Is a new method of diagnosing a disease patentable? Can it survive a motion to dismiss? And, irrespective of the current precedent, should a new method of diagnosing a disease be patentable? These are questions the U.S. Court of Appeals for the Federal Circuit, the solicitor general and medical diagnosis patent holders are struggling with.

Last year, in Athena Diagnostics v. Mayo Collaborative Servivces, the Federal Circuit held diagnostic claims ineligible under 35 U.S.C. Section 101, upholding, and perhaps expanding, the U.S. Supreme Court’s holding of the 2012 case, Mayo Collaborative Services v. Prometheus Laboratories. What’s more, on Jan. 20 the Supreme Court denied certiorari in Athena against the backdrop of pleas for clarification from the Federal Circuit, the solicitor general, and multiple amici briefs, including one from the former chief judge of the Federal Circuit. So, without additional clarification in sight, medical diagnosis patent holders, researchers and practitioners are left to make do with the current landscape.

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