Genetic Inventions, Intellectual Property Rights, and Licensing Practices
The objective of the project on Genetic Inventions, IPRs and Licensing Practices, launched in March 2001, is to gather information on the exploitation of patents for genetic inventions and the impact strategic intellectual property use has on research, product development, and health care. Documenting the benefits and costs of various approaches to the patenting and licensing of genetic inventions should help governments in evaluating whether the needs of society - the research community, industry, health care providers, and consumers - are being adequately met by the present system of intellectual property protection.
Patent protection has been fundamental to the development of new biotechnology firms and pharmaceutical product development more generally. There is a perception, however, that patents for genetic inventions are "special" and somehow different from other patents. In part, this may be because the genome is believed to represent a "unique key" for all future research and inventions. As gene patents proliferate, a number of issues have been raised by interest groups, including pharmaceutical and biotechnology firms, medical practitioners, public researchers, and patient groups. These issues include: dependency problems, the reluctance of researchers to enter fields where genes have already been patented or where multiple groups are competing to patent a same gene, restrictive licensing practices, royalty stacking, database access problems. However, there is no sense as to how frequently these issues arise, or whether they have any real costs. Indeed, it might be argued that the research community is adapting quickly to the new environment with strategies such as the creation of consortia and patent pools and the co-ownership of genes by patient groups that address some of the initial difficulties.
The challenge for governments is to understand how to assure legitimate access to genetic information and best distribute research results, funded by the public, for the public's benefit. The project will delve into the policy tools available to governments to reach this objective.
Guidelines for the Licensing of Genetic Inventions