January 2014 april 2014 newsletter

January 2014

newsletterSouth AfricAn Pr effortS SPArk drug controverSy

generic krkA to receive dAmAgeS in Nexium cASe

cASe rePort: SuPreme court reverSeS medtroNic ruling

ASSociAtion focuS: biotecanada

4

6

20

highlightS thiS iSSue:

other contentS >>

14

news and intelligence from life sciences intellectual property review

Page 18

hive mentality: Susana Soares and open source research

founding Sponsor:

april 2014

Sun Pharma to acquire rival ranbaxy

aurobindo Pharma Sued over angiomax

Protecting bio-markerS and PerSonaliSed medicine

indian Patent law: uP for a fight

4

6

22

highlightS thiS iSSue:

other contentS >>

20

founding Sponsor:

Page 14

Patients in a test tube:

horizon discovery’s cell line-creating

technology

Expert intellectual property services for the life science industry

www.potterclarkson.com

Translating Innovation

102217 LSIPR Advert:Layout 1 09/04/2014 16:21 Page 1

LSIPR Newsletter 04:14 edItoR’S LetteR/coNteNtS 3

www.lifesciencesipreview.com

Life Sciences IP Review is published by: Newton Media Limited, Kingfisher House, 21-23 Elmfield Road, Bromley, BR11LT, United Kingdom+44 203 301 8200Director Nicholas LipinskiPublisherJohn HaleyTelephone: +44 203 301 8205Email: [email protected] editorMartin EssexTelephone: +44 203 301 8211Email: [email protected] editorLeonie MercedesSub-editorRos BromwichJournalistsEd Conlon, Max WaltersEditorial assistantDavid BrookeProduction and designFisherman Creative©Newton Media Limited 2014All 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)

the personal touchScouring the internet for information on personalised medicine, I came across this quote: “Would your teenaged son buy the same clothes as his grandmother? Probably not. But when they get sick, they’re likely to receive just about the same treatment and drug choices.”It sums up perfectly why we need personalised medicine, and that’s exactly what gene editing has the potential to offer. If you can find the precise genetic fault in a chromosome, then potentially you can tailor an individual’s treatment to his or her specific needs.Inevitably, the medical focus tends to be on cancer but treatments for diseases such as Huntington’s and cystic fibrosis may well benefit too.Because it’s such an exciting prospect, scientists are competing fiercely in this ground-breaking field of research and, as financiers race to back them and personalised medicine moves out of the laboratory and into the hospital, their IP will no doubt become increasingly valuable.In this issue of LSIPR, we talk to Horizon Discovery, one of the companies competing in the gene editing field, not just about the science but also about the problems and delays involved in patenting technologies and compounds as patents multiply.Horizon’s chief technology officer calls it “a sort of free-for-all” but he’s optimistic that once the patents start to be published, and companies are required to take licences to use the technologies, things will settle down.Elsewhere, Stephanie Pilkington of Potter Clarkson tells us that with careful patent drafting it’s possible to capture significant IP value in the closely related area of biomarkers—used to indicate the presence of a particular disease—which could also help develop personalised treatments.However, she adds a note of caution: there’s divergence between the approaches adopted in the US and Europe, providing a challenging environment for those seeking to protect and develop their assets. The good news is that with care, it’s possible to capture significant value in this clinically and commercially important area, she argues.Martin Essex, Managing editor

Contents4 News 4 SunPharmatoacquirerivalRanbaxyfor$3.2bn 4 UKHighCourtstrikesdownHerceptinpatents 5 NovartisandGSKin$14.5bnIPexchange 6 AurobindoPharmasuedoverAngiomax 6 DepomedsettleswithgenericsoverGralisedispute 7 TevaasksUSSupremeCourttostayrulinginCopaxonecase 8 PfizercriticisesIndianpharmapatentpolicy 8 AstraZeneca‘hasvalue’saysformerPfizerlawyer 9 MallinckrodtpicksupActharinQuestcormerger 10 LillybeatsbackchallengetoAlimtapatent 10PurduesuesTevatoblockOxyContinchallenge 12FederalCircuitrulesagainstRocheinTamiflucase 12ActaviswinsLialdagenericappeal14 IPstrategy:HorizonDiscovery Patientsinatesttube18 Casestudy TheCopaxonebattle20 Expertcomment Protectingbiomarkersandpersonalised/stratifiedmedicine22 Expertcomment Indianpatentlaw:upforafight

EDItorIalPaNElMaryannearmstrong,partner,Birch,Stewart,Kolasch&BirchLLPVictoriaBeniac-Brooks,partner,Marks&ClerkLLPWolfgangBublak,partner,BardehlePagenbergtrevorCook,partner,WilmerCutlerPickeringHaleandDorrLLPGabrielDiBlasi,partner,DiBlasi&AssociatesPaulEngland,TaylorWessingLLPJanisFraser,principal,Fish&RichardsonPCPennyGilbert,partner,PowellGilbertandrewJenner,directorofIPinnovationandtrade,IFPMAashwinJulka,managingpartner,Remfry&SagarlarsKellberg,corporatevicepresident,corporatepatents,NovoNordiskA/SJudithKim,partner,Sterne,Kessler,Goldstein&FoxSimonKremer,partner,MewburnEllisLLPNathalieMoll,secretarygeneral,EuropaBioMatthewNielsen,partner,MarshallGerstein&BorunLLPCarolinePallard,partner,NederlandschOctrooibureauMichaelPitzner-Bruun,partner,KromannReumertNabeelarasheed,shareholder,McAndrews,Held&MalloyLtd.Jasonrutt,headofpatents,RouseJosétrigueros,partner,LeyvaMontenegroTriguerosAbogadosSCJoachimWachenfeld,partner,Vossius&PartnerJaneWainwright,partner,PotterClarksonLLPGordonWright,partner,Elkington&FifeLLP,onbehalfofCIPAFranz-JosefZimmer,patentattorney,Grünecker

NewS4 LSIPR Newsletter 04:14


mumbai, india

Mumbai-based Sun Pharmaceutical Industries is buying Indian rival Ranbaxy Laboratories in a merger worth $3.2 billion, the companies have confirmed.

The transaction will strengthen Sun Pharma’s product portfolios in dermatology, urology and anti-infectives.

According to a presentation given by the companies on April 7, the transaction will create the fifth largest specialty generic pharmaceutical company in the world, and the largest in India, with 184 Abbreviated New Drug Applications (ANDAs) in its pipeline.

The combined company’s revenues are estimated at $4.2 billion on a pro forma basis, with yearly earnings of $1.2 billion, in 2013. It will operate in 65 countries and have 47 manufacturing plants in five continents.

Japanese pharmaceutical company Daiichi Sankyo, which holds about 63.4 percent of

Sun Pharma to acquire rival ranbaxy for $3.2bn

Sun Pharma to merge with Ranbaxy

uk high court strikes down herceptin patentslondon, uk

The UK High Court has invalidated two patents covering Roche’s breast cancer drug Herceptin (trastuzumab) after a challenge by generic drug maker Hospira.

Hospira sought to make a generic version of the blockbuster drug after a supplementary protection certificate covering the product expires on July 28, 2014.

It argued that the ‘115 patent, which covers a dosing regime, is obvious and that the ‘455 patent, covering a composition of trastuzumab, lacks novelty over a previous Patent Cooperation Treaty application by Herceptin co-developer Genentech. Hospira did not challenge the product’s underlying patent EP 0,590,058, also held by Genentech.

In the April 10 ruling, Justice Colin Birss found both of the patents at suit to be invalid.

A spokesperson for Roche told LSIPR that it was analysing the court ruling and considering its next steps. She added: “There are currently no approved trastuzumab biosimilars in

Europe. Subsequently, we anticipate the impact of this decision will be minimal.”

Hospira said in a statement: “We are very pleased with this decision, which helps pave the way for our trastuzumab product.”

Patents invalidated

Between 1999 and 2003, worldwide sales for Herceptin totalled 49 billion Swiss francs ($56 billion). European sales from 2010 to 2013 totalled eight billion Swiss francs ($9 billion).” n

LSIPR Newsletter 04:14 NewS 5


Mintz Levin adds three in Bostonlaw firm Mintz levin Cohn Ferris Glovsky and popeo pC has added three partners to its ip team. William Geary, lisa adams and Christina Sperry have joined the firm’s Boston office.

Formerly partners at Nutter McClennen & Fish llp, they bring experience in medical technology, healthcare and life sciences.

Geary prepares and prosecutes patent applications, with an emphasis in the fields of medical devices, polymers and advanced materials and chemicals.

adams handles patentability evaluations as well as preparation and prosecution of patent applications while Sperry focuses on domestic and international patent preparation and prosecution, as well as infringement, validity and right-to-use opinions.

IP group joins O’Melveny’s New York officeUS law firm O’Melveny & Myers llp has hired lisa Barons pensabene, Marc pensabene, and Filko prugo at its New York office.

The three join as partners and will work in the firm’s ip and technology practice. Barons pensabene will also head the firm’s life sciences litigation practice.

Barons pensabene and prugo represent innovator pharmaceutical companies in Hatch-Waxman cases, and bring a combined 40 years of experience to the firm.

Bradley Butwin, who chairs the firm, said: “lisa, Marc and Filko—all first-chair patent trial lawyers—give us the ability to serve a host of clients, ranging from biotechnology and pharmaceutical companies to computer hardware and software companies in aNDa and traditional patent litigation.”

INBrIEF

basel, switzerland

Novartis and GSK have agreed to create a consumer healthcare business in a joint venture that involves the exchange of assets worth billions of dollars.

The deal combines Switzerland-based Novartis’s OTC unit with GSK’s Consumer Healthcare division.

As part of the agreement, Novartis will acquire GSK’s oncology products for $14.5 billion, then a further $1.5 billion depending on meeting a development milestone.

It would also have opt-in rights to GSK’s oncology R&D pipeline.

Novartis will also divest its vaccine business, with the exception of flu, to GSK for $7.1 billion plus royalties. Novartis has started a separate sales process for its flu vaccine business.

Novartis said on April 22 that it will divest its Animal Health division to Lilly in a separate transaction, allowing it to focus its portfolio on innovative pharmaceuticals, eye care and generics.

The chief executive of Novartis, Joseph Jimenez, said: “We believe the divestment of our smaller vaccines and Animal Health divisions will enable us to realise immediate value from these businesses for our shareholders, and those divisions will benefit from being part of large, global businesses that are also leaders in their segments.

“Patients will benefit from even higher levels of innovation that this focus may afford. Looking ahead, this positions Novartis well for future healthcare industry dynamics.”

Andrew Witty, chief executive of GSK, said that the Novartis OTC portfolio is “highly complementary to GSK’s”. He added: “Opportunities to build greater scale and combine high quality assets in vaccines and consumer healthcare are scarce.” n

novartis and gSk in $14.5bn iP exchange

Ranbaxy’s outstanding shares, will become Sun Pharma’s second-largest shareholder.

News of the merger comes just months after Ranbaxy was hit by another import ban from the US due to concerns about one of its Indian manufacturing plants.

Sun Pharma’s managing director Dilip Shanghvi said about the merger: “In high-growth emerging markets, Ranbaxy provides a strong platform which is highly complementary to Sun Pharma’s strengths.

“We see tremendous growth opportunities and are excited with the prospects to create lasting value for our shareholders through a successful combination of our franchises.”

Arun Sawhney, managing director and chief executive of Ranbaxy, said: “We believe this

transaction brings significant value to all

Ranbaxy shareholders. Sun Pharma has a

proven track record of creating significant

long-term shareholder value and successfully

integrating acquisitions into its growing

portfolio of assets.

“We are confident that Sun Pharma is the ideal

partner to help us realise our full potential

and are excited to participate in future value

creation opportunities,” he added.

As LSIPR went to press the transaction was

still subject to approval by Sun Pharma

and Ranbaxy shareholders, and the Indian

government. It was expected to close by the

end of 2014. n

Novartis and GSK join forces



Cooley expands life sciences patent teamCooley llp has recruited ivor Elrifi and Heidi Erlacher to its patent counselling team serving the life sciences and technology sectors.

The hiring of Elrifi and Erlacher, both from Mintz levin, will mean Cooley llp has the largest life sciences patent group in the US.

Jim Brogan, who chairs the firm’s ip practice, said: “The addition of ivor, Heidi, and their team establishes Cooley as one of the pre-eminent, fully integrated ip firms ... This group’s deep experience and extensive relationships across the country and internationally will be invaluable.”

alongside them will be a team of four former partners from Mintz levin. The group will work in both the Boston and New York offices.

Mylan sues FDA following Celebrex decisionMylan has filed suit against the FDa, challenging a decision regarding generic drug marketing exclusivity on the generic version of pfizer’s arthritis drug Celebrex (celecoxib).

The pharmaceutical company said that the FDa “seriously erred” in its decision, and maintains that it is in a position to get final approval to market a Celebrex generic after the drug’s remaining patents expire on May 30.

in the decision, the FDa ruled that 180 days of marketing exclusivity is available only to applicants that have first filed a paragraph iV certification to an original patent, and then made a timely paragraph iV certification to a reissued patent.

This was despite an earlier appellate court decision that held the original patent invalid, and a later decision that held the reissued patent invalid.

INBrIEFnew jersey, us

US-based The Medicines Co has sued Aurobindo Pharma after claims the Indian pharmaceutical company infringed two patents related to its heart drug Angiomax (bivalirudin).

The lawsuit, filed at the US District Court for the District of New Jersey on April 11, was filed in response to Aurobindo’s application to market a generic version of the drug.

The Medicines Co has asserted two patents in the lawsuit, US numbers 7,582,727 and 7,598,343.

The New Jersey-based company says Aurobindo filed an ANDA with the US Food and Drug Administration (FDA) for approval to make a generic version of the drug without reasonable basis that it would infringe the patents.

The ‘727 and ‘343 patents, which cover pharmaceutical formulations of bivalirudin and processes of making the drug, will expire in July 2028. In its complaint, The Medicines Co said that it is entitled to a six-month period of exclusivity following the patents’ expiration.

Angiomax prevents the formation of blood clots during angioplasty. The drug

registered sales of $608.6 million last year, which accounted for around 88 percent of Aurobindo’s net revenue.

The Medicines Co is seeking a judgment that the ANDA was an act of infringement and that any commercial sale or manufacturer would amount to infringement.

It adds that a generic should be given approval before the patents have expired in 2028. It is also seeking damages and attorney’s fees.

Aurobindo did not respond to immediate requests for comment. n

aurobindo Pharma sued over angiomax

Ivor Elrifi Heidi Erlacher

Gralise dispute settled

ANDA under fire

depomed settles with generics over gralise disputenew jersey, us

Depomed, a California-based pharmaceutical company, has settled litigation with two of three companies that sought to launch generic versions of its Gralise (gabapentin) product before patents covering it expire. Gralise is used to treat pain after shingles. Sales of the product totalled $36 million in 2013.

The settlements with Incepta and Zydus allow the companies to start selling gabapentin tablets on January 1, 2024.

Depomed filed patent infringement cases against Actavis, Incepta and Zydus at the US District Court for the District of New Jersey in 2012, after the generic drug makers filed ANDAs with the US FDA to market generic versions of Gralise.

Depomed’s litigation with Actavis is still pending. n



washington, dC, us

Teva has filed an application with the US Supreme Court to stay a ruling by the US Court of Appeals for the Federal Circuit that allowed generic drug makers to enter the market before the expiry of Teva’s patents covering its $4.3 billion-a-year multiple sclerosis drug Copaxone (glatiramer acetate).

The application comes a week after the Supreme Court agreed to hear Teva’s appeal against the Federal Circuit decision in its case against two generic pharmaceutical company teams seeking to launch their own versions of Copaxone: Sandoz and Momenta, and Mylan and Natco.

In July last year, the Federal Circuit invalidated a patent covering Copaxone, allowing generic drug makers to enter the market on May 24, 2014, the day the remaining Copaxone patents expire.

The invalidated patent was due to expire on September 1, 2015.

In its application to stay the appeals court’s ruling, Teva said the Supreme Court’s intervention was needed before the May date “to ensure that its decision on the merits next term will not come effectively too late to prevent irreparable harm to Teva”.

The case is due to be heard by the Supreme Court when the next term begins in October. A decision on the case may not be handed down until early 2015, by which time competitors’ products could have been on the market for nearly a year.

Teva’s prior requests to stay the ruling had been denied, although it argued that now “there is at least a fair prospect—if not a strong probability—of reversal” of the appeals court’s decision.

It added: “Accordingly, Teva should not now be left without the injunction that the District Court granted to protect Teva against irreparable harm.”

Teva told LSIPR that it has no further comment related to the litigation. n

See Copaxone case study, p18

teva asks uS Supreme court to stay ruling in copaxone case

News25


LsIPR Newsletter 02:14

HOW TO FORTIFY YOUR INNOVATIONS, IDEAS AND TRADEMARKS

Innovations, models and trademarks are a valuable asset in any business. They enhance a company’s

distinguishing capacity, boost its impact, strengthen its competitive position and make it more attractive to

investors. Therefore, there is every reason to give Intellectual Property a prominent place in your business

strategy. We can support you by protecting and enriching your innovations, models and trademarks,

thanks to our extensive range of services and the expertise of our trademark, design and patent specialists

who find solutions where others don’t. We are the largest consultancy in Intellectual Property in the

Netherlands and one of the most pioneering firms in Europe. If you would like to know more, visit www.nlo.nl

Supreme Court decides



delhi, india

Pfizer’s associate general counsel, Justin McCarthy, has sent a letter to India’s ambassador to the US, Subrahmanyam Jaishankar, urging the Indian government to “shift from using destructive IP policy as an access strategy”, according to reports.

It is not the first time Pfizer has commented on India’s IP practices. In March 2013, Pfizer’s chief IP counsel Roy Waldron told the US House Committee on Ways and Means’ subcommittee on trade that India’s business environment for innovative industries had “deteriorated significantly”.

He added: “India has systematically failed to interpret and apply its IP laws in a manner consistent with recognised global standards.”

The testimony refers to the Indian Patent Office’s decision to deny patent protection to cancer therapy Glivec (imatinib). The drug was not deemed to show “enhanced efficacy”, which Waldron said limits the ability to obtain

a patent, adding that the requirement was against the WTO’s Trade-Related Aspects of IP Rights (TRIPS) Agreement.

Ranjan Narula, managing partner at Ranjan Narula Associates, said it is not fair to say the Indian patent system is not working, although he added: “There are certain provisions in the Indian Patents Act, within the larger framework of the TRIPS Agreement, that allowed India to develop an IP regime which restricted the grant of patents and required stricter criteria for inventions to be patentable and enforceable in India.”

The US pharmaceutical industry has been “disturbed” by the Glivec decision, he said. “The revocation of certain patents for not being inventive and the grant of a voluntary licence for not meeting the reasonable requirements of the public in India is leading to a conclusion that Indian courts are tilted towards protecting local industry.”

A spokesperson for Pfizer told LSIPR: “The issuance of unwarranted compulsory licences,

Pfizer criticises indian pharma patent policy

unfair revocation of valid patents, and denial of patentability of inventions in India are critical areas of concern in our industry.”

She added: “We look forward to collaborating and engaging with the Indian government to develop sustainable solutions that will enable us to continue to provide access to innovative medicines.” n

london, uk

AstraZeneca’s portfolio does not appear to offer a long pipeline of marketed products with long periods of exclusivity, says Jason Rutt, head of the patents group at Rouse in London and former head of Pfizer’s UK patent department.

Speaking to LSIPR on April 28 after Pfizer confirmed its interest in merging with the UK-based pharmaceutical company, he said: “AstraZeneca has a reasonable number of products that are off-patent, or that will go off-patent fairly shortly, and I can see that there’s value there for Pfizer.”

AstraZeneca appears to have boosted its research and development portfolio, and has a good oncology pipeline, he said.

“Something that seems understated is that AstraZeneca has some fairly good Alzheimer’s medicines in development, and Alzheimer’s was seen as a very attractive target within Pfizer.

“Pfizer’s real strength is as a late-stage development and marketing company,” Rutt

said, adding that if the deal were to go ahead, it would get “some good late-stage candidates”.

Concluding a month of big pharma mergers, and a week after the news was reported by The Sunday Times, Pfizer confirmed it had submitted an indication of interest to

AstraZeneca’s board of directors regarding a possible merger transaction in January.

It added that after “limited high-level discussions” AstraZeneca declined to pursue negotiations, and discussions between the companies were stopped.

Pfizer contacted AstraZeneca again on April 26 seeking to renew discussions, although AstraZeneca again “declined to engage”, Pfizer said.

“Pfizer believes the possible combination would create a highly complementary mapping of products, pipeline and operating assets to Pfizer’s new operating structure,” the company said on April 28, including boosting its oncology portfolio in areas including lung cancer and breast cancer.

Pfizer said that it was currently considering its options.

Rutt told LSIPR that Pfizer’s bid was “intriguing”, and unusual for the company, which tends to close transactions that are more like “takeovers than mergers”.

“Pfizer has always bought big companies that had products it really wanted,” he said. n

astraZeneca ‘has value’ says former Pfizer lawyer

AstraZeneca: products in the pipeline

India’s patent system targeted



dublin, ireland

Dublin-based Mallinckrodt Pharmaceuticals has announced it will buy US biopharmaceutical company Questcor Pharmaceuticals for $5.6 billion.

As part of the deal, which is expected to close in the third quarter of this year, Mallinckrodt will acquire Questcor’s lead product Acthar (corticotropin).

The multiple sclerosis drug comprises most of Questcor’s net sales, which totalled $799 million in 2013.

Acthar has been approved by the US FDA for 19 indications, many related to the treatment of autoimmune and inflammatory diseases.

Mallinckrodt said it expects Acthar will be a “strong complement” to its portfolio of specialty pharmaceuticals, which it added

to with its $1.4 billion purchase of Cadence Pharmaceuticals in February.

Mallinckrodt’s chief executive Mark Trudeau said of the transaction: “We will … have an increasingly diversified specialty pharmaceuticals portfolio, which will include novel therapeutics for pain management, as well as central nervous system, renal, rheumatologic and other autoimmune and inflammatory disorders.”

Don Bailey, chief executive of Questcor, said: “I strongly believe Mallinckrodt is the right partner to support the continued growth of Acthar in the highly specialised markets that we serve.”

He added: “Questcor commercial operations will function as a separate business unit within Mallinckrodt and, given the complementary nature of our businesses and product portfolios, we expect this to be a seamless transaction.” n

mallinckrodt picks up acthar in questcor merger

Schiff Hardin expands IP litigation teamSchiff Hardin llp has expanded its ip group with the hiring of imron aly as a partner.

aly will co-lead the pharmaceuticals and biologics patent litigation team at the firm’s Chicago office. He focuses on patent infringement and trade secret litigation, with an emphasis on pharmaceuticals, medical implants and devices.

Before joining Schiff Hardin, aly was a partner at Winston & Strawn llp in Chicago.

Stephen Hankins, leader of Schiff Hardin’s ip group, said aly’s “diverse practice” and expertise in pharmaceutical and medical device litigation would make him a perfect complement to the team.

INBrIEF



indiana, us

The US District Court for the Southern District of Indiana has upheld a patent covering Eli Lilly’s second biggest drug Alimta (pemetrexed disodium), after a challenge by Teva’s US pharmaceutical arm.

Judge Tanya Walton Pratt found on March 31 that Teva failed to show by “clear and convincing evidence” that Lilly’s 7,772,209 patent is invalid for obviousness, obviousness-type double patenting, inadequate description or lack of enablement.

Lilly launched the case after a group of companies, including Teva, filed ANDAs with the US FDA for approval to make and sell pemetrexed disodium products covered under the ‘209 patent.

The patent describes a method of administering chemotherapy drug pemetrexed with folic acid and vitamin B12 to reduce the incidence of toxicity. It is due to expire on May 24, 2022, while the compound patent will expire on January 24, 2017; both including paediatric exclusivity.

Alimta is used in the treatment of nonsquamous cell non-small cell lung cancer. In 2013 it generated $2.7 billion in revenues.

Michael Harrington, senior vice president and general counsel for Lilly, said: “We are pleased with the district court’s ruling on Alimta’s vitamin dosage regimen patent and are confident that the patent is valid and enforceable.

“The significant scientific research that Lilly performed in support of the vitamin dosage regimen patent deserves IP protection. We continue to emphasise that protection of IP rights is extremely important to the biopharmaceutical industry and the patients we serve.”

Teva did not immediately respond to a request for comment. n

lilly beats back challenge to alimta patent

Supreme Court rejects Teva’s request to stay Copaxone rulingThe US Supreme Court has rejected Teva’s request to stay an appeals court ruling that allows generic drug makers to enter the market with their own versions of multiple sclerosis drug Copaxone (glatiramer acetate) before its patents expire.

The Chief Justice of the US said that Teva had demonstrated “a fair prospect of success on the merits” in its appeals against the US Court of appeals for the Federal Circuit’s decision, but denied Teva’s application citing the company’s potential to recover patent infringement damages.

The appeals court invalidated one of the patents covering Copaxone, 5,800,808, which is due to expire on September 1, 2015.

EMA and Australian regulator collaborate on orphan drugsThe European Medicines agency (EMa) and the australian Therapeutic Goods administration have agreed to share the full assessment reports “related to marketing authorisations of orphan medicines”.

if the same marketing authorisation application is received in parallel by the regulators, they will be able to use scientific exchange to start evaluation of the medicine.

However, the regulators will reach their own conclusions about whether the medicine is suitable to be authorised in their respective markets.

EMa said in a statement: “Global collaboration on orphan medicines and rare diseases is particularly important in view of the small number of patients worldwide and the need for the limited number of studies performed to benefit patients regardless of where they live.”

INBrIEF

No to Teva

Alimta patent valid

new york, us

OxyContin (oxycodone hydrochloride) maker Purdue Pharma has filed suit against Teva to stop the generic drug maker trying to litigate claims to a patent for which it had filed a Paragraph III certification.

Teva filed an ANDA in 2011 seeking approval from the US FDA to make and sell a generic version of Purdue’s blockbuster painkiller OxyContin.

Its Paragraph III certification indicated that it would start marketing its generic oxycodone hydrochloride extended release tablets only after Purdue’s patents covering the product expire.

The case, which was brought at the US District Court for the Southern District of New York on April 3, relates to US

patent 6,488,963, which covers a method of formulating pharmaceutical products.

In the complaint, Purdue argued that Teva could have pursued, but did not pursue, the patent claims in its prior litigation with Purdue, which have now concluded. n

Purdue sues teva to block oxycontin challenge

OxyContin generic sought

Client: Birch, Stewart, Kolasch & Birch, LLP (BSKB) ContaCt: Elizabeth Richards, [email protected], 703.205.8000

ae: Jeff Lupisella x225 PM: Jeff Lupisella x225 VeR. : full page, full bleed

PRojeCt: BSKB-073 ‘13 Ad Placement Mod. date: 11.21.13 Thu 4:08 PM

Run date: March/April 2013 Pub: WIPR- LSIPR Print Ad 4CP: n n n n Size: (Trim: 210mm x 297mm)(Bleed: 216mm x 303mm)

Confidential: Information contained within this document is only intended for the recipient. Copying, distribution or communication of this document is stricly prohibited.

13221 Woodland Park Rd., Suite 420, Herndon, VA 20171 tel 703.437.8018 fax 703.437.8268 vizual.com



ViiV improves access to TivicaySpecialist HiV company ViiV Healthcare has announced it will license its HiV medicine Tivicay (dolutegravir) to the Medicines patent pool, with the aim of increasing access to the drug in developing countries.

The news comes two months after Tivicay was approved by the EMa, and eight months after the FDa gave its approval to market the drug.

according to figures quoted by ViiV, 99 percent of children and 93.4 percent of adults living with HiV reside in developing countries.

ViiV’s chief executive Dominique limet said that the World Health Organization recently cited dolutegravir as a development priority for future anti-retroviral treatments for children.

Roche buys IQuum to develop molecular diagnosticsSwiss pharmaceutical company roche has bought US-based molecular diagnostic company iQuum for $275 million.

roche will acquire iQuum’s laboratory-in-a-tube (liat) system, which allows healthcare professionals to perform rapid molecular diagnostic testing and make treatment decisions in an environment closer to patients, with minimal training.

roland Diggelmann, chief operating officer for roche Diagnostics, said: “We welcome iQuum’s employees, who will continue to focus on the development and manufacturing of the liat analyzer and assays.”

iQuum’s chief executive and founder Shugi Chen said: “We are very excited to continue developing innovative solutions as part of the roche Molecular Diagnostics team.”

INBrIEF

Roche grows molecular diagnostics

new jersey, us

The US Court of Appeals for the Federal Circuit has thrown out a lower court ruling that found Natco Pharma infringed a patent covering Roche’s flu drug Tamiflu (oseltamivir phosphate).

In a two-to-one decision, the appeals court found that the ‘483 patent, held by pharmaceutical company Gilead, is invalid for obviousness-style double patenting. The ruling gives Natco another opportunity to try to invalidate the patent so it can make a generic version of Tamiflu.

Gilead, along with Tamiflu marketers Roche and Genentech, sued India-based Natco after it filed an ANDA with the US FDA, seeking approval to make a product covered by the ‘483 patent.

During the case, filed at the US District Court for the District of New Jersey, Natco argued that the ‘483 patent was invalid for obviousness-type patenting over Gilead’s ‘375 patent, which like the ‘483 patent is directed at antiviral compounds and the method for their use.

Gilead said that even though the ‘483 patent expires 22 months after the ‘375 patent, as the ‘375 patent was issued after the ‘483 patent it could not serve as a reference for double patenting.

The district court agreed, and found that Natco infringed the Tamiflu patent.

Natco appealed against the ruling to the Federal Circuit, which on April 22 vacated the district court’s decision and remanded the case.

In a statement on its website, Natco said it was pleased with the Federal Circuit’s decision. According to IMS Health figures quoted in the statement, Tamiflu’s US sales reached about $495 million in the 12 months to September 2013.

A spokesperson for Genentech told LSIPR: “We are disappointed with the decision by the Court of Appeals for the Federal Circuit, but note that the appellate court did not opine on patent validity, and nor had the district court previously.”

She added: “We are studying the court’s decision, and considering various options and next steps.” n

actavis wins lialda generic appeal

federal circuit rules against roche in tamiflu case

Actavis triumphsflorida, us

The US Court of Appeals for the Federal Circuit has reversed a lower court decision that found Actavis’s generic version of Shire’s ulcerative colitis drug Lialda (mesalamine) infringes US patent 6,773,720.

Circuit judge Todd Hughes ruled on March 28 that the US District Court for the Southern District of Florida’s constructions of Lialda’s active ingredient’s “inner lipophilic matrix” and “outer hydrophilic matrix”, claimed in the ‘720 patent, “impermissibly broaden” the ordinary meaning of the terms.

The appeals court has referred the case to the district court for further proceedings using claim constructions consistent with its opinion. The ‘720 patent claims a controlled release oral pharmaceutical composition for treating inflammatory bowel diseases including Crohn’s disease and mild to moderate ulcerative colitis.

Dublin-headquartered Shire sued Actavis for patent infringement after the pharmaceutical company, also based in Dublin, filed an ANDA with the US FDA for approval to market a generic version of Lialda.

It told LSIPR in a statement that it “remains dedicated to defending its IP”.

According to IMS Health figures quoted by Actavis, Lialda generated revenues of $576 million in the 12 months to January 31, 2014. n



We Take Care Of Innovators – And Imitators.

Wherever Innovations Are Created –

Imitators Are Never Far Behind.

Since 1924, we’ve been protecting and defending intellectual property rights – in Germany and around the world.

The fact that our practice regularly takes a leading position in independent rankings is not only due to our professional

expertise – but also to our emphasis on building close partnerships with our clients. That’s why each of our clients is

assigned a like-minded and personally compatible contact person for their individual support.

www.grunecker.de

140124_AZ_210x297_ENG.indd 2 24.01.14 09:42

IP StRategy: HoRIzoN dIScoveRy14 LSIPR Newsletter 04:14


Patients in a test tube

LSIPR Newsletter 04:14 IP StRategy: HoRIzoN dIScoveRy 15


editing the genomeAs a better understanding of how genes function in disease is developing, personalised medicine is becoming a reality for more patients.

Since the 1990s, advances in technology have allowed the manipulation, or ‘editing’, of the human genome so that the function of certain genes and how genetic mutations cause the onset of disease can be studied.

There are several varieties of this so-called ‘genome editing’. One of the most recent methods, the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) system, uses a bacterially-derived protein and synthetic guide ribonucleic acid (RNA) to make breaks in targeted parts of the genome.

UK-based Horizon Discovery uses a combination of genome editing methods to create cell lines—what it calls ‘patients in a test tube’—which model the genetic anomalies found in patients with cancer and other diseases, for use by companies in the business of drug discovery and development, as well as in clinical diagnostic development.

“Gene editing allows Horizon Discovery to manipulate the genome,” explains Eric Rhodes, vice president of research and development, and chief technology officer at the company. “We can essentially recreate patient populations.

“As long as you have a unique patient population for a disease, you can recreate that disease in a cell and use that to test drugs to see if they have an effect.”

Personalised medicineThe technology’s potential application as a research tool in the development of personalised medicine is clear. It is an approach that can stop patients receiving treatments that will not work for them, while reducing the chance of an adverse effect.

Horizon Discovery brings together CRISPR, another genome editing method called Zinc Finger Nucleases, and its own proprietary recombinant adeno-associated virus (rAAV) technology to make gene point mutations, knockouts, deletions and insertions on the genome, and create a variety of different cell lines. Drug development companies can use them to see how a population will respond to a medicine before introducing it to a patient.

As gene function is often a factor in the development of cancer, Horizon Discovery has been focusing on creating research tools to assist in the development of treatments for the disease, although it is not limiting itself to oncology.

“Outside oncology there are other things you can do, such as modify cells to make them resemble monogenic diseases, such as Huntington’s or cystic fibrosis.

“Different types of gene editing are used to make specific cells, such as a cell that is typical of a certain type of cancer,” Rhodes explains.

“For example we may take a kidney cell and recreate kidney cancer by mutating a gene. We sell the non-mutated version of the cell next to the mutated version, so researchers can do studies to see the difference between the two when they’re treated with a drug.”

HorizonDiscovery’scellline-creatingtechnologyhasthepotentialtoadvancepersonalisedmedicine.Buthowdoesthegeneeditingcompanystaycompetitiveinacrowdedfield?LSIPRfoundout.

15


IP StRategy: HoRIzoN dIScoveRy16 LSIPR Newsletter 04:14


These isogenic cell lines are called X-MAN (gene X–mutated and normal) and they model the genetic anomalies that are often responsible for the development of cancer, among other diseases. These cell lines are used by researchers to identify the effects of individual genetic anomalies on drug activity, patient responsiveness, and resistance.

Since its establishment in 2005, Horizon Discovery has been augmenting its portfolio with cell lines developed in many academic institutions based in the US, and some in Europe. It now holds a library of more than 550 genetically defined cell lines.

a defined technologyWhile many of its technologies have been in-licensed from other companies, part of Horizon Discovery’s strategy is to create IP of its own. “We’ve created patents ourselves—some technology patents and some that are focused on disease-specific applications,” Rhodes explains, estimating the company holds between 50 and 70 patents.

The company uses its own platform for drug discovery. Upon finding targets that look as though they have potential in the treatment of cancers, Horizon Discovery will sometimes develop chemical compounds and patent those as well.

However, Rhodes says, there can be delays patenting technologies and compounds in the crowded field of genome editing, as patents multiply.

“You may file for one patent at the US Patent and Trademark Office, then end up with ten different smaller patents because the office imposes limits,” Rhodes says.

“Often you file a patent on a broad idea, and the patent office asks you to be more specific. For example, in cancer, we found that patients with a particular mutation are more likely to be treated with a certain class of drug, so in our application we might name something very broad like ‘patients who have lung cancer’—and the office will come back to you and ask ‘what do you mean by lung cancer?’.

“You have to be more defined, so then you start breaking it down.”

Patent offices require applications to be more specific. “You can’t say ‘any one of these 100 genes causes lung cancer’. The office limits you to saying in any single patent that one gene or up to five cause the cancer,” Rhodes says.

“Patents can be general in some ways, such as

in applications for methods, but they have to be very specific when it comes to genes.”

As more innovators are citing gene function in their patent claims, the patent office has “got wiser” over the last 20 years on how to deal with patents that mention genes in their claims, Rhodes says. “They’ve realised the difference between genetic information and the value of it.”

looking forwardWhile protecting its technologies may be one obstacle—a slow process that, Rhodes says, is getting faster—Horizon Discovery’s biggest challenge is staying ahead in such a competitive sector. “Gene editing is highly competitive right now so there are lots of academics involved,” Rhodes says.

“The patent office is probably inundated with applications related to these new technologies, and it’s going to take some time to tease all of these things apart.”

He likens the situation to the influx of new technologies that followed the discovery of small interfering RNA’s (siRNA) potential use in genome regulation. First reported in 1999, siRNA can be used to stop the expression of, or ‘silence’, certain genes in the genome.

“There was a flood of different patent applications from various directions, and it took many years to sort it all out,” Rhodes says.

He estimates there are about ten other established companies involved in gene editing. What is the company’s plan as the field develops?

“We’re continuing to look into the genetic editing space and trying to develop technology there. That is the main focus for us right now,” he says.

Does its unique position as the sole licensee of rAAV technology give Horizon Discovery an edge? “Ten years ago, there was only one gene editing technology. Now there are at least four commonly accepted gene editing technologies—maybe even five.”

He says that CRISPR’s relative simplicity, compared with the other technologies, means that many academics, biotechs and pharmaceutical companies are taking a ‘do-it-yourself ’ approach with the technology, rather than licensing from other companies with expertise.

“It’s simple enough, at least to approach—that’s why there’s so much competition. The patents are so new that many of them haven’t been published yet,” he says, though he predicts that once the patents start to be published, and companies are required to take licences to use the technologies, things will settle down, and the level of competition will subside.

Until then, however, “it’s a sort of free-for-all and a commercial game right now”. n

“You may file for one patent at the US Patent and Trademark Office, then end up with ten different smaller patents because the office imposes limits.”

www.powellgilbert.co.uk

Intellectual Property… It’s in our DNA

Powell Gilbert is a London-based law firm focusing on litigation and helping the world’s leading life sciences companies defend their intellectual property all around the globe.

From biotech to pharma, few law firms know life sciences better than we do… and we have the PhDs to prove it.

18 LSIPR Newsletter 04:14


caSe Study

TheCopaxonebattle

Copaxone (glatiramer acetate) is a blockbuster drug for the treatment of multiple sclerosis, created by Yeda Research and Development Co Ltd. The patents that cover Copaxone, including the process for its preparation, have been extensively litigated around the globe, and in India the patent for the preparation of

Copaxone expires on May 23, 2015. For this process patent, several proceedings are currently pending before various bodies in India, including the Delhi High Court, the Intellectual Property Appellate Board and the Indian Patent Office (IPO).

The battle in India began in 2007, when Teva Pharmaceutical Limited, the exclusive licensee

of Yeda, initiated infringement proceedings against Natco Pharma Ltd, a generics company based in Hyderabad. Mylan, a US-based pharmaceutical company, is the partner of Natco for Copaxone. While the infringement proceedings were pending, Mylan Pharmaceuticals filed a review petition in November 2013 under Section

ArgumentsoverthetermofthepatentsgrantedareattheheartoftheCopaxoneconflict,saysArchanaShanker.

LSIPR Newsletter 04:14 19


caSe Study

77 of the Indian Patents Act before the IPO, challenging the term of the patent granted by the Indian process patent 190759 which was granted on May 15, 2004.

The Indian Patents Act, since its inception in 1970, has been amended several times to make its provisions compliant with the World Trade Organization’s Agreement on Trade-Related Aspects of IP Rights (TRIPS). One such provision was in relation to the term of a patent. There have been revisions to the 1970 Act through three amendments: the Patents (Amendment) Act 1999, the Patents (Amendment) Act 2002 and the Patents (Amendment) Act 2005.

The 2002 amendment increased the term of a patent in relation to all inventions to 20 years. Prior to that amendment, the term of every patent granted under the unamended act was 14 years in respect of all inventions, except for inventions relating to the process for preparing food or pharmaceuticals, for which the term was seven years from the date of filing of the application, or five years from the date of sealing of the patent, whichever was shorter.

The main challenge in Mylan’s review petition was on the issue that a patent could not have been granted in relation to the patent application for the process for preparing Copaxone, as the term of a patent for this application under the unamended act expired prior to the grant of a patent. (A similar writ petition has been filed by Natco but is pending before the Delhi High Court and is therefore sub judice.)

under review The main arguments by Mylan in its review petition can be summarised as follows:

• The term of a patent under Section 53 of the Indian Patents Act should have expired on May 23, 2002 in relation to the process patent application for Copaxone; and

• The IPO made an error in issuing the Letters Patent on March 15, 2004 for a period of 20 years from the date of filing of the application based on the amendments made by the Patents (Amendments) Act 2002. The grant of a patent was therefore void ab initio.

Without going into the merits of the case, the patentee dealt with the review petition on these preliminary issues:

• A similar issue is pending before the High Court of Delhi in a writ filed by Natco and, therefore, does not merit any interference by the Controller;

• The review petition is time-barred, having been filed after 11 years from the grant of a patent and, therefore, suffers from laches and delay;

• Mylan has no locus standi to file a review petition as Mylan was neither the applicant nor party to any proceedings under the Indian Patents Act; and

• The Patents (Amendment) Act of 2002 came into effect on May 20, 2003 and the payment of the sealing fee, a condition prior to the grant of a patent, was effected on March 15, 2004. For this reason, the IPO rightly granted the applicant a patent term of 20 years.

In March 2014, the Joint Controller of patents issued the order on the review petition but did not comment on the interpretation of law relating to the provisions of the term of a patent. The main findings of the Controller included the following:

• A similar issue is pending before the High Court in relation to the same patent and, therefore, this matter did not merit any interference;

• Under Section 77 of the Indian Patents Act, the review petition filed by Mylan suffered from delay and laches as it took ten years and three months for Mylan to file the review petition;

• Mylan does not have the locus standi to file the review petition as Section 77 makes it clear that a review petition can be

entertained only if filed by an applicant/opponent or by a concerned party to the proceedings. Mylan is neither the applicant to the concerned application nor the patentee or the licensee; and

• On condonation of delay, the Controller refused to condone the delay and held that the timelines prescribed under the law are not merely directory in nature. He further held that any delay in filing the review petition cannot be cured by filing a petition, particularly as the delay in filing the review petition was unreasonable and unexplainable.

The Controller also held that the Patent Act does not empower the Controller to disregard the institutional mechanism and timelines prescribed by the act and the rules as that would result in the total collapse of the system.

Mylan challenged the order of the Controller of patents before the Delhi High Court. The court dismissed the writ petition filed by Mylan but permitted it to file an intervention application before the Delhi High Court in the pending writ petition filed by Natco. The High Court petition is likely to come up for hearing in July this year.

The Delhi High Court’s interpretation of the provisions relating to the term of a patent will be interesting. On the delay in the grant of patents by the IPO, the Delhi High Court in Nitto Denko Corporation v UOI (WP[C] Nos. 3742/2013 and 3756/2013) directed the Indian government to constitute a committee to look into the issues of providing a programme for a time-bound disposal of pending patent applications and to recommend ways and means to ensure that new applications are decided within the statutory timeframe fixed by the statute. n

Archana Shanker is a senior partner and head of patents and designs at Anand and Anand. She can be contacted at: [email protected]

Archana Shanker heads Anand and Anand’s patent practice. A graduate of Law School, Delhi University, North Campus, she went on to complete her postgraduate diploma in bioinformatics and pharmaceutical regulatory affairs. She is an active contributing member of various international bodies, such as the Asian Patent Attorneys Association (APAA), Association Internationale pour la Protection de la Propriété Intellectuelle (AIPPI) and the Fédération Internationale des Conseils en Propriété Industrielle (FICPI).

“ThereviewpetitionfiledbyMylan

sufferedfromdelayandlachesasit

tooktenyearsandthreemonthsforMylantofilethereviewpetition.”

20


exPeRt commeNt LSIPR Newsletter 04.14

Interest in the promise of biomarkers and personalised/stratified medicine is building. In the UK, for example, the government announced a Diagnostics

for Stratified Medicine Catapult centre in August 2013, and partners including the Technology Strategy Board and the Medical Research Council have committed to spend more than £200 million ($336 million) over a five-year period to promote the development of stratified medicine, providing the tools, processes and systems for identifying the right therapy for the right patient, at the right time and at the right dose.

The “revolutionary” National Lung Matrix trial announced by Cancer Research UK in April 2014 and jointly funded by Cancer Research UK, AstraZeneca and Pfizer with support from the UK National Health Service (NHS) illustrates this approach, where the aim is to select test compounds for trial in particular patients taking into account the genetic profile of their cancer.

be needed to accommodate developments in how the USPTO and courts interpret these provisions. A strong plan for follow-on research, development and patent filing to build on the company’s expertise and market position will give the most commercially robust protection.

at the ePo In Europe, the challenges are different. Although ways of using known medical devices may be difficult to protect at the European Patent Office (EPO), the EPO generally takes a less restrictive view of the types of invention for which protection is possible. Particular claim formats are required and the EPO’s very strict approach to amendments and entitlement to priority means that options may be unnecessarily limited unless bases for those claim formats are included in priority and international (Patent Cooperation Treaty) applications, for example.

At the EPO, a method claim relating to an invention linking a particular biomarker to a

How feasible is it to protect innovation in this sector? Divergence between approaches in the US and in Europe, for example, provides a challenging environment for those seeking to protect and develop their assets, but with care, it is possible to capture significant value in this clinically and commercially important area.

The US Patent and Trademark Office (USPTO) memorandum to examiners issued in March 2014 (http://www.uspto.gov/patents/law/exam/ myriad-mayo_guidance.pdf) presents a significant challenge to obtaining protection and explaining its commercial value. The USPTO guidance seeks to ensure that all applications of a particular biological finding are not monopolised; a patent applicant, on the other hand, might typically seek to ensure that all commercially important aspects are encompassed.

A challenge for obtaining protection, therefore, is to be able to focus on those commercially important aspects while leaving open a sufficient number of other applications to satisfy the USPTO. A range of options of varying scope is likely to

Protecting biomarkerS and

PerSonaliSed/Stratified medicineWithcarefulpatentdraftingandprosecution,

itispossibletocapturesignificantIPvalueintheclinically—andcommercially—

importantareaofbiomarkers,saysStephaniePilkingtonofPotterClarkson.



exPeRt commeNt

Product Characteristics, unlike references to particular indications or dosage forms, which it is typically possible to leave out under the so-called ‘skinny label’ provisions.

Of course, robust biomarkers are potentially very useful not only in delivering personalised/stratified medicine but also in developing therapeutic molecules and treatment regimes. Can this activity be protected and is that protection useful? The EPO will permit claims to screening methods as long as they are considered not to contravene the “contrary to morality” provisions, which typically means that they have to be limited to non-human animals, or to methods that would be acceptable as human clinical trials. Again, using the right wording when drafting the priority document preserves maximum flexibility.

Infringement considerations may vary across Europe and other territories in view of different provisions relating to experimental use and Bolar-type exemptions; preparations for the Unitary Patent and Unified Patent Court add a further layer of complexity in Europe in view of the separation provisions providing for exemptions to infringement of a patent with unitary effect.

Prosecution and enforcement both remain challenging for biomarker/personalised/stratified medicine claims. The long timescales involved and the potential for changes in patent office and court interpretation emphasise the need for early and ongoing awareness throughout the development team of the potential of biomarkers and personalisation, and for a flexible and thorough approach to securing protection for them. n

Stephanie Pilkington is a partner in the biotechnology and pharmaceuticals group at Potter Clarkson LLP. She can be contacted at: [email protected]

Stephanie Pilkington, MA(Cantab), PhD, CPA, EPA, has been advising on IP aspects of personalised and stratified medicine for many years for industrial and academic clients, building on her research and pharmaceutical industry background. She has extensive experience before the EPO and regularly advises on filing and prosecution strategy as well as oppositions, appeals and due diligence.

biomarker for a patient as part of the method, for example. For some biomarkers this may not be a concern, for example where the biomarker varies with time and the essence of the invention lies in monitoring a changing biomarker parameter. For other more fixed biomarkers, for example a particular genotype, careful thought is required when drafting to anticipate as far as possible the different ways in which such information may be obtained and accessed for a particular patient.

Biomarkers may also lie in more unusual areas, for example in defining a patient subgroup by reference to failure to respond to a particular previously-tried therapy, again emphasising that ability to refer to information rather than a specific physical investigation step may be important.

Personalised/stratified medicine and other biomarker-related claims can be very valuable as part of a product lifecycle management strategy, or a strategy for securing protection reflecting the technical challenges involved in gaining regulatory approval for a known but previously unapproved compound. Particularly in the latter case, moves at least in Europe towards greater transparency in the disclosure of clinical trials and regulatory submissions highlight the need for early and careful review of trials data with potential biomarkers and personalisation/stratification in mind, followed by suitable patent filings, before the trials information enters the public domain. Otherwise, opportunities for securing the broadest possible protection in relation to biomarkers and stratification may be lost.

In terms of potential infringement, it may be difficult for a generic manufacturer to exclude biomarker-related information from regulatory documents such as the Summary of

“Astrongplanforfollow-onresearch,developmentandpatentfilingtobuildonthecompany’sexpertiseandmarketpositionwillgivethemostcommerciallyrobustprotection.”

particular treatment option typically would not include either the step of obtaining a sample from the patient or the step of treating the patient in the selected way. At the USPTO, in contrast, it may be necessary to include at least one of these steps. The method claim may be supplemented with a ‘second medical use’ claim that focuses on a compound for use in a method of treatment characterised by the treatment selection method.

Again, a modular approach during drafting may be best in accommodating these conflicting and shifting requirements: the broadest claims or statements of invention can focus on the ‘core’ of the invention, in appropriate formats for the EPO and USPTO, with different steps that can be added as needed in different territories.

The EPO’s view on which features need to be in a second medical use claim or treatment selection method claim may also be shifting. The EPO may require more explicit reference in the claim to the determination of a particular

22 LSIPR Newsletter 04:14


INdIaN PateNt Law

India has been the hub for all that excites ire and admiration in those with an interest in pharmaceuticals. Generic manufacturers and access-for-medicine foundations applaud, and innovators seethe at the way India has become a tough place for innovative companies to do business. There is frequent debate about the extent to which Indian law is being correctly applied and whether Indian statute is compliant with the World Trade Organization’s Trade-Related Aspects of IP Rights (TRIPS) Agreement.

Amid the controversy, many forget that the issues associated with Indian patent law have a strong retrospective element. After India signed up to TRIPS at the beginning of 1995, it was granted ten years to introduce all the necessary changes. The key one for the pharmaceutical industry was the introduction of pharma product patents in 2005. Given that the lead time for development of a new pharmaceutical is more than ten years, a product marketed in 2014 was probably the subject of a pre-2005 patent application. Glivec (imatinib) is a good example of such a product.

Given how much conflict is based on past law, what can we expect in the future? The Indian Patent Office (IPO) has issued draft guidance to examiners on how to treat future applications. India is unrepentant, unapologetic and bristling for future clashes.

The preamble to the guidance gives a useful insight into the IPO’s mindset. It acknowledges the value that good patents bring in terms of ‘promoting innovation and technological development’ (para 1.17). However, it is proud of the way that India is viewed as the ‘pharmacy of the world’ (para 1.16) and quotes a World Health Organization request to the Indian government in 2004:

“As India is the leader in the global supply of affordable antiretroviral drugs and other essential medicines, we hope that the Indian government will take the necessary steps to continue to account for the needs of the poorest nations that urgently need access to antiretrovirals, without adopting unnecessary restrictions that are not required under the TRIPS Agreement and that would impede access to medicines.”

This is the ‘level playing field’ point frequently made by innovative pharmaceutical companies. Medicines are researched, developed and sold in a global marketplace. Pharmaceuticals are

up for a fight InternationaldamagemayresultfromIndia’sstepstoformaliseitsisolationistpatentsregime,saysJasonRutt.



INdIaN PateNt Law

enormously expensive to develop. If certain countries protect a pharma product and others don’t, then the consumers of the first country end up paying disproportionately more to fund that innovation. In effect, certain countries are funding the healthcare of others. Few begrudge sub-Saharan Africa this relief, but an emerging superpower such as India is seen as another issue altogether. What is the reality?

Pharmaceutical inventions typically include: (i) compounds, including salts and polymorphs; (ii) uses of the compound to treat disease; (iii) formulations; and (iv) processes for manufacture.

The Indian guidance has little that is contentious to say about the patentability of formulations and processes, and such claims are rarely important in defining exclusivity for a product. Turning to compounds and uses, however, it is clear that the IPO has strong objections to inventions that transgress the infamous Section 3 of Indian patent law.

compoundsThe guidance on patentability of basic compounds appears sensible and standard. It departs on what are regarded as new forms of a known substance.

Section 3(d) of the Patents Act describes non-patentable inventions as including:

“Mere discovery of a new form of a known substance which does not result in enhancement of known efficacy or mere discovery of any new property or new use for a known substance.”

Most major patent offices would regard a new compound form, such as a salt of a known free base, as novel. The question of patentability then turns upon whether the new form, such as a salt, is inventive over the free base, ie, does it have any surprising advantageous properties?

The Indian guidelines state: “for the purposes of this clause, salts, esters, ethers, polymorphs, metabolites ... shall be considered the same substance unless they differ significantly in properties with regard to efficacy”.

At first glance these guidelines appear confused, deciding that novelty will be assessed when conflated with inventive step. However, most importantly, does it work in practice and get to the ‘right’ answer? Most patent offices would view a salt that has significantly different properties when compared to the free base with regard to efficacy as inventive.

a new use of a compound in the treatment of disease. Such claims are a cornerstone of pharma innovation and patenting.

For example, the compound sildenafil was marketed by Pfizer as Viagra™ for the treatment of erectile dysfunction. Later, the same compound was found to be useful in pulmonary arterial hypertension. Pfizer chose to develop the medicine as Revatio™. It is not an obvious leap from erectile dysfunction to pulmonary arterial hypertension so most countries would acknowledge that patent protection is in order. This could be either in the form of a second medical use claim or a method of treatment claim, as a reward for the insight, perseverance and expense of a patent.

Not so in India. The IPO’s guidance is notably terse:

“[Use claims] are not to be considered as inventions, since the claimed subject matter pertains to neither product nor process.”

The IPO has clearly maintained that Swiss-style claims: “the use of X in the preparation of a medicament to treat disease Y” are clearly not process claims.

The guidance goes on to say: “Further, an objection with regard to Section 3(i) would be invoked.”

Section 3(i) lays out that methods of treatment are unpatentable. In terms of Section 3(i) the IPO is merely following explicit statute.

The position taken by the IPO strikes at the heart of what the patent system is set up for: the incentivisation of research to treat human suffering. If every country followed India’s line there would be no research and clinical development would stop. However, this does not seem to pose a problem for patent officials, and instead they seem confident that they can appropriate the technology because other countries will pay for it.

This is an unsustainable position in the longer term, but there are no clear answers as to how matters will play out as India’s global economic position strengthens. n

Jason Rutt is head of patents at Rouse. He can be contacted at: [email protected]

Rouse is a global IP law firm, headquartered in London and with offices across Russia, the Middle East and Asia. Rouse’s affiliate firm in India is RNA IP Attorneys, with offices in Gurgaon and Chennai.

The IPO goes on to offer strong guidance that efficacy is a narrow test of therapeutic efficacy.

A compound may show efficacy in an in vitro assay. That efficacy may then be confirmed in clinical trials. But there is a huge leap from efficacy as a mode of action and a successful drug. A successful medicine needs to be formulated into a stable composition where the active drug does not stick in tableting machines. The formulation needs to have on-the-shelf stability and not decompose before it reaches patients. It needs to be tolerated, avoiding side-effects. A narrow focus on ‘efficacy’ is not helpful.

Much of the argument the IPO brings relies on the idea that such properties are implicit in a compound and that these advantages are brought blinking into the sunshine in an effortless manner. They’re not. However this takes no account of predictability or incentive: how likely is it that if I research a new form it will have properties that solve the problem?

In summary, one should consider the value of the invention. If a further form of the basic compound has an intrinsic value or advantage then there is an advantage to consumers using it. The innovator has given the world something and should be rewarded. However, if the new form is not fundamentally advantageous to patients then why would they not use the form patented in the earlier patent? The refusal of such applications is politics interfering in the logical application of law.

use patentsThe same thinking infects the other contentious element around Section 3: the inability to patent

“Ineffect,certaincountriesarefundingthehealthcareofothers.Fewbegrudgesub-SaharanAfricathisrelief,butanemergingsuperpowersuchasIndiaisseenasanotherissuealtogether.”

... IP only.

Legal Services

Patent | Trademark | Design | Copyright Litigation | Prosecution | Advice Searches | Valuations | Portfolio Management License Agreements | Unfair Competition Law

Technical Areas

Chemistry | Life Sciences | Pharma | Medical DevicesElectronics | Mechanics | Automotive | EnergyInformation Technology | Software | Computer Technology

BARDEHLE PAGENBERGPartnerschaft mbBPatentanwälte Rechtsanwälte

Prinzregentenplatz 781675 MunichGermanyT +49.(0)89.928 05-0F +49.(0)89.928 [email protected] | Dusseldorf | Paris | Barcelona | Milan

January 2014 april 2014 newsletter

Documents