Projekt

Fraunhofer-Institut für
System- und Innovationsforschung ISI

Intellectual Property Rights and Diagnostics: the Implications for Pharmacogenomics

Intellectual property rights (IPR) have been generally considered an important incentive for innovation as they facilitate the sharing of new knowledge (from inventions) with the scientific community and society as a whole. In parallel, they reward the inventor with the exclusive right to exploit the invention but only for a limited time. In spite of its stimulating effect on innovation, patenting has on occasion been suggested to potentially inhibit research. A particular case is the proliferation of DNA patents, resulting in limited access to novel treatments and diagnostics (e.g. as a result of high licensing fees). This argument is particularly supported by cases where patent holders have made broad claims (e.g. Oncomouse patent) or exert strict monopoly rights (e.g. Myriad Genetics holds or has licensed several patents on the breast cancer genes BRCA1 and BRCA21 and exerts strictly its monopoly rights in the USA by not allowing testing of the genes outside its laboratory). Further evidence in this direction is provided through a recent study indicating the negative impact of patenting and licensing practices on diagnostic research and testing carried out by clinical laboratories. Although substantial empirical evidence to support the potentially inhibitory effects of IPR on research is still lacking, a wider concern with regards to diagnostic tests remains, especially as emerging techniques allow the detection of multiple mutations at a time (microarray-based tests) to diagnose disease susceptibility or drug disposition. In this context, the development of patent thickets (a situation where different owners have overlapping patent rights requiring multiple licenses) could pose a significant barrier. The emergence of new applications for pharmacogenomics may further complicate the situation.

In this project the ETEPS network investigates the current implications of molecular diagnostic patents for the development and clinical use of pharmacogenetic testing. This analysis ETEPS will provide information on

  1. The key institutions involved in developing relevant diagnostic tests, and their experiences of exploiting their patents as well as the challenges posed by the patents of other organisations in the development of their products and services.
  2. The extent to which European clinical diagnostic laboratories are able to develop and offer molecular diagnostic tests in the current environment
  3. Detailed case studies on the development of specific tests that can provide key lessons for future licensing, diagnostic service provision, and the development of policy in this field.
Status:
Finished project 12/2007 - 12/2008

Clients:
  • European Commission DG JRC, IPTS
  • within the ETEPS AISBL framework
Partners:
  • Dr. Michael Hopkins; SPRU Science and Technology Policy Research, University of Sussex, Brighton, UK
  • Dr. Christien Enzing; TNO Centre for Technology and Policy Studies, Delft, NL
  • Mr. Stuart Hogarth, ISS, University of Nottingham, Nottingham, UK