Supreme Court lets Monsanto off the hook

readmore p2

Monsanto asked the Supreme Court to reject the ap-peal without hearing, as farmers did not need to be concerned about a lawsuit, but the farmers argued that Monsanto’s promise was weak, because it can only be applied to contamination of up to 1 percent.

“Monsanto never has and has committed it never will sue if our patented seed or traits are found in a farm-er’s field as a result of inadvertent means. The lower courts agreed there was no controversy between the parties and the Supreme Court’s decision not to re-view the case brings closure on this matter,” said Kyle McClain, Monsanto’s chief litigation counsel, in an emailed statement.

Daniel Ravicher, executive director of the Public Patent Foundation and lead counsel for the plaintiffs, said in a statement that the Supreme Court decision was dis-appointing but that “it should not be misinterpreted as meaning that Monsanto has the right to bring such suits”.

The seed company, which is the top producer of geneti-cally engineered seed sand of the herbicide glyphosate,

Biotechnology company Monsanto’s promise not to sue 73 farmers whose crops inadvertently contain traces of its patented genetically modified seeds is sufficient, the US Supreme Court ruled on 13 January.

The justices left intact a federal court decision that threw out a complaint against Monsanto. The lower court highlighted that Monsanto promised not to sue famers whose crops contain traces of Monsanto’s biotechnology products.

The Organic Seed Growers and Trade Association, along with dozens of organic and conventional fam-ily farmers, seed companies and public advocacy groups, sued Monsanto in March 2011 at the US District Court for the South District of New York, seeking pre-emptive action to ensure that Monsanto would not sue them if the company’s seeds contami-nated their crops.

Monsanto critics lost in district court and in the US Court of Appeals for the Federal Circuit. The ap-peals court decision now stands.

Purdue suffers loss in Teva patent case A New York federal judge has ruled that Teva Pharmaceuticals did not infringe Purdue Pharma’s patents for the narcotic OxyContin.

US district Judge Sidney Stein con-cluded that Purdue failed to prove that Teva had infringed its patent (7776314) when it sought US Food and Drug Ad-ministration (FDA) approval to sell a bioequivalent of OxyContin.

He stated that while Teva infringed at least three of Purdue’s patents, it wasn’t liable for the infringement, because it demonstrated that the patents were ‘obvious’, making them invalid. Purdue plans to appeal.

3M Innovative Properties secures injunction

The Delhi High Court has granted a preliminary injunction to 3M Innovative Properties against MS Venus Safety over patent infringement.

3M learnt that an Indian company, Venus Safety & Health Pvt, and its distributor, Safety Solutions, were manufacturing and selling respira-tory protection devices that infringed its patents. It filed a complaint at the Delhi High Court.

On 18 December 2013, the court found the patent valid and ordered an injunc-tion, restraining Venus from continuing its infringement of 3M’s patent.

3M’s patent covers a personal respira-tory device that is capable of protecting the wearer’s respiratory system from dust and particles suspended in the air, or from unpleasant or noxious gases.

readmore p2

readmore p2

i p p r o l i f e s c i e n c e s . c o m

ISSUE01123.01.2014 TH

UR

SD

AY Pr oIPLIFESCIENCES

2

NewsInBrief

Supreme Court lets Monsanto off the hookContinued from page 1

has filed more than 140 lawsuits against farm-ers for planting their seeds without permission or paying royalties.

It has settled 700 cases without going to court.

Purdue suffers loss in Teva patent caseContinued from page 1

In July 2013, Purdue took Teva to the US Dis-trict Court for the Southern District of New York, after the FDA, citing safety concerns, said that it would no longer be accepting any applications for generic versions of the original, frequently abused version of OxyContin, which is a narcotic used to treat pain from cancer and other conditions.

The FDA, facing pressure from law enforce-ment agencies, made that announcement on the same day that the patent for the old form of the drug expired.

Concluding that Teva has not infringed any valid patents asserted by Purdue, Stein ruled that although Purdue proved by a preponderance of the evidence that Teva’s proposed products infringed four patents, “Teva has proved by clear and convincing evidence that the asserted claims of those patents are invalid”.

Philip Strassburger, general counsel at Purdue Pharma, said: “We are confident in the strength and validity of our patents and are disappointed in the court’s decision. We intend to appeal.”

Last year, Purdue settled a patent infringe-ment lawsuit against Actavis over OxyContin.

In a statement at the time, the companies said that Purdue had granted Actavis a licence to sell “defined quantities” of a generic version of the drug.

3M Innovative Properties preliminary injunctionContinued from page 1

Corresponding patents for the same invention have also been granted in several other coun-tries, including the US, Australia, Brazil, Japan, South Korea and Russia.

Bisman Kaur of Remfry & Sagar, which repre-sented 3M in the case, said: “The initial steps towards preparation of the case involved efforts towards conducting due diligence in evaluating the patentability of the invention covered by the subject patent and conducting investigations into the infringing product.”

“Sales channels for the infringing product were identified, including obtaining details of the in-fringers business activities, and samples of the infringing product were procured for conduct-ing an infringement analysis.”

3M India said in a statement: “We are pleased with the court’s decision to uphold our intellectual property rights. 3M defends its inventive work and protects its investments in research and develop-ment throughout the world so that it may continue to bring innovative products, such as respiratory protection devices, to the marketplace.”

“3M will continue to enforce its rights against unauthorised use and infringement in India and elsewhere.”

Allergan claims victory for Lumigan

Allergan has delayed four rival pharmaceuti-cal companies from marketing generic ver-sions of its glaucoma drug Lumigan, when a judge ruled that their proposed products would infringe five patents owned by the branded drug company.

Allergan sued Actavis, Hi-Tech Pharmacal, Lu-pin, and Watson at the US District Court for the Eastern District of Texas on 26 August 2011.

Latest newsAlnylam acquires Sirna’s assets and intel-lectual property for $175 million

p4Latest newsAstellas Pharma and ClearPath Develop-ment team up to form a portfolio of infectious disease vaccine development companies

p6Patent profileThe latest patent grants in Europe, Aus-tralia, Japan and the US p8TPP insightThe Trans-Pacific Strategic Economic Part-nership Agreement has few supporters

p10SPC outlookSupplementary protection certificates are under discussion in Europe

p12People movesPatrick Cantrill joins Bond Dickenson, ArticleOne Partners adds to board of directors, and more

p15

IPProINBRIEF

NewsInBrief

Foreign filing. Made simple.

Visit www.inovia.com to change your foreign filing practices for good.

Change can be a beautiful thing.

We’re combining technology and buying power to revolutionize the way the industry approaches

foreign filing and patent translations.

INO MIP Full Page Ad Oct 13 HERO.indd 1 10/4/13 2:18 PM

AT THE VERY HEART OF LIFE SCIENCE IP LAW IN ITALY“…Dynamic, first-rate founder Cesare Galli has a wealth of experience under his belt. His broad practice encompasses both contentious and non-contentious issues, but he is especially feted in the pharmaceutical litigation realm, where he has triumphed in some of the country’s most high-profile battles. He is supported by the clever and collaborative Mariangela Bogni” (IAM Patent 1000, 2013)

www.iplawgalli.it

IP Law Galli.indd 1 14/11/2013 15:574

NewsInBrief

www.ipprolifesciences.com

US district Judge Michael Schneider ruled that the companies’ formulas would infringe Aller-gan’s patents for the drug.

Judge Schneider rejected arguments that the patents were invalid, and ordered the US Food and Drug Administration to not grant regulatory approval until the patents have ex-pired in 2027.

Allergan sought an injunction and damages covering legal fees and costs.

The companies argued that the patents cover-ing the drug bore a resemblance to the ones covering Allergan’s other product, Lumigan 0.03 percent. The appeal courts upheld the patents, which expire in August, for that treatment.

In his opinion, the judge stated that newer patents are for a solution that limited red eyes, which caused some patients to stop taking the treatment.

Sales of Allergan’s eye care pharmaceuticals totalled $2.12 billion in the first nine months of last year.

Alnylam acquires Sirnia’s assets and IP for $175 millionAlnylam has acquired Merck subsidiary Sirnia Therapeutics, which specialises in RNA inter-ference (RNAi) therapeutics, for $175 million.

RNAi is a biological process in which RNA mol-ecules inhibit gene expression, typically by caus-ing the destruction of specific mRNA molecules.

The acquisition includes intellectual property and RNAi assets, such as pre-clinical thera-peutic candidates, chemistry, siRNA, conju-gate and other delivery technologies.

Under the agreement, Alnylam will pay $175 million in cash and equity, $25 million in cash, and $150 million in common stock.

Merck can to receive up to $105 million in de-velopment and sales milestones per product.

The dispute began in 2004 when Biosig sued Nautilus at the US District Court for the Southern District of New York, claiming that the device maker infringed its patent for a heart rate monitor that a user grips while us-ing exercise equipment.

Nautilus countered with a motion for summary judgement that the patent was invalid on the grounds that a “spaced relationship” rendered those product claims indefinite.

The district court agreed and granted Nauti-lus’s motion, holding the patent indefinite un-der patent law. Biosig appealed against the decision to the Federal Circuit, which reversed the lower court’s ruling in April 2013.

The Biosig decision, along with other allegedly permissive Federal Circuit rulings, “has grant-ed patent owners a ‘zone of uncertainty’ into which competitors may enter only at risk of an infringement suit,” said Nautilus in a statement.

Nautilus petitioned the US Supreme Court in September 2013 to consider reviving its suit.

Daiichi wins dismissal ofApotex patent caseA federal judge has dismissed an Apotex lawsuit that sought to invalidate a disclaimed Daiichi-owned patent for the blood pressure drug Benicar.

Daiichi disclaimed the patent and in 2006 asked the US Food and Drug Administration to delist it, but the agency never acted on the request, according to court documents.

US district Judge Sharon Coleman said that because Daiichi disclaimed the disputed pat-ent that there was no legal battle on which she could make a ruling.

The FDA’s failure to delist is not a basis for Ca-nadian company Apotex to “seek a declaratory judgment regarding a non-existent patent”, the judge stated in her 9 January opinion.

Apotex sued Daiichi in 2012 at the US Dis-trict Court for the Northern District of Illinois.

Merck is also eligible to receive up to $10 mil-lion in milestone payments and single-digit royalties on Alnylam products covered by Sirna Therapeutics’s patent pool.

Sirna Therapeutics will now be integrated into Alnylam’s platform for delivery of RNAi thera-peutics, including multiple granted patents and a range of technologies for application to RNAi therapeutics.

“We are excited to enter this agreement with Merck. We believe the acquisition of Sirna Therapeutics will complement and extend our own progress and continued focus on RNAi therapeutics, including siRNA-conju-gate technologies,” said John Maraganore, CEO of Alnylam.

“Indeed, we believe that the acquisition of Merck’s RNAi technologies and intellectual property will further our efforts to build a new class of medicines, advancing them to patients in need.”

The transaction is subject to closing condi-tions, including the requirements under the Hart Scott-Rodino Anti-trust Improvements Act.

Supreme Court to hearNautilus v Biosig caseThe US Supreme Court has agreed to hear a case highlighting the difficulty of challenging a patent under the second paragraph of 35 USC §112.

The disputed patent (5337753), which belongs to Biosig Instruments, covers a heart rate monitor associated with exercise appara-tus and procedures.

The Supreme Court will look at two questions in the case: whether the Court of Appeals for the Federal Circuit’s acceptance of ambigu-ous patent claims with multiple interpretations defeats the statutory requirement and distinct patent claiming; and whether the assumption of validity dilutes the requirement of particular and distinct patent claiming.

NewsInBrief

We know how to treat your intellectual property.

6

NewsInBriefA finding of non-infringement would have ena-bled it to release its generic version of the drug and compete with Mylan, which also has plans to market Benicar.

Apotex argued that it continues to exclude com-petition in the market and continues to have pre-clusive effect, preventing it from competing with its generic version of the Benicar drug until the end of Mylan’s 180-days of exclusivity.

Mylan, based in Canonsburg, Pennylsvania, lost a challenge to another Benicar patent in 2010, but was the first to apply for FDA per-mission, giving it the exclusive rights once the patent expires.

Enzo does it to the tune of $61 million

Enzo Biochem has obtained an additional $12.4 million in pre-judgement interest in its case against Applied Biosystems (ABI) over patent infringement.

US district Judge Janet Arterton rejected ABI’s argument that Enzo is not entitled to pre-judgement interest because it postponed filing the suit for more than seven years after it became aware of potential claims, finding a lack of evidence.

Enzo requested a pre-judgement interest, which is meant to match the licensing fee that an in-fringer would have paid to the patent holder.

The pre-judgement award brings the total dam-ages sum to $61 million.

“Given the absence of prejudice to ABI and the Supreme Court’s mandate that pre-judgement in-terest should ‘ordinarily be awarded’ to restore in-fringement victims to the same position that they would have been in absent infringement ... the court concludes that an award of prejudgment in-terest is appropriate,” said Judge Arterton.

Enzo initially filed the suit in June 2004, ac-cusing Applera subsidiaries Tropix and ABI of infringing six patents.

Four of the patents were assigned to Yale Uni-versity, after which Enzo received an exclusive licence.

In November 2012, a jury sitting in the US Dis-trict Court for the District of Connecticut found that ABI had directly and indirectly infringed five claims of one of Enzo’s patents, which re-lates to the use of non-radioactive labels.

Enzo was awarded $48.6 million in damages.

The court had previously granted a summary judgement, when in 2007 Judge Arterton ruled that three of Enzo’s asserted patents were in-valid based on indefiniteness and anticipation of prior art.

The Court of Appeals for the Federal Circuit in 2010 reversed that ruling for two of the patents, finding that Enzo’s claims were not indefinite.

Astellas and ClearPath team up for RSV vaccineAstellas Pharma and ClearPath Development have teamed up to form a portfolio of develop-ment companies focused on vaccines targeting infectious diseases.

Astellas launched its first company, RSV Cor-poration (RSVC), in December 2013 and will fund RSVC’s development of a virosome vac-cine technology, licensed from Mymetics Cor-poration for respiratory syncytial virus (RSV) through completion of a Phase 2b human proof-of-concept study.

Mymetics will collaborate with RSVC on the de-velopment of the vaccine.

It could receive up-front and post proof-of-concept milestone payments of up to $82 mil-lion for its technology, as well as other royal-ties and payments.

Under the agreement with ClearPath, As-tellas received exclusive rights to acquire RSVC as well as further develop and market the vaccine product.

“This partnership highlights our commitment to build a global vaccine business and repre-sents a highly efficient model for bringing in-novative vaccines to market. It is also a unique opportunity for Astellas to utilise external, cut-ting edge science and technology to enhance our ability to generate innovative drugs, as part of the Reshaping Research Framework pro-gramme announced in May 2013,” said Kenji Yasukawa, senior vice president at Astellas.

“Together we are harnessing our collective resources to accelerate development of this promising, early stage asset and will replicate this scalable, outcome driven model across future portfolio companies,” said Chuck Finn, chairman of ClearPath.

RSV is a respiratory pathogen that infects pa-tients of all ages. The infection can be especially severe in infants and older adults with chronic pulmonary or cardiovascular disease. Currently, there is no vaccine available for the virus.

The virosome vaccine consists of membrane nanoparticles containing the native key viral surface proteins that are targets of the immune system, but currently lack the genetic material required to cause infection.

Boehringer and Teva face anti-trust allegationsAmerican Sales Co has brought a class action complaint against Boehringer Ingelheim Phar-maceuticals and Teva Pharmaceuticals over a $120 million pay-for-delay deal to keep generic versions of Aggrenox off the market.

Drug distributor American Sales filed the com-plaint at the US District Court for the District of Connecticut on 2 January.

It has paid more for Aggrenox than it would have in absence of the agreement, according to its complaint.

It has joined Miami-Luken, which filed a com-plaint in November 2013. Aggrenox is pre-scribed to reduce the risk of stroke in patients

NewsInBrief

7

NewsInBrief

who have had transient ischemia of the brain or completed ischemic stroke due to a blood clots.

The complaint stated that Boehringer and Barr Laboratories, which was acquired by Teva in 2008, reached a reverse-payment deal after Barr filed for an Abbreviated New Drug Appli-cation (ANDA) at the Food and Drug Adminis-tration in May 2007.

The deal will allow Barr to market a gener-ic version of Aggrenox once Boehringer’s patent expires.

In return, it will promote Aggrenox for a year and receive upfront payments based on its ability to increase the drug’s sales.

American Sales alleged that Barr could have entered the market lawfully if it challenged Boehringer’s patent, but it was more profitable for Barr to delay entry in exchange for “a deal that could be worth as much as $120 million over seven years”.

The deal enabled Boehringer to sell Aggrenox at “artificially inflated, supra-competitive pric-es”, according to the complaint.

American Sales is seeking judgement that the companies have violated Sections 1 and 2 of the Sherman Anti-trust Act.

It also wants an award for damages due to overcharges, said the complaint.

Glenmark braces for patent law-suit over cancer drugGlenmark Pharmaceuticals is facing a patent infringement lawsuit over a generic version of cancer drug Treanda in the US.

Teva Pharmaceutical subsidiary Cephalon dis-covered the company sought approval to sell a cheaper copy of the cancer drug and filed the suit at the US District Court for the District of Delaware on the 26 December 2013.

Glenmark has plans to sell generic version of leukaemia treatment drug in the American mar-ket before the expiry of patent and applied to the US Food and Drug Administration seeking marketing approval.

Teva acquired Cephalon in October 2011 in a bid to create a large portfolio of cancer drugs.

Treanda is the lead drug under this portfolio at present

Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukaemia. The patent will expire only in March 2029.

Actavis faces Merck challenge

Merck & Co is attempting to block Actavis from marketing a generic version of the its NuvaR-ing, a contraceptive drug.

On 24 December 2013, Merck filed the complaint at the US District Court District of Delaware, when Merck & Co learnt of Actavis’s Abbreviated New Drug Application (ANDA) filing with the US Food and Drug Administration (FDA) seeking approval to market NuvaRing in October of that year.

Merck is seeking to prevent Actavis from com-mercialising its ANDA product prior to the expi-ration of its patent (5989581) in 2018.

The lawsuit comes under the provisions of the Hatch-Waxman Act, which can result in a delay for a FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing.

According to a statement: “Actavis believes it may be a ‘first applicant’ to file an ANDA for the generic version of NuvaRing and, should its ANDA be approved, be entitled to 180 days of generic market exclusivity.”

NuvaRing is a combined hormonal vaginal contraceptive ring that includes both oestrogen and progestin to prevent pregnancy.

8

NewsInBrief

The Patent ProfileIPPro highlights the latest patent grants in Europe, the US and elsewhere

Send all grants to frankiwebb@ipprolifesciences.com

The Japan Patent Office (JPO) has issued a patent for skin whitening Israeli Biotechnology Research (IBR).

The patent covers the use of carotenoid prep-arations for promoting skin whitening with the combination of phytoene and phytofluene (IBR colourless carotenoids).

The patent application, entitled Carotenoid Compositions Useful for Whitening Skin, was granted in Japan four months after it was grant-ed in the US.

Liki von Oppen-Bezalel, vice president of business development and marketing at IBR, said: “This additional patent to be issued now in Japan, joins the series of patents and ap-plications in IBR’s portfolio related to the co-lourless carotenoids, including correspond-ing patent application recently allowed in the United States.”

“It further strengthens the position of IBR’s colourless carotenoids products portfolio for topical use and oral supplementation as key proprietary ingredients for the beauty industry and IBR’s position as an innovator in the field.”

Athersys has received several patents from the JPO for its proprietary cell therapy technology.

The first patent (5398941) covers non-embry-onic, multipotent stem cells, such as MultiStem, and applies to all therapeutic applications.

The second (5399709) covers the use of such stem cell therapies for the treatment of immune dysfunctions, such as graft-versus-host dis-ease (GvHD), and inflammatory diseases and autoimmune disorders (eg, inflammatory bowel disease (IBD)).

The third patent covers the treatment of brain in-juries, such as stroke and traumatic brain injury, with such multipotent stem cells.

“These patents will provide the company impor-tant protection for its cell therapy products in Japan and their use in a number of significant disease areas, including stroke, IBD, GvHD and others,” said William Lehmann, president and CEO at Athersys.

Adocia has obtained two patents, in Japan for the BioChaperone PDGF composition and in the US for the BioChaperone polymers.

Both patents will protect Adocia’s research in the field of chronic wound healing, specifically for diabetic foot ulcers.

The BioChaperone PDGF product is protected by two families of patents. The first one cov-ers the complexes between the BioChaperone polymers and PDGF, while the second covers the BioChaperone polymers.

The BioChaperone polymers, a proprietary technology specifically developed by Adocia, are covered by the other patent.

This patent has been granted by the US Patent and Trademark Office (USPTO). The protec-tion of these BioChaperone polymers is now established in the US, Australia, China, Rus-sia, France and South Africa. It is valid until 26 September 2027.

“We are very pleased by these positive deci-sions on two of our strategic patent families, especially because they have been granted by the very demanding national United States and Japanese patent offices. Our product for the treatment of diabetic foot ulcer is patent pro-tected until at least 2026,” said Remi Soula, di-rector of business development and intellectual property at Adocia.

“The granting of these patents consolidates our 22 families strong patent portfolio. For six of these families, the US patent has already been delivered.”

IP Australia has awarded Pluristem Therapeutics a new patent for a placental cell therapy.

The patent claims methods for the use of adher-ent placental cells for the treatment of ischemia, which is a restriction of blood supply to tissues, and for treatments of conditions requiring con-nective tissue repair or regeneration.

This is the 27th patent granted to Pluristem and it adds to other countries in which the company has patent protection.

The European Patent Office (EPO) has granted BrainStorm Cell Therapeutics a new patent for isolated cells and populations used to treat-ment of neuro-degenerative diseases.

This patent relates to the method of pro-duction of the company’s proprietary stem cells induced to secrete large quantities of neurotrophic factors for the treatment of neuro-degenerative diseases.

“We are confident that strengthening our patent portfolio in the European Union, together with le-veraging our Orphan Drug status there, will posi-tion us well when we pursue European marketing approval of our stem cell therapy,” commented Chaim Lebovits, president of BrainStorm.

Aphios Corporation continues to expand its intellectual property portfolio with a new patent from the USPTO.

The patent (8540847) covers methods for the substantially continuous processing of cellulosic biomasses with a supercritical, critical or near critical fluid to produce ethanol, bio-fuels and high-value end products.

Trevor Castor, inventor of the Aosic platform, explained: “Cellulosic biomass is tightly wound for obvious mechanical strength reasons. In order to breakdown cellulose into its individual sugar molecules, cellulosic biomass must be expanded to enhance the access of enzymes that cleave the polymeric bonds between indi-vidual sugar molecules.”

Enzymotec has obtained a patent from the USPTO for a lipid preparation method.

The patent’s claims covers a method for enhanc-ing dietary calcium absorption, bone formation, and bone mass maximisation in non-infant chil-dren or adults, by administrating routinely a di-etary supplement or food article that comprises the lipid preparation of the invention.

“We are very pleased to be granted a patent, which we believe validates our research and development efforts and enhances our future products value proposition,” said Ariel Katz, president and CEO of Enzymotec.

“The potential market for such products is large and growing, and we will continue to invest in innovation to bring the highest quality nutritional ingredients to our customers.”

The USPTO has issued NeoStem a new pat-ent for AMR-001, a chemotactic stem cell product enriched for CD34+ cells that treats injury from vascular.

Additionally, the EPO has notified the company of its intent to award the same patent in jurisdic-tions in Europe.

Robin Smith, chairman and CEO of NeoStem, said: “The continued expansion of our intel-lectual property portfolio both domestically and internationally expands the commercial possibilities for AMR-001, should it receive regulatory approval.”

Send all grants to frankiwebb@ipprolifesciences.com

6th China IP Counsel Congress

May 15~16, 2014 | Shenzhen, Chinahttp://www.ipcounselcongress.com/2014shenzhen

Interpretation of the Fourth Amendment on Patent Law of China The Value that Patent Capitalization Brings to Enterprises Technical Achievement Conversion & Development Tendency and Successful Cases of Commercialization Patent International and Domestic Placement Strategy Key Elements in Claims or Legal Rights Safeguard for Enterprise Patent Information and Intelligence Analysis

180+ IP Directors, Patent Directors, Chief Patent Engineers, Chief IP Counsels, Heads of Legal Counsel, R&D Directors, Project Managers...

70+

14+ Insightful and Passionate Speeches and Discussions10 Networking and Countless Business Development Opportunities

20+ Industry Expert Speakers

2-Day Brainstorming1 Congress

2 Workshops

For registration, please contact:Allen SunTel: +86-21-51720000 Ext:126E-mail: allen.sun@jfpsgroup.com.cn

CIPCCCIPCC

Organized By Presenting Sponsor Media PartnerParticipating Sponsor

Media Partner

Partnered By

Stolmár & Partner München Stuttgart Seoul iP Frontline

WORLD’S LEADING IP PORTAL

Pr oIPLIFE SCIENCES

Improving the IP Practice by Real Cases Dissection & Trend Analysis

Pr oIPLIFESCIENCES

The Trans-Pacific Strategic Economic Partner-ship Agreement (TPP) caused a stir in 2013, when whistle-blowing website WikiLeaks pub-lished the trade deal’s confidential intellectual property chapter.

The TPP agreement aims to enhance trade and investments, promote innovation, and help economic growth between Pacific Rim

nations. It currently involves 12 countries, with the list expected to expand.

Led by the US, the TPP is being negotiated between Australia, Brunei Darussalam, Canada, Chile, Ja-pan, Malaysia, Mexico, New Zealand, Peru, Singa-pore and Vietnam. It was originally drafted in 2005 in a bid to harmonise IP protections and address emerging trade issues in the 21st century.

Negotiations are still going on behind closed doors. Anyone who is not closely linked to the proposal is being kept in the dark, including the Australian Senate, which was denied any details of Australia’s role in the TPP agree-ment by the country’s own government.

WikiLeaks published the chapter concerning IP on 13 November 2013, exposing several

Divide and conquerThe Trans-Pacific Strategic Economic Partnership Agreement has had a negative reaction since it was published on WikiLeaks, from activist movements to congressmenFRANKI WEBB REPORTS

11

TPPFocus

draft proposals on IP laws and litigation for the participating countries, which could al-low pharmaceutical patent owners to charge higher prices for longer periods of time and either stop or delay generic competition from producing less expensive versions that are vital to global health, according to the TPP’s detractors.

The leaked document contained provisions that would make it easier for pharmaceutical companies to obtain patents in developing countries, with rights lasting for more than 20 years, while also strengthening companies’ ability to limit access to scientific data neces-sary for others to develop new medicines.

Since the IP chapter’s release, the provisions on pharmaceutical products have provoked significant controversy among doctor groups such as Medicins Sans Frontières (MSF, also known as Doctors Without Borders), with much of the anger vented at the US, which is seen as the lead negotiator.

“The TPP, as any regional or global norm-se tting negotiation, could be framed in a way that could promote both innovation and ac-cess to medicines, but unfortunately, the text that we have seen is really not about promot-ing innovation and accessibility, it’s about lon-ger monopolies and decreasing patent qual-ity and setting limits to generic competition,” says Judit Rius Sanjuan, an IP attorney and US manager at MSF Access Campaign.

“For example, the leaked text shows second-ary patenting and evergreening as a top prior-ity of the US government.”

The evergreening of patents has become par-ticularly infamous in the pharmaceutical busi-ness, where the ‘repackaging’ of out-of-patent medications are allegedly used to keep com-mon compounds out of the public domain.

WikiLeaks claims that the wording of the TPP shows that the US is attempting to enforce its highly restrictive vision of IP globally and on itself. Julian Assange, the founder and editor-in-chief of WikiLeaks, reportedly said: “The US administration is aggressively push-ing the TPP through the US legislative pro-cess on the sly.”

“If instituted, the TPP’s intellectual property regime would trample over individual rights and free expression, as well as ride rough-shod over the intellectual and creative com-mons. If you read, write, publish, think, listen, dance, sing or invent; if you farm or consume food; if you’re ill now or might one day be ill, the TPP has you in its crosshairs.”

The US Trade Representative (USTR) has defended the agreement, saying: “We be-lieve the best approach to pharmaceutical IPR issues in the TPP would be one that offers countries flexibility based on their individual circumstances.”

“This flexible approach is based on prec-edent: previous US trade agreements cov-ered by the May 10, 2007 bipartisan agree-ment. Under May 10, developing free trade agreement partners (like Peru) were offered greater flexibility relative to more developed trade agreement partners (like [South] Ko-rea). In TPP, we are seeking to pursue a similar idea, using previous agreements—like those with Peru, Australia, Chile, [South] Korea, and Singapore—as benchmarks, but keeping an open mind as to how these stan-dards can be tailored to reflect the situa-tions of individual partners.”

Due to its secrecy, many have assumed that the US is proposing that richer countries in the TPP implement its standards, protecting man-ufacturers of brand-name drugs as a result.

“One can surmise that the US is proposing that wealthier countries in the TPP be required to join the standards of richer nations such as Australia, South Korea, and Singapore, and poorer countries with the likes of Peru,” wrote Sean Flynn, associate director at the Wash-ington College of Law, who was writing on the academic-run blog infojustice.org.

The USTR has admitted that a proposal for 12 years of data exclusivity for biologics is included in the TPP, explaining: “In the TPP negotiations, opinions vary on the best term of patent protection for biologics. Standards also vary across the TPP region. Some TPP countries currently have no data protection for biologic drugs. Some have [five] years. Others have [eight].”

“Traditionally, the US approach to trade ne-gotiations has been to base proposals on existing US law, where the current standard is 12 years.”

Simply proposing 12 years of data exclusivity is controversial enough, according to Flynn: “The USTR statement mentions that ‘opinions vary’ on 12 years of data exclusivity—and that is true within the administration.

Indeed, the presidential budget asked Con-gress to endorse a reduction of data exclusiv-ity in the US to seven years. This is an area in which there is no US—much less interna-tional—consensus on what minimum terms (if any) of data exclusivity should apply to bio-logic drugs.”

Another key portion of the released IP chapter would see surgeons given the opportunity to patent surgical methods, which under current World Trade Organization (WTO) rules is ex-cluded from patent law. The only countries in the world to recognise medical method pat-ents are the US and Australia. As of 2009, more than 80 countries had banned medical procedure patents.

“We are very concerned with some of the pro-posals that are on the table—how they will

negatively going to impact health, especially access to medicines in developing countries, where it will affect medical operations,” saysRius Sanjuan.

Knowledge Ecology International (KEI) pro-vided a detailed report of the draft provisions on various types of IP, concluding that the draft goes well beyond existing rules such as those in the WTO agreement on Trade-Related As-pects of Intellectual Property Rights (TRIPS).

As an example, the TPP text requires parties to provide judges with the “authority to order injunc-tive relief that conforms to the provisions of Article 44 of the TRIPS Agreement”, but it surpasses the likes of TRIPS and the Anti-Counterfeiting Trade Agreement (ACTA), in regards to preliminary in-junctions, limiting them to those where “delay is likely to cause irreparable harm”.

ACTA contains no explicit time constraint, only that action be taken “without undue delay”, while TRIPS makes no reference to the speed of a decision.

Congressmen have joined the ranks of activist movements, speaking out against the agree-ment. In December 2013, six members urged President Obama to ensure that the TPP does not include provisions that would limit access to affordable healthcare.

In the letter, the politicians argued that pro-posed provisions relating to data exclusivity, patent lifespans and enforcement could “de-lay generic competition and increase the price of medicine,” which would lead to “prevent-able illnesses and deaths”.

The opposition to the TPP has taken a comi-cal turn with movements and critics dubbing it “NAFTA on steroids”.

The North American Free Trade Agreement (NAFTA) was implemented to boost trade and investment, and aid participating countries’ economies. But as Public Citizen points out, congressional rejection of the TPP provides a stark reminder of the damage that past pacts such as NAFTA have caused.

“NAFTA’s two-decade legacy of tumult and hardship for millions of people in North America could similarly hasten the downfall of the at-tempt to expand the NAFTA model via fast track and the TPP. If so, it would constitute a unique benefit of an otherwise damaging deal.”

In December 2013, after four days of nego-tiations, delegates from 12 countries failed to reach an agreement over the TPP. The USTR said that “substantial progress” had been made in the TPP talks, and there are plans for the del-egates to meet again this month, after negotia-tions had fallen through with Singapore.

The agreement remains divisive, but until a full and frank text is published for all to see, the arguments will continue. IPPro

12

SPCInsight

Italy is involved in an in-depth and wide-rang-ing debate on supplementary protection cer-tificates (SPCs).

Several proceedings are pending as to the meaning and consequences of the Court of Justice of the European Union (CJEU) case law relating to SPCs, following the Medeva decision and the recent decisions in the cases C-443/12 and C-493/12.

Interpretation of Article 3(a)

The first problem concerns the interpretation of Article 3(a) of the SPC Regulation ((EC) No 469/2009) and the notion of “active ingredi-ents which are not specified in the wording of the claims of the basic patent”, which is the statement used in Medeva decision. This statement appears to be inconsistent with the meaning of the cited provision, because even an active pharmaceutical ingredient not men-

tioned may be protected by a basic patent and fall within its scope of protection, and then jus-tify the granting of an SPC.

In this respect, in a recent dispute before the Court of Turin, my team and I had the op-portunity to frame an argument for the court, which said that the infringement test is the only relevant assessment, as it is outlined within Article 69 of the European Patent Con-vention (EPC) and the protocol interpreting the provision.

This consideration seems to be consistent with the ruling of the CJEU, which in its de-cision of 12 December 2013 in C-493/12 de-clared—even though the motivation appears ambiguous—that under Article 3 of the SPC Regulation, “it is possible to reach the conclu-sion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the

EPC and Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically”, even to the ac-tive ingredient at issue.

As a result, what does matter is the fact that the product represents a specific implementa-tion of the patent and consequently falls within its scope of protection.

The protection of the SPC, moreover, refers to the active pharmaceutical ingredient, but it fol-lows the rules of patent law and consequently does not extend solely to an identical active ingredient. In the Italian dispute mentioned above, the Italian Patent and Trademark Of-fice on December 11 2013 granted the SPC with regards to a product that contains an ac-tive ingredient, combined with a second active ingredient, which falls within the scope of pro-tection of the corresponding patent, although it is not expressly mentioned in the claims.

After MedevaSupplementary protection certificates have been under discussion in Europe. Cesare Galli of IP Law Galli provides the Italian perspective on the key areas

Ces

are

Gal

liS

enio

r par

tner

IP L

aw G

alli

SPCInsight

13

SPCInsight

Interpretation of Article 3(c)

It should not be the case that two complemen-tary certificates referring to distinct market au-thorisations, with different durations and with possibly overlapping scopes of protection, are granted in succession, with the result of dupli-cating the protection and extending the first one.

This situation typically occurs when the prod-uct covered by a patent contains the active ingredient that a second patent already refers to, combined with other substances, or other active ingredients.

The misunderstanding seems to arise from the fact that the protection granted to the product is different from that one relating to the active ingredient.

The decision in C-422/10, at point 33 (which refers to paragraph 40 of the Medeva deci-sion), seems to admit the grant of the SPC in respect of the product even when the active ingredient is used in combination with other substances, but only once, solely for the first medicinal product comprising, among its sub-stances, the active ingredient.

On this point, it may be worthy to note that Article 3(c) of the SPC Regulation, ‘conditions for obtaining a certificate’, states that “a cer-tificate shall be granted if, in the member state in which the application referred to in Article 7 is submitted and at the date of that application ... (c) the product has not already been the subject of a certificate”. In this context, for the purposes of granting an SPC, ‘product’ necessarily means the patent-ed active ingredient, since the rationale that governs the system of the SPC is to extend the patent protection, and, therefore, the ex-clusive rights of using an invention (ie, the ac-tive ingredient claimed in the patent) in order to compensate, at least in part, the discrepan-cies that occurred during the years between the issuance of the patent and the first mar-keting of the drug, which requires the carrying

out of checks performed by the government for granting the marketing authorisation.

The issue came up recently before the Ital-ian courts, in relation to the SPC on an active pharmaceutical ingredient, namely telmisar-tan in combination with hydrochlorothiazide.

Some proceedings are still pending on this matter. In one of these disputes, my team and I argued that the protection granted would have constituted a (further) unjustified exten-sion of exclusive rights (although the protec-tion referred solely to the use of telmisartan in combination with hydrochlorothiazide) since the active ingredient had already benefited from the extension of protection with a previ-ous SPC on the sole telmisartan mono.

The active ingredient should have been con-sidered ‘free’ when the first complementary certificate expired, ie, in December 2013. In that case, it has been argued that this inter-pretation of Article 3(c) of the SPC Regula-tion is also confirmed by the fact that clause (d) of the same provision states that the rel-evant market authorisation for the purposes of granting the SPC, pursuant to clause (b) of the same provision, “is the first authorisation to place the product on the market as a me-dicinal product” and consequently, that is not the case of the authorisation for the combina-tion of telmisartan and hydrochlorothiazide, referred to in the case at issue for granting the intended SPC.

These considerations have now been ac-cepted by the CJEU with the decision of 12 December 2013 in C-443/12 (referring to an almost identical situation, an SPC relating to irbesartan in combination with hydrochlorothi-azide), which held that the aforesaid provision precludes “that, on the basis of the same pat-ent, but an authorisation to place a medicinal product on the market after another contain-ing the active substance in the composition with another active ingredient which is not, as such, protected by the patent, the holder of this same patent has released a second

supplementary protection certificate concern-ing this combination of active ingredients”. According to this principle of law, the ongo-ing disputes involving telmisartan should be decided: a decision is, in fact, expected later this year.

Ex-post adjustments

In an Italian court, a third theme was pro-posed, although preliminary to the above, namely the ability to correct, ex post, claims to realign the patent with the SPC so that the patent contains in the claims the active ingre-dient covered by the certificate.

With regards to this situation, two issues have been highlighted: we have firstly chal-lenged the legitimacy of the reformulation, which shall be allowed solely if it deter-mines an actual limitation of the patent and has its basis in the original application (with regards to telmisartan, French and German judges has delivered different decisions); and secondly, we have also taken into ac-count the protection of third parties, since the limitation was carried out after the grant of the SPC, so the certificate was unlaw-ful at the time of grant, and, even though the limitation obtained by the patentee had been legitimate, the certificate would have not been eligible for an “ex post recovery of its validity”.

This is because third parties would have been legitimately entitled to rely on the in-validity of the patent, simply inferable by comparing the combination of the active ingredients referred to in the SPC and the original claims of the patent, which did not protect such combinations.

The overriding argument of the duplication of protection makes it unlikely, however, that the decisions that will be delivered by the Italian courts in the above disputes will examine these further issues, although the issue covering the legitimacy of an ex-post cancellation of an invalidity reason affecting the SPC may be addressed. IPPro

“ Third parties would have been legitimately entitled to rely on the invalidity of the patent, simply inferable by comparing the combination of the active ingredients referred to in the SPC and the original claims of the patent, which did not protect such combinations

”

14

IndustryEvents

World Pharma Licensing Congress

Location: LondonDate: 17-18 February 2014www.iprconnections.com

The pharmaceutical industry is facing a precipice. As patents on existing blockbuster drugs expire, big pharma companies are forced to parachute off the proverbial patent cliff. This legal escarpment means the end of pat-ent protection on various blockbuster drug products, opening the market to generic substitutes.

The World Pharma Licensing Congress is the platform to exchange ideas and establish creative partnerships.

23rd Annual EU Pharmaceutical Law Forum

Location: BrusselsDate: 14-15 May 2014www.informa-Ls.com/event/eupharmalaw2014

This conference provides an unrivalled opportunity for legal professionals working in private practice and in-house counsel to get a complete round-up of the most important legal decisions made over the past 12 months.

This meeting is Europe’s most respected pharmaceutical law confer-ence and has gained a solid reputation for covering the most important topics and attracting the very best speakers.

15

Industry appointments

PeopleMoves

Editor: Mark Dugdalemarkdugdale@ipprolifesciences.com Tel: +44 (0)20 8663 9620

Deputy editor: Georgina Laverseditor@ipprotheinternet.com Tel: +44 (0)20 8662 9628

Reporter: Franki Webbfrankiwebb@ipprolifesciences.com Tel: +44 (0)20 8663 9621

Account manager: Wayne Edwardswayneedwards@ipprolifesciences.com Tel: +44 (0)208 663 9625 Publisher: Justin Lawsonjustinlawson@ipprotheinternet.comTel: +44 (0)20 8663 9628

Designer: John Savagejohnsavage@ipprotheinternet.comTel: +44 (0)20 8663 9648

Office fax: +44 (0)20 8711 5985

Published by Black Knight Media Ltd.Provident House, 6-20 Burrell RowBeckenham, BR3 1AT, UK

Company reg: 0719464

Copyright © 2013 Black Knight Media Ltd. All rights reserved.

Patrick Cantrill is to join national law firm Bond Dickinson LLP from Walker Morris LLP.

Cantrill will join the firm’s intellectual property department as partner.

He has nearly 30 years of expertise gained from working both in UK and overseas practic-es and of managing IP portfolios for blue chip and international organisations.

Cantrill has experience in both contentious and non-contentious IP and media law mat-ters, and he has handled major and cross-border IP litigation. He has been involved suc-cessfully in a number of high profile patent, design and trademark cases.

Nick Page, chairman of Bond Dickinson, com-mented: “We are extremely pleased to an-nounce Patrick’s appointment as a partner in our IP Department. He is one of the most ac-complished lawyers in his field and he will be a first rate addition to our intellectual property and media practice. We look forward to work-ing with him as we develop our presence in London and internationally.”

He has experience of overseas jurisdictions, in particular East Asia and served at Walker Morris as the co-chair of the China trade practice group.

Article One Partners has added former Phil-ips’s chief IP officer Ruud Peters to its board of directors in New York.

Peters will contribute to the strategic direc-tion of Article One in his new position on the board.

At Philips, Peters was responsible for patent and licensing in a number of fields, including telecommunications, medical systems, and in-formation systems, among others

He has also participated in numerous stan-dards bodies, such as the International Or-ganization for Standardization and European Telecommunications Standards Institute, of-fering important contributions to current inter-national IP policies.

Snell & Wilmer LLP has appointed Brian Arnold as partner in its IP litigation group.

Arnold joins the firm’s Los Angeles office from Loeb & Loeb LLP.

He focuses his practice on patent litigation and complex commercial cases involving IP matters.

Arnold has litigated patent infringement matters involving a wide variety of technol-ogies, including automotive service equip-ment, portable digital audio devices, computer software, computer storage devices, optical displays, spinal instrument systems, injec-tors for medical imaging systems, slot ma-

chines, computer-related imaging systems, artificial fire logs and food products.

Arnold also represented clients in patent and trademark licensing negotiations and disputes in various industries.

A former senior official with the Federal Trade Commission (FTC), Edward Glynn, has joined Edwards Wildman LLP in Washington.

Glynn joins the firm as partner in its IP department.

Glynn represents consumer products and services, pharmaceutical and dietary supple-ments, and advertising and marketing compa-nies in federal and state regulatory matters, government investigations, and litigation.

He also regularly counsels clients on mergers, acquisitions, and joint ventures reviewed by the FTC and the anti-trust division of the De-partment of Justice, as well as in proceedings before the National Advertising Division of the Council of Better Business Bureaus.

Duane Morris LLP has promoted two lawyers to partner in its IP group.

Michelle Donovan, who works for the firm out of its San Diego, San Francisco and Silicon Valley offices, specialises in IP and internet law, and litigation and licensing.

Her clients hail from industries such as phar-maceutical and biotechnology, high-end con-sumer electronics, software, cosmetics and personal care products, real estate develop-ment, education, staffing, food and beverage, and social networking.

Houston-based Diana Sangalli focuses on IP litigation and patent preparation and prosecu-tion. She has represented clients in technolo-gies such as optical disc recognition, wireless LANs, telecommunications networks, web-page authentication and offshore platforms.

She has also prepared and prosecuted patent applications covering a variety of electrical, mechanical and computer-related technolo-gies for small, medium and large-sized cor-porations in the oil and gas, computer, tem-perature instrumentation, semiconductor and consumer product industries.

Edwards Wildman LLP has added a new IP attorney to its Hartford office.

Bryan Zerhusen joins the firm as partner.

Zerhusen focuses on domestic and foreign patent preparation, prosecution and coun-selling for companies within the healthcare, chemical and life sciences industries.

He counsels clients in all areas of molecular biol-ogy, biochemistry and biotechnology. Zerhusen has experience in licensing, due diligence in-

vestigations and re-examination proceedings. His clients include solo inventors, start-up and early-stage companies, academic institutions and foreign law firms.

He has also represented global corporations in the medical biotechnology, agricultural biotech-nology, diagnostic, chemical, pharmaceutical and medical science sectors.

EIP has strengthened its IP litigation practice with the addition of lawyer Matthew Jones from Teva Pharmaceuticals Europe.

He joins as a partner in the firm’s London office.

Jones has extensive experience of handling large-scale multi-jurisdictional patent litigation, related to the blockbuster drug Copaxone. He has also acted in litigation relating to a wide range of technologies, including electronics, telecommunications, cryptography, optics, and mechanical devices. IPPro

Pr oIPLIFESCIENCES

Saufung Ma is a senior associate in Taylor Wessing LLP’s intellectual property department. He works on both contentious and non-contentious IP matters, including patent litigation and trademark prosecutions.

Ma spent six months in Taylor Wessing’s Cambridge office where he assisted with a number of venture capital, inward investment and acquisition projects, particularly in relation to technology-rich businesses.

He has a degree in Biochemistry from Oxford University, a PhD in Molecular Biology and Medi-cine from Imperial College, and was awarded a distinction from BPP Law School. Ma is a mem-ber of Taylor Wessing’s pro bono committee. He speaks fluent Cantonese.

Take with...

16

IndustryPeople

IPPro takes five with Saufung Ma, an up-and-coming senior associate in Taylor Wessing LLP’s intellectual property team

How did you get into intellectual property law?

I realised quite early on that I’m a nerd, as I remember taking an alarm clock apart to see how it worked when I was about five-years old.

It all snowballed from there—I went on to do science at school, science at university (I studied at BBP Law School) and now I get to do science (with a bit of law) at work.

What do you specialise in and why? As my research degree was about the sur-face proteins on parasites and vaccine de-velopment, it probably isn’t surprising that a lot of my cases are in the pharmaceutical and life sciences sectors.

Having a science background helps when the first page of the patent contains a giant chemical markush formula and the second has a table full of mass-spec data. Having a science background also means I get to love the work I do. What is a typical day for you?

I’m a morning person so will have been to the gym and had breakfast by the time I’m at my desk at 8am. After that, there is no ‘typical’ day.

Some days, we will be working with experts and barristers to prepare for a case. Patent litigation is very much a team effort, with the experts being absolutely key. They provide the technical background against which the case is judged and have the unenviable task of teaching the lawyers about the topic,

sometimes on a single point in excruciating detail. We are lucky in having a fantastic pan-el of experts to call upon, including nobel lau-reates and leaders in their respective fields.

Other days, we will be in meetings or having calls with lawyers across Europe, in the US and/or Asia.

Many of Taylor Wessing’s clients are global with the UK being only a part, albeit usually an important part, of their overall commercial strategy, and coordinating litigation and ad-vice across jurisdictions is central to our work.

Only recently, we were in the final stages of negotiating a pan-European patent settle-ment and had to call on our German team for advice. Having an extensive international network of our own offices helps.

How do you get ready for an especially difficult case?

Things do get manic on the first day of trial as we make sure the right documents and peo-ple arrive at the right place at the right time. It isn’t unheard of to be dealing with last minute requests or submissions by the other side as we are walking to court. However, trial is the culmination of many months of planning and hard work by the entire team.

Do you have any advice for students thinking of getting into IP law?

First of all, congratulations on picking IP! It can be a very technical area, both in terms of law and also the underlying subject matter, the combination of which sometime results in a lot of confusion.

It helps to see the wood from the trees, so it is useful to understand how the law works in this area and also what it is trying to achieve. You can then see how the commercial and scientific aspects fit within the legal frame-work and use it to your advantage. IPPro

12+ Hours of Networking • 17 CPD Points • 35+ Speakers

Europe’s leading pharmaceutical law conference on competition law, patent litigation and regulatory frameworks

Wednesday 14 - Thursday 15 May 2014, The Hotel. Brussels, Brussels, Belgium

Sponsors:

Media Partners:

Informa Life Sciences’ 23rd Annual

EU PHarMaCEUtiCal law ForuM

To register +44 (0) 20 7017 7481 registrations@informa-ls.com

www.informa-ls.com/pharmalawPlease quote CQ5222Pro when booking

Scan with smartphoneQR Reader App:

IndustryPeople