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

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dc.contributor.authorTIMOCIN CANTEKIN, Zeynep
dc.date.accessioned2018-01-08T11:50:12Z
dc.date.available2018-01-08T11:50:12Z
dc.date.issued2017
dc.descriptionAward date: 22 November 2017en
dc.descriptionSupervisor: Professor Giovanni Sartor, European University Instituteen
dc.description.abstractFollowing 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.en
dc.format.mimetypeapplication/pdf
dc.identifier.citationFlorence : European University Institute, 2017en
dc.identifier.doi10.2870/106056
dc.identifier.urihttps://hdl.handle.net/1814/49748
dc.language.isoenen
dc.publisherEuropean University Instituteen
dc.relation.ispartofseriesEUIen
dc.relation.ispartofseriesLAWen
dc.relation.ispartofseriesLLM Thesisen
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subject.lcshGenes -- Patents
dc.subject.lcshBiotechnology
dc.subject.lcshPatent laws and legislation -- Europe.
dc.titlePersonalised medicine and patent law : an overview of the patenting of genetic inventions under United States and European law in relation to genetic diagnostic testsen
dc.typeThesisen
dspace.entity.typePublication
eui.subscribe.skiptrue
person.identifier.other38375
relation.isAuthorOfPublication573723b4-a7cd-4f6a-ab87-04482408054e
relation.isAuthorOfPublication.latestForDiscovery573723b4-a7cd-4f6a-ab87-04482408054e
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