january 2014 march 2014 newsletter · case report: supreme court reverses medtronic ruling...

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

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news and intelligence from life sciences intellectual property review

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march 2014

Myriad suffers setback in atteMpt to block aMbry brca test

‘patent cliff’ blaMed for contraction in irish econoMy

the brca battle continues

disclosure of clinical data a key concern

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Page 14

Virtual organs: strand life sciences reduces drug development risks

Winner 2011Shortlisted 2012 and 2013

2013

Expert intellectual property services for the life science industry

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Translating Innovation

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LSIPR Newsletter 03:14 edItoR’S LetteR/coNteNtS 3

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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)

Virtual organsYou want to know whether patients are going to react badly to your new drug. What do you do? There’s only so much testing you can do on animals, never mind volunteers. Here’s a new idea: the virtual organ.Strand Life Sciences’ ‘virtual’ liver allows companies to test a drug’s toxicity using computer simulations, in an advance that will, potentially, cut the failure rate during drug development. In this issue of LSIPR we find out how the Bangalore-based company is going about protecting and licensing this fascinating technology.Our case report this month is all about genes. The US Supreme Court has ruled already that naturally occurring nucleic acid sequences can’t be patented because they are products of nature. Moreover, claiming they are “isolated” will not make them eligible for a patent, although the methods of using them might be.With this in mind, Ambry Genetics announced that it wanted to offer screening for the BRCA1 and BRCA2 genes. Myriad filed for a preliminary injunction to prevent it from doing so. The US District Court Utah, Central Division, concluded that Myriad is unlikely to be successful because Ambry had raised a substantial question about the validity of the claims of the patents at issue. The preliminary injunction was not granted but the case is still to be heard fully on its merits and we’ll be sure to cover that when it happens.Our expert comment this month is about how licensing agreements can help when it comes to sharing and using copyrighted material, and our conference call looks at the issue of disclosure of clinical data.During the Life Sciences Law Forum, held in London in March, one speaker wondered whether the resources to deal with such disclosure were available, adding that as the information is disclosed at a global level, a national approach to regulating it won’t work. We must take a global, joined-up approach, she said.Conference delegates also heard that while the political will exists for the introduction of the Unified Patent Court, and that there is indeed a need for it, implementation is unlikely before 2016.We hope you find all this both useful and interesting.Martin Essex, Managing editor

Contents4 News 4 MyriadsufferssetbackinattempttoblockAmbryBRCAtest 4 GenericscircleasVirginiacourtinvalidatesCelebrexpatent 5 EliLillytargetsmorethan30genericsinEffientpatentcase 6 UpdatetoUPCrulesclarifies‘opt-out’scheme 7 IdenixbringsGileadpatentbattletoEurope 8 MylanfightsoffTeva’sPerforomistchallenge 9 ‘Patentcliff ’blamedforcontractioninIrisheconomy 10 PfizersuestoblockViagrageneric 12 NovartislaunchesGleevecactionagainstDr.Reddy’s

14 IPstrategy:StrandLifeSciences Virtualorgans:cuttingdrugdevelopmentrisks18 Legalupdate TheBRCAbattlecontinues20 Expertcomment Copyrightcomplianceinthelifesciencesindustry23 Conferencecall LifeSciencesLawForum:disclosureofclinicaldataakeyconcern

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.Josétrigueros,partner,LeyvaMontenegroTriguerosAbogadosSCJoachimWachenfeld,partner,Vossius&PartnerJaneWainwright,partner,PotterClarksonLLPGordonWright,partner,Elkington&FifeLLP,onbehalfofCIPAFranz-JosefZimmer,patentattorney,Grünecker

NewS4 LSIPR Newsletter 03:14


UTAH, US

Genetic diagnostic company Myriad Genetics and other patent holders have been denied a motion for a preliminary injunction that would have kept rival company Ambry Genetics from selling its own test for the BRCA gene mutations that put women at risk of developing breast and ovarian cancer.

On March 10, Robert Shelby, a judge at the US District Court for the District of Utah, said that Myriad is not entitled to the remedy of preliminary injunction, and that it was unable to establish that it was likely to succeed on the merits of its claims.

While Myriad had shown it was likely to suffer “irreparable harm” if Ambry continued to offer its cheaper BRCA test, Ambry raised “substantial questions” about

Myriad suffers setback in attempt to block ambry brca test

Suffering a setback

generics circle as Virginia court invalidates celebrex patentvirginiA, US

The US District Court for the Eastern District of Virginia has invalidated one of Pfizer’s patents covering blockbuster arthritis drug Celebrex.

Reissue patent RE44,048, which is held by Pfizer subsidiary G.D. Searle, covers methods of treating osteoarthritis and other conditions with Celebrex’s active ingredient celecoxib.

The ruling makes Pfizer’s fourth-biggest selling drug, which made nearly $3 billion in worldwide sales last year, vulnerable to generic competition much earlier than the ’048 expiry date of December 2, 2015 (including six months of paediatric exclusivity).

Pfizer said it disagreed with the ruling and “will pursue all remedies, including an immediate appeal of the court’s decision”.

Actavis and Mylan said that they expect to launch generic versions of Celebrex after the remaining three celecoxib patents expire in May.

Pfizer brought the action against generic drug makers Teva, Mylan, Watson Laboratories (now Actavis), Lupin and Apotex on March 5, 2013, the day the US Patent and Trademark Office (USPTO) issued the ’048 patent.

that it is “very consistent with patent office procedure and previous court cases”.

She said that Pfizer had originally tried to file the reissue patent application as a divisional patent application. Despite the application being refused by the USPTO as a divisional application, Pfizer tried to enforce the patent as a divisional in the case.

“Either the patent shouldn’t have been reissued if the USPTO considered the reissue patent under the safe harbour of 35 USC 121, or the patent office has taken a different stance than the court and the USPTO did not consider the method claims to be obvious over the earlier composition and compound claims,” she said.

“The USPTO seemed to have possibly missed that an obviousness-type double patenting rejection could have been made during the reissue prosecution.”

Pfizer aren’t down and out yet, Armstrong continued: “The fact that the reissue was issued by the USPTO gives Pfizer a basis to argue that the claims are not obvious,” she said.

“At this point Pfizer needs to argue on the merits of patentability and perhaps that because the method and compound claims had originally been subject to restriction requirements meant the patent office considered them to be two different inventions.” n

The generics had filed Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration (FDA), seeking approval to market a generic version of Celebrex after Pfizer’s basic compound patent covering the drug expires, but before the expiry of the ’048 patent.

In 2008, the US Appeals Court for the Federal Circuit invalidated the original method of use patent, 5,760,068, after a challenge from Teva. After the ruling, Pfizer worked with the USPTO to correct “prosecution errors”, which eventually led to the issue of ’048 as a valid reissue of ’068.

MaryAnne Armstrong, a partner at Birch, Stewart, Kolasch & Birch LLP in Virginia, said that the court decision was correct, and

Circling Pfizer

LSIPR Newsletter 03:14 NewS 5


Teva and UK NHS to collaborate on dementia researchIsraeli pharmaceutical company Teva has announced it will collaborate with the UK government’s National health Service National Institute for health research (NIhr) on a new clinical drug development initiative.

Teva will invest about $20 million in clinical development in the UK and an additional $1 million in dementia research.

“We are delighted to collaborate with NIhr on both clinical development and early dementia research. It will be a catalyst for innovation to take place within a healthcare system that is admired the world over,” said michael hayden, Teva’s president of global r&D and chief scientific officer.

UK Prime minister David cameron said: “This is an excellent area for Britain and Israel to collaborate on.”

EPO strike action to continue in AprilStaff at the European Patent Office (EPO) are to go on strike in april, following on from three days of industrial action in march.

more than 4,000 of the office’s 6,000 workers voted on the proposals, with around 90 percent voting in favour of taking action.

EPO spokesman Oswald Schröder confirmed strike action is to take place, adding: “as on similar occasions in the past, the EPO will ensure that neither the quality of its services nor the continuity of their delivery is affected by the announced industrial actions.”

Staff at the munich-based office have highlighted grievances such as a block on union-related mail and problems with the office’s disciplinary committee.

INBrIEF

Collaborating

indiAnA, US

Eli Lilly has filed suit against more than 30 generic drug makers at the US District Court for the Southern District of Indiana for allegedly infringing three patents related to platelet inhibitor drug Effient (prasugrel).

The accused generics makers include Actavis, Dr. Reddy’s and Teva. Effient is used to prevent the formation of blood clots in acute coronary syndrome patients who have undergone an angioplasty.

Eli Lilly is the exclusive licensee of the three patents at suit, which are held by co-plaintiffs Daiichi Sankyo and Ube Industries.

In the complaint, Lilly argued that the two patents ’703 and ’325, which cover use of the drug with aspirin, were infringed by all defendants, while Mylan infringed the composition of matter patent (’726) in addition to the method of use patents.

According to the complaint dated March 12, the generics filed ANDAs with the FDA for approval to make and sell generic Effient tablets before expiry of the three patents.

Effient is Eli Lilly’s 10th-biggest selling drug. Its sales of Effient totalled $508.7 million worldwide in 2013.

eli lilly targets more than 30 generics in effient patent case

whether the claims at issue are patent-eligible, he said.

In June last year, the US Supreme Court invalidated a number of Myriad’s patent claims directed to BRCA testing after it decided that genes are not patent-eligible “simply because they have been isolated from the surrounding genetic material”.

Soon after the judgment, a number of genetic testing companies, including Ambry, started offering similar tests with a lower pricetag. Myriad had been offering its BRCA test for $4,040; Ambry’s was $2,200.

Myriad filed for a preliminary injunction against Ambry in July to stop it marketing the test, also arguing that it infringed 10 of Myriad’s patent claims that were not invalidated in the Supreme Court ruling.

Four of the claims were directed to primers, or pairs of synthetic DNA strands, and six of

the claims related to methods for analysing BRCA1 and BRCA2 sequences.

Ambry’s chief executive Charles Dunlop said on March 10: “Today’s win is a victory for the entire genetics community. We’ve all believed for years that products of nature should not be patentable and were thrilled with the Supreme Court ruling in June 2013 affirming this principle.

“We stood by our convictions after Myriad sued Ambry and are exhilarated by today’s ruling.”

A spokesperson for Myriad told LSIPR that the court’s ruling was not unexpected: “The court did not rule on the merits of the case—that will be decided later,” he said.

“Myriad is still in the early stages of litigation and is confident it will prevail based on the strength of the evidence,” he added. “Myriad continues to believe its patents are valid and enforceable.” For analysis see page 18. n

Targeting generics



Sanofi and UCB team up to develop anti-inflammatory small moleculesSanofi and UcB have joined in a study to help treat immune-mediated diseases.

The companies will team up to develop anti-inflammatory small molecules that could eventually be used to treat diseases such as gastroenteritis and arthritis.

The deal will see both firms sharing the profits equally, but Sanofi has committed to a series of milestone payments, including an upfront fee of €100m ($138m) paid to the Brussels-based firm.

Elias Zerhouni, president of global research and development at Sanofi, said: “Immune-mediated diseases affect individuals, families, and communities and impact the economies of countries and nations. Joining efforts with UcB, we will address a scientific challenge in immunology, and increase the chances of accelerating discovery and developments of future therapies.”

US FDA puts Sun Pharma plant on ‘import alert’The US Food and Drug administration (FDa) has announced that it has put an ‘import alert’ on Sun Pharma products.

The exact reason has not yet been disclosed, but the FDa issues such warnings when there is a concern about the manufacturing practices of a product.

The Sun Pharma plant in Gujarat, India manufactures antibiotic cephalosporin, which is used to treat skin and urinary tract infections.

Sun Pharma has 25 plants globally, 11 of which are in India. The company announced the ban would have little effect on profits, for the plant accounts for less than one percent of them.

INBrIEFLondon, UK

The Unified Patent Court (UPC) has clarified its opt-out scheme, making clear that when a European patent has been opted out of the scheme, its associated supplementary protection certificate (SPC) will follow.

The UPC preparatory committee published its 16th draft of the court’s rules of procedure on March 6, taking into account comments received by the committee from practitioners and the industry between June and October last year.

It said the draft is intended for information only, and is not a call for a further round of written comments, although it added that any remarks may be submitted at an oral hearing later this year.

Its legal group will now examine the new draft set of rules “at the level of participating EU member states”, it said.

Paul England, a senior associate at Taylor Wessing LLP in London, said the manner of application of the opt-out to SPCs had been a “very large area of uncertainty”, and that the 16th draft rules have filled in or clarified most of the important issues.

“However,” he added, “as with any rules, it will be possible to find lacunae—‘what if?’ scenarios—for a long time to come.”

Language remains an area of great difficulty, he said. “The drafting committee has been unable to decide on a rule for statements of claim. It is now becoming likely that a simple rule of claimant’s choice will have to prevail, but there will be concern that this will prejudice defendants.”

England also noted that the addition of security for costs provisions may deter patent assertion entities.

According to the new rules on preliminary injunctive relief, the UPC is now required to have regard to unreasonable delay, and take into account the potential harm caused to either party by the grant of, or refusal to grant, injunctions.

England said this was unexpected. “It suggests that balance of convenience considerations, familiar in the English courts, are intended to carry more weight than the merits at the provisional stage.”

London-based Bristows partner Alan Johnson, in his rundown of the draft’s highlights on the firm’s website, agreed that the language regime remains uncertain, and added that the scope of preliminary objections is “still very limited”.

He said that no “substantive change” was made to the rule concerning bifurcation, and that despite much lobbying from the industry, there was no guidance included in the new draft rules.

The committee still cannot agree on the right of the Court of Appeal to grant leave to appeal procedural matters including decisions to bifurcate, he added.

“The Court of Appeal will have to resolve this,” he said.

Hosea Haag, a patent attorney from Ampersand in Munich, said that from a first look at the 16th draft and digest of the comments received “a very good job was done”.

However, “as with all procedural rules … the judges will have to fill the gaps the lawmaker left,” he added. n

update to upc rules clarifies ‘opt-out’ scheme

Making choices

Developing molecules



MASSAcHUSeTTS, US

Massachusetts-based Idenix Pharmaceuticals has filed patent infringement cases against Gilead Sciences and its European subsidiaries in France, Germany and the UK.

In its filing on March 14, Idenix argued that Gilead infringes its European patent EP 1 523 489, which covers nucleosides for treating the hepatitis C virus, and said it is seeking remedies with respect to Gilead’s marketing and sales of drugs that contain sofosbuvir which, it believes, infringe the patent.

The European cases are the latest developments in Idenix’s battle with Gilead. In December 2013, it filed suits against the biotechnology company at the US District Court for the District of Massachusetts and the US District Court for the District of Delaware, seeking to keep Gilead from selling any drugs containing sofosbuvir.

Five days after the US cases were filed, Gilead launched its hepatitis C drug Sovaldi,

which has sofosbuvir as its active ingredient. Although it launched only on December 6, 2013, its worldwide sales had reached $136 million by the end of the year.

Analysts have predicted it will replace cholesterol-lowering drug Lipitor (atorvastatin calcium) as the world’s biggest selling drug.

Maria Stahl, senior vice president and general counsel at Idenix, said: “We are pleased to have been granted this European patent, and today’s filings further confirm Idenix’s conviction in the strength of our IP portfolio and the resolve we have to protect it.

“Idenix has invested significant resources in nucleoside drug discovery and in building a valuable IP portfolio—and we will continue to vigorously defend it. These proceedings, along with the US infringement actions we filed in December, are part of a concerted effort to safeguard these technologies.”

Gilead did not respond to a request for comment.

Also in December, the USPTO declared a second patent interference between one of Idenix’s patents and a Gilead patent application, both of which relate to nucleoside compounds for the treatment of hepatitis C infection. n

idenix brings gilead patent battle to europe

Bringing battle to Europe

*



deLHi, US

Gilead Sciences has received another challenge to its application to patent Sovaldi (sofosbuvir) in India.

Patient representative group the Delhi Network of Positive People (DNP+) and the US-based lawyer-led IP organisation Initiative for Medicines Access and Knowledge (I-MAK) filed an opposition against Gilead Sciences and its New Jersey-based subsidiary Pharmasset’s primary patent application for the drug at the Indian patent office.

The application 6087/DELNP/2005, made by Pharmasset in 2005, stemmed from a 2004 Patent Cooperation Treaty application and

dUbLin, ireLAnd

Horizon Pharma is set to acquire Dublin-based Vidara Therapeutics in a merger worth about $660 million, the companies announced on March 19.

The new company, which will be known as Horizon Pharma plc, will operate in Ireland.

US company Horizon will add Vidara’s drug Actimmune to its portfolio, which includes arthritis therapies Duexis, Vimovo and Rayos (known as Lodotra in Europe and certain Asian countries).

Actimmune (interferon gamma) has been approved in the US as a treatment for chronic

is still under examination in India. It covers “modified fluorinated nucleoside analogues”, which provide compositions and methods for treating the hepatitis C virus.

The complaint follows an opposition filed by I-MAK last November against Gilead and Pharmasset’s secondary application in India for the drug.

In a letter dated March 17, DNP+ and I-MAK argued that claims 1 to 20 in the application are not patentable, and asked the Controller of Patents at the patent office that it be refused in its entirety.

“Undeserved patents of the nature applied for in ’6087 afford a company, such as the applicant,

granulotamous disease and severe, malignant osteopetrosis. Its sales revenue totalled $58.9 million in 2013.

Under the agreement, Horizon will acquire 74 percent of Vidara’s shares, while Vidara’s shareholders will retain the remaining 26 percent.

Horizon’s chief executive Timothy Walbert said: “The addition of Actimmune complements our commercial business model focused on targeted promotion to primary care physicians and specialists.

“The combined company would have a portfolio of four proprietary products and an international platform that builds on our

sovaldi meets resistance in india

horizon boosts portfolio with Vidara merger

artificial exclusive rights, which then allow it to price a medicine beyond the reach of not only Indian patients, but also many in need in other developing and even developed countries,” the groups wrote in the complaint.

I-MAK’s co-founder and director of IP Tahir Amin told LSIPR: “We do not believe the patents are merited given the prior art. Unmerited patents would block legitimate competition that ultimately impacts affordability and access for millions, especially in middle-income countries.”

According to reports, lawmakers in the US are pressuring Gilead to explain the high price of the drug, which currently stands at $1,000 a pill, or $84,000 for a 12-week course.

Gilead did not respond to a request for comment. n

strategy of organic growth and acquisitions. We look forward to working with the Vidara team to bring our companies together to accelerate the creation of shareholder value.”

When contacted by LSIPR, Vidara declined to comment. n

WeST virginiA, US

The US District Court for the Northern District of West Virginia has upheld the validity of four patents covering Mylan’s Perforomist (formoterol fumarate) inhalation solution.

The March 24 decision enjoins Israeli generic drug maker Teva from making or selling its own formoterol fumarate inhalation product.

Perforomist is an inhalable solution for the long-term treatment of chronic obstructive pulmonary disease, including bronchitis and emphysema.

Mylan filed suit against Teva after it filed an ANDA seeking approval from the FDA to make a generic version of Perforomist.

It said that Teva’s proposed product infringes four patents that cover “bronchodilating compositions and methods”, which are not due to expire until June 2021.

Mylan’s chief executive Heather Bresch said of the judgment: “The court’s decision to recognise the validity of the patents covering Mylan’s Perforomist inhalation solution not only affirms the strength of our IP on this product, but also our broader respiratory portfolio, including Mylan’s combination product currently in development.

“We are excited about the growth of our respiratory franchise and look forward to continuing to meet unmet needs in this increasingly important space.”

Teva was not available for comment. n

Mylan fights off teva’s perforomist challenge

Breathing easier

Growth through acquisition



dUbLin, ireLAnd

A contraction of 0.3 percent in Ireland’s economy last year has been linked to the expiry of several key pharmaceutical patents.

The data, from Ireland’s Central Statistics Office (CSO), showed that gross domestic product fell by 0.3 percent in 2013 after a decline of 2.3 percent in the last quarter of the year compared with the quarter before.

The CSO also reported a 3.3 percent decline in the industrial sector, which includes the manufacture of pharmaceuticals, and a €1.03 billion ($1.43 billion) decline in net exports.

Many multinational pharmaceutical companies choose to base their manufacturing plants in Ireland for its lower tax rate.

US company Eli Lilly has manufacturing facilities in Ireland; its blockbuster drugs Cymbalta and Humalog, which respectively

sold $4.9 billion and $2.5 billion in their last full year of exclusivity, went off patent in 2013.

Pfizer, GSK and Teva also have manufacturing plants in the country, while Actavis moved its headquarters to Ireland when it bought Dublin-based Warner Chilcott last year. n

‘patent cliff ’ blamed for contraction in irish economy

Natco receives tentative approval to sell Tamiflu genericThe US Food and Drug administration (FDa) has given Indian drugmaker Natco Pharma tentative approval to sell a generic version of roche’s influenza drug Tamiflu (oseltamivir phosphate), according to The Times of India.

The tentative approval is for multiple strength capsules ranging from 30mg to 75mg. The firm has joined with US-based company alvogen to market the oseltamivir phosphate capsules.

In the 12 months to September 2013, Tamiflu made sales totalling nearly $500 million.

In a statement, Natco said that it may have first-to-file approval to make a generic version of the drug, which would allow it 180 days of market exclusivity.

INBrIEF

The patent cliff loomed

News1 LsIPR Newsletter 02:14


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neW yorK, US

Pfizer has filed patent infringement suits against India-based Torrent Pharmaceuticals in an attempt to stop it selling a generic version of erectile dysfunction drug Viagra (sildenafil citrate).

In complaints filed at the US District Courts for the Southern District of New York and the District of New Jersey, Pfizer claimed that Torrent’s proposed sildenafil pill infringes its patent covering the drug.

The patent at suit, 6,469,012, covers methods of treating erectile dysfunction by administering sildenafil. It expires in October 2019.

Viagra is one of Pfizer’s biggest selling drugs and sales of it totalled $1.88 billion in 2013 even though the compound patent expired in several European countries last June.

In December, Pfizer and Teva agreed to settle all Viagra-related patent litigation, allowing the Israeli generic drug maker to launch its own version of the product in December 2017. n

pfizer sues to block Viagra generic

AstraZeneca sells Alderley Park siteastraZeneca has sold its alderley Park, cheshire, site to manchester Science Parks (mSP), a public-private partnership and science park operator.

The sale is part of the anglo-Swedish pharmaceutical company’s plan to establish a new global centre for r&D and corporate headquarters in cambridge. Financial terms of the transaction were not disclosed.

astraZeneca’s chief executive Pascal Soriot said the deal was a “sensible choice”, adding: “The new owner is committed to building on astraZeneca’s life science legacy at the site and ensuring it remains a centre of biotechnology innovation in the North West of England.

“It will lead to future growth and offer significant opportunities for new jobs to be created.”

Monsanto and MIT join forces to create agricultural productsUS agriculture company monsanto has created a new company, Preceres LLc with researchers from the massachusetts Institute of Technology (mIT).

Preceres will be focused on discovering and developing materials and methods for delivering rNa into plants and insects to create agricultural products.

The companies have agreed that monsanto will develop delivery agents for the development of innovative biological solutions from mIT.

The combination of Preceres’ novel delivery discovery assets with monsanto’s BioDirect technology will potentially provide solutions for sustainable pest, virus and weed control, monsanto said.

INBrIEF

Generic blocked

Delivering RNA

deLHi, indiA

The Delhi High Court has dismissed Teva’s action to stop Hyderabad-based Natco Pharma from marketing a generic version of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Teva holds the Indian patent 190,759, which covers a method for making the drug, and made $4.3 billion from sales of Copaxone last year. The remaining US patents covering the drug are due to expire in May 2014.

Teva sought a permanent injunction against Natco in 2007 to keep it from selling its own glatiramer acetate drug, also known as copolymer-1, under the trademark ‘Glatimer’ or any other mark.

It alleged that Natco’s use of the “well-known process” to manufacture copolymer-1 in India infringed Teva’s patent. It also filed to restrain Natco and its partners from exporting the product outside India.

Natco made a counterclaim, arguing that Teva’s patent is invalid due to lack of novelty.

In a February 28 decision, Justice S Muralidihar said that the court did not “consider it necessary to deal with any of the parties’ applications”, and dismissed the case.

“We are very pleased with the decision by the New Delhi High Court to dismiss and take no action in this matter,” Natco said.

“We continue to believe that the sole Indian process patent is invalid, as reinforced by the outcomes of numerous other legal proceedings. We also are pursuing other challenges against this patent.”

Natco added that the Indian patent office refused to grant two additional patent applications that would have covered the copolymer-1 product.

In July last year, the US Court of Appeals for the Federal Circuit invalidated one of Teva’s Copaxone patents.

Teva did not respond to a request for comment.

The Delhi High Court was scheduled to hold another hearing on Teva’s action, including a petition to invalidate the ’759 patent, on March 5. n

indian court dismisses teva’s attempt to block copaxone generic

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Baxter International to split into two companiesBloomberg has reported that drugmaker and medical device company Baxter International will split into two individual companies.

One will focus on developing biotechnology and pharmaceuticals, while the other will sell medical products.

according to a statement, Baxter’s drug division had $6 billion in revenue, and the medical product unit had more than $9 billion.

The deal is due to be completed by the middle of next year.

J&J partners with start-up on Alzheimer’sJanssen, the pharmaceutical arm of Johnson & Johnson, has said it will finance San Francisco start-up alector’s efforts to develop treatments for alzheimer’s.

The companies have not disclosed financial terms of the deal.

The companies have a prior relationship in that about 12 alector employees work at the Janssen Labs @QB3 incubator in mission Bay, San Francisco.

alzheimer’s is the most common form of dementia and affects more than five million people in the US.

R&D spending among pharmaceutical firms increasesr&D spending in the top 20 pharmaceutical firms has gone up, according to research published by Genetic Engineering and Biotechnology News.

The research goes against industry expectations that most pharmaceutical firms were cutting back funding in research.

roche, Novartis and Johnson & Johnson, the three biggest spenders in research and development, were all shown to increase their spending by an average of five percent.

INBrIEF

R&D spending rises

deLAWAre, US

Novartis has sued generic drugmaker Dr. Reddy’s Laboratories for infringing a patent related to its chronic myelogenous leukaemia (CML) drug Gleevec/Glivec (imatinib mesylate).

The case, filed at the US District Court for the District of Delaware on March 26, relates to reissue patent RE43,932, of which Novartis Pharmaceuticals Corporation is the exclusive licensee.

Novartis launched the case after Dr. Reddy’s sent an ANDA to the US FDA seeking approval from it to make and sell generic 100mg capsules of imatinib mesylate.

In its letter of notice to Novartis, Reddy’s said it believed the RE932 patent is invalid and unenforceable, and that it will not be infringed by the manufacture and sales of its imatinib mesylate capsules.

Novartis asked the court for judgment that the patent is valid and enforceable, that Reddy’s imatinib mesylate capsules infringe the patent, and for a permanent injunction to keep Reddy’s from making the drug.

First approved by the FDA in 2001, Gleevec has been described as a “miracle drug”. According to a study published in Nature Education before the introduction of Gleevec, the survival rate for patients with CML was 30 percent within five years. By contrast, 87 percent of CML patients taking the drug survive over the same period.

According to drugs.com, Gleevec sales totalled more than $1.8 billion in 2013.

In April last year, the Indian Patent Office refused Novartis’s application for an Indian patent covering the drug, deeming the patent too similar to an earlier version. n

stem cell patent indicates support for regenerative medicine research

novartis launches gleevec action against dr. reddy’s

Action launched

WASHingTon, dc, US

The USPTO has issued a patent to Israeli biotechnology company BrainStorm Cell Therapeutics, which covers stem cell technology that can be used in the treatment of neurodegenerative diseases such as Parkinson’s and Alzheimer’s.

US patent 8,663,987 was granted days after US Senators Barbara Boxer (D-CA) and Mark Kirk (R-IL) introduced legislation to establish a strategy to boost research into regenerative medicine.

It covers BrainStorm’s proprietary stem cells, which are derived from autologous bone marrow cells, and can support the neural cell network by protecting existing motor neurons, promoting motor neuron growth and re-establishing nerve-muscle interaction.

BrainStorm is developing its own NurOwn stem cell therapy for the treatment of motor

neurone disease, or amyotrophic lateral sclerosis (ALS), sometimes known as Lou Gehrig’s disease, and is preparing for the technology’s phase II trial.

“The recent bill introduced to the US Senate to support regenerative medicine research is yet another indication of the increasing recognition that stem cells hold the promise for curing life-threatening and debilitating conditions like ALS,” said BrainStorm’s president and principal executive officer Chaim Lebovits.

“We are very encouraged by the bill’s proposal to appoint a council that would develop and maintain a national strategy for the promotion of regenerative medicine research and development, including identifying priorities and sources of funding, as well recommending policies to overcome barriers in research and product development.” n



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

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IP StRategy: StRaNd LIfe ScIeNceS14 LSIPR Newsletter 03:14


LSIPR Newsletter 03:14 IP StRategy: StRaNd LIfe ScIeNceS 15


Developing a drug remains a hugely uncertain, and therefore expensive, business. Many promising drugs fail further along the development

process, even if they have been tested on animals. Furthermore, researchers can be left in the dark if it’s unknown why they failed, and have to return to square one.

“Even when compounds pass all the animal tests and look good after testing on humans, one in 10 actually reaches the market—in other words, nine of the 10 fail,” says Kalyanasundaram ‘Kas’ Subramanian, chief scientific officer at Bangalore-based informatics and data analysis company Strand Life Sciences.

“If the molecule fails somewhere early in the process, it’s not a problem because you always have backups you can test. But if the molecule fails after you’ve tested it on humans, it’s a huge economic loss because of the time you invested and the money spent on conducting clinical trials, which are very expensive,” he adds.

With the cost of developing a new drug in the billions, pharmaceutical companies are looking to change the odds in their favour.

developinga‘virtual’liverMoving research from the lab bench to the realm of data analytics could be a solution.

One reason so many candidate drugs fail is that they have a toxic effect on the liver. While it is the liver’s job to detoxify substances that enter the body, the detoxification process can often convert a benign molecule into something that is itself toxic.

“It’s a very difficult problem to crack, because toxicity is not due to any one particular mechanism that you can see,” Subramanian says. “There are many different ways a drug can be toxic to the liver.”

He suggested creating a computer model of a healthy liver capable of generating the likely outcomes when a drug molecule is introduced. The virtual liver allows researchers to see not only whether a candidate drug is likely to fail but also why it would fail, by simulating the drug’s effect on normal liver function.

“Understanding the mechanism helps you decide whether you can salvage what’s going wrong in the series, or if you have to shelve the entire series. You can do all this before testing on humans,” says Subramanian.

The ethical benefits of using the virtual liver are plain, as it reduces the need to test on animals. Also, drugs having no ill-effects on humans that may have been vetoed for failing during animal tests may get their fair shake.

Pharmaceutical companies have already begun to use the virtual liver as a tool in the research and development process, to develop treatments for conditions where the liver is a vital part of the biology, such as diabetes and cardiovascular diseases.

NeweraThe completion of the Human Genome Project (HGP) in 2000 heralded a new era for medical science, as the endeavour to map the entire human genome delivered a new understanding of genes’ involvement in disease.

Virtualorgans: cutting drug development risksStrandLifeSciences’‘virtual’livercouldcutthefailureratewhendevelopingdrugsbygivingresearchersaclearerideawhichofthepotentialdrugsareunlikelytowork.HowdoestheBangalore-basedcompanyprotectandlicenseitstechnology?

LSIPR Newsletter 02:14 15


IP StRategy: StRaNd LIfe ScIeNceS16 LSIPR Newsletter 03:14


“There was a lot of excitement in biology that the path of medicine would change completely,” says Subramanian.

The HGP paved the way for next generation sequencing, which then introduced a new way to search for drug candidates: high-throughput screening, in which thousands of tests are run rapidly to identify new drugs for disease targets.

With so much data generated by this high-volume method of experimentation, four computer science professors from the Indian Institute of Science decided to develop a platform geared towards licensors to help them make sense of the figures, and Strand Life Sciences was born.

IPprotectionStrand decided not to protect its platforms with patents, opting instead to keep some of its technologies and processes as trade secrets. In fact, the company started looking into patenting its creations only after making the virtual liver available in 2010.

“After we started taking the virtual liver out into the industry there were a lot of questions,” Subramanian says.

“We were trying to model biology so people would ask: what is the biology that’s been captured, how you are modelling it, how can you use it and so on. It seemed as though we would have to disclose a lot of what we did, so we felt that we needed to protect it.”

The virtual liver is one part of a suite of software-based solutions that Strand offers. Thousands of laboratories around the world use its Avadis Next Generation Sequencing platform that analyses, manages and visualises data from experiments.

“We didn’t go for patenting Avadis, because we didn’t feel that there was any value in trying to protect it via a patent,” Subramanian says.

“A lot of our patents are around understanding mechanisms, with most covering the virtual liver. While the virtual liver manifests as software, in the sense that all these mechanisms are eventually captured as software, it pertains more to biological systems than pure software patents.”

In February, Strand received a US patent covering the virtual liver’s method of predicting organ toxicity; however, landing the patent wasn’t quite as straightforward a process as the team may have hoped.

“There was lots of back and forth with the examiner,” Subramanian says.

Many methods relating to testing for liver toxicity exist in the prior art, although for different methodologies and processes, he explains. Strand had to convince the examiners that its technology is distinctly different.

Progress in the EU, however, has been much faster, and Subramanian hopes that a second virtual liver patent covering a method for identifying liver toxicity using metabolite profiles will be issued this year.

LendingtheliverSo far, about 10 pharmaceutical companies are using the virtual liver as part of their drug development processes, although this isn’t on a licensing basis: “Our business with the virtual liver is more of a consulting or services model,” Subramanian explains.

“For the purposes of assessing toxicity, pharmaceutical companies will send us their compounds. We then run the compounds through the assays we’ve developed here in Bangalore, and run simulations using the data that come from the assays, and generate reports for them.

“The virtual liver is too complex to hand over to somebody.”

Subramanian says that some cosmetics companies have been in touch too, to assess their products’ potential toxicity using Strand’s virtual hair and skin models.

GeneticpanelsBuilding on its data analysis expertise, Strand is also currently developing a collection of genetic ‘panels’ to test individuals’ genetic predisposition to developing certain diseases.

Whereas genetic diagnostic companies like Myriad and Gene by Gene look for mutations on single genes to make their diagnoses, Strand searches for all the different kinds of genes that are involved in the development of the disorder, putting them together into a panel that can be measured using next-generation sequencing.

The panels are “in a sense” proprietary, Subramanian says, as Strand has already carried out the analysis, determined which genes to examine, figured out which regions are most important and worked out how to interpret the mutations.

“The next step is understanding the relevance of the data,” he says.

“We have a huge team at Strand that has been reading all the literature and curating every mutation-to-phenotype association that is known or reported in the literature. We now have more than 100,000 of these catalogued.”

Strand is starting to offer its genetic diagnostic tests to around 30 hospitals in India, and will begin establishing its own Strand Centers for Genomics and Personalized Medicine in the US and UK.

“There’s going to be a Strand centre at the El Camino Hospital in Mountain View, California, and we are in discussions with several other community hospitals,” Subramanian says.

“Our strategy is not to go after the Mayo clinics and Harvard Medical Schools because they will want to offer their own services. But there are many smaller hospitals that serve local communities that are interested in offering this to their patients, but don’t have the expertise or wherewithal to create it.”

As companies such as Strand work to tackle the risks associated with drug development, one thing is certain: as demonstrated by the popularity of the services provided by gene-diagnostic companies, the desire to find out what the medical future holds for us is not going away any time soon, as we enter an age of personalised medicine. n

“While the virtual liver manifests as software, in the sense that all these mechanisms are eventually captured as software, it pertains more to biological systems than pure software patents.”

LSIPR Newsletter 03:14 IP StRategy: StRaNd LIfe ScIeNceS 17


10

SPE

AK

ER

PR

OF

ILE

S

EUROPEAN PATENT ATTORNEYS : CHARTERED PATENT ATTORNEYS : TRADE MARK ATTORNEYS

... pharmaceutical and life science patent advice from the bench to the market place

Dr Gordon Wright Partner

Dr Richard Gillard Partner

Dr Oliver Kingsbury Partner

Dr Richard Cooke Partner

Dr Richard Oldroyd Associate

Helen Brearley Associate

Elkington and Fife LLPThavies Inn House 3-4 Holborn Circus

London, UK EC1N 2HAwww.elkfi fe.com

elkfi fe@elkfi fe.com Tel: +44 (0)20 7936 8800

Sophy Denny Associate

Samantha Busher Associate

18 LSIPR Newsletter 03:14


LegaL uPdate

TheBRCAbattlecontinues

University of Utah Research Foundation et al v Ambry Genetics Corporation On June 13, 2013, the US Supreme Court handed down a seminal decision for the biopharma industry in Association for Molecular Pathology v Myriad Genetics, Inc, 133 S. Ct. 2107 (2013) (Myriad). In the Myriad decision the court held that naturally occurring nucleic acid sequences are not patent-eligible subject matter because they are products of nature.

In addition, claiming nucleic acids as being “isolated” will not render the nucleic acids patent-eligible. The court, however, left open the question of whether claims directed to methods of using the nucleic acids may be patentable.

Following the Myriad decision, Ambry Genetics announced that it would offer screening of the BRCA1 and BRCA2 genes,

the subject of the Myriad patents. Myriad filed for a preliminary injunction to prevent Ambry from offering genetic tests using the BRCA1 or BRCA2 genes.

This decision from the US District Court Utah, Central Division is in response to that request for a preliminary injunction.

It should be noted at the outset that a “preliminary injunction is a drastic and extraordinary remedy that is not to be routinely granted”—National Steel Car Ltd v Canadian Pacific Railway, Ltd 357 F.3d 1319 (Federal Circuit 2004). To obtain a preliminary injunction the plaintiff must show the following:

1) Irreparable harm in the absence of the preliminary injunction;

2) That the plaintiff is likely to succeed on the merits of the case;

3) That the balance of equities is in favour of the plaintiff; and

4) That a preliminary injunction would be in the public interest.

The court considered each of these factors in its decision. This article considers the decision by the court with regard to factor 2), ie, whether the plaintiff was likely to succeed on the merits. The court concluded that Myriad was unlikely to be successful because Ambry had raised a substantial question about the validity of the claims of the patents at issue.

The claims involved in the suit can be essentially grouped as either “primer” claims, which were directed to various DNA primers, or “method” claims, which were directed to screening and diagnostic methods using the BRCA1 and/or BRCA2 genes.

With regard to the primer claims, Myriad argued that the Supreme Court held in Myriad that claims directed to ‘synthetic’ nucleic acids are patent-eligible and the

MyriadhasfailedtoobtainararepreliminaryinjunctiontostopAmbryofferinggenetictestsusingtheBRCA1orBRCA2genesasAmbryraisedasubstantialquestionaboutthevalidityoftheclaimsofMyriad’spatents.MaryAnneArmstrongreports.



LegaL uPdate

claims to nucleic acids are patent-ineligible under 35 USC§101 only if they are directed to ‘naturally occurring’ nucleic acid molecules.

Thus, Myriad argued that the reason that the Supreme Court found complementary DNA (cDNA, used by Myriad in its tests for the BRCA genes) to be patentable subject matter was because cDNA is synthetic. The court in following the more commonly accepted interpretation of the Myriad decision held that whether or not the nucleic acid is synthetic is not the determining feature in finding whether a nucleic acid is patent-eligible subject matter.

Rather, a nucleic acid is patent-eligible only if the sequence of the nucleic acid does not occur in nature. Thus, the court stated that “this court interprets AMP [Myriad] to stand for the proposition that even synthetic, non-cDNA, isolated DNA is patent-ineligible where it reflects the same nucleotide sequence as the genomic DNA.”

The primers recited in the Myriad claims may have been synthetic, but the sequences of the primers were the same sequences found in the natural BRCA1 and BRAC2 genes. This is likely to be the case with many claims directed to primers because the length of primers is short. Unless a primer has been somehow modified with an artificial nucleic acid residue, the sequences of the primers are typically the same as a naturally occurring sequence and therefore subject to the same analysis used in the Utah decision.

Method claimsMore noteworthy was the court’s treatment of the method claims. As mentioned above, the Supreme Court left open the question of patent-eligibility of method claims because only nucleic acid claims were considered by the court. The court stated: “It is important to note what is not implicated by this decision. First, there are no method claims before this court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.” Association for Molecular Pathology v Myriad Genetics, Inc, 133 S. Ct. 2107, 2119 (2013).

In considering the method claims, the court in Utah found that “the only ‘inventive concepts’ in their method claims are the patent-ineligible naturally occurring BRCA1 and BRCA2 sequences themselves. The

claims contain no otherwise new process for designing or using probes, primers or arrays beyond the use of BRCA1 or BRCA2 sequences in those processes.” The court further found that the method claims improperly “preempt a law of nature” and concluded that “the defendant [Ambry] has raised a substantial question concerning the method claims’ subject matter eligibility for patent.”

The finding by the court with regard to the method claims is particularly important because, as noted, the Supreme Court had left this question open in the Myriad decision. In addition, the position taken by the court appears to be going in a different direction from that adopted by the USPTO. On March 4 this year, the USPTO issued a guidance memorandum to US patent examiners to implement procedures for examiners to determine patent-eligible subject matter in view of Myriad and Mayo Collaborative Services v Prometheus Laboratories, Inc, 566 US 132 S. Ct. 1289, 101 USPQ2d 1961 (2012).

The memorandum presents various examples of claims. Example E has the following two claims.

o Claim 1. A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.

o Claim 2. A method of amplifying a target DNA sequence comprising:

(a) Providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of Claim 1, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;

(b) Heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;

(c) Cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridise with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and

(d) Repeating steps (b) and (c) at least 20 times.

The memorandum states that Claim 1 is not directed to patent-eligible subject matter because, similar to the analysis used in Utah, the sequences of the primers are the same sequences that occur in nature and the primers’ molecules are not “markedly different” from the nucleic acid occurring in nature.

However, the memorandum states that method Claim 2 is claiming patent-eligible subject matter. Claim 2, like the Utah claims, recites primers that are products of nature being used with conventional and known process steps and reagents. However, the USPTO states that such a claim is patentable because “the claim as a whole recites something significantly different from the natural products, ie, the claim includes elements in addition to the judicial exceptions that amount to a practical application of the natural products.”

It should be noted that the Utah decision is for a request for a preliminary injunction, which is difficult to obtain in a patent infringement case, and the case is still to be heard fully on its merits. However, the decision does present an important indication of the direction in which some US district courts are leaning with regard to the patent-eligibility of the types of method claims in Myriad. The decision is particularly important because it appears to be in the opposite direction from the position being taken by the USPTO. n

MaryAnne Armstrong is a partner at Birch, Stewart, Kolasch & Birch, LLP. She can be contacted at: [email protected]

“TheUSPTOstatesthatsuchaclaimispatentablebecause

‘theclaimasawholerecitessomething

significantlydifferentfromthenatural

products’.”

20


exPeRt commeNt LSIPR Newsletter 03.14

Manyresearchersareunawareofthelegalitieswhenitcomestosharingandusingcopyrighted

material,butlicensingagreementscanhelp,saysKateAlzapiediofcopyrightlicensingfirm

RightsDirect.

Now that the rapid exchange of scientific research and product information across international borders has

become commonplace, rights holders and users of published material face an increasingly complex set of issues involving reuse rights, permissions, restrictions and fees.

Copyright laws vary from one country to the next, making the resulting mix of obligations difficult to reconcile and enforce, especially for global, research-driven organisations with employees working in different countries.

Research and information professionals in the pharmaceutical and life sciences industries depend on the ability to disseminate important information quickly for a variety of reasons—to accelerate drug discovery, to keep physicians and patients informed, to communicate with government regulatory authorities and to monitor the safety of drugs in the pipeline and in the marketplace.

The challenge, especially for the medical affairs professional, corporate librarian or pharmacovigilance team, becomes sharing business-critical content in a timely fashion while respecting the rights of the content rights holders.

copyright awareness in the workplace Researchers and other knowledge workers tend to forward information to their peers quite often, yet many of them are unaware of their responsibilities when it comes to using copyrighted material.

According to last year’s Information Consumption and Use Survey by research and advisory firm Outsell (commissioned by US not-for-profit organisation the Copyright Clearance Center, © 2013 Outsell Inc, www.outsellinc.com), 81 percent of knowledge workers at global companies share information with their immediate team members at least once a week and often daily.

But the majority of surveyed workers—65 percent—believed that if they could access content online for free, then they were free to share it without the permission of the copyright holder. Not many knew that there might be terms and conditions related to sharing that online content. For example, while an Open Access title may be free to download and access via the internet, there

through email. Nearly half of them reported cutting and pasting the material into an email before sending. Collaboration tools such as Lotus Notes, Microsoft SharePoint and company intranet sites are commonly used by companies to capture, annotate, store and share information in a single location.

But who is most likely to be sharing and storing this content, and for what purposes? The following scenarios are based on interviews conducted by RightsDirect with information specialists at several global pharmaceutical companies, and serve to demonstrate how and why content is shared both internally and externally.

Sharing key research findings with R&D project members

The staff of corporate libraries (also called knowledge centres or scientific information centres) play a key role in the licensing and distribution of scientific content to their R&D colleagues. Fast dissemination of the latest scientific articles enhances productivity and can often speed the pace of drug discovery.

Maintaining pharmacovigilance databases of company products

Drug monitoring helps ensure the safety of drugs in the development pipeline and those already approved for marketing. Storing

may be specific terms prohibiting the reuse of the article for commercial purposes.

Some organisations adopt copyright policies to educate and guide their employees on copyright compliance. In those organisations, awareness among employees tended to vary considerably. The same Outsell study revealed that only 44 percent of respondents were even aware of their own organisation’s copyright policy. Of the rest, 32 percent were not certain of the details and a further 24 percent were either unaware of a policy or said that such a policy did not exist.

As the evidence suggests, low organisational awareness of copyright issues is the norm and presents several challenges for senior management, compliance officers and information specialists.

content sharing habits and challenges In order for pharmaceutical and life sciences workers to perform well, collaboration is vital. Sharing published scientific content from journals, books, newspapers and magazines throughout the organisation and across borders is crucial to the ongoing exchange of ideas.

Email is the preferred tool for employees. In fact, 84 percent of surveyed employees said they forward content to co-workers and others

copyright coMpliance in

the life sciences industry



exPeRt commeNt

offer licences permitting employees to share published content legally at all. And clearing permissions individually, one publisher at a time, can prove to be quite challenging for multinational organisations.

A better and more comprehensive solution is an annual repertory licence that simplifies the licensing of content and helps researchers and other knowledge workers to use copyrighted materials without having to seek multiple individual permissions.

Multinational copyright licences allow cross-border sharing of copyrighted materials throughout the entire organisation. The ideal licence would cover millions of rights from tens of thousands of international publishers, and also cover a broad range of content types and authorised use cases. With an annual, multinational copyright licence in place, medical professionals in pharmaceutical companies and healthcare organisations would be able to lawfully reuse content within their organisation in a variety of ways that typically occur every day.

For example, the Multinational Copyright License developed by RightsDirect allows sharing of digital and print content such as full-text scientific articles within the organisation; enables the sharing of single digital or print copies of an article with healthcare professionals and other customers who request them; allows the storage of articles for records, projects and pharmacovigilance databases; and lets users submit copies of articles to government agencies for regulatory filings.

It is clear that pharmaceutical and life science companies can benefit from a consistent set of permissions across all participating rights holders and reduced time pursuing permissions individually. In doing so, these same companies will be demonstrating their respect for the IP of others as well as their willingness to conduct business in a socially responsible manner. n

Kate Alzapiedi is RightsDirect’s business development director, responsible for copyright licensing solutions across Europe. She has an extensive background in scientific, technical and medical publishing with more than 15 years of experience at Elsevier Publishing and Excerpta Medica Medical Communications.

Kate Alzapiedi can be contacted at: [email protected]

These days, consumers are paying closer attention to corporate practices and policies than ever before. According to APCO Worldwide Inc’s 2013 Champion Brand Study (http://apcoworldwide.com/champion/#/1), the majority of the public (71 percent) said they cared more about a company’s behaviour today than they did just 10 years ago.

As business activities become increasingly complex, a growing number of companies is voluntarily embracing the value of fostering an enterprise-wide culture of integrity and transparency. This heightened focus on corporate social responsibility is slowly expanding to include a greater awareness of—and respect for—copyrighted material and the IP rights of others.

For years, global organisations have been working to protect their own IP from misuse or misappropriation by others. It makes sense, then, to extend and expand this same respect and protection to include materials produced and distributed by others.

To do this, companies need to have the right policies, training, processes and monitoring tools in place in order to have any chance of succeeding. Naming a point person for copyright issues in the organisation is essential, as is the proper implementation of copyright guidelines.

MakingcopyrightcomplianceeasyWhile technology has made it easy to find and use content, obtaining copyright permissions can be difficult, time-consuming and expensive. Subscriptions and access to publisher databases provide basic usage rights, but sharing rights granted by publishers differ. Some publishers do not

“Theideallicencewouldcovermillionsofrightsfromtensofthousandsofinternationalpublishers,andalsocoverabroadrangeofcontenttypesandauthorisedusecases.”

published information about the company’s products in up-to-date databases allows the pharmacovigilance department to distribute time-sensitive information quickly as an early warning tool for the detection, assessment and prevention of possible adverse effects.

Responding to requests for scientific information from customers

Medical affairs departments are often asked to provide patients, doctors and other healthcare professionals with scientifically-validated information, including full-text articles from peer-reviewed journals. These published works typically come with specific permissions and restrictions guiding how they can be distributed.

Keeping regulatory authorities informed

As the agencies responsible for the scientific evaluation of medicines used in their jurisdictions, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require that any adverse reactions to medicines be promptly reported by the manufacturers and applicants for new drugs. Using copies of previously published material in the process of obtaining regulatory clearance for drugs and medicines is where copyright compliance becomes important.

Displaying information for educational purposes

The sharing of published product information on tablets and smartphones is a vital sales tool, whether for display during an individual sales call or for showcasing at a large medical conference. However, some employees may not be fully aware of the licence limitations that apply to the reuse or redistribution of these materials.

What all these scenarios have in common is the ongoing need to distribute copyrighted materials to perform a required business task. But often copyright is perceived by employees more as an interruption to the exchange of information rather than as a facilitator of it.

copyright compliance and the socially responsible companyTrust in a company’s commitment to the public good often takes decades to build. Yet it can be ruined in minutes through a seemingly minor misstep that results in unwanted scrutiny from regulators, governments, customers and the media.

BIOIPCC-LSIPRSavetheDatevF.indd 1 2/18/14 11:12 AM



coNfeReNce caLL

The issue of disclosure of clinical data was brought to public attention by science writer Ben Goldacre’s 2012 book Bad Pharma, and the European Medicines Agency will publish its policy on the subject shortly.

During the Life Sciences Law Forum, held in London in March, Bonella Ramsay wondered whether the resources to deal with such disclosure were available, and said that as the information is disclosed at a global level, a national approach to regulating it “just won’t wash”. “We must take a global, joined-up approach,” she said.

Moreover, considering the volume of IP in the new wave of clinical data and who would want to use the information—doctors, patients and rival pharmaceutical companies—John Dougherty said that although in theory it will advance medicine, whether the new transparency would restore trust is another question.

A number of bodies in the US and Europe have adopted, or are due to adopt, codes on transparency and disclosure this year.

A DLA Piper-conducted survey of in-house counsels on the most pressing legal issues in the life sciences industry revealed that the top issue of all for them was compliance. It was followed by technology transfer, with patents and government investigations in joint third.

Asked about the key issues that will change the sector in the next three to five years, the counsels ranked market access first, the trend towards transparency second and personalised medicine third, with biosimilars and social media also appearing within the responses.

Ramsay said that after a period of consolidation, more convergence is likely

There is still a lot of uncertainty about how the court will operate with regard to fees, as well as the language of proceedings, which Cooke described as “extremely complicated”. If patent validity and infringement proceedings are bifurcated, they may end up going ahead in different languages, he said.

At the moment, it seems sensible to opt out of the court altogether, Cooke said, even though it is unclear how much it would cost to opt out, or indeed opt back in.

Interpretations of the Bolar exemption may also present difficulties. After consultation, it was decided that in the UK the exemption should be broadened so that other companies, not just generics, may perform clinical studies on patented products without the fear of infringing.

An amendment to the UK Patents Act that takes this broadening into account is due toward the end of the year. However, this means being left with legislation with a Bolar exemption that differs from that in other UPC member states, Cooke said.

It would be prudent for patent holders to continue to file for national patents, which allows the opportunity to opt out of the UPC, and then opt back in. However, patent holders cannot be sure that it will be possible to opt back in.

Mercer recommended that patent owners with a potential blockbuster on their hands file for a European patent to protect it, as well as some national applications. Another strategy would be to designate the European patent as a ‘bundle’ of individual national patents and opt out of the court, he said. n

life sciences law forum: disclosureofclinicaldataakeyconcernAmajorissueforlawyersinthepharmaceuticalindustryistransparencyoverclinicaldata,saidtheco-chairsofDLAPiper’sgloballifesciencessector,BonellaRamsayandJohnDougherty,speakingatPracticalLaw’ssecondannualforum.

in the future, especially with the emergence of personalised medicine, where business and regulatory models do not yet exist.

Patients will be able to monitor their conditions using converged technologies. How do royalty models fit when you have that kind of convergence? “As these are converged issues, lawyers should converge their practices,” she said.

upc: much more to be doneWhile the political will exists for the introduction of the Unified Patent Court (UPC) next year, much more still needs to be done, Adam Cooke, a partner in DLA Piper’s IP and technology group, said at the Life Sciences Law Forum.

Cooke said there is a need for the UPC but it is unlikely that it will be fully implemented before 2016.

Chris Mercer, immediate past president of the Chartered Institute of Patent Attorneys and consultant at Carpmaels & Ransford LLP, said the preparatory committee was due to meet in March to discuss procedural issues and the 16th draft of the rules.

january 2014 march 2014 newsletter · case report: supreme court reverses medtronic ruling...

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