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Human genes have been the subject of patent protection for quite some time. It has become common practice to grant patents for genes isolated from the human body, meeting the conditions of novelty, inventive step and industrial applicability. Even though the initial wave of criticism against human gene patents has quieted down, the controversy lingers on as the current patent landscape for human genomic science gives rise to new concerns.
Objections have especially been raised with regard to the exploitation and licensing of gene patents. Mixing metaphors, thoughtful observers are increasingly expressing concerns that the exponential growth of patents claiming human DNA sequences may lead to a ‘patent thicket’ or even a ‘patent tsunami’. It is feared that an abundance of patents will lead to royalty stacking and ultimately frustrate the use of technology, leading to a ‘tragedy of the anticommons’ in upstream research. An anticommons effect may not only arise from the emergence of patent thickets, but also from ‘blocking patents’. Concerns have equally been expressed with regard to downstream research in the genetic field. New inventions might not find their way into products and a ‘translational gap’ might widen to form a ‘valley of death’.
The authors in the present collection have reflected on the impact of gene patents and have explored various measures to deal with possible hindering effects, each in their own way and from their own, theoretical or practical, experience. Their papers form the very basis of this book.
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.
At present the genetics community is increasingly concerned that patents might lead to restricted access to research and health care. Thoughtful observers are increasingly expressing concerns that the exponential growth of patents claiming human DNA sequences may lead to patent thickets, royalty stacking and, ultimately, to a ‘tragedy of the anticommons’ in the genomic field. An anticommons effect may also arise from blocking patents. Concerns have also been voiced with regard to downstream research as new genetic inventions might not find their way into products and a translational gap might emerge.
In an attempt to capture and comprehend these recent developments, and to reflect on potential remedies, the Centre for Intellectual Property Rights of the University Leuven (Belgium) organised a two-day international workshop on ‘Gene Patents and Clearing Models: From Concepts to Cases’ on 8–9 June 2006. This workshop took place in the framework of a research project on ‘Gene Patents and Public Health’ sponsored by the Fund for Scientific Research Flanders (FWO, Belgium – Grant number G.O120.04), EuroGenTest (a Network of Excellence set up under the European Union Framework Programme 6 – Contract number 512148) and the Vancraesbeeck Fund (K.U.Leuven, Belgium). For the research that led to the workshop and the present book, as well as for the workshop, we are very grateful to those organisations.
The workshop aimed at exploring models designed to render patented genetic inventions accessible to further use in research and to diagnosis and/or treatment in further depth, and to investigate alternative models.
Intellectual property rights have, from their inception, been shaped by international treaties. National legislators have had to look at the international scene to gain some insight into the prevailing intellectual property standards. This trend was less prominent in the field of patent law, and it was only with the coming into effect of the Agreement on Trade-Related Aspects of International Property Rights (TRIPS Agreement) that key international standards with regard to patents were established. In that regard, TRIPS seemed to constitute einen Meilenstein von enormer Bedeutung (a major milestone), since, for the first time in patent history, it introduced a worldwide framework of minimum standards with regard to the grant, scope and use of patent rights.
The present paper describes the global standards for the patenting of biotechnological inventions and offers an in-depth and critical comparison with those of European and national regimes. Section B describes the TRIPS rules for the patenting of biotechnological inventions and centres on six key issues: plants and animals, the human body, ethics, human rights, traditional knowledge and health. Section C examines the European patent biotech framework and revolves around the same topics. This examination demonstrates clearly that European patent law has adapted itself to the new reality of biotechnology in many ways, but that various issues remain unsettled and so call for further reflection and debate. In section C, a number of national patent systems for biotechnological inventions are considered, focusing on the same six topics.
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