Genetic inventions, intellectual property rights and licensing practices

This publication is an edited and amplified version of the rapporteur’s report of the Working Party on Biotechnology expert workshop, “Genetic Inventions, IPR, and Licensing Practices”, held in Berlin in January 2002. Invited speakers included practitioners from industry, government, public research organisations (PROs) and the legal community.

The meeting aimed to inform OECD member countries about:

• The challenges raised by the proliferation of patents on genes and gene fragments, and by the licensing strategies of firms, research bodies and others.
• Studies and empirical data that could shed light on the economic impact of the present system of intellectual property (IP) protection for genetic inventions, in particular studies that explore how patenting and licensing practices have influenced the research process, new product development and the clinical diffusion and use of novel treatments and
• The advantages and disadvantages of various policy measures, within and outside the IP regime, which could be used to address any systemic breakdowns in access to genetic inventions.

The focus of this report is the identification of any systematic problems encountered by researchers, firms or clinical users of DNA patents in their attempts to gain legal access to genetic inventions. The report also explores solutions that might be considered remedies to specific access problems.

The major conclusions of the workshop were that:

• The patentability of genetic inventions is not fundamentally in question among the users of the system.
• The available evidence does not suggest a systematic breakdown in the licensing of genetic inventions.
• The few examples used to illustrate theoretical economic and legal concerns related to the potential for the over-fragmentation of patent rights blocking patents uncertainty due to dependency and abusive monopoly positions appear anecdotal and are not supported by existing economic studies.
• In specific areas there is evidence of problems associated with the numbers and breadth of gene patents now being issued.
• Many consider the rise of patents with reach-through claims problematic and feel that this may require government attention. Empirical studies have shown problems arising over access to diagnostic genetic tests, although the exact cause of these problems has not been fully elucidated.
• The licensing system is not static but is adaptive. Companies, governments and civil society are reacting rapidly to deal with the increasing complexity of the intellectual property system in this area. Policy-based solutions to current problems will have to be able to cope with the system’s evident adaptability.
• Continued monitoring of patenting and licensing of genetic inventions is necessary. So too is the collection and analysis of robust economic data as a basis for action to ensure that access does not become more problematic. More rigorous, data-intensive studies of licensing practices in particular are critical if policy makers are to embark on significant reform of the present system.

[Adapted from authors text]