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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Call for abstracts: “Analyzing the societal dimensions of synthetic biology” summer school

The Europäische Akademie GmbH – a research institution of the Federal State of Rhineland-Palatinate and the German Aerospace Center (DLR) – is currently inviting applications for the international summer school:

“Analyzing the societal dimensions of synthetic biology”

The target groups are graduates, Ph.D. students, and post-docs in synthetic biology, science and technology studies, philosophy, and associated fields in the natural and social sciences. Please find details of this call at http://www.ta-synbio-summerschool.de.

Applications including an abstract of max. 400 words and a CV should be sent by 10 March 2014 to: Kristin Hagen, Europäische Akademie GmbH, Wilhelmstr. 56, 53474 Bad Neuenahr-Ahrweiler, Germany; or via e-mail to: kristin.hagen@ea-aw.de.

The summer school is funded by the German Federal Ministry of Education and Research (BMBF) and organised jointly by: Kristin Hagen and Margret Engelhard (Europäische Akademie Bad Neuenahr-Ahrweiler, http://www.ea-aw.de), and Georg Toepfer (Center for Literary and Cultural Research Berlin, http://www.zfl-berlin.org).

Paper on “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”

By Timo Minssen

I am pleased to announce that my co-author Professor Jens Schovsbo from the University of Copenhagen and I completed a paper addressing “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”.

This perspective article, which has been written upon request by the medical journal “Personalized Medicine”, deals with the legal aspects of biobanking and points towards the concerns, interest, and choices that should be considered when establishing and operating a biobank. It focuses on public biobanks in a university setting and the specific challenges posed by PM with a special focus on publicly funded biobanks, commercialization issues and the involvement of industry.

To this end we start out by briefly discussing differing definitions of the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. The next part describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. Based on our finding we then sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and intellectual property rights (IPR). After this we use an on-going interdisciplinary research project based at the University of Copenhagen (UCPH) to illustrate how the legal and ethical challenges might be dealt with analytically and in a practical way that reflects the concerns and interest of stakeholders in biobanking and results in a transparent, legally and ethically robust system. In our closing remarks we make recommendations on how to improve the legal framework for biobanking and in particular for the challenges posed by PM.

We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional set up. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights (IPRs).

We will publish the paper on SSRN as soon as we receive the approval by “Personalized Medicine”. I’ll keep you posted.

UPDATE: The full paper is now available here.

Introducing Guest Blogger Timo Minssen

Timo Minssen is Associate Professor of IP & Innovation Law at the University of Copenhagen (UCPH), Centre for Information & Innovation Law (CIIR), Denmark. Before joining UCPH, Timo graduated from law school in Göttingen (Germany) in 2001 and was trained in the German court system from 2002-2003. He also passed the Swedish “juris licentiate” (LL.Lic.) and “juris doctor” exams (LL.D.) and holds two IP- and Biotech- related masters degrees from the Universities of Uppsala and Lund (Sweden). In addition he worked for a Life Science company and for various law firms in Sweden and Germany.

From 2007-2009 Timo was a stipendiary at the Max Planck Institute for Intellectual Property and Competition Law in Munich. He was also responsible for a course in comparative patent law at the Chicago-Kent College of Law (USA) and worked for the European Patent Office. At Lund University he was engaged as a teacher at the Faculty of Law and in interdisciplinary epigenetics research at the Pufendorf Institute for Advanced Studies. At UCPH he is co-leading CIIR’s Copenhagen Biotech & Pharma Forum and teaches international classes for both students and pharma professionals in EU-, Competition-, and Pharmaceutical Law and IPR. Timo is a frequent speaker on a variety of topics and has published extensively in comparative US and European patent law, EU- and Competition Law. In 2013-14, he will be a Visiting Scholar at the Petrie-Flom Center, and later at the University of Oxford.

See a full listing of Minssen’s research here.