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ARTICLE · 12 FEBRUARY 2019

Federal Circuit Finds A Diagnostic Method Ineligible Under Section 101

In another diagnostic method dispute, the Federal Circuit found the asserted patent claims ineligible under 35 U.S.C. Section 101.

United StatesIntellectual Property

In another diagnostic method dispute, the Federal Circuit found the asserted patent claims ineligible under 35 U.S.C. Section 101. In Athena Diagnostics v. Mayo Collaborative Services, Athena is the exclusive licensee of the '820 patent, covering methods of diagnosing neurological disorders such as myasthenia gravis (MG) by detecting antibodies to a protein referred to as MuSK. The '820 inventors discovered a relationship between MuSK antibody production and the autoimmune disorder MG. Athena also sells a test called FMUSK that evaluates the antibodies. After Mayo introduced competing tests that allegedly practice the claims of the '820 patent, Athena sued Mayo for infringement in the District of Massachusetts. Mayo moved to dismiss under Rule 12(b)(6), arguing that the asserted claims are invalid under 35 U.S.C. Section 101. The district court granted Mayo's motion, concluding that the '820 patent claims are directed to ineligible subject matter. 

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