Patents and genes: some new titles

The IPKat has recently found himself confronted with three new titles that, in their very different ways, address issues arising from the patentability of genetic material. In this post he says a little bit about each of them.

Gene Patents and Collaborative Licensing Models: Patent Pools, Clearinghouses, Open Source Models and Liability Regimes is the tenth volume in the Cambridge Intellectual Property and Information Law series. Edited by Geertrui Van Overwalle (University of Leuven, Belgium/University of Tilburg, the Netherlands), this book brings together the thoughts of more than 30 contributors and brings their combined brain-power sharply to bear on the book's focal point: striking the right balance between the positive and negative aspects of both the patent monopoly and the weapons that are developed to combat it.

So what precisely is this book about? Let the publisher, Cambridge University Press, explain:

"Concerns have been expressed that gene patents might result in restricted access to research and health care. The exponential growth of patents claiming human DNA sequences might result in patent thickets, royalty stacking and, ultimately, a 'tragedy of the anti-commons' in genetics. The essays in this book explore models designed to render patented genetic inventions accessible for further use in research, diagnosis or treatment. The models include patent pools, clearing house mechanisms, open source structures and liability regimes. They are analysed by scholars and practitioners in genetics, law, economics and philosophy. The volume looks beyond theoretical and scholarly analysis by conducting empirical investigation of existing examples of collaborative licensing models. Those models are examined from a theoretical perspective and tested in a set of operational cases. This combined approach is unique in its kind and prompts well founded and realistic solutions to problems in the current gene patent landscape.

• Descriptions of major models currently used to deal with patent thickets enable the reader to develop a complete view of the models and evaluate existing operational examples

• Case studies describe how each model functions, and the critical evaluations enable the reader to compare the advantages and disadvantages of the various models

• Concluding chapters analyse and compare solutions put forward by the various authors, thereby examining openings for the future".

Says the IPKat, while the interplay of legal, ethical, technical and commercial considerations may not be as complex as the genetic map of an organism, it is sufficiently convoluted area to require a multidisciplinary approach. This book provides that approach and leaves the reader with a very positive feeling that, the current patent system, as checked and balanced by competition law and enhanced by attainable win-win contract licensing strategies, possesses the necessary qualities to achieve the desired ends: disclosure of and access to technical information, its availability for use, protection both for investment and for development and the protection of the various public interests. Merpel adds, it is also refreshing to see how much thinking and writing has been done outside the United States: the bibliographies contained quite a few names and writings that were quite unknown to her and which, she feels, have definitely enriched her view of the topic. Both Kats are ashamed that their algebra isn't up to it and that they struggle terribly with some of the economics, even when the authors really do make an effort to assist them by explaining their terms pretty clearly. Maybe in another life ...

Bibliographic data: Hardback. xxxv + 477 pages. ISBN 13: 9780521896733. £75 (US$120). Web page here. Rupture factor: small.

Justice In Genetics: Intellectual Property and Human Rights from a Cosmopolitan Liberal Perspective is an offering by Louise Bernier, Professor and Head, Law and Life Sciences Program, University of Sherbrooke, Québec, Canada. According to publisher Edward Elgar,

"Providing new insight into the ideas surrounding one of the longest running and hotly debated governmental issues – the global access to healthcare challenge – Louise Bernier develops an original theoretical framework that builds upon cosmopolitan liberal theory. This groundbreaking analysis offers a useful justification for engaging in a global and more equitable redistribution of health-related resources.

The author examines if and how this theory of distribution translates into positive law and analyzes the barriers to legal compliance and global distributive justice in health. Other topics analyzed in this book include intellectual property and international human rights, and the extent to which the philosophy and structure of each of these normative systems furthers the goal of distributing benefits equitably and globally; the use of strong and original normative landmarks to justify relying on a cosmopolitan approach to global justice based on health needs; and the social, political, economic and legal obstacles and opportunities resulting from the commercialization of the quickly evolving field of genetics.

Ultimately, the book exemplifies the groundwork needed to initiate policy discussions and to eventually undertake concrete changes to achieve international redistribution of the resources emerging from genetics. As such, it will be of great value to students and scholars interested in health, law, human rights and intellectual property".

Says the IPKat, if you are not a Cosmopolitan Liberal you may not find yourself nodding in comfortable agreement with the author's position. However, a casual look at the sources and materials upon which she has drawn soon shows that she is far from alone in expressing her sentiments: you can pretty well compile a Who's Who of People Who Don't Like the Patent System from her footnotes. Having said that, Louise Bernier has raised a case against the current state of IP which is entitled to an answer, part of which is based on the fact that, in a hierarchy of human values, we appear to have placed issues of healthcare and access to medicines lower than wealthcare and access to the means of continuing to stay alive. Merpel adds, in her conclusion Professor Bernier affirms that new forms of commercialisation of IP should be explored -- on this basis the positive approach taken in Geertrui Van Overwalle's book (reviewed above) might well commend itself to her.

Bibliographic data: xiii + 255 pages. Hardback. ISBN 978 1 84844 315 0. Price £65 (with online discount from the publisher, £58.50). Web page here. Rupture factor: small.

Patents for Chemicals, Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy, now written by Philip W. Grubb and Peter R. Thomsen, is the welcome Fifth Edition of what used just to be plain good old Grubb. The IPKat has all four earlier editions on his bookshelf and will happily jettison any number of less worthy titles to accommodate the Fifth and subsequent editions. Oxford University Press, the fortunate publisher of this work, introduces it as follows:

"The chemicals, pharmaceuticals and biotechnology industries worldwide rely upon being able to patent inventions in order to protect investment in research and development, and to reap commercial rewards. An increasingly globalized sector requires a global perspective, and Philip Grubb's highly acclaimed book guides the reader through the legal and procedural complexities of the British, European, Japanese and US patent systems, and explains in detail the role of patent practitioners (both in-house and in private practice) in maximizing the commercial potential of their client's or company's innovative products.

This eagerly awaited fifth edition provides vital updating to take account of the latest legal developments, while retaining focus on the relevant technology and industry practices that sets it apart from more general books on patent law and procedure.

Patents for Chemicals, Pharmaceuticals and Biotechnology provides the reader with a complete description of the techniques and industry know-how that underlie successful patent practice and portfolio management and will be invaluable to all patent agents and practitioners working in the area of patent law. With its lucid and accessible presentation and practical approach, this book will also be welcomed by scientists, researchers and managers without a legal background".

Reviewing this work is a pleasure. Clear print, equally clear articulation of the law; helpful glossary; lots of examples. This book is actually of great value not just for readers with a chemi-, pharma- bio- bias but serves very well as an explanation of the operation of the patent system even for those whose interests lie in other spheres. There is enough comparison of the UK, Europe and the United States to enable the reader to identify those points at which problems are going to arise, even though it may take more than a flip through these pages to find the answer. But a European reader who has to get his American counterpart on the phone will at least be able to brief himself well before he dials.

Bibliographic data: Hardback. xlv + 537 pages. ISBN13: 9780199575237, ISBN10: 01995752. Web page here. Rupture factor: substantial.