australia and Yvonne D’Arcy, a Brisbane resident who was diagnosed with breast cancer.

Rebecca Gilsenan, a lawyer at Maurice Blackburn who represented Cancer Voices, argued that Myriad’s patent is a discovery, not an invention and that “the isolation of BRCA1 is no more than a medical or scientific discovery of a naturally occurring phenomenon”.

But in a ruling delivered on February 15, Justice John Nicholas said that Myriad’s patent is valid because it concerns isolated material that has been extracted from naturally occurring DNA and, as a result, consists of an “artificial state of affairs”—an essential requirement under Australia’s patent law.

“There is no doubt that naturally occurring nucleic acids DNA and RNA … cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated,” he concluded.

Myriad has also been successful in defending its cancer gene patents in the US: in 2012, the US Court of Appeals upheld its BRCA1 patent and another for BRCA2, a gene mutation linked to ovarian cancer. The US Supreme Court has since agreed to review this decision and a ruling is expected later this year.

IN BRIEF Marks and Clerk opens in Edinburgh BioQuarter

Sydney, Australia

D’Arcy said that patenting genetic material is morally wrong, while Cancer Voices said gene patenting will stifle research, the development of treatments and access to diagnostic testing (Myriad has exclusive rights to perform diagnostic testing on the BRCA1 gene).

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Myriad’s patent ‘is valid’.

John Fairbairn, a partner at Minter Ellison in Sydney, said the Australian Federal Court decision does not change Australia’s patent law but supports national patent office practice that isolated DNA and RNA sequences are patenteligible, regardless of the species from which the biological material originates. “It reflects the status quo,” he said.

Kim O’Connell, partner at King & Wood Mallesons agreed, but added that the judgment would provide certainty for the scientific community. “Unless the decision is overturned … it appears that the law in relation to the patentability of biological material is settled,” she said.

Both Fairbairn and O’Connell believe the ruling isn’t likely to be overturned unless it reaches the High Court. “It would require a reconsideration or reframing of the principles outlined in the landmark 1959 decision, National Research Development Corporation v Commissioner of Patents [cited by Nicholas in his decision] ... that can only be done by the High Court,” said Fairbairn.

Chris Williams, special counsel at Gilbert + Tobin’s patent practice in Sydney, said that any appeal against the decision is unlikely, as Cancer Voices Australia has been de-registered since last year’s court hearing, leaving only Yvonne D’Arcy as plaintiff.

“Cancer Voices and D’Arcy were both ordered to pay the costs of Myriad, as routinely occurs in Australian cases. This may prevent the individual from persisting with the appeal,” he said. n

Life Sciences IP Review

Scottish First Minister Alex Salmond said: “[The companies’] opening at BioQuarter increases the concentration of life sciences companies at Edinburgh’s centre of excellence, and it represents a significant boost for a sector that is growing jobs and economic opportunities in Scotland.”

Verdesian Life Sciences acquires Northwest Agricultural Products US nutritional and plant health technologies company Verdesian Life Sciences has acquired Northwest Agricultural Products, which specialises in amino modulators and crop protection.

Financial terms of the deal were not disclosed, but Verdesian chief executive JJ Grow said: “The acquisition of NAP underscores Verdesian’s strategic focus on plant technologies that enhance the uptake of key nutrients using multiple modes of action as well as aligning plant health nutritional technologies with agronomic practices.

“NAP’s differentiated products—its bioscience lines, in particular—are highly complementary to Biagro Western’s, which Verdesian acquired in 2012.”

New prize promises riches for innovation Billionaires including Facebook founder Mark Zuckerberg and Google co-founder Sergey Brin have launched the Breakthrough Prize in Life Sciences, which will award five annual prizes of $3 million each for achievements in the field.

The prize, which was launched in February, aims to “recognize excellence in research aimed at curing intractable diseases and extending human life”, according to its website.

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News

IN BRIEF Canadian court upholds Gleevec validity Canada’s Federal Court has upheld the validity of a Novartis compound patent covering its cancer treatment Gleevec.

The patent had been challenged by generics drugs manufacturers Teva and Apotex on the grounds of lack of utility, as well as lack of sufficiency and alleged overly broad claims.

But Justice Snider found in Novartis’s favour, primarily because he found that Novartis had done sufficient tests before filing the patent to demonstrate the utility of the patent claims.

Nigeria and Cameroon agree to tackle fake drug trade Representatives from Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and the Cameroon Standard and Quality Agency have signed a memorandum of understanding between the countries to tackle the movement of counterfeit and dangerous drugs.

LSIPR Newsletter 02:13

BRICK nations catching up on patents, as Brazil looks to life sciences London, UK

In a report published by Thomson Reuters on February 20, the BRICK nations were shown to have filed almost as many patents as the G7 nations in 2011.

The report, entitled Building Bricks: Exploring the Global Research Impact of Brazil, Russia, India, China and South Korea, is based on data drawn from the Thomson Reuters Web of Knowledge, Derwent World Patent Index, and third-party data from organisations including the World Bank.

Thomson Reuters’ director of research evaluation Jonathan Adams and former manager of contract research services David Pendlebury authored the paper with IP analyst Bob Stembridge.

The report compares the number of patents filed in the BRICK countries in recent years as well as other metrics including the number of researchers or academic papers published in the country to represent their economic innovation.

Under the terms of the memorandum, officials from both countries will share best practice, and the NAFDAC will pass on its experience and techniques for tracking and identifying fake medicines.

It found that in 1992, the G7 nations (US, UK, France, Germany, Italy, Canada and Japan) filed 6.2 patents for every one filed in the BRICK nations (Brazil, Russia, India, China and South Korea).

NAFDAC director general Paul Orhii said: “Counterfeiting of products has been a major problem. The counterfeiters have devised ways because of the sophistication in printing technology and the globalisation of the counterfeiting business has become very complicated to deal with and one country alone is not enough to deal with this problem.”

By 2011, the number of patents filed by the BRICK nations had increased six-fold from 106,724 in 1992 to 663,451, taking the ratio down to 1.2 G7 patents for every one patent filed in BRICK nations.

Supreme Court hears arguments in Bowman v Monsanto

China and South Korea were shown to be filing the majority of these patents in recent years, between them accounting for 84 percent of all filings by BRICK countries in 2010.

The controversial case concerns whether or not farmer Vernon Hugh Bowman infringed Monsanto’s patent for a variety of herbicide resistant soya beans.

Monsanto alleges that, in planting secondgeneration seeds without its agreement, Bowman infringed the company’s patent, while Bowman’s lawyer argues that once the seeds have been sold, the patent rights to them should be deemed exhausted as they relate to second-generation seeds.

The figures used represent patents filed by all parties, both domestic and foreign, in their respective countries.

The data also showed local trends in patent filing behaviour. Brazil was shown to be investing in the life sciences and transport, with India leading the way in pharmaceuticals and organic fine chemistry.

Russia, as well as filing patents related to food chemistry and medical technology, was shown to be investing heavily in nucleonics and explosives.

Avi Freeman, partner at Beck Greener in London, said that the change in Chinese

Life Sciences IP Review

BRICK nations are rising.

patent law in 2009, which applied a standard of absolute novelty, has made China a more desirable destination for filing patents, and could have been a factor in the dramatic increase of patents filed in the country.

He cited the close relationship between the European and Chinese patent offices as a probable factor for the increase in the number of academic reports published.

Trevor Cook, partner at Bird & Bird in London, said that the figures in the report could paint a misleading picture of the countries’ economic status, as they do not compare the number of international patents filed.

“The figures give a completely misleading impression of the international significance of that technology,” he said.

Do the figures suggest that China is on the way to achieving its goal of becoming a knowledgebased economy by 2020?

“I think that you would require much more granularity in the figures to draw any conclusion as to the nature and importance of the knowledge-based economy to these various countries,” he said. . n

How to fortify your innovations, ideas and brands

As you may have noticed, recently we launched a new name and new look. These two changes should tell you we are perfectly ready for the future. In this future, innovations, ideas and brands will determine even more whether a company will be successful. Therefore, protecting and fortifying these innovations, ideas and trademarks has become pivotal. We use the following ingredients: innovation, expertise, passion, teamwork, creativity and experience. It is exactly what we have been doing for the past 125 years. For more information, you are most welcome to visit us at www.nlo.nl

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News

LSIPR Newsletter 02:13

Bristol-Myers Squibb loses Baraclude patent fight with Teva to vigorously defend our intellectual property rights,” she said.

Delaware, US

A US judge has invalidated pharmaceutical company Bristol-Myers Squibb (B-MS)’s patent covering its hepatitis B treatment Baraclude (entecavir), agreeing with generic manufacturer Teva Pharmaceuticals that the invention of the active compound in the drug was obvious to anyone skilled in medicinal chemistry.

A Teva spokesperson said the company is pleased with the ruling but did not wish to comment further.

Teva filed for FDA approval of its generic version of Baraclude in 2010, but B-MS filed a lawsuit and secured a 30-month block on the generic’s launch. B-MS’s entecavir patent was due to expire in February 2015.

The ruling only affects B-MS’s patent rights in the US. Unless overturned or reversed, it will allow Teva to produce a competing generic product subject to approval from the US FDA. In a 171-page judgment published on February 12, Judge Burke of the US District Court of Delaware said that the evidence of prima facie obviousness put forward by Teva was “multi-faceted and compelling”, and that BMS’s evidence of non-obviousness “was not particularly compelling” and “did not strongly persuade the court”.

Teva argued that a person of ordinary skill in the art—in this case, a medicinal chemist— would have had reason or motivation to select the lead chemical compound carbocyclic 2’-deoxyguanine (2’-CDG) and modify it by adding a carbon atom to arrive at entecavir based on common knowledge, existing prior art and traditional drug-making methods at the time of discovery.

Teva also argued that entecavir’s inventors were guilty of inequitable conduct for failing

B-MS: disappointed with the court’s decision.

to disclose information to the US Patent and Trademark Office (USPTO) at the time of filing, but Burke rejected this claim.

A spokesperson for the B-MS said the company is disappointed with the court’s decision and believes it is incorrect.

“BMS will appeal against the court’s decision and we are evaluating all other legal options

James Flaherty, an associate at Foley Hoag LLP in Boston, said: “The district court’s obviousness decision is certainly detailed, with 58 pages devoted to findings of fact and 67 pages to legal standards and conclusions. This level of detail and analysis is wise given the lukewarm reception obviousness challenges to chemical patents have received at the Federal Circuit in recent years.”

Flaherty also said that the impact the ruling has on the generics market depends on whether the Federal Circuit chooses to affirm or reverse it.

“An affirmance would give renewed hope and support to generic drug manufacturers challenging chemical patent claims on the basis of obviousness, while a reversal will continue the trend of obviousness attacks on chemical patents facing an uphill battle at the Federal Circuit,” he said. n

Nuvo Research and Apotex reach Pennsaid patent settlement Delaware, US

Canadian pharmaceutical firms Nuvo Research and Apotex have agreed a patent settlement allowing Apotex to launch a generic version of Nuvo’s arthritis treatment Pennsaid (diclofenac sodium) in the US in April 2014, or earlier under certain circumstances.

The settlement ends five months of litigation—in August 2012, Nuvo attempted to block the release of generic versions of Pennsaid by filing patent infringement claims against Apotex and generic drug manufacturer Lupin Pharmaceuticals at the US District Court of Delaware.

Nuvo’s composition of matter patent for

Pennsaid expired in 2003, but the company was granted a patent for methods of administering the treatment in September 2012, which expires in 2029. Nuvo has also developed a follow-on product, Pennsaid 2%, which is awaiting approval from the US FDA. Under the terms of the settlement, Apotex is free to launch a generic version of Pennsaid on the earlier date of either 45 days after the first commercial shipment in the US of Pennsaid 2% or April 1, 2014.

Nuvo has yet to reach a settlement with Lupin, but Tina Loucaides, vice president and general counsel at Nuvo, said proceedings will be initiated.

“Apotex was the first generic Pennsaid filer, so they had priority, but we’ll now be

Life Sciences IP Review

concentrating on settling with Lupin. We’re very pleased to have reached a settlement with Apotex, and our strategy now is to focus on Pennsaid 2%, which we believe is a better product,” she said.

Kathleen Carr, a partner at Edwards Wildman Palmer LLP in Boston, said the terms of the settlement are unusual.

“The follow-on 2% product, which has not yet been approved, potentially could end up triggering the 1.5% original product for launch 45 days later. So, the newly developed product would only be on the market for 45 days before a generic version of the original product would be allowed market entry,” she said. n

News

LSIPR Newsletter 02:13

UK appeals court upholds Genentech patent

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IN BRIEF

London, UK

Gilead and Teva settle over Viread

England’s Court of Appeal has affirmed a 2012 High Court ruling that pharmaceutical company Genentech’s patent covering human vascular endothelial growth factor (hVEGF) antagonists is valid and has been infringed by Regeneron and Bayer Pharmaceuticals’ drug Eylea.

Gilead Sciences and Teva Pharmaceuticals have settled patent litigation over Gilead’s Viread treatment for HIV and chronic hepatitis B.

Genentech filed a patent covering the use of hVEGF antagonists to treat “non-neoplastic diseases characterised by excessive neovascularisation [diseases characterised by the excessive growth of blood cells or tissue, excluding the growth of tumours] wherein the hVEGF antagonist is: (a) an anti-VEGF antibody or antibody fragment; (b) an anti-VEGF receptor antibody or antibody fragment; or (c) an isolated hVEGF receptor,” in 1992.

But pharmaceutical companies Regeneron and Bayer challenged the patent and sought a declaration of non-infringement to allow them to launch VEGF Trap-Eye (later named Eylea)—a treatment that uses VEGFs to target non-neoplastic neovascular disease agerelated macular degeneration, which causes leaking blood vessels in the eye and is a leading cause of premature blindness.

Regeneron and Bayer argued that the patent lacks novelty and inventive step and is insufficient in its description, because “it merely provides information about the known use of VEGF antagonists and their use for treating disorders” and because its claims are speculative, covering “a huge range of non-neoplastic diseases and disorders without the experimental work needed to support them”. Genentech counterclaimed for infringement.

On March 22, 2012, High Court judge Justice Floyd found in favour of Genentech and concluded that the patent “is not invalid on any ground alleged” and has been infringed by VEGF Trap-Eye. Regeneron and Bayer appealed against Floyd’s ruling and challenged his decision to construe the meaning of “a medicament for the treatment of a non-neoplastic disease or disorder characterised by undesirable excessive neovascularisation” differently from the definitions put forward by Regeneron and Bayer and Genentech.

But on February 21, the Court of Appeal upheld Floyd’s findings.

The settlement was reached the day before a trial on the matter was due to start in the US District Court for the Southern District of New York.

Under the terms of the settlement, Teva will be permitted to market a generic version of Viread from December 15, 2017.

John Milligan, president of Gilead, said that while the company believes strongly in the validity of its patent, the settlement “removes some uncertainty and minimizes further distraction”.

Genetech won at the Court of Appeal.

Lord Justice Kitchin said: “I have some difficulty…in identifying precisely where it is said that the judge has fallen into error”.

Supporting Floyd’s decision to dismiss Regeneron and Bayer’s argument that patent is insufficient, he added: “A claim for an invention of broad application may properly encompass embodiments which may be provided or invented in the future and have particularly advantageous properties… provided such embodiments embody the technical contribution made by the invention.

“VEGF Trap-Eye does indeed embody the technical contribution made by the patent; it has a therapeutic effect in patients suffering from age-related macular degeneration by treating the angiogenesis associated with that condition, and it does so by binding to VEGF and inhibiting its biological activity.”

Genentech and Regeneron did not respond to requests for comment. A spokesperson for Bayer said the company “is disappointed with the judicial decision and intends to appeal to the Supreme Court to reconsider” but added that as Genentech’s patent expired in October 2012, the ruling does not prevent it from marketing Eylea. n

Life Sciences IP Review

Medicines Patent Pool and ViiV Healthcare tackle paediatric HIV The Medicines Patent Pool (MPP), a UN-backed organisation founded to lower the cost of HIV medicines through licensing patents, has announced a collaboration with leading pharmaceutical companies to increase the availability of life-saving paediatric HIV drugs.

The MPP launched the collaboration with ViiV, itself a joint venture between GlaxoSmithKliine, Pfizer and Shionogi after the companies agreed that abacavir, a key drug in the fight against HIV, can now be supplied to the countries that need it most under a patent licence, ViiV and the MPP have also agreed to negotiate licences in the future for paediatric HIV drugs that are currently in development.

Eastern Biotech & Life Sciences expands into Oman Dubai-based genetic testing and diagnostics company Eastern Biotech and Life Sciences has opened its first foreign office in Muscat, Oman.

Headquartered in the Dubai Biotechnology and Research Park, the company won the The Gulf Capital SME Info Small Business of the year Award in 2012.

10 News

LSIPR Newsletter 02:13

India’s Patent Office revokes Sutent cancer drug patent Mumbai, india

India’s Patent Office has revoked pharmaceutical company Sugen and licensee Pfizer’s patent for the cancer drug Sutent (sunitinib), agreeing with Indian drugs maker Cipla that it lacks inventive step.

An injunction preventing Cipla from launching a generic version of sunitinib, has also been lifted.

Sugen was granted a patent for sunitinib in 2007. Cipla filed a post-grant opposition in 2008, arguing that the invention of the active compound in Sutent would have been obvious to anyone skilled in medicinal chemistry, based on prior art published on previous compounds used in anti-cancer treatments.

Cipla also argued that Sugen had failed to disclose information required under Section 8 of India’s Patent Act.

In its counterargument, Sugen attributed Cipla’s lack of inventive step claim to hindsight bias, but the claim was upheld and the patent revoked in September 2012.

Sugen appealed against this decision at Delhi’s High Court, and was granted an injunction preventing Cipla from launching its sunitinib.

Cipla appealed against the injunction at India’s Supreme Court and in November, the case was referred to the assistant controller of patents.

The decision to revoke Pfizer’s patent was published by the controller on February 11.

Cipla is now free to produce sunitinib unless Sugen and Pfizer can have it reinstated.

A spokesperson for Pfizer said that the company is disappointed with the Indian Patent Office’s decision and plans to appeal against it.

“This ruling may further deter innovative companies from engaging in local

partnerships and investing in the healthcare industry in India.

“While Pfizer understands the Indian government’s intent to improve affordability and access to medicines, these concerns need to be addressed holistically to ensure both the quality and availability of innovative medicines,” said the spokesperson.

Ranjna Dutt, a partner at Remfry & Sagar, said it would be a wise decision to appeal against the Patent Office’s finding, given how important sunitinib is to Sugen.

Dutt welcomed the controller’s decision to reject Cipla’s claim of non-disclosure, adding that the controller did not observe the information disclosure requirement under Indian law very strictly, but said: “It was a little surprising that the controller accepted Cipla’s claim that Sugen’s application lacks inventive step—this decision is not well-reasoned.” n

FDA approves generic heroin substitutes washington DC, US

The US Food and Drug Administration (FDA) has approved two generic versions of Reckitt Benckiser’s heroin replacement tablet Suboxone—despite Reckitt’s claims that the product is unsafe.

Suboxone (buprenorphine and naloxone) is the most commonly prescribed opiate addiction treatment in the US. In 2012, it had sales of $625 million and accounted for 20 percent of Reckitt’s operating profits.

Reckitt obtained the US rights to the product in 2002 but has been battling generic competition since its orphan drug status expired in October 2009.

In September 2012, the company announced it was withdrawing Suboxone tablets from sale over concerns that they could be accidentally taken by children and filed a petition urging practitioners to switch to its follow-up product, Suboxone Film. Suboxone Film retains its patent until 2022 and dispenses one dose at a time through a strip of film placed under the tongue.

The company also asked the FDA to deny any applications for generic versions of Suboxone without unit-dose packaging.

The FDA rejected this petition. In a letter dated February 22, it said there is no evidence

to suggest banning products that don’t use unit doses would reduce accidental poisoning. The FDA also said that regulatory controls already in place for Suboxone are adequate.

Amneal confirmed that its generic could be available at pharmacies by early March. In a recent statement, Activis said it intends to begin shipping the product immediately.

“While Reckitt has declared its intention to withdraw Suboxone tablets from sale in the future, our understanding is that this product continues to be shipped and sold … Reckitt’s own actions undermine…its claims with respect to the severity of this safety issue,” the letter added.

Reckitt Benckiser said in a statement that it is disappointed with the FDA’s decision but will not be reintroducing Suboxone tablets. Share prices of the company fell by more than 4 percent following its announcement.

The approved generic versions of Suboxone will be sold by New Jersey pharmaceutical companies Amneal and Activis.

In a statement released on February 25, Chirag Patel, president and co-chairman of Amneal, said: “The FDA’s decision to approve the first generic equivalents to Suboxone tablets will ensure that millions of patients in the US ... now have access to a high quality, low cost generic version.”

Chintu Patel, CEO of Amneal, added: “We appreciate the FDA’s thorough assessment of Reckitt’s Citizen’s Petition and applaud their recent decision to deny it in its entirety. The FDA determined that Reckitt’s petition did not raise valid scientific or regulatory issues associated with the product, which Amneal contended in its comments on the petition. Physicians should have no concerns in writing prescriptions for the generic tablet form of the product.”

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Adam Samansky, partner at Edwards Wildman Palmer LLP in Boston, said: “Innovator pharmaceutical companies are continually trying to bring new products to market that address unmet needs and drive value for the company’s shareholders.

“In today’s litigious climate, and even where a new product presents a clear clinical benefit, generic competitors…routinely accuse innovators of anticompetitive behaviour when the innovator then seeks to withdraw an old product.

“In this case however, while the FDA specifically noted that the Commentergenerics’ allegation of an alleged intent by RB to ‘delay approval of generic versions of its products’ under 505(q)(1)(E) was not a basis for the agency’s denial of RB’s Petition, [it] referred allegations of anticompetitive business practices to the Federal Trade Commission,” he added. n

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12 biotech cluster

LSIPR Newsletter 02:13

Hub and spoke?

Life sciences in Northern France It seems an unlikely place for innovation, but Lille and its surroundings play host to a burgeoning life sciences industry. LSIPR visited to find out more.

T

he French biotech and life sciences industry is, if not necessarily booming, more than pulling its weight in a tough economic climate. In the teeth of the worst crisis in living memory, France finds itself playing host to some of Europe’s most innovative companies in the sector, driven by clusters of research and development across the country.

One of the largest of these clusters is in the Lille Nord-Pas de Calais region. Its genesis is a mix of geographical accident and strategic design, but today it plays host to more than 800 companies involved in the biotech sector, employing more than 22,000 people.

Geographically, it makes sense. Lille is extremely well served by transport links, making it easy to do business whether you’re from London or Berlin. Indeed, Nord France Invest, which aims to attract business to the region, trumpets the fact that the city lies almost in the middle of six European

“Eurasanté provides participating companies with training on the legal aspects of R&D including IP protection, as well as guidance on the regulatory challenges of conducting clinical trials.”

capitals. And it’s no coincidence that Lille has a Eurostar station, the first city stop in continental Europe for those arriving from London. The local government and industry lobbied hard to ensure that happened.

More than that though, there is a strong academic rationale for the industry. The University of Lille Nord de France is spread across six different campuses, and is one of the largest in the country. In a similar vein, the local hospital is actually seven hospitals, employing 2,750 doctors. So the potential for innovative companies to gain support from academic institutions and the profession that may end up practising their inventions is huge.

Of course, the Lille Nord-Pas de Calais region is not alone in this. Most biotech and life sciences clusters grow up around academic institutions and medical facilities, almost by definition. There are other assets too, though.

For start-up companies, seed capital worth up to €1 million is available in the right circumstances, while companies working in the Eurasanté Bioincubator facility in the Bio Business Park can benefit from substantial tax breaks (sometimes an effective corporate tax rate of zero), given the right criteria. Eurasanté is an agency designed to stimulate economic development of the health sector in Lille and its surrounds.

But who are the companies? Well, there are some big pharmaceutical players with a presence in the region, as you’d expect. The likes of AstraZeneca, Bayer Schering Pharma and GSK Biologicals all have operations there. There are food and nutrition companies (Roquette is perhaps the most significant in this area), and then there are myriad smaller players, start-ups and SMEs, which have developed in the region, and many of which have benefited from the tax incentives available.

Life Sciences IP Review

In the cluster Name: Genfit Founded: 1999, Lille Business: Cardiometabolic diseases Employees: 80 IP: 250 patents/patent applications

biotech cluster

LSIPR Newsletter 02:13 As for intellectual property, Eurasanté provides participating companies with training on the legal aspects of R&D including IP protection, as well as guidance on the regulatory challenges of conducting clinical trials and the ethical burdens companies in the sector must observe.

That said, when LSIPR visited, a spokesperson for one company managed to show a slide to journalists containing information about developing technology that was not yet protected by IP. He hastily withdrew the slide on realising his mistake, but perhaps such errors indicate that IP education, especially for the newer companies, could be improved.

conference will take place in Dresden later this year, before returning to Lille in 2014.

Other networking and education opportunities come in the form of the BioFit conference, which was held in Lille in 2010 and again, in December 2012. Panels on collaborative R&D, IP in the tech transfer process, and out-licensing deals with big pharma all aimed to provide guidance on the various hurdles companies need to overcome in order to secure their innovations. With more than 350 attendees spread between academia, pharmaceutical companies, tech transfer offices and cluster representatives, in theory it provides an excellent opportunity for innovative companies to fill the gaps in their knowledge. The BioFit

Lille Nord-Pas de Calais may not be the largest life sciences cluster around (or even the largest in France), but it does boast some unique assets that should ensure it continues to grow. And France, Europe and the wider life sciences and biotech industry should all hope that it does. After all, cluster development is a strategic objective of Europe’s Competitiveness Council, and in a sustained economic downturn, the ability to innovate is arguably more crucial than ever. n

In the cluster Name: Genoscreen Founded: 2001, Lille Business: Genomic services Employees: 30 IP: At least three patents, including biomarkers for Alzheimer’s

In the cluster Name: Alzprotect Founded: 2008, Lille Business: Anti-Alzheimer’s drugs IP: Founders André Delacourte and Patricia Melnyk named inventors on multiple patents

In the cluster Name: Innobiochips Founded: 2008, Lille Business: Multiplexed immunoassays Patents: At least two granted

Life Sciences IP Review

13

14 legal update

LSIPR Newsletter 02:13

Mexican Senate proposes bill to reduce life term of medicine patents The Mexican Senate has published a bill which, if adopted, will reduce the life term of medicine patents in Mexico by up to one year.

The bill was introduced in February by Senator Martha Palafox Gutierrez and proposes amending Article 23 of Mexico’s Industrial Property Law to include a ‘special’ life term for patents composed of a substance or substances listed under Sections I and III of Article 221 of Mexico’s Health Law. This includes drugs, and active ingredients and raw materials related to drugs.

The life term proposed in the bill is 20 years starting from the date the first patent application for the substance or product is filed abroad but under the current law, this 20-year term can begin from the date of filing in Mexico.

According to the bill, the proposed changes are intended to “combat social inequality” that has “polarised society” by providing Mexican families with better access to medicine and healthcare.

But Jorge Mier y Concha, a partner at Arochi Marroquin & Lindner in Mexico City, said the proposals are at odds with the Paris Convention and the Patent Cooperation Treaty.

“It’s very unlikely it will succeed but if it does, this would be a big problem for the medical industry. You would have a specific term for Mexico that is different for the life terms in other countries. This contradicts the Paris Convention, which states that all jurisdictions should be treated equally,” he said.

New bill ‘contradicts Paris Convention’.

“Pharmaceutical companies could work around this by filing applications in Mexico at the same time as filing in other jurisdictions.”

Rosa Nuria Becerril, a partner at Becerril, Coca & Becerril SC agreed. “The arguments passed in the bill neither clearly nor roundly justify the reduction of the term. The medical sector would not be the only one affected by this bill should it pass—there would be a strong

Life Sciences IP Review

decrease in private investment in Mexico from the pharma sector, which would cause loss of employment, and it would surely cause an incredibly strong increase in the cost of pharmaceuticals,” she said.

Pharmaceutical companies could work around this by filing applications in Mexico at the same time as filing in other jurisdictions, but Mier y Concha says this would be expensive and impractical. “It would lead to a lot of uncertainty, as there is no guarantee the patent will be allowed.”

Mier y Concha added that the Mexican Association of IP Practitioners is discussing the bill and is likely to file comments in opposition to the proposals “very soon”.

The bill is being reviewed by the Development Commission of Trade and Industrial Health and the Commission of the Senate and is up for discussion in mid-March. n

legal update

LSIPR Newsletter 02:13

15

UK patent change paves way for pharma innovation The UK government has announced a change to the Patent Act that will allow parties to run drug trials without infringing other parties’ patents.

The change is in response to a consultation carried out by the UK Intellectual Property Office late last year, in which life sciences stakeholders were invited to give their views on the proposed amendment.

A summary of the consultation said that the proposal to change the law was supported by the “overwhelming majority”.

After the law is changed, drug development companies may trial new innovative drugs, whatever country they are seeking regulatory approval in. This covers all situations where another company’s patent is implicated in the research.

It is hoped to make the UK a more attractive location for carrying out innovative clinical and field trials.

The minister for Intellectual Property Lord Younger said: “The government is keen to create a supportive environment for pharmaceutical research and development in the UK. Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.”

James Robertson, partner at Marks & Clerk in London, said: “This is excellent news for many in the UK life sciences industry, including originator drugs companies, clinical research organisations, publicly funded research bodies and charities.”

He added that the plans will reduce the costs and “legal uncertainty” associated with

UK patent law has been brought in line.

“The plans will reduce the costs and ‘legal uncertainty’ associated with patent infringement.” patent infringement, adding: “This will help remove the need for off-shore clinical and field trials, encourage UK manufacturing, and give UK patients earlier access to innovative new drugs.”

Participants in the consultation described Germany as a more “industry-friendly” location for carrying out drug trials, as it exempts from patent infringement any studies

Life Sciences IP Review

or trials necessary to bring a drug to the market in any country.

“By adopting this research exemption, the UK government is bringing UK patent law in line with patent laws in other European countries,” Robertson said.

“By removing the risk of patent infringement, this change will remove some of the costly obstacles to undertaking clinical and field trials in the UK, specifically those required by the MHRA and EMA to obtain regulatory approval to market, and those required by NICE to support health technology assessments.

“This will be of particular benefit to pharmaceutical companies developing new drugs, and to clinical trials companies.”

The amendments to the UK Patent Act are proposed to come into effect on October 1, 2013. n

16 legal update

LSIPR Newsletter 02:13

India publishes feedback on draft biotech guidelines India’s patent office has released comments submitted in response to draft examination guidelines for biotechnology patents published in December 2012.

Twenty-one organisations submitted comments, including the Biotechnology Industry Organization (BIO), Organisation of Pharmaceuticals Producers of India (OPPI) and the National Biodiversity Authority.

While all agreed there was a need for greater clarification on how India’s Patent Law should be interpreted, most of those commenting called for significant revisions before the guidelines are finalised.

BIO and OPPI said that India’s guidelines present a broader interpretation of obviousness than is found in other jurisdictions, and criticised the assertion in paragraph 11 that microorganisms, compounds and other products isolated from nature are not patentable subject matter.

“This is contrary to the laws of many jurisdictions … it denies patent claims for essentially all of the basic biotechnology inventions which are necessary to the further research and development of eight innovative biotechnology products,” said BIO. Law firm Kan & Krishme said paragraph 11 is at odds with Section 3 of India’s Patent Act, arguing: “It is very clear from the wording of Section 3(j) that microorganisms are patentable. Therefore, it is very surprising that microorganisms

Mumbai: home to India’s patent office.

“BIO and OPPI said that India’s guidelines present a broader interpretation of obviousness than is found in other jurisdictions.” have been included in the category of nonpatentable subject matter.”

DePenning & DePenning said this is contrary to European Parliament Directive 98/44/EC and last year’s Myriad ruling in the US, while Krishna and Saurastri suggested that the paragraph be amended to read: “As per Section 3(c) [of India’s Patent Act] products directly isolated from nature are not patentable subject matter. The term ‘directly’ conveys without anyone or anything intervening.

“Hence, whenever a substance (living or nonliving) is obtained or isolated from nature on account of substantial human and technical intervention and if the substance is properly characterized either by its structure, or by other parameters and it meets the criteria of patentability, ie, it is ‘new’ in the absolute sense of having no previously recognized existence, it is not obvious to the person ordinarily skilled in the art and has industrial applicability, then such a substance per se is patentable.”

Life Sciences IP Review

BIO also expressed “significant concerns” over a lack of clarity in paragraph 10 of the guidelines on whether certain types of cells are patentable subject matter, and recommended that this be amended to allow for the patenting of stem cells and other modified cells useful for therapeutic purposes, while law firm Remfry & Sagar criticised the recommendation included in the guidelines that gene sequences may be patented but only if patentees can disclose how it may be used in industry.

“Expressed sequence tags (ESTs) give information that can in turn be used to determine gene expression and further used in drug designing. ESTs can be valuable, inseparable and sometimes even specific during the designing of a particular drug at a later stage. Keeping in mind all the aforesaid, it may not be possible at a particular stage at which the claim for an EST is being sought to mention the precise industrial use,” said the firm in its response.

The most common objection was to illustrative examples included in the guidelines to provide guidance on novelty, inventive step and industrial applicability.

Nearly all those who commented said these examples lacked clarity, and law firm Anand and Anand said some were at odds with patent office practice and should be removed “unless supported by patent office decisions or case laws”.

Dr Ruchi Tiwari, deputy controller of patent and designs in India, said that a committee is now reviewing the feedback and that finalised guidelines are likely to be published soon. n

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18 Genetic engineering

LSIPR Newsletter 02:13

A novel approach Oxitec’s pioneering insect sterilisation technique could eradicate dengue fever and malaria and cut crop damage worldwide. LSIPR spoke to CEO Hadyn Parry about the company’s development and its approach to protecting its inventions.

I

n the past 10 years, research teams have built biomechanical body parts, printed synthetic meat and mapped the human genome. They might even have discovered the legendary Higgs boson.

But despite these advancements in science and medicine, malaria, dengue fever and crop damage caused by insects remain a growing problem Dengue cases have increased 30-fold since the 1960s and malaria kills more than 500,000 each year, while agricultural pests cause famines around the world. Yet there are no approved vaccines for either disease and until now, the most popular method of pest control has been spraying harmful pesticides and keeping fingers crossed.

“In public health, there is a mindset that the best you can do is spray chemicals and try not to make the problem any worse. The idea that you can solve it is completely novel,” says Hadyn Parry.

Parry is the CEO of Oxitec, a company founded in 2002 after researchers at Oxford University’s zoology department developed a method of sterilising insects that could wipe out disease-carrying species and provide a safer, more affordable way to reduce the population of agricultural pests such as fruit flies and bollworms.

“We’ve had to patent with an idea of where we’re going to need patents in 10 years’ time or more.”

Researchers have been working on sterile insect techniques (SITs) for years, but all have so far relied on radiation. As Parry explains, this method is costly and works only on a limited number of species.

“People have tried traditional SITs with mosquitos and have never been able to make it work. It has been impossible to find the perfect dose of radiation that will damage the species enough so it can’t breed, but not so much that it’s unfit.”

Instead of radiation, Oxitec uses genetic engineering to breed insect strains that are healthy, but produce offspring that will die before reaching adulthood. Where possible, the company breeds only the non-damaging

Life Sciences IP Review

sex of each species (such as male mosquitos, which do not bite), meaning that unlike radiation techniques, it can wipe out local pest populations without causing further environmental damage.

Depending on an insect’s life cycle, it can take between two and four years to develop a healthy ‘sterile’ strain. This is done in laboratories, where the insects are fed on artificial diets and put through rigorous tests to check their fitness. Oxitec then carries out cage trials in the insect’s natural environment and, if these trials are successful, the sterile strain is released into the wild.

This development process can take up to 10 years, and perfecting the pre-release rearing method is key to Oxitec’s success. “This has to be perfected so that we can release millions of insects in the field. Otherwise, the technique is not cost-effective,” he says.

These rearing methods make up the bulk of Oxitec’s patent portfolio and while the company is heavily involved in drawing up patent claims, its patent prosecution is handled externally by law firm Marks and Clerk.

“Most of our IP is around how DNA is inserted into the insects and how we make sure it’s stable and safe. We’re also developing patents around

Genetic engineering

LSIPR Newsletter 02:13

19

the rearing and release of insects for species that no-one has addressed before. And as the company develops, there’s a lot of scope for patenting at the molecular end and in terms of the technology’s application, such as production and monitoring techniques,” says Parry.

While SITs already exist, Oxitec’s genetic engineering methods are unique, meaning the company has had little trouble patenting its inventions.

“There is some existing prior art, such as on how to rear insects on a large scale, but other SITs are so limited in the number of insect species they can be applied to that it doesn’t produce much.”

Oxitec’s work is so research intensive that Parry believes it would be extremely difficult for anyone to copy the company’s ideas before it could stop them.

“Anyone wanting to copy our technology would have to go through the same 10 year research and development cycle, so time is on our side. The easiest way to copy us would be theft, but then we’d also have commercial law on our side,” he adds.

The geographical scope of Oxitec’s work offers added IP protection, as any companies wanting to emulate its technology would have to go through the same national regulatory approval process. Because of the limited threat of infringement, Parry says the company assumes an open and transparent approach to its inventions.

“If someone calls me and asks, ‘can I film in your laboratories?’ I always say yes. We open our doors to everyone and have had radio and TV crews visiting our Brazilian labs for weeks,” he says.

Of course, Oxitec has to keep some information confidential. To ensure trade secrets are not leaked, the company chooses its employees and research partners carefully. “A lot of our IP protection is built on trust. That’s probably the best form of protection you can have— although we do have contracts as well,” he says.

While most companies begin by prosecuting patents in China, the US and Europe, most of Oxitec’s work is done in developing countries.

And as dengue fever is found in more than 100 countries, a tactical approach to patent prosecution is essential.

“When you first file for patent protection, you can’t file for the whole world, so you make a selection. Over time though, this selection may not be as accurate as you might have thought,

“A lot of our IP protection is built on trust.” so we’ve had to patent with an idea of where we’re going to need patents in 10 years’ time or more. Having that foresight has perhaps been our biggest challenge.”

Oxitec has already carried out successful tests in Cayman, Malaysia and Brazil. The company has now been asked to develop sterile dengue strains in Florida, Bolivia and Paraguay.

“We’ve proved that we can transfer our technology to different countries, and that people in those countries can be trained to use our techniques. If we can prove beyond doubt that the sterile strain of the denguecarrying Aedes aegypti is effective, then we’re hoping we’ll secure the funding to start working on Anopholes [the mosquito that spreads malaria].”

If its success continues, Oxitec’s work could have a tremendous global impact and could save millions of lives. But for Parry, it doesn’t

Life Sciences IP Review

stop there—he would also like to see the company’s technology applied to cattle pests and insects that mankind has caused to move out of their natural habitat.

“In France, for example, they have a pest called red palm weevil. It’s a major pest in the Arab world, where it destroys oil and date palms and now, it is ruining the palm trees that are central the scenery and culture of France’s south coast. You couldn’t even dream of removing infestations of invasive species using chemicals, but it’s possible with sterilisation,” he says.

Ten years ago, Oxitec was set up because the technology it had developed was so novel that there was no network through which to license it. As the company continues to grow, Parry is aware that other companies may try to replicate Oxitec’s success, but at the moment, it’s in a league of its own.

“When a young company develops a new small molecule drug, it knows there are tens or hundreds of companies out there with very good synthetic chemistry capabilities who will take your drug and try to modify or copy it.

In our world, there simply aren’t people with mosquito-rearing abilities, but I’m sure there will be in time,” he adds. n

20 case report

LSIPR Newsletter 02:13

Australia: The Myriad case The Federal Court in Australia has ruled in Cancer Voices Australia v. Myriad Genetics that isolated genetic material is patentable in Australia. Karen Sinclair explains the relevant issues.

What are the issues at stake in the case?

The most significant aspect of this case is that it is the first time an Australian judicial authority has decided whether genetic subject matter is patent-eligible. Although it has long been the case that IP Australia has granted patents on isolated genes, genetic sequences, DNA, RNA, proteins and the like, this practice has been based on a precedent set by a late 1950s Australian High Court decision (known as the NRDC case) handed down long before anyone even really understood genetic technologies, let alone how they might be commercially utilised.

There was widespread concern that a decision in favour of the applicant to remove genetic subject matter from patent-eligibility might

hobble the highly innovative Australian life sciences industry, commercially isolate Australia as a destination for new medical treatments, set Australia apart from accepted IP standards in other parts of the world, and open the floodgates to an extension of the decision to other essentially chemical subject matters such as microbially derived drugs or medically effective drugs isolated or extracted from the environment.

What did the court office decide?

A single judge of the Federal Court decided that the decision in NRDC (National Research Development Corporation v Commissioner of Patents [1959] HCA 67; 102 CLR 252) remains good law, and that since the isolated genetic sequences claimed in the Myriad patent

Life Sciences IP Review

were an ‘artificially created state of affairs’, they constitute patent-eligible subject matter.

Nicholas J highlighted the very sweeping scope allowed to him under this precedent stating that, even if ‘an isolated nucleic acid ... may be assumed to have precisely the same chemical composition and structure as that found in the cells of some human beings’, in the absence of human intervention, naturally occurring Case: Cancer Voices Australia v Myriad Genetics Inc Court: Federal Court of Australia, Sydney Judge: Justice John Nicholas Decision: Case dismissed, isolated DNA ruled patentable

case report

LSIPR Newsletter 02:13 nucleic acid does not occur outside the cell, and ‘isolated’ nucleic acid does not exist inside the cell, and it is thus itself an ‘artificial state of affairs’.

The applicants did not challenge that the subject matter of the claims in suit had either a ‘discernible effect’ or ‘utility in a field of economic endeavour’—the other two requirements of patent-eligible subject matter set down by the NRDC decision.

Importantly, from a global perspective, the judge distinguished this case from the US Court of Appeals decision in The Association for Molecular Pathology & Ors v US Patent & Trademark Office and Myriad Genetics Inc 689 F3d 1303 (2012)—a parallel matter awaiting a decision by the Supreme Court of the US, stating that: the evidence in each case was different; the law as between the US and Australia is different; and so too is the constitutional setting in which patent legislation operates in the US when compared to that in Australia.

He also distinguished the situation from wellknown British cases relating to similar issues.

Is there anything unusual about the case?

The most unusual aspect of the case from an Australian perspective was not the decision itself, but rather the fact that the applicant was a non-profit organisation that banded together with other interested parties including professionals providing pro bono services with a view to changing the tide of Australian patent law and practice primarily on moral grounds. The case was commenced in the courts against the backdrop of a number of government-directed enquiries, all of which ultimately concluded that it was inappropriate to exclude genetic subject matter from patenteligibility.

One of the enquiries was conducted by a Senate Standing Committee that considered, from late 2011 into early 2012, whether a Private Member’s Bill seeking to exclude

“The legal tenets argued were very narrow, and the judge’s decision soundly based on a long-standing precedent of the most superior Australian court.” genetic subject matter and a potentially extensive list of related chemical subject matter should be passed by the Australian Parliament.

The shadow of well-known, long-standing, conservative lobbyists has been cast long over all these activities including the court case.

Do you think there will be an appeal?

The respondents were awarded costs by the judge: this may mitigate any appeal by the applicant. In fact, Cancer Voices Australia, one of the primary applicants, was deregistered by this Australian Securities and Investments Commission as an operating entity in late 2012, and only its separately registered South Australian and New South Wales-based arms remain in operation. Presumably there is no financial connection between these remaining arms and Cancer Voices Australia which would enable the respondent to recoup the costs awarded. With the prospect of what might be a public relations disaster for the respondents, it seems unlikely that costs will be sought against the other applicant, Mrs Yvonne D’Arcy, a cancer sufferer herself.

One might imagine, however, that the respondents’ position might harden if an appeal was lodged by the applicants. The

Organisation: Myriad Genetics Inc

Organisation: Cancer Voices Australia

Founded: 1991

Founded: 2000

Headquarters: Salt Lake City, US

Headquarters: National network across Australia

Business: Molecular diagnostics 2012 revenue: $496 million

Business: Volunteer representative of Australians affected by cancer

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decision itself, moreover, left little scope for an appeal as the legal tenets argued were very narrow, and the judge’s decision soundly based on a long-standing precedent of the most superior Australian court.

What grounds might form the basis of an appeal?

There was little evidence led by either party, and much of what was offered was indisputable scientific fact. Argument was essentially limited to the correct application of long-standing law. While the court went to some lengths to consider the state of the law in other commercially significant and highly respected IP jurisdictions, for a variety of precedent-based reasons, and since overseas decisions carry no weight in Australian law, it was ultimately a straightforward matter for the judge to dismiss the relevance of these other potential influences. The only foreseeable basis for an appeal would be that the judge got the law wrong, but that seems unlikely.

What implications does the case have for the industry in Australia and internationally?

The outcome of the case is that the law and practice surrounding the patenting of genetic subject matter in Australia maintains the status quo. It is possible that the aforementioned well-known, long-standing, conservative lobbyists may seek to have another crack at having the patent statute amended to exclude what they consider to be morally controversial subject matter, but the weight of both judicial and educated opinion would seem to be against them, as is the current political climate in Australia, which is far more focused on political polls and personalities than substantive issues.

Internationally, although Australian judicial opinion is reputed to be widely respected, each jurisdiction will need to make its decision, if required, in the context of its own national patent statute and precedent which, as Nicholas J was at pains to point out, is different from that in Australia at least in the US and in the UK. n Karen Sinclair is a principal at Watermark Intellectual Asset Management in Melbourne. She can be contacted at k.sinclair@watermark.com.au

22 case report

LSIPR Newsletter 02:13

India: The sunitinib case

Sugen’s patent for anti-cancer drug sunitinib has been revoked by the Indian Patent Office. Ranjna Mehta-Dutt and Swarup Kumar at Remfry & Sagar explain the details of the matter.

In October 2007, Sugen Inc was granted a patent for anti-cancer drug sunitinib (Patent No. 209251) by the Indian Patent Office (IPO).

In September, 2012, this patent was revoked by the IPO on grounds of obviousness in a postgrant opposition proceeding filed by Cipla.

The patentee challenged this decision by filing a writ petition before the High Court of Delhi primarily claiming that principles of natural justice were not followed since the opposition board’s recommendations were not supplied to it for rebuttal.

During the pendency of the writ, the Delhi High Court granted an order restraining Cipla from marketing a generic version of sunitinib, against which Cipla appealed at the Supreme Court. The Supreme Court in November 2012, lifted the injunction against Cipla and directed the Controller to dispose the postgrant opposition after giving both parties an opportunity to present submissions on the joint recommendations of the opposition board.

Accordingly, fresh hearings were conducted by the Controller of the IPO eventually leading to

the issue of a decision revoking the patent of Sugen Inc.

What are the issues at stake in the case?

There were primarily two issues: (1) Whether the invention claimed in Patent No. 209251 was obvious or not in view of the documents cited by Cipla during the post grant opposition; and (2) Whether appropriate information in accordance with the requirements of Section 8 of the Patent Act was disclosed by the patentee or not.

What did the Controller decide?

The Controller upheld the recommendations of the opposition board that the invention claimed in the patent did not involve inventive step and was obvious to a person skilled in the art in view of cited prior art.

To elaborate, it was held that invention claimed was obvious in view of documents

Life Sciences IP Review

D1 (US5886020), D2 (WO9850356) and D3 (WO9961422). Interestingly, all the three cited documents are in the name of Sugen, Inc. The Controller observed that teaching of D1 and D2 could be modified to introduce the polar group Z taught by D3 to formulate a compound which does not possess the (alkyl) group but retains the protein tyrosine kinase inhibitory activity. The Controller also relied upon the fact that the compounds disclosed in D1, D2 and D3 were used for treatment of the same category of disease as the impugned patent.

On the second issue, the Controller held that the patentee had fulfilled its duty to furnish all the information required under Section 8. On the allegation by the opponent that many details/documents were not furnished to the IPO, the Controller held that “The details cited by the opponent are from the World Intellectual Property Organization (WIPO) website and espacenet which is freely available to the Controller and Examiner.”

Therefore, this ground for revocation was not maintainable.

case report 23

LSIPR Newsletter 02:13 existing knowledge or having economic significance or both …”. Contrary to this, the Controller held that “the commercial success of the instant product (sunitinib) as submitted by the patentee cannot be considered as an evidence of a patentable invention”. Therefore, the criteria of economic significance appear not to have been taken into account in this judgment.

(3) The Controller has drawn support from two foreign judgments and an Indian author’s comment, while there has of late been a plethora of judgments from various forums, including the Intellectual Property Appellate Board (IPAB), on this and related issues, which have not been taken into account.

Do you think there will be an appeal?

Given the importance and background of the matter and the commercial success of this crucial drug it is, in our opinion, most likely that the decision of the Controller will be appealed by the patentee.

What grounds might form the basis of an appeal?

Is there anything unusual about the case?

The aspects which could be considered to be unusual are: (1) The efficacy data provided by the patentee, in the language of the Controller “for few selected compounds” which were not the closest prior art, were considered not to be good enough for considering the claimed compound inventive. This stance could be considered by some to be an ‘inventive step-plus’ requirement such as under Section 3(d) of the act. While sufficiency of increase in efficacy has arguably been considered pertinent for judging whether a compound or derivative is a mere new form of a known substance or not, applying a similar parameter for judging inventive step could be considered to impose a stricter requirement.

(2) The expression ‘inventive step’ is defined in Section 2(1)(ja) of the Patent Act 1970, as “a feature of an invention that involves technical advance as compared to the

The grounds of an appeal should be limited to the grounds on which a patent has been revoked which, in the present instance, is lack of inventive step and the invention being obvious in view of cited prior art. The basic grounds on which the appellants (patentee) could, inter alia, rely is that the patent has been revoked erroneously. In other words, the claims of the patent, contrary to what the Controller held, are non-obvious and involve inventive step. The point that no reliance was placed on the criteria of economic significance while judging on non-possession of inventive step could as well be challenged.

What implications does the case have for industry in India and internationally?

This revocation on a narrower interpretation of inventive step criteria could further compound problems for innovative companies who are already battling the might of Section 3(d) of the Patent Act. On the other hand, the Controller’s decision on compliance with the requirements of Section 8 is a pragmatic and practical step forward for the patent applicants. n

Life Sciences IP Review

“The grounds of an appeal should be limited to the grounds on which a patent has been revoked which, in the present instance, is lack of inventive step.”

Patent in question: IN209251 Owner: Sugen licensed the patent to Pfizer Patent covers: Sunitinib, a drug used to treat renal cancer Opponent: Cipla Ruling authority: Indian Controller General of Patents Designs and Trademarks Decision: Patent revoked

Organisation: Pfizer Founded: 1849 Headquarters: New York City, US Business: Pharmaceuticals 2011 revenue: $67.4 billion

Organisation: Cipla Founded: 1935 Headquarters: Mumbai, India Business: Generic pharmaceuticals 2012 revenue (year to March 31, 2012): Rs 6977.50 crore ($1.27 billion)

Ranjna Mehta-Dutt is a partner at Remfry & Sagar. She can be contacted at: ranjna.dutt@remfry.com Swarup Kumar, managing associate at Remfry & Sagar. He can be contacted at: swarup.kumar@remfry.com

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