In today's edition of Nature (March 26) scientists from the JRC Institute for Prospective Technological Studies (IPTS) have published results from an on-going study conducted together with the European Techno-Economic Policy Support Network (ETEPS) with the support of EuroGentest, an EU-funded Network of Excellence (NoE) in the domain of genetic testing.
The study, entitled "Intellectual Property and Diagnostics", contains a compilation of evidence on where and how a representative sample of laboratories is exploiting DNA patents. It analyses the impact of this behaviour on European companies and clinical laboratories engaged in the development and provision of genetic tests and socio-economic consequences for the development of diagnostics and patient access to these diagnostics.
The purpose of such prospective studies, the speciality of JRC-IPTS, is to assess whether regulation at a European level in a given area is required.
Conducted across Europe, the study notes that genetic testing laboratories have generally had little experience of dealing with patents and require more support to negotiate the changing patent landscape around them. However, in many cases laboratories also lack awareness, experience and support to resolve patent-related issues, in an environment where patents are of increasing prominence. Private and public health insurers may thus end up having to provide more support due to increased costs relating to patented tests.
The concept of Intellectual Property Rights (IPR) is generally considered an important incentive for innovation as it facilitate the sharing of new knowledge and its application (invention) with the scientific community and society as a whole. In spite of its stimulating effect on innovation, it has been suggested that intellectual property also has the potential to inhibit research as a result of the proliferation of DNA patents, resulting in limited access to novel treatments and diagnostics, for example as a result of high licensing fees. Yet little empirical evidence exists on the actual impact that current patenting and licensing practices may have for the development and wider adoption of diagnostics. The study aims to fill this void.
Sibylle Gaisser, Michael M. Hopkins, Kathleen Liddell, Eleni Zika & Dolores Ibarreta, "The phantom menace of gene patents", Nature 458, 407-408 (26 March 2009) | doi:10.1038/458407a