Federal Circuit Summary

Before Judge Newman, Lourie and Stoll. Appeal from the United States District Court for the District of Massachusetts.

Summary: Claims reciting only conventional steps to detect a natural law, are patent-ineligible under § 101.

Athena Diagnostics (“Athena”) sued Mayo Collaborative Services (“Mayo”) for infringing a patent related to methods for diagnosing neurological disorders by detecting antibodies to MuSK, a membrane protein. The inventors of the patent discovered the association between MuSK antibodies and neurological disorders, and the asserted claims recited steps to detect the antibodies to MuSK. Mayo moved to dismiss, arguing that the asserted claims of the patent are invalid under § 101. The district court granted Mayo’s motion, concluding that the claims were invalid under § 101 for claiming ineligible subject matter.

The Federal Circuit affirmed. The Federal Circuit followed the two-part test set forth by the Supreme Court. First, the Federal Circuit held that the claims were directed to a law of nature, which is the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases. The Federal Circuit stated that the claimed advance was only in the discovery of a natural law and that the additional recited steps only apply conventional techniques to detect that natural law. The Federal Circuit also pointed out that the specification of the patent described the claimed steps for observing the natural law as conventional. For the second step, the Federal Circuit held that the claims did not provide an inventive concept sufficient to transform an unpatentable law of nature into a patent-eligible application of the law. The Federal Circuit stated that the steps of the claims not drawn to the law of nature only required standard techniques to be applied in a standard way, as described in the specification. Thus, the Federal Circuit held that the district court correctly concluded that the claims at issue were directed to a natural law and lacked an inventive concept.

Judge Newman dissented, writing that the decision improperly “enlarge[s] the inconsistencies and exacerbate the judge-made disincentives to development of new diagnostic methods.” Judge Newman stated that eligibility should be determined for the claim considered as a whole, and considered as a whole, the claims were directed to new multi-step methods of diagnosing a neurological disorder, not a law of nature.

This case is: ATHENA DIAGNOSTICS, INC. v. MAYO COLLABORATIVE SERVICES

Edited by: Paul Stewart

Written By: Nathan J. Lee and Christie Matthaei