Patenting Genes: An Analysis of the Interaction Between Law and Industry in Policy Formation

Authors: Scullion, J.

Editors: Kretschmer, M. and Soetendorp, R.

Volume: 3

Publisher: Bournemouth University

Place of Publication: Poole, England

Abstract:

Juliet Scullion’s paper is a highly original effort, tracing the origins of current public policy on patenting genes through industry analysis and an examination of the evolution of law. For lawyers, it may be disconcerting to have case law analysed not for its authority but for the arguments advanced dealing with the main objections to the patenting of genetic material. Yet this provides a rich and rewarding perspective, helped by Scullion’s background as a genetic scientist.

The first chapter gives an overview of UK case law post 1980, preparing gradually the way for the controversial European Directive on the Legal Protection of Biotechnological Inventions (98/44/EC) which provides for patents for biological material that previously may have occurred in nature. Scullion points out that the famous Clinton/Blair declaration of March 2000, commending Human Genome Project scientists for releasing their results into the public domain - data that “should be freely available to scientists everywhere” - directly contradicts the UK Patent Regulations 2000, implementing the 1998 Directive.

The paper then provides a useful compilation of industry surveys, including data on patent applications filed (by 2000, there were 355,000 genetic sequences published in patents applications), location of industry clusters, and spending on R&D. Scullion suggests that the information contained in a company’s patent portfolio provides the best available indication to investors about the prospects of a biotech company in a volatile and high risk environment.

In a final chapter, a specific instance of policy making is investigated as a case study. In the successful lobby for the 1998 Directive, the industry had campaigned under the slogan “No patents - No cure” appealing to the public benefits of intellectual property law. For policy makers, however, the persuasive shift appeared to be increasing competition for investments in a global industry, exerting upward pressure on legal systems for the strongest patent protection. Scullion subjects the recent European consultation exercise Towards a Strategic Vision of Life Sciences and Biotechnology (COM (2001) 454 final) to detailed scrutiny, including follow-up interviews with key participants. The analysis appears to bear out the suspicion that policy is pre-framed by the needs of an important “knowledge industry”, rather than wider public concerns of access to scientific research or ethical considerations.

Martin Kretschmer

Source: Manual

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