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Intellectual Property Litigation Patent Licensing and Transactions Patent Litigation

Patenting Diagnostic Tests: Can We Expect Changes?

This article discusses the jurisprudence applied to determining patent eligibility of claims for diagnostic methods, and the expectation for changes in analysis of patent eligibility under §101 in the near future.


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Since the Supreme Court’s landmark decision in Mayo Collaborative Services et al. v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), the lower courts have repeatedly found patent claims for medical diagnostic methods to be ineligible for patenting under 35 U.S.C §101. In Mayo, the Supreme Court held that a claim for correlating levels of a drug metabolite in a patient’s blood to drug efficacy was not patent eligible under §101, because the claim at issue merely recited a law of nature — one of the judicial exceptions to patent eligible subject matter under §101.

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