Bioethics News

US Personalized-Medicine Industry Takes Hit from Supreme Court

August 24, 2016

(Nature) – Over the past decade, the Supreme Court has used a series of patent cases to clarify what the USPTO should consider patentable. Natural phenomena and abstract ideas, for example, are not patentable, according to section 101 of the US patent code, and the court has attempted to distinguish between these categories and true inventions. Two of those Supreme Court cases touched directly on the biomedical industry. In 2012, the Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision struck down two patents on medical diagnostics, and in the 2013 Association for Molecular Pathology v. Myriad Genetics ruling, the court threw out patents on gene sequences used to assess cancer risk. In the wake of those decisions, many lawyers predicted that patents on inventions that are important to personalized medicine — particularly, diagnostic tests that could match individuals to a particular therapy — would be hard to come by, potentially driving away investors.

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