Personalised medicine and patent law : an overview of the patenting of genetic inventions under United States and European law in relation to genetic diagnostic tests
Florence : European University Institute, 2017 , EUI LLM theses, Department of Law
TIMOCIN, Zeynep, Personalised medicine and patent law : an overview of the patenting of genetic inventions under United States and European law in relation to genetic diagnostic tests, Florence : European University Institute, 2017 , EUI LLM theses, Department of Law - http://hdl.handle.net/1814/49748
Retrieved from Cadmus, EUI Research Repository
Following the U.S. Supreme Court decisions in Mayo Collaborative Services v. Prometheus Labs. Inc. and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the future of patentability of genetic material is uncertain. In the U.S., the decision in Myriad which allowed the patenting of cDNA molecules seems to have limited the force of the concerned voices from the genomic research community that had called for substantial limitations on the patenting genetic material based on the argument that these patents seriously inhibit genomic research and prevent broader provision of genetic diagnostic tests to the public. In the EU, and in markets under the EPC, the patentability issue remain unclear due to lack of judicial guidance. This status quo coincides with the ambitions of governments in both sides of the Atlantic for incentivising research and investment in personalised medicine, a field that is dependent on genetic diagnostic tests and promises radical improvement in public healthcare provision, but also potentially lots of profit and tax. In the light of all these, this paper explores social, political and more particularly legal issues surrounding developments in genomic technologies and personalised medicine, and offers an extensive overview of the limits of substantive patent law in the patenting of genetic inventions in the U.S. and Europe. The paper concludes that the approach of the Biotechnology Directive under EU law setting an over-arching industrial applicability requirement for gene patents offers a balanced response to the challenges created by these patents. Other solutions such as widening the scope of compulsory licensing or the experimental use exception, or creating a sui generis gene right are also visited. Finally, new CRISPR technology that might further challenge the existing legal frameworks is briefly introduced.
Award date: 22 November 2017; Supervisor: Professor Giovanni Sartor, European University Institute
Cadmus permanent link: http://hdl.handle.net/1814/49748
Full-text via DOI: 10.2870/106056
Series/Number: EUI LLM theses; Department of Law
LC Subject Heading: Genes -- Patents; Biotechnology; Patent laws and legislation -- Europe.