issue002 - IPPro Life Sciences

05.09.2013

LIFESCIENCES

T H U R S D AY

IPPro

ISSUE002

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Cell regeneration tech not infringed, says US appeals court Skincare developer SkinMedica has lost a four-year patent infringement case against regenerative therapy company Histogen. The US Court of Appeals for the Federal Circuit delivered its non-infringement ruling in the case on 23 August. SkinMedica filed the infringement claim in 2009, accusing Histogen of breaching two of its patents on extracellular protein generation (6372494 and 7118746), a technology used to provide regenerative medical treatments and create anti-aging products.

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IPA slams US ‘discrimination’ allegations India is continuing to deny that its patent laws favour its domestic pharmaceutical industry over foreign companies.

The Indian Pharmaceutical Association (IPA) on 19 August rebuked claims that the Indian Patent Act is discriminatory to US companies. Roy Waldron, CEO of Pfizer, accused India of unnecessarily denying intellectual property rights in a letter to the US Trade Representative (USTR). He pointed to Section 3(d) of the country’s patent law, saying that it made it more difficult to obtain patents for some products. Section 3(d) prohibits the patenting of new forms of known substances that do not enhance efficacy. It is designed to encourage companies only to patent breakthrough innovations and deter them from attempting to patent new uses of known chemical substances.

Nestlé and Mastix in chewing gum spat

Earlier this year, Section 3(d) was used to invalidate a patent for Novartis’s leukaemia drug Glivec. It was later used to revoke GlaxoSmithKline’s patent covering the salt form of lapatinib.

Nestlé Health Science has accused Mastix Medica of infringing one of its patents with a new chewing gum treatment for chronic kidney disease.

DG Shah of the IPA responded to Waldron’s allegations in an 18-page open letter.

The Swiss healthcare company filed its complaint on 23 August in the US District Court for the District of New Jersey.

“If the US believes that section 3(d) in the Indian Patents Act is violative of the TRIPS Agreement, the remedy is in triggering the dispute resolution mechanism,” wrote Shah. India amended its patent laws in 2005 to conform with the World Trade Organization’s (WTO) agreement on intellectual property rights, specifically the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

It is asserting a patent covering “oral compositions for absorption of phosphorous compounds” against Mastix. The patent was registered in October 2010 by CM&D, a subsidiary of Nestlé.

If a country believes that a law or policy of a country discriminates against its companies, it can challenge them through the WTO’s dispute settlement system.

The complaint claims that Mastix has infringed and continues to infringe the patent by making and preparing to sell RenaGum without authority within the US.

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NewsInBrief IPA slams US ‘discrimination’ allegations Continued from page 1

Nestlé and Mastix in chewing gum spat Continued from page 1

RenaGum is chewing gum formulated with chitosan to help patients with chronic kidney disease maintain normal phosphate levels. Mastix markets itself as a provider of underused emerging dosage forms such as tableted In the letter, Shah argued that larger foreign chewing gum, chewable tablets and lozenges. companies have flooded the Indian patent office with numerous applications, preventing do- Nestlé is seeking damages for infringement and mestic generic companies from producing and an injunction preventing the release of Renamarketing affordable drugs for Indian patients. Gum in the US.

IPProINBRIEF

Denying that India was targeting US companies, Shah added: “It would have made no difference to the ... rejection of the patent for Glivec, if the patentee happened to be an Indian company.”

Last year, India gave a compulsory licence to The parties did not respond to requests for comment. generic player Natco to produce Nexavar, because Bayer, its inventor, failed to develop it and NPEs bring one in five US make it accessible and affordable in the country.

patent suits

IPA and Pfizer did not respond to requests Non-practicing entities are responsible for for comment. around 20 percent of patent litigation in the US, to a new report by the US GovernCell regeneration tech not infringed, according ment Accountability Office (GAO).

says US appeals court

The report was published on 22 August under the title Assessing Factors That Affect Patent A district court ruling in May 2011 held that His- Infringement Litigation Could Help Improve togen was not liable for infringement, but Skin- Patent Quality. Medica appealed against the decision, alleging misconstruction of its patents. GAO is statutorily obliged to study the consequences of NPE patent litigation after Article On 23 August, Judges Raymond Clevenger and 34 of the America Invents Act came into effect Sharon Prost delivered the appeal court’s main March. jority decision, upholding a request for summary judgement from Histogen based on their finding The report described that, after fluctuating only of non-infringement. slightly between 2000 and 2010, the number of patent infringement suits brought in the US The judges ruled that the text used in Skin- increased by about a third in 2011. The report Medica’s patents was not strong enough to attempts to explain this increase, noting that limit others from using a particular 3D cell-gen- increasing numbers of so-called ‘patent trolls’ eration method involving beads—the technol- may have played a part. ogy that Histogen had been accused of using without permission. It stated: “Stakeholders knowledgeable in patent litigation identified three key factors that Judge Prost, presenting the decision, stated: likely contributed to many recent patent infringe“It is [clear] that, although the inventors never ment lawsuits. First, several stakeholders GAO explicitly redefined “culturing . . . cells in three- interviewed said that many such lawsuits are dimensions” to exclude the use of beads, they af- related to the prevalence of patents with unclear fected a clear implicit disclaimer of culturing with property rights; for example, several of these beads from the scope of their claimed invention. ” stakeholders noted that software-related patents often had overly broad or unclear claims Judge Randall Rader, chief judge of the appeals or both.” court, dissented from the decision, stating: “To my eyes, the four references to beads relied “Second, some stakeholders said that the poon by this court are ambiguous. They do not tential for large monetary awards from the meet the exacting standard imposed by this courts, even for ideas that make only small concourt’s precedent.” tributions to a product, can be an incentive for patent owners to file infringement lawsuits.” Gail Naughton, CEO and chairman of the board at Histogen, commented on the decision: “We “Third, several stakeholders said that the are excited to have confirmation from the Feder- recognition by companies that patents are a al Circuit Court of Appeals that Histogen’s tech- more valuable asset than once assumed may have nology is unique, and outside of SkinMedica’s contributed to recent patent infringement lawsuits.” patent rights.” Although not citing them as the main reason for SkinMedica, which has been owned by Allergan rising numbers of infringement suits, the report since December 2012, did not respond to a found that NPEs did bring one in five of all patrequest for comment. ent lawsuits between 2007 and 2011. Continued from page 1

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Theory insight

Academic Dr Laura Biron discusses the concept of intellectual property

Conference preview

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LES (USA & Canada) 2013 Annual Meeting chair Brian O’Shaughnessy reveals what’s in store for attendees

Unitary patent

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Dr Aloys Hüttermann of Michalski · Hüttermann & Partner on what life sciences companies may do when the unitary patent system is implemented

Dundee biotech

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GlycoBioChem’s Dr Francesco Rao on setting up shop in Dundee

Russia overview

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Russian pharma is looking rosy, according to Vladimir Biriulin of Gorodissky & Partners

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IPPro

LIFESCIENCES

Editor: Mark Dugdale [email protected] Tel: +44 (0)20 8663 9620 Reporter: Franki Webb [email protected] Tel: +44 (0)20 8663 9620 Account manager: Wayne Edwards [email protected] Tel: +44 (0)208 663 9625 Associate publisher: Carlos Northon [email protected] Tel: +44 (0)20 8663 9623 Published by Black Knight Media Ltd. Provident House, 6-20 Burrell Row Beckenham, BR3 1AT, UK Copyright © 2013 Black Knight Media Ltd. All rights reserved.

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NewsInBrief Concluding the report, GAO recommended that the US Patent and Trademark Office take into account the various trends identified in patent infringement litigation, and use it when examining patents and applications, in order to improve overall patent quality.

Horizon settles patent dispute with Par

innovation and breadth of the Duexis patent able facemask for a breathing system. The comportfolio,” said Timothy Walbert, CEO of Hori- pany’s complaint refers to BMC’s Willow, iVolve, zon, in a statement on 22 August. RESmart CPAP, and RESmart Auto-CPAP as the infringing products. “Duexis offers important potential advantages to patients suffering from osteoarthritis who In the complaint, ResMed asked the US ITC to are at risk of developing upper gastrointestinal issue a limited exclusion order and cease and ulcers and we look forward to many years of desist orders. continued growth.”

ResMed takes ITC action to enforce sleep aid patents

Horizon Pharma has entered into settlement and licence agreements with Par Pharmaceuticals to resolve a patent dispute over Duexis The US International Trade Commission (US (ibuprofen and famotidine) tablets. ITC) will launch a patent investigation into Chinese medical device company BMC Medical, Under the licence agreement, Horizon has after receiving an infringement complaint about granted Par Pharmaceuticals non-exclusive its sleep therapy products. rights to retail generic ibuprofen and famotidine product in the US under the company’s Abbrevi- The complaint was filed on 19 July by ResMed ated New Drug Application (ANDA). Ltd of San Diego, California. The settlement agreement will see the parties The San Diego company is alleging that BMC dismiss the patent infringement complaint filed Medical violated Section 337 of the Tariff Act of by Horizon in the US District Court for the Dis- 1930 with its 3B Medical units. trict of Delaware on 17 January. The products infringe asserted patents for Horizon took issue with Par Pharmaceuticals af- breathing systems to prevent sleep apnoea, acter it filed an ANDA with the US Food and Drug cording to ResMed. Administration for a generic version of Duexis. ResMed is asserting eights patents against “We believe this settlement validates the BMC Medical, including a patent for an adjust-

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“We’re encouraged by the ITC’s action to investigate this case against BMC,” said ResMed global general counsel and chief administrative officer David Pendarvis. “For more than two decades, ResMed has generated significant advances in innovative products for sleep-disordered breathing therapy. We invest over $100 million in research and development each year to fuel these advances and other companies should not be allowed to infringe ResMed’s intellectual property by using our technology.” The US ITC is yet to make a decision on whether there is a violation of Section 337. The agency will set a target date for completion of the investigation within 45 days of ResMed’s initial complaint. If the US ITC finds in favour of ResMed, the BMC Medical breathing systems at dispute could be banned from being imported into the US.


NewsInBrief South Korea to guarantee IP The Korea Credit Guarantee Fund (KODIT) began granting guarantees of up to 1 billion won ($900,000) to new business ventures and small and medium companies based on their intellectual property in August.

Eisai previously licensed a generic version of delivered on 27 August, with the court upholdAricept to Ranbaxy Labs in November 2010. In ing the ruling at first instance that Covidien’s April 2011, Wockhardt received permission to trocar products do not infringe on patents belonging to AMR. prepare a second generic formulation.

Covidien wins keyhole surgery device appeal

The Korean Intellectual Property Office (KIPO) is to support the cost of evaluating the value of IP held by business start-ups and SMEs, while KODIT is to guarantee the results of the IP evaluations in order for companies to procure funds for commercialising their IP rights, including patents.

“We are pleased the court recognised that Covidien’s trocar products are differentiated from our competitors,” said Steve Blazejewski, president of surgical supplies at Covidien.

Covidien has triumphed against Applied Medical Resources in a patent action before the US “As we have demonstrated, we will vigorously Court of Appeals for the Federal Circuit protect our innovative products, solutions and intellectual property.” In May 2011, Applied Medical took Covidien to court in connection with Covidien’s marketing of specific ‘trocar’ devices, surgical instruments AMR did not issue a public statement on the decision. Since 2000, the company Around 300 billion won ($2.7 million) is to be used in keyhole surgery. has brought five patent infringement suits provided in guaranteed support. KODIT plans The appeal decision in Covidien’s favour was against Covidien. to increase the budget further depending on the success of the programme, according to the agreement between the fund and KIPO, which was signed on 6 August. The IP-based guarantee is not designed to differentiate guarantee ceilings based on a company’s sales figures, but to provide a guaranteed ceiling of 1 billion won based on IP evaluation results to ensure that only the best rights benefit. “The agreement is expected to make it easier for companies with excellent IPRs to procure funds,” said KIPO commissioner Kim Youngmin. “We will actively support this to help increase IP-based financing in Korea.” KIPO received 396,996 IP applications in 2012, up 7 percent from 2011. Trademark applications experienced a 7 percent growth of 132,522 while registrations went up by 9.3 percent to 77,903, according to KIPO’s 2012 annual report.

LIFE SCIENCES INTELLECTUAL PROPERTY

Patent applications have also risen 5.6 percent to 188,915.

Eisai licenses generic version of Aricept

EUROPEAN PATENT AND TRADE MARK ATTORNEYS

Eisai has entered into a non-exclusive licensing agreement with a generic drug manufacturer to create a generic version of its Aricept product. Aricept is the trade name for Donepezil, which is a centrally acting reversible acetylcholinesterase inhibitor. The agreement grants certain rights, including the right to market and sale a generic version of Aricept. It allows the generic drug company, which could not be named for legal reasons, to distribute the drug only within the US. The agreement also covers a non-exclusive license to Eisai IP covering donepezil hydrochloride (23mg), including a US patent (8481565) covering a method for stabilising anti-dementia drugs.

At Mewburn Ellis we offer outstanding service and cost-effective strategies for all aspects of Intellectual Property protection in the Life Science sector. To find out more please contact us.

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NewsInBrief

Patent suit on the Horizon for Activis Activis is being pursued for patent infringement after it filed an application to make generic versions of anti-inflammatory drug Rayos. The infringement claim was filed by Horizon Pharma with the US District Court for the District of New Jersey on 28 August. Horizon accused Activis of infringing five US patents, which cover the drug and its dispensor, after the company applied for permission from the US Food and Drug Administration (FDA) to make generic versions of the drug. Activis filed its Abbreviated New Drug Application (ANDA) concerning Rayos with the FDA earlier this year, notifying Horizon of the application on 15 July. In the filing, Activis claimed that its production of Rayos would not infringe on the patents in dispute, and, in the alternative, that the patents should be found invalid or unenforceable. The infringement case which Horizon brought in response on 28 August was filed in conjunction with SkyePharma subsidiary Jagotec, which owns the patents but licenses all five to Horizon. Horizon and Jagotec are seeking declarations of infringement of each of the five patents, an injunction to prevent Activis launching generic

versions of Rayos, and, should the company could be accelerated if an application qualifies go ahead and begin manufacturing the drug, for one of four criteria, including inventions for monetary relief. environmental technology. There were 22 public responses to the scheme from IP firms and attorneys, some of which raised serious concerns regarding the risk of granting invalid patents, accordThe UK Intellectual Property Office (IPO) has ing to the IPO’s report on the government’s shelved plans to implement a ‘superfast’ service response to feedback. that could have seen patents granted within The deadline for submitting comments passed 90 days. in June. UK business secretary Vince Cable originally proposed plans for the superfast service The IPO also stated that there was a risk that rapid grants would be seen as more advantalast year. geous than standard patents. Costing an applicant between £3500 and £4000, the service would have set stricter Darren Smyth of law firm EIP in London said deadlines for submitting information as well there was little evidence that showed support as a minimum period of one month, between for the superfast service from applicants. He publishing and granting an application, to allow concluded that with the service it would be extremely difficult to mitigate disadvantages to third parties to respond. third parties and there would be a higher risk of If patent applicants could meet these require- granting invalid patents. ments, their applications could have been processed within three months rather than the “For these reasons and others, there appeared to be very little likely demand for the service. current average of four and a half years. Furthermore, some respondents suggested Timescales for patent processing can change that introduction of the service could potentially depending on the invention and circumstances. impact on the IPO’s reputation for delivering afIn the UK, obtaining a patent can be relatively fordable, high quality patents,” said the IPO. short by world-wide patent standards. “Following careful consideration of the reDespite this, the UK government said examination sponses received and the specific concerns

‘Superfast’ patent plan stops dead

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NewsInBrief raised, the government has decided not to The US Federal Trade Commission and the implement the proposed superfast service, Department of Justice will review the settlement or to make any changes to the IPO’s existing agreement, in compliance with US law. acceleration services.” The office received just over 20,000 patent applications in 2012, according to its annual report.

Teva sues Perrigo over generic inhaler

Teva Pharmaceuticals is taking Perrigo to court alleging that the generic drug company’s soonto-be released asthma treatment infringes four Avanir Pharmaceuticals has entered into a set- patents for its ProAir HFA inhaler. tlement agreement with Actavis over Nuedexta, a drug that helps to control unmanageable Teva Pharmaceutical Industries filed the claim emotional outbursts. on 16 August in the US District Court for the Dis-

Avanir settles dispute with Actavis

The drug manufacturer accused Perrigo of knowingly and purposely infringing the licensed patents, claiming that: “As a result of the foregoing facts, there is a real, substantial, and continuing justiciable controversy between plaintiffs and defendants as to liability for the infringement of the [patents].” “Defendants’ actions have created in plaintiffs a reasonable apprehension of irreparable harm and loss resulting from defendants’ threatened imminent actions.”

trict of Delaware.

The drug manufacturer is seeking compensation for damages and an injunction preventing the release of Albuterol until the patents reach expiration.

Perrigo’s Albuterol Sulfate inhaler allegedly infringes four US patents that are licensed to Teva for ProAir (7105152; 7566445; 6446627; and 8132712).

Teva also offered to sell Perrigo’s generic Albuterol ANDA product in the US before expiration in the event that Perrigo gains approval before the district court issues its judgement.

Avanir filed lawsuits in the US District Court for Teva’s complaint stated that Perrigo infringed the District of Delaware on 11 August 2011. the asthma inhaler patents when it applied for an Abbreviated New Drug Application (ANDA) Actavis’s settlement agreement with Avanir with the US Food and Drug Administration begrants it the right to sell a generic version of fore the expiration of all four patents. Nuedexta from 30 July 2026. In its ANDA, Perrigo claimed that the patentsOn top of the settlement with Actavis, Avanir in-suit are “invalid, unenforceable, and/or would also settled with Sandoz last month. The com- not be infringed by the manufacture, use, impany is pursuing litigation against the remaining portation, sale or offer for sale of its Albuterol ANDA filers. ANDA product.”

Notably, Teva and Perrigo have a collaboration agreement in place for the generic drug Temodar, a treatment for adults suffering from newly diagnosed glioblastoma multiforme.

Avanir sued Actavis as well as Sandoz, Par Wockhardt, Impax and Watson to prevent them from marketing a generic version of Nuedexta, for which they have submitted Abbreviated New Drug applications (ANDA).

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Under the agreement, Teva will manufacture, market and distribute the product in the US but will share the cost and profits with Perrigo. Perrigo declined to comment, while Teva did not respond to requests for comment.


NewsInBrief

The Patent Profile

IPPro highlights the latest patent grants in Europe, the US and elsewhere

The US Patent and Trademark Office (USPTO) patent application for its core technology to treat awarded Rational Biotechnology a new patent multiple sclerosis (MS), the company revealed for a high-throughput cell transfection device on 22 August. and methods on 20 August. The therapy is similar to the technology that the Rational Biotechnology originally filed the pat- company uses for traumatic brain injury, cancer, ent (8513000) in April 2010. and Alzheimer’s disease. The patent explains: “Transfecting biology cells A lifetime MS treatment could cost an estimated with nucleic acid molecules is an essential pre- $1.2 million per patient, according to Premier. requisite in elucidating how genes function in complex cellular context and how their activities There are approximately 400,000 diagnosed could be modulated for therapeutic intervention.” cases of MS within the US alone. On a worldwide basis, there are nearly 2.5 million con“Traditionally studies are carried out on a low firmed cases of the illness. throughput gene-by-gene scale, which has created a huge bottleneck in functional genomic “Multiple sclerosis is a devastating disease study and drug discovery.” which has destroyed the lives of many tens of thousands of patients. We believe that Premier OncoMed Pharmaceuticals received a patent Biomedical is on the path to make a very major (8507442) from the USPTO on 13 August, cov- breakthrough in defeating this illness,” said Dr ering methods of treating cancer with its mono- Mitchell Felder, chairman of Premier’s Scientific clonal antibody Vantictumab. Advisory Board. Vantictumab targets the Wnt signalling pathway. The European Patent Office (EPO) has awardIt is currently in phase one of a study to assess ed medical device maker Medipurpose a patent its effectiveness in treating patients suffering for its babyLance safety ‘heelstick’ product. from advanced solid tumours. The patent (2303123) was awarded on 23 OncoMed has several patents and pending ap- August. The patent provides protection in the plications for Vantictumab in 14 different coun- EPO’s 38 member states. tries and in Europe. The USPTO has confirmed the validity of a “The issuance of this patent further validates the patent (6835084) held by Bal Seal for the use novelty of this promising antibody and the inno- of a canted coil spring-based electrical convative nature of OncoMed’s ongoing discovery nector in active implantable medical devices. programmes,” said CEO Paul Hastings. The patent was validated on 23 July. The patent will expire in 2029. The USPTO not only confirmed the original Health Enhancement Products (HEPI) has ac- claims in the patent for medically implantable quired the intellectual property of Wellness Test- electrical connectors unamended, it also aling Company on 19 August. lowed an additional 39 claims based on submissions presented by the company. HEPI presented the transaction to shareholders at the annual meeting in Detroit on 21 August. “It’s an affirmation of our patent,” says Rick Dawson, CEO of Bal Seal, “but it’s also an acIt will transfer all of the assets to WellMetris a knowledgment of the fact that our spring-based subsidiary formed solely to deal with the connectors have been and will continue to be the product of innovation, not duplication. We’re new assets. pleased to have a validation of the value that The acquisition covers an analysis and records our engineering work and experience have management system that allows governments, brought to this industry.” employers and insurers to assess the health of The USPTO granted Yukon Medical a patent a population to effectively focus prevention and for its new Vial Access and Injection System intervention to lower healthcare costs. on 21 August. At the shareholder meeting, HEPI also presented a design for a human reader device and a prototype for a bovine reader device, which measures biomarkers for transition cow syndrome and respiratory disease. HEPI filed the patent application for the technologies on 15 June.

“Each of our patents validates our ongoing promise to patients and caregivers through our advanced product designs. Our recent regulatory clearances and patent issuances demonstrate to our customers we are continuing to listen innovate and bring new products to market.” The USPTO has issued a patent to Atlantic Pharmaceuticals. The patent covers Atlantic’s SMART/ Script abuse deterrent drug delivery system. SMART/Script is designed to increase the difficulty of extracting a drug out of an oral dosage form and to deter the abuse of medications via known routes of misuse, including chewing, snorting, and injecting. “Based on its potential to retard or delay a drug’s release rate when physically disrupted, we believe that a SMART/Script enabled dosage form could serve an important role in decreasing the epidemic prescription drug abuse problem currently observed in the US,” said Anthony Soscia, president of Atlantic Pharmaceuticals. Exalenz Bioscience has received a patent from the USPTO for its BreathID Platform technology that evaluates the liver condition of a patient. Exalenz Bioscience was awarded the patent (8512258) on 21 August. The BreathID system is a platform capable of assessing a range of gastrointestinal disorders through continuous flow of the patient’s exhaled breath. “We are enthusiastic about today’s patent. Exalenz intends to develop an impressive product pipeline based on the BreathID Technology Platform. Today’s achievement marks the latest progress in this ongoing initiative, “ said Exalenz Bioscience CEO Lawrence Cohen. Galena Biopharma has obtained a patent for a breast cancer treatment from the EPO. The patent was awarded on 21 August. It covers NeuVax, a vaccine for the prevention of relapse in certain breast cancer patients. “This patent expands our intellectual property protection for NeuVax in Europe, and further validates our novel, cancer immunotherapy approach to preventing the recurrence of breast cancer in women who otherwise have no treatment options,” said Mark Ahn, CEO of Galena Biopharma.

The patent (8475404) covers sterile access to standard drug vials and needle-free drug prepa- The patent expires in April 2028. ration and administration. Yukon’s Vial Access and Injection System also provides a patent pending passive needle safety feature that actiSend all grants to vates after delivery of the medication.

[email protected]

“These advancements mark yet another milePremier Biomedical is pursuing an international stone for us,” said Todd Korogi, CEO of Yukon.

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IPTheory

Conceptually speaking

IPPro talks to academic Dr Laura Biron about intellectual property as a concept CARRI SWANN REPORTS Does ‘intellectual property’ accurately describe the underlying concept?

normally be able to say. At the moment, the law protects tangible property in a way that creates several clear legal entitlements: people have quite strong rights to control access to or use That is a really interesting question. Many peo- of their property. What’s interesting is whether ple point to the foundation of the World Intel- the term ‘intellectual property’ refers to this very lectual Property Organization (WIPO) in 1967 strong full-blooded notion of property. as the first time that ‘intellectual property’ came into common usage as a catch-all term to cover In my work, I have to first of all look at whether quite diverse and distinct areas of law: copy- this strong notion of ownership is the right way right, trademarks, patents, and trade secrets. to understand property. Secondly, I have to conIt’s worth noting that some legal historians ques- sider whether it’s right to conceptualise objects tion whether the term is accurate as an umbrella that are essentially abstract, like works of art or term for what developed historically as quite inventions or words, as property. separate areas of law. The main question for a philosopher to consider is what the word ‘property’ really means here. In my work, I’ve explored whether describing something as property automatically enables you to say things about it that you wouldn’t

somebody has to a tangible object should automatically be the same when we talk about intellectual objects. I’ve argued for a more nuanced understanding of property generally, leading to a better understanding of ‘intellectual property’ specifically. I have suggested that we have ontological reasons for distinguishing different bundles of rights, different conceptions of ‘property’, based on their subject matter.

Why have we adopted a system that commercialises things such as art, music and human progress, and places limits on how much we share these?

Seeing the concept of property as a bundle of different rights—to control, exclude, and so on—prompts us to ask, can the rights in the bundle vary to create different degrees and va- There are arguments to be made in favour of rieties of ownership? If so, then problems may commercialising some objects of human knowlarise if we assume that the bundle of rights that edge. Commercialisation is often a matter of

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IPTheory

I think that sometimes we forget this in debates about IP. Nonetheless, sometimes commercialisation can go too far. Sometimes, creators market their products so aggressively and invest so heavily in advertising that they inflate the true value of their products. These creators are using the IP system to recoup costs that were not really a factor in the creation of the work—they’re simply trying to make a profit. There have been examples of pharmaceutical companies engaging in this type of activity, as well as the entertainment industry. In cases like this, I think commercialisation can undermine the objectives of the IP system. Moving on to what I see as the second part of the question, it doesn’t follow from commercialising something that you actually have to restrict access to it and exclude people from it. It’s true that people who invest labour in producing a piece of music or an invention will want some way of recouping their costs, but it doesn’t follow from this that the reward or incentive in question needs to be a property right. There are alternative ways of incentivising people to go out and create things, or to reward their creative efforts.

Is there anything you would like to say about alternatives to IP? Are there any that you see as preferable—and viable?

the information in the patent particularly intelligible or accessible to others because we have a very proprietary model, but in a more communicative system the onus would be on the patent owner to try and make the information in the patent as clear and accessible as possible. Even in the case of trademarks, the communicative approach is relevant. Some people try to expand the function of a trademark way beyond just preventing consumer confusion, attempting to restrict any and all unauthorised references to the mark, even informally and in artworks. The protection of the Olympics logo is a good example. By changing the way we look at trademarks, we could create a culture in which individuals are free to communicate well and draw on existing objects, whilst retaining the core purpose of a trademark to guard against consumer confusion. I think that there are all sorts of ways that we could think differently about trademarks using that model. That’s the theoretical framework I’ve looked at, which is all about communication. In terms of policy considerations, I’ve been involved for several years with a project called the Health Impact Fund (HIF), based on an idea by philosopher Thomas Pogge, which he’s developing together with economist Aidan Hollis. The HIF offers a new way of paying for pharmaceutical innovation, which is designed to supplement the patent system. It essentially suggests a system of government rewards for pharmaceutical companies and other healthcare innovators, which would provide them with an alternative revenue stream to the patent licensing system.

I’ve approached this question in my work in two Governments are asked to put forward a pot of money, which will be used to reward innovators ways: conceptually, and in policy terms. for their contributions to healthcare once they Firstly, I’ve considered different ways of concep- relinquish their patent rights. The reward will be tualising intellectual objects. Specifically, I’ve directly in proportion to the actual health impact talked about the communicative function of IP, that their inventions make. and whether it would be more appropriate to use copyright, trademarks and patents as ways Under the HIF system, products that are everof communicating valuable information instead greening existing inventions, and so don’t have a great deal of additional impact, or products of—or as well as—treating them as property. that are essentially cosmetic products, probably Each type of IP instrument plays an important wouldn’t bring substantial rewards, and might role in fostering and facilitating communica- continue to be funded via the patent system. tion. It’s perhaps most obvious in copyright, However, life-saving products and those that where there’s already a lot of literature about have a significant health impact would be how copyright protection overlaps with free- rewarded accordingly. dom of speech. Some writers say, for example, that publishing something without their The strength of this proposal is its potential consent is a bit like forcing them to speak to promote the twin goals of enabling both against their will. widespread access and valuable innovation in the healthcare sector, which the patent Patents also serve an important communicative system does not always adequately encourfunction since, to apply successfully for a age. It’s also a great example of the contripatent, you have to disclose the information that bution that philosophy and other academic the patent contains. At the moment, there isn’t disciplines can make to policy debates about much of an incentive for companies to make intellectual property. IPPro

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“

Creators market their products so aggressively and invest so heavily in advertising that they inflate the true value of their products

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Dr Laura Biron

making use of human ingenuity and creativity, making sure that certain objects of value are available for people to enjoy. Many works of art, music and invention that we take for granted would not have come to fruition if it had not been for commercial enterprises of some kind.

ConferencePreview

Doing the deal

IPPro hears from Licensing Executives Society (USA & Canada) 2013 Annual Meeting chair Brian O’Shaughnessy, who reveals what’s in store MARK DUGDALE REPORTS What are you aiming for attendees to take away from this year ’s Annual Meeting?

is very significant and it will have an effect on the biotechnology industry that will reverberate for many years. But the overall implications are fairly straightforward. We know that people will have to adjust their portfolios and This meeting comes at a critical time as the in- claim strategies and things of that nature. tellectual property world faces the most signifi- But what he’s really going to talk about is the cant changes in more than 50 years. Beyond evolution of Myriad. new US patent reform legislation, there is an increased focus on IP monetisation and the ad- Myriad began as a Silicon Valley startup biotech vent of non-practicing entities, or ‘patent trolls’, company. It developed a sophisticated licenswhich have spurred several ‘anti-troll’ bills that ing regime and was able to perpetuate itself are now pending in US Congress and threaten through very savvy and comprehensive licensour industry as a whole. We’ve also seen a ing programmes that elevated it from startup to number of very significant cases addressing world-class leader in the diagnostics market. issues such as equitable relief for standard essential patents. I think this keynote address is emblematic of

What other highlights can attendees How important is monetisation becoming? look forward to?

I think that the main thing I want to convey is that with all of this change comes a sense of urgency. The LES Annual Meeting is a unique gathering where people can come and learn from leading industry experts and thought leaders about pivotal developments and what those developments might mean for their careers. It’s also an opportunity to make their voices heard, whether it’s to exchange information with a colleague or to debate some of the most important issues of our time. The goal is for every attendee to leave with fresh perspectives, new connections, strategies and tools to encourage success in today’s every-changing IP landscape. IPPro

We’ve just added a couple of hot topic panels, which we deliberately delayed filling until now, knowing that there would be late-breaking industry developments to address as the meeting approached.

The general counsel of Myriad Genetics is giving a keynote speech— what’s in store for attendees?

One such development is the effect of standard essential patents enforcement. We’ve had very significant events here in the US, including one of the International Trade Commission’s decisions in Apple v Samsung being overruled by the president’s office, which is a very unusual step. So we’ve added a hot topic panel to look specifically at standard essential patents.

I think the overriding message I would like to convey here is that Richard Marsh is not going to the talk only about the Supreme Court case. Obviously, the Supreme Court decision

The second hot topic is, of course, the troll phenomena. This has gained a tremendous amount of steam over the summer and we now have six different bills pending in US Congress attempting

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Chair of the 2013 annual meeting LES USA & Canada

I think monetisation is becoming an increasingly important aspect of IP management. There is a growing recognition by both licensers and licensees that IP assets can be monetised and this is driving a more sophisticated system of valuation. We actually have a great deal of programming in our upcoming meeting from what I consider to be stellar leaders in the field of IP valuation.

The annual meeting is a bit of a ‘call to arms’ for the licensing industry. It’s an opportunity to become educated about steps that might be taken in US Congress that will impact the economy, industry and innovation, as well as individual careers.

Brian O’Shaughnessy

All of these developments are having a profound effect on our industry and how we do business. The meeting, which is themed ‘IP Matters in Every Deal’, is designed to address these developments head on and to provide attendees with seasoned insights and analysis from top industry leaders, as well as strategies for managing the changing IP landscape. The programme will look at what’s going on in IP commercialisation across industry sectors generally and how all of these dramatic changes have come to bear on licensing.

how LES differs from many other patent-oriented societies. Rather than focusing on dissecting the thought processes of the Supreme Court and what’s going to happen to patent law going forward, Marsh will talk more about what the business implications of this decision are and the history of Myriad as a company, particularly how it exploited licensing in an effective business model that allowed the company to grow from one man’s vision to the world-renowned diagnostics company that it is today.

to stem the tide in troll litigation. Each one is worse than the last and each one will have a profound effect on the licensing professional and the industry as a whole. Quite frankly, if any of these bills pass there would be a deleterious effect on the licensing industry. In fact, it would make it very difficult to survive as a licensing enterprise.


Think big. The powerful IP process built for big business.

Think M U R G I T R O Y D. murgitroyd.com/big

EUPatents

The unitary project

The unitary patent system is on its way. IPPro talks to Dr Aloys Hüttermann of Michalski · Hüttermann & Partner about what may happen when it’s implemented MARK DUGDALE REPORTS European bodies report that applicants could be able to file unitary patents as early as January 2014. Given that the Unitary Patent Court agreement is yet to be ratified, how likely is this?

Furthermore, it seems unlikely that there will be ratification of the Agreement on the Unified Patent Court in Germany this year since we have elections in September. The UK, which must ratify too, seems to be waiting for Germany before it ratifies.

conventional European patents and validate country by country, and if they decide to stick to the conventional European patent, should they ‘opt-out’ from the Unitary Patent Court?

Alexander Ramsay, vice chairman of the Unified Patent Court’s Preparatory Committee, Absolutely unlikely, because first of all also recently told on a conference in Paris that mid There are three different scenarios that patenthe—often overlooked—changes to the direc- 2016 or early 2017 is a reasonable estimate, so tees may follow after their patents have been tive (1215/2012) have to come into force before who am I to disagree? granted by the European Patent Office (EPO): the whole system may start. There is a draft (i) applying for unitary patent; (ii) conventional just recently published so this will probably not Should life sciences companies validation without opt out; and (iii) conventional go for a unitary patent, or keep validation with opt-out. come before midst of 2015.

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EUPatents tack. Therefore, it will be possible to record not spend their money on opting out their patthe ‘opt-out’ in advance before the system has ents beforehand. Of course, when a potential liteven started. igation arises then the decision about opting-out should be made, and if yes, an opt-out should For conventional future and existing European be filed as the first measure in order to avoid patents, the question is two-fold. being attacked by the alleged infringer.

The question of whether to opt-out is presumably one of the most highly debated within the Please note that one major disadvantage of the patent departments of companies, especially unitary patent is that there will be no ‘thinning- life sciences and pharma firms, since for them out’ any more, ie, keeping a patent in selected IP is essential. The answer depends on whether countries only and dropping less important you trust the Unified Patent Court or not. countries as annuity fees rise over time. However, in pharma, thinning-out is usually not an However, in my opinion patentees—even if they issue. On the contrary, patentees usually file do not really trust the Unified Patent Court— supplementary protection certificates (SPCs) should bear in mind that the unitary patent syswhen these are available, which means that tem as a whole is politically desired and probthey will keep their patents in all countries over ably will not go away or miraculously disappear, their whole lifetime. no matter how many patentees opt-out or not. Therefore, patentees cannot avoid the Unitary However, when choosing a unitary patent, pat- Patent Court if they file at the EPO—the only entees may not opt-out from the Unitary Patent alternative would be to file national patents Court, which means that they have to trust that country-by-country. the Unitary Patent Court has a high quality of jurisdiction. Furthermore, under the Unitary As a result, patentees should try to gather some Patent Court regime, a central nullity attack is in-house experience within the opt-out period so possible, which could destroy the unitary patent that they are not completely helpless when optas a whole. Under the existing validation re- out is no longer available. gime, this—at least de jure—has to be done country-by-country, thus increasing the burden From my discussions with IP counsel, I have for attackers. come to the view that they see it as I do and will therefore try out the Unified Patent Court, On the other hand, filing a litigation suit at the probably in somewhat less important cases. Unitary Patent Court will give you the possibility For really important cases, at least at the beto stop infringers in the whole unitary patent ter- ginning, they will probably still opt-out, but this ritory, whereas—at least de jure—litigation had may change if it turns out that the Unified Patent to be done country-by-country, too. Court comes to reasonable jurisdiction.

Therefore, in the life sciences sector, companies will usually only opt for scenarios (i) and (iii). Scenario (ii) may be more prominent for companies in the mechanical or consumer goods sectors, where validations in a maximum of three countries is the rule. According to the EU, 50 percent of all granted patents are validated in three countries (Germany, France and the UK) or fewer. For future patents, if patentees go for a unitary patent once it’s available, they have no option but to choose the Unitary Patent Court. For existing patents, as well as future patents that are commonly validated, it is true that there is an ‘opt-out’ possibility, ie, the patentee may say that the Unified Patent Court is not responsible. This ‘opt-out’ may be registered and is valid as long as no proceeding has begun, which essentially means that the patentee has the choice unless there is no nullity at-

Undoubtedly for the life sciences sector (especially for companies that also have a link to pharma), the unitary patent will be a huge costsaver since validation costs, especially translations, will decrease tremendously. Observers have therefore labelled the unitary patent as a “gift for the pharmaceutical industry”, although others have been less positive, with some calling it a “Danaan gift for the pharmaceutical industry”, given the fact that a central attack is possible.

The unitary patent is system has long been labelled as of most benefit to SMEs—in practice, do you expect this to be proven true, and why?

Since in my experience, especially in life sciences, the fate of many small and mediumsized enterprises (which are usually start-ups) hangs on their IP, this may be true to some extent. SMEs and start-ups in particular need on the one hand broad protection for their patents and that not so essentially for the reason that they want to sue infringers, eg, in Hungary or The question of whether to opt out beforehand in Romania. However, they usually licence their or just before commencing litigation seems technology and for this reason broad protection simple at first: since an opt-in is possible at any is essential to gather revenue. time, of course patentees should opt-out as a safeguard. However, according to the published On the other hand, SMEs are usually short of lidraft rules of the Unified Patent Court, opting quidity, especially when they are start-ups in the out will be subject to a fee that, according to early years. Since in the conventional validation rumours, will be around €200 to €400, which system the largest amount of money must be makes it unattractive for larger companies to spent right after grant for validations and transopt-out completely. Keep in mind that the three lations, ie, quite early, unitary patents may be attop companies, Bosch, Panasonic and Sie- tractive for them, even though they later cannot mens, have around 1000 patents granted per ‘thin out’ their portfolios. IPPro year at the EPO. On the other hand, a safeguard opt-out is only then necessary if patentees have reason to fear that without opting out competitors may file a central nullity attack at the Unified Patent Court. However, the competitors have no experience of how the Unified Patent Court will rule. Therefore, I would expect that the danger of being attacked would not be significantly higher than it is today. Bear in mind that in Germany nullity suits may be filed for patents at any time. When looking into literature (eg, Keukenschrijver, Nichtigkeitsklage), we learn that less than 10 percent of all nullity suits are filed ‘out of the blue’, ie, not in a context of a litigation suit. Therefore, I will advise my clients that unless extraordinary circumstances apply, they should

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Partner Michalski · Hüttermann & Partner

The de jure aspect is important because usually the strategy would be to start an infringement or nullity suit in just one country, typically Germany or to a lesser extent the UK, and then either seek an agreement or hope that courts in other countries would follow the verdict, which in my opinion, at least for German verdicts, is more or less always the case.

How do you expect a unitary patent system to benefit the life sciences sector in the EU (or participating member states) once it is operational?

Dr Aloys Hüttermann

Unitary patents are undoubtedly huge costsavers for applicants that have a policy of broad validation, including non-London-Agreement countries. Since many life science companies have this policy, especially when they are active in or have ties to pharmaceuticals, where a validation in nearly all countries is usually done, this may be very attractive to them.


TradeSecrets

Eli Lilly v Huang: what’s new and what’s old in trade secret protection in China

Interlocutory injunctions are on the table for companies whose trade secrets have been misappropriated. Bird & Bird’s Christine Yiu reports In Eli Lily v Huang, the Shanghai No.1 Intermediate Court recently issued the first interlocutory injunction order in a trade secret action based on Article 100 under the new PRC Civil Procedure Law. This decision marks a positive step towards effective trade secret protection in China, and also serves as a reminder for companies to review their internal protocol in order to minimise risk of trade secret breach by an ex-employee.

Eli Lilly v Huang This trade secret dispute involves Eli Lilly and Company, the US pharmaceutical corporation, its Chinese subsidiary, and a former chief chemistry researcher of that subsidiary. Huang was employed on 3 May 2012, upon which he signed a confidentiality agreement undertaking various confidentiality obligations to the employer. On 19 January 2013, Huang downloaded 21 confidential documents from the company server without authorisation. Despite Eli Lilly’s repeated requests, Huang declined to delete any of those documents but elected to resign. Eli Lilly discharged Huang on 27 January 2013, and later sought redress in the court by bringing a trade secret misappropriation action under the Anti-Unfair Competition Law against Huang, seeking injunctive relief and damages in the amount of RMB 20,000,000 ($3.3 million).

100 thus allows a court to grant interlocutory in- With this in mind, employment termination should be handled carefully and with a welljunction against trade secret perpetrators. thought through protocol. Individualised risk Chinese courts would consider the following assessment should be conducted even before factors when granting an order under Article the intention to terminate is communicated to 100: (i) whether the alleged harm is occurring or the employee. Such an assessment would help about to occur; (ii) whether the applicant would to identify the level of exposure to trade secrets suffer irreparable harm that cannot be remedied by that employee or anyone working for or with by payment of damages; (iii) whether an ap- him/her, and the potential of any data breach. propriate security bond has been posted by the With a clear understanding of the overall risk, applicant against cross-damages; and (iv) any the employer may then take tailored steps to issues of public interest. Eli Lilly provides an ex- execute the termination. The trade secret manemplary case in which a court would be comfort- agement aspect could include: Reviewing the existing terms on the conable in granting an interlocutory order upon an • fidentiality obligation in the employment application by a trade secret holder. One factor contract and/or company policy; that may have worked in favour of granting such Monitoring IT use of the employee and asorder in that case is that the interlocutory relief • sessing the nature and scope of confidenwas sought against the ex-employee and not tial information that has been downloaded the new employer. to his/her personal phone or computer; Requesting the employee to return any Accordingly, in line with previous intellectual • work computer and documents that are property rights legislation, the new Civil Proceemployer property; dure Law sets forth a clear basis for seeking an Restricting the employee’s further access interlocutory injunction in trade secret cases, • to confidential information stored in the and thus affords aggrieved trade secret holdcomputer and office; and ers the same level of protection compared to • Conducting an exit interview: it could serve other IP rights holders. as an opportunity to remind the employee of his/her existing and ongoing confidentiNonetheless, it is important not to lose focus ality obligations, and to request for specific even after an interlocutory injunction order is post-employment undertakings to reinobtained. Continual monitoring on the part of force any such obligations. the employer remains vital to prevent any new or further disclosure by the ex-employee. Noncompliance with court orders has always been In the event that a court action is unavoidable, a problematic area in the Chinese legal sys- taking the above steps would also help to setem, as a breach of court order is rarely pun- cure evidence required for such proceedings ished with a heavy fine or imprisonment unless and increase the chance of obtaining an interthe breach is shown to be repeating and se- locutory injunction, which is now confirmed to rious. A disgruntled ex-employee may not act be an available remedy in China through the sensibly, and judges may be sympathetic to a case of Eli Lilly v Huang. IPPro

On 2 August 2013, the Shanghai No. 1 Intermediate Court issued an interlocutory injunction order prohibiting Huang from disclosing, using or allowing others to use the alleged trade secret contained in the 21 confidential documents Huang downloaded from Eli Lilly’s server and had refused to delete. Eli Lilly deposited RMB 100,000 ($16,300) with the court person who has recently lost his or her job. as a security bond for the order.

Managing employee termination and protecting trade secrets

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Partner Bird & Bird LLP

In general, employee termination should be treated as both a HR and trade secret matter that calls for case-specific evaluation and handling. Even if the employment contract clearly sets out the confidentiality obligation, on an emotional level an ex-employee may feel that they created the know-how and hence is morally justified to take it away. In some extremely hostile cases, an ex-employee would deliberately ‘lose’ the company laptop or even empty out the entire office (including furniture and computer servers) because they do not want the ex-employer to benefit from their work.

Christine Yiu

In granting the interlocutory injunction to prevent further disclosure of trade secrets, the court applied Article 100 of the new PRC Civil Procedure Law, which came into effect on 1 January 2013. Article 100 of the Civil Procedure Law provides, in relevant part, that a court may order a party to perform or refrain from doing certain acts if the other party would be harmed or if it would be difficult to enforce the judgement otherwise. Similar interim measures were previously available under separate statutes of Patent Law, Trademark Law, and Copyright Law, but not the Anti-Unfair Competition Law, which governs trade secret actions. The new Civil Procedure Law now codifies these interim measures, and as a general rule applicable to all civil proceedings in China, Article


DundeeFocus

That’s not a hub: this is a hub

Dr Francesco Rao of GlycoBioChem tells IPro about setting up shop in Dundee MARK DUGDALE REPORTS What does GlycoBioChem do and how did the company come about?

The main biotech hub in the UK is the Cambridge area. The big advantage there is that there is a critical mass of university spinout companies. GlycoBioChem is a University of Dundee spin- The Dundee/Tayside area is not quite there yet, out limited company based on the discovery and though we have some established companies development of novel drugs for the purposes of here such as Cyclacel, CXR biosciences, and Dundee Cell Products. research and treatment of human diseases.

Many of my colleagues have been recruited from academia to patent agencies and are trained in patent law. Having a former research scientist working for patent agencies helps transition ideas into patents. However, to get the patent finalised is slow, and I remain hopeful that this will change.

The company started from research from the laboratory of Professor Daan van Aalten, which looks at a very unusual sugar modification to proteins known as ‘O-GlcNAc’. This modification plays a role in neurodegenerative diseases such as Alzheimer’s disease. This particular research area allows for a unique approach to developing a therapeutic against Alzheimer’s.

With regards to how important patents are to a successful and beneficial biotech sector, I would say that it’s essential. It is important to have patents in biotech as it can help secure external investment and enables us to approach a larger pharmaceutical company with our idea or product and know that our ideas are protected. IPPro

However, we have a number of advantages located in the Tayside area, mainly very affordable office/lab space, which is in close proximity to the university and hospital. This coupled with our close location to St Andrews, Edinburgh, Aberdeen and Glasgow means that we have access to develop our business. Dundee airport is five minutes by car from the university and a direct flight to London City Another potential therapeutic that we are devel- airport takes an hour and a half. It would be oping is a novel drug to reduce the inflammation good to have a direct flight to Amsterdam or in diseases such as Asthma. Heathrow, as much of our business is based in Europe/the US. In addition to our drug development strategies, GlcyoBioChem provides reagents and services.

I would say that the UK patent system has been a hindrance in the past, but this appears to be changing. In the last five years, I have seen many UK academic institutes recruit dedicated people to facilitate academics research/ideas into a patent.

What aims does the University of Dundee set for its spinout companies in this sector, and how much of an emphasis is there on producing licensable IP?

If you build it, they will come

The University of Dundee is keen to create a stimulating environment for spinout companies. To achieve this this, there is a dedicated team at research and innovation services to help academics patent their ideas. This is important for the university as it’s a source of revenue, but also most UK research funding councils want to see applied research and IP. The University of Dundee is keen to aid the development of a spinout company and in the licensing of IP. The university helps to ‘preincubate’ spinout companies and gives advice regarding IP matters. Once the spinout has established, there is the ‘incubation’ phase, where companies can transferred to a physically different office/lab space, while still receiving support.

What is BioDundee’s mission?

In your opinion, what more does Dundee need for it to compete with other hubs in the UK?

Managing director GlycoBioChem

We are a young company and are actively producing intellectual property. Since starting out, we have an exclusive licence for two potential therapeutic drugs. The first pertains to a novel treatment against Alzheimer’s disease and the second against Asthma. We are actively working on these areas and looking for a company to partner with us to develop this further. We are open to the possibility of pharmaceutical companies buying our IP.

The UK patent system is often called a hindrance rather than a help—in your opinion, how important are patents to a successful and beneficial biotech sector?

Dr Francesco Rao

What about GlycoBioChem IP?

Dr Allison Beattie of BioDundee tells IPPro what her organisation does to promote Dundee as a life sciences hub BioDundee is a partnership between the public, private and academic sectors. Our mission is to build on the strength of the life sciences sector in Dundee and Tayside internally through: nnowledge and skills development; building partnerships and collaboration; and information exchange and networking. While externally promoting and positioning the Dundee life sciences sector to relevant audiences as a centre of world-class life science activity, we aim to facilitate cooperation between the Dundee City Council, Scottish enterprise, academia and private enterprise.

How is it working to develop Dundee into a life sciences hub? It’s BioDundee’s strategic event programme and marketing strategy that has successfully turned the city into a hub for life sciences. Our events are targeted at both companies and academics and range from networking evenings to training programmes, and knowledge exchange seminars. Our events are tailored to our members and fill a gap in the market to ensure continued support and attendance.

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PharmaInsight

Welcome to the club

Russia’s pharmaceutical market is coming along nicely. Vladimir Biriulin of Gorodissky & Partners gives IPPro an overview of the current situation MARK DUGDALE REPORTS Furthermore, before the entry into force of Russia’s patent law in 1992, chemical substances were not patentable in the Soviet Union. But from 1992, Russians began patenting more medicines and more pharmaceuticals, because it was allowed. Now, all of those patents are about to expire—the term is 20 years, although some may be extended for not more than five years because of clinical trials—and when the patents expire, generics will flood the market. While a patent is in force, generics can be fought, as they could be before Russia joined the WTO.

The pharmaceutical industry in Russia is developing quite nicely. In 2011, approximately 1300 patents were granted. Of those, only 350 were granted to foreign applicants and about 770 went to domestic applicants. In 2012, the proportion remained the same, because foreign applicants obtained only 620 patents while Russian patent holders obtained almost 900 patents. It’s worth noting that most of these Russian patents belong to medical research institutes. Also, these figures are not complete because they only include pharmaceutical products. There are other patents is- Now, the situation is even better, because the sued for chemical substances—they might also law prohibits generics entering the market with be pharmaceuticals. the clinical data confidentiality provision. Since I would also like to point out that the Rus- a lot of patents are now expiring, we expect a lot sian government is developing the domestic of generics will try to come to the market after pharmaceutical industry. Thanks to the gov- the expiry of the relevant patents.

What has been the most significant effect of Russian joining the Word Trade Organization? The most positive development to come from Russia joining the World Trade Organization (WTO) is a new clinical trial data provision. There is a law on the circulation of drugs in Russia and there is a very important provision in that law that—because of the struggle against generics—says that clinical data should be kept confidential for six years. The provision was pending the entry of Russia to the WTO, but it has now been in force for a year.

What else is happening in the Russian pharmaceutical market?

The big pharmaceutical companies are all in Russia and a pattern of them acquiring Russian companies is emering. This information is confidential, but there are mergers and acquisitions between foreign companies and Russian ones. The government is also taking steps to domesticate the production of pharmaceuticals. As a result, foreign companies are willing to give licences to Russian What are pharmaceutical companies companies and locate the production of their meddoing ahead of their patents expiring? icines. This process is also in their favour because the Russian labour force is cheaper than many The process, from what I am able to under- places, including Europe and the US. IPPro stand, is that the companies, knowing that their patents will expire soon, are developing new patents or developing continuations that could improve the earlier existing patent. But the WTO has not only strengthened Russia’s position, it’s a matter of prestige, but it is in more in favour of the foreign companies that conduct clinical trials, because now their data will be kept confidential.

How are in-house counsels handling patent licences in Russia?

I’m rather pessimistic about in-house counsels because they only work for one company and This is also a very important factor for foreign they cannot have the competence to draft or pharmaceutical companies, because now they register licence agreements. Therefore, and it is do not have to worry about generics entering my personal experience, in-house counsels are the Russian market once their patents expire. not very qualified, unfortunately.

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Partner Gorodissky & Partners

ernment, the scope of the Russian market grew 12 percent in 2012 in comparison to 2011. This is certainly less than the index of the market before the 2008 financial crisis, but nevertheless the figure is quite impressive.

This is a number of provisions that should be mandatorily included in licences, but in-house counsels often fail to include them. Many foreign companies also do the same. We then have to advise them how those licences should be corrected. This is—while we speak about this subject—the disease of both the Russian and foreign in-house counsel. Licences are often given to us for registration and we have to spend a lot of time rectifying their mistakes.

Vladimir Biriulin

What are patent grants saying about the Russian pharmaceutical market?


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PeopleMoves Her patent work includes advising client on medical and optical devices, electromechanical technology, and cleantech. Arko also has experience in trademark searching, registration and enforcement for clients offering a range of products and services. UK-bases EIP opened its San Diego office in May 2013. Arko is the first lawyer to have been hired at the office. Sheppard, Mullin, Richter & Hampton LLP has hired life sciences lawyer Lorna Tanner as partner in its IP practice group. Tanner joined the firm on 13 August and is to be based in its Palo Alto office. Prior to her arrival at Sheppard Mullin, Tanner served as a partner at Foley & Lardner, where she advised clients in the pharmaceutical, biotechnology and medical device clients.

Industry appointments Lisa Tyner and James Cullem have joined the intellectual property practice of McCarter & English LLP. Tyner will be based in the firm’s New York office, while Cullem will work out of its Boston office. Both will serve as special counsel. Cullem is a registered patent attorney with more than 15 years of experience. His expertise is in both business development and handling IP licensing issues for early-to-mid stage biotech companies. Tyner specialises in patent prosecution and due diligence investigations in life sciences, and assists clients with the preparation of patentability, infringement, validity, and freedomto-operate opinions.

Her practice focuses on strategic advice concerning patent portfolio development and management. Her areas of technical expertise include pharmaceutical ingredients, drug delivery technology, biologics including modified proteins and viruses, green technologies, and years of experience representing Fortune 500 medical devices. companies. She also represents clients in postgrant proceedings before the Patent Trial and Duane Morris has hired litigator Steven Cowley Appeal Board (PTAB) of the United States Pat- as a partner in its Boston office. ent and Trademark Office (USPTO). Cowley joined the firm on 14 August from EdMoore focuses on biotechnology and chemistry, wards Wildman Palmer in Boston, where he had with an emphasis on molecular and cellular biolworked for nearly 22 years. ogy, small molecule chemistry, medical devices, agricultural chemistry, and food additives. His practice focuses on complex business litigation, with substantial work in trademark and Woodward, who has more than 25 years of copyright disputes, patent litigation and trade patent prosecution experience in the pharmasecrets. His clients include technology, manuceutical, chemical and biotech industries, like facturing and financial services companies. McBee represents clients in post-grant proceedings before the USPTO PTAB. IP firm Finnegan, Henderson, Farabow, Garrett & Dunner will be relocating its European office VLP Law Group LLP has hired Dianne Reed to from Brussels to London. the firm’s IP group. She joins as senior partner.

Miles & Stockbridge PC has added seven new Before joining, Reed founded her own firm, the attorneys and a patent agent to its IP practice. Reed IP Law Group, which was later was taken over by the Boston-based firm Mintz, Levin, The firm welcomes Susan McBee, Chester Cohn, Ferris, Glovsky & Popeo. Moore, and David Woodward as principals, Richard Henderson as of counsel, Bryan Reed has more than 30 years of experience Jones and David Vanik as counsel, and Shazi in a variety of patent practices representing Jiang as an associate. a selection of clients, including established companies, investors, non-profit organisaWilliam Brett Stauffer joins the firm as a tions, and universities. patent agent. She also has experience as a patent law expert All eight joined the firm on 26 August. in pharmaceutical patent litigation. They all moved to the firm from the Washing- IP firm EIP has hired patent attorney Cynthia ton DC office of Baker, Donelson, Bearman, Arko as a senior associate. Caldwell & Berkowitz. Arko joined the firm’s San Diego office on 14 McBee has more than 25 years of experience August from IP firm Knobbe Martens, where she in patent and trademark management and 15 had served for five years.

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The Washington DC based firm opened its Brussels office in 1993. The move to London will take place later this year, with all members of the Brussels office expected to be making the transition. Anthony Tridico, managing partner at the Brussels office, confirmed: “We are currently in the final stages of lease negations for office space in the Holborn section of London.” UK IP firm Marks & Clerk has promoted UK and European patent attorneys Aimee Cawley and Richard Gibbs to partnership. Cawley is based in Manchester and specialises in chemical and mechanical patent prosecution, while Gibbs is based in Glasgow. Gibbs’s specialism is in the fields of biotechnology and other life sciences. IPPro


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NETWORK WITH 150 SENIOR EXECUTIVES FROM IP RELIANT INDUSTRIES

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SHOWCASE YOUR CAPABILITIES IN SUPPORT OF INNOVATION

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DISCUSS THE FUTURE OF INNOVATION WITH WORLD LEADING TECHNOLOGY INVESTORS

www.londonpatentsummit.com Tel:

+44 (0) 207 352 4356

[email protected] IPR Connections Ltd 535, King’s Road The Plaza London, SW10 0SZ United Kingdom

LPS 2013 Industry Partners:

IPPro

LIFESCIENCES

iP Frontline WORLD’S LEADING IP PORTAL

www.iprconnections.com

www.londonpatentsummit.com

IndustryEvents

The 2013 Intellectual Property LES (USA & Canada) 2013 The London Patent Summit Owners Association (IPO) Annual Meeting Annual Meeting Location: Boston Date: 15-17 September 2013 www.ipo.org

Location: Philadelphia Date: 22-25 September 2013 www.lesannual.org/ippro

The 2013 Intellectual Property Owners Association (IPO) Annual Meeting provides concurrent sessions on patents and trademarks, including ethics sessions for patent and trademark attorneys.

Don’t miss your chance to join over 1,000 of The London Patent Summit is an annual meeting your colleagues for the licensing industry’s best platform for patent regulators, policy makers, opportunity for content and connections. board-level patent managers, as well as patent experts and investors in a dialogue designed Programme highlights include: Richard Marsh, to address and discuss best practices and Myriad Genetics’ top lawyer, on taking a com- solutions to enhance global, regional and pany from concept to reality; Ger Brophy, GE national patent management strategies. Healthcare Medical Diagnostics, on how innovation is improving healthcare; a panel debating “non-practicing entities”, and whether they frustrate or further society’s interests; interactive workshops delving into real world successes and failures, and exposing new best practices; and much more.

Join IPO on September 15-17, 2013 at the Sheraton Hotel in Boston, MA. Patent topics including Patent Case Law Updates; AIA: Looking Backward and Forward; Patent Damages and Injunctive Relief; Recent Developments in International IP; Corporate Collaborations with Universities; Trade Secret Enforcement; and Ethics. Trademark topics include Trademark and Copyright Case Law Updates; E-Discovery; Fair Use; Recent Developments on the Internet; Global Trademark License Agreements; Non-Traditional Marks; and Ethics.

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Location: London Date: 7-8 October 2013 www.londonpatentsummit.com


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