New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”

By Timo Minssen

I am pleased to announce that we have today published the following paper:

Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN.

This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It is currently under review by Edward Elgar.  A longer journal-version will follow.

Abstract: 

An effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significance is the development of standards. Considering recent developments within the software and ICT industries, it seems fair to assume that the process of standardization may also have significant impact on the development and adoption of Synthetic Biology (SB). Within SB different standardization efforts have been made, but few have assumed dominance or authority. Standardization efforts within SB may differ within various technical areas, and also the basic processes of standard creation can be divided into various categories. The different technical areas and processes for standardization differ in their speed, handling of interests and ability to dodge possible IPR concerns.

Out of this notion arises i.a. the following questions: How comparable is engineering in SB to more traditional fields of engineering?; What type of standards have emerged and what bearing have IPRs on these?; and, How applicable are the approaches adopted by the standards-setting organizations in the information and communication technology (ICT) to biological standards? These and further legal issues related to IP, regulation, standardization, competition law & open innovation require a careful consideration of new user-generated models and solutions.

Before this background, our paper seeks to describe IP and standardization aspects of SB in order to discuss them in the context of the “open innovation” discourse. We concentrate on describing the technology and identifying areas of particular relevance. Ultimately we also sketch out open questions and potential solutions requiring further research. However, due to the limitation of this paper we do not aim to create elaborated theories or to propose solutions in more detail. Rather this paper, which will be complemented by more extensive follow-up studies, provides a first overview on the complex questions that we are currently dealing with.

To achieve this modest goal, section 1 commences with a brief introduction to the fascinating science of SB and a description of recent technological advances and applications. This will lead us to section 2, in which we will address standard setting efforts in SB, as well as the relevance and governance of various IPRs for specific SB standards. This provides the basis for section 3, in which we debate problematic issues and summarize our conclusions.

Speech at US Patent Experts Conference in Naples Florida

The University of Akron School of Law will host the 2nd Annual Midwinter Patent Experts Conference in Naples, Florida February 10-11, 2014. The conference will be held at the Naples Hilton Hotel.

The faculty for the program includes, from the judiciary, the Hon. Kathleen O’Malley and the Hon. Richard Linn, of the Federal Circuit, as well the Hon. Roger T. Hughes, of the Federal Court of Canada. From the executive branch, the current acting director of the PTO, the Hon. Teresa Stanek Rea, will participate, as will the current Chairman of the Patent Trial and Appeal Board, James S. Smith, and former Administrative Patent Judge William F. Smith. Former PTO Deputy Director Sharon Barner and former Commissioner for Patents Robert Stoll will also participate. Robert A. Armitage, the father of the Leahy-Smith America Invents Act, will also be a featured participant.

A number of law professors who specialize in patent law are also included in the program. They include Dean Timothy Holbrook and Assoc. Professor Timo Minssen, Christal Sheppard, Dennis Crouch, Jason Rantanen, W. Keith Robinson, William Hubbard and Dr. Heinz Goddar. Senior corporate lawyers include Sharon R. Barner, Vice-President of Cummins Inc., and Richard Rainey, in charge of worldwide IP litigation for GE.

I have been invited to participate in a panel debate on “non-obviousness” and to give a speech on “A comparative US/European view on the law of non-obviousness” . My presentation will provide an introductory overview over relevant legal frameworks and various doctrinal concepts of the European and U.S. non-obviousness assessment. I will also discuss recent case-law developments that are of particular practical relevance. Special emphasis will be laid on chemical and biotech case law. I intend to argue that the KSR-induced, more flexible US-approach to obviousness has moved closer to the European approach and that I welcome this development. Yet, I also underline that specific statements in KSR and subsequent case law rightfully attracted criticism in both Europe and the US. Moreover, I plan to point out that by carefully aligning national case law with EPO precedent, recent U.K. decisions have applied a more “patent-friendly” approach with respect to, inter alia, the “obvious to try” issue and selection inventions. These decisions provide valuable insights and arguments to those who fear that KSR inevitably tipped the pendulum towards an overly strict non-obviousness standard, which disregards hindsight problems, the dynamics of the research environment, and the importance of patents in pharmaceutical R&D.

View the slides from this presentation here.

Book Review: Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective

By Timo Minssen

Following a request by the European Competition Law Review (Sweet Maxwell), I have today submitted a review of the recent publication  “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). The full contribution (6 pp.) is curently undergoing peer-review.

In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, systemizing and arranging a compilation of very interesting papers written by high profile authors. This has resulted in a very readable book providing a superb overview and up-to-date analysis of recent developments that have such a substantial impact on a significant area of law and practice. But are there any flaws?

Considering the numerous useful case law citations, as well as the wide scope of the book, it is a little unfortunate that the book does not contain a table of cases or a bibliography of material cited by the respective authors. Also it might perhaps have been beneficial to include some contributions from the pharmaceutical industry, private practice or NGOs. There is of course no doubt that all papers have been written by very competent authors and address real-world issues with much devotion to facts, details and commercial realities. But additional contributions by the industry or “field workers” would probably have enriched the numerous debates that are placed in such an extraordinarily complex environment at the interface of business realities, competition, technological innovation, and access to health care.

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Video Now Available: Responsibility and Integrity in the Pharmaceutical Industry

On November 21, the Petrie-Flom Center hosted a lecture by Neil Flanzraich on responsible pricing strategy, access to care, clinical trial design, outsourcing, and other topics that raise thorny but crucial issues for pharmaceutical and biotechnology companies.  (You can read a summary of the lecture here.) You can now view the lecture online.

Mr. Flanzraich graduated from HLS in 1968, and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012. He is the Executive Chairman of Kirax Corporation and the Executive Chairman of ParinGenix, Inc., both of which are privately owned biotech companies. He previously served as the Vice Chairman and President of Ivax Corporation, an international pharmaceutical company, which was sold to Teva in 2006 for an enterprise value of $10 billion.

Neil Flanzraich on Responsibility and Integrity in the Pharma Industry

This afternoon, the Petrie-Flom Center welcomed Neil Flanzraich for a lunchtime talk on responsibility and integrity in the pharmaceutical industry.  Mr. Flanzraich is the Chairman and CEO of Cantex Pharmaceuticals, Inc. and Executive Chairman of Kirax Corporation. He was previously Vice Chairman and President of Ivax Corporation, Chairman of North American Vaccine, Inc., chairman of the life Sciences legal practice group of Heller Ehrman White & McAuliffe, and Senior Vice President and General Counsel and a member of the Executive Committee of Syntex Corporation. He is also a member of the boards of directors of Chipotle Mexican Grill, Inc. and Equity One, Inc., among a variety of other positions.  Mr. Flanzraich was appointed by Harvard Law School Dean Martha Minow as an Expert-In-Residence at the Harvard Innovation Lab (i-lab) in the fall 2012, and we were thrilled to have him join us to share some his experiences.

During today’s lecture, Mr. Flanzraich focused on the need for integrity and accountability in all areas of life, but especially in the pharmaceutical industry. At the broadest level, he emphasized that consistent honesty requires motivation and commitment, and in the business world, it is incumbent upon company leadership to set the right example, reinforced by frequent and sincere messaging encouraging honesty and discouraging dishonesty.  This is the way for companies to be truly successful over the long term, even if it means possible sacrifices over the short term. Mr. Flanzraich suggested that leaders must establish the right corporate culture of trust, but also verify compliance through audits and other types of oversight.

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Big relief for Big Pharma: Indian Patent Office rejects application for compulsory license

Aditya Gupta

By a detailed order passed last week, the Indian Patent Office rejected an application for compulsory license filed by a generic drug manufacturer BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) seeking a license of Bristol Myers Squibb’s (“BMS”) Indian patent for an anti-cancer drug. The Indian Patent Office found that BDR had not made out a prima facie case for grant of a compulsory license since it had not made efforts to obtain a voluntary license from BMS on reasonable terms and conditions.

Though the Indian Patent Office did not go into the merits of BDR’s application and rejected it on preliminary grounds, this victory will help restore pharmaceutical companies’ faith in the Indian patent system.

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On Access and Accountability: Two Supreme Court Rulings on Generic Drugs

By Marcia Boumil and Gregory Curfman

In 2013 the U.S. Supreme Court issued two important rulings in cases involving the marketing of generic drugs. In Federal Trade Commission v. Actavis, the Court addressed the law governing a controversial pharmaceutical marketing practice known as reverse payment agreements, or pay for delay – a byproduct of the Hatch-Waxman Act.  This occurs when a generic drug company identifies a vulnerable patent held by a brand-name drug manufacturer and seeks Food and Drug Administration (FDA) approval for a generic version before the patent expires, provoking a lawsuit by the brand-name company for alleged infringement. A subsequent settlement involves the brand-name company paying the generic company to delay commercialization of its product (but not beyond the expiration of the patent). The FDA alleged that reverse payment agreements violate antitrust laws. The Supreme Court held that their validity would be evaluated on a case-by-case basis using the “rule of reason” standard. According to this standard, only those agreements that restrain trade will be viewed as violations of anti-trust law.

In the second case, Mutual Pharmaceutical v. Bartlett, the Court affirmed its 2011 ruling in Mensing v. PLIVA and held that generics manufacturers are substantially immune from civil claims regarding injuries caused by their products whether the tort claim be based upon failure to warn (Mensing) or design defect (Bartlett). The basis of the decision resides in the FDA requirement that generic drug labels be consistent with the label of the brand-name equivalent. Just days after the Bartlett decision issued, the FDA indicated its intent to propose a revision to the labeling requirements for generic drugs to create parity with branded drugs. If adopted, this revision could vitiate the law set forth in Mensing and Bartlett.

For more coverage of these cases, see the New England Journal of Medicine essay here.