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European recommendations on patenting and licensing genetic tests
A working group of the European Society of Human Genetics (ESHG) has brought out new recommendations on the patenting and licensing of genetic tests [Aymé et al. (2008) Eur. J. Hum. Genet. 16: S3-S9]. The recommendations are accompanied by a background paper covering the associated ethical, legal and social issues [Soini et al. (2008) Eur. J. Hum. Genet. 16: S10-S50].
Whilst it is generally recognised that patents can be beneficial for society, if they drive innovation and progress, they can also be problematic particularly in the field of genetics and genetic testing. Part of the problem is that identification of a gene or mutation associated with a particular trait is not an invention but a discovery, which is not patentable according to the European Patent Convention (EPC). Nonetheless, despite strong public and scientific opinion against the principle of patenting life, estimates suggest that patent applications have been filed for nearly 20% of human genes (see previous news story).
Genetic testing is an increasingly important part of medicine, and the proper use of patents for genetic tests should promote innovation and better healthcare services through a fair reward for the inventors. Indeed, the prospect of IP protection is one of the factors that drive translational research in the field of medical genetics. For example, patenting of novel technologies for genetic testing, such as PCR and microarrays, promotes investment whilst still allowing innovation around the technology. However, once a gene-disease association has been proven, the relative ease with which a novel test can be developed using a current technology platform make the patentability of the genetic test itself significantly more complicated.
The ESHG have reconciled these viewpoints with respect to genetic testing by recommending that:
(1) the breadth of the claims in genetic patents should be limited; for example, by limiting the patent on use of a test to a specific disease, as occurred in the case of the Myriad BRCA1 patent for breast cancer (see previous news story)
(2) the number of patents should be reduced by limiting the patentable subject matter; for example, by prohibiting patenting of specific gene variants
(3) a professional or scientific body should issue an annual statement on the obviousness/ non-obviousness to increase the quality of granted patents
(4) the concept of utility in patent law be redefined to take account of downstream clinical experience (i.e. clinical validity and utility associated with testing).