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Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC

United States Court of Appeals for the Federal Circuit

February 6, 2019, Decided

2017-2508

Opinion

 [***1340]  [*746]   Lourie, Circuit Judge.

Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. (collectively, "Athena") appeal from the order of the United States District Court for the District of Massachusetts holding that claims 6-9 of U.S. Patent 7,267,820 (the "'820 patent") are invalid under 35 U.S.C. § 101 and dismissing Athena's complaint under Rule 12(b)(6). Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 275 F. Supp. 3d 306 (D. Mass. 2017) ("Decision"). Because the district court correctly concluded that the claims at issue are directed to a natural law and lack an inventive concept, we affirm.

I. Background

Athena Diagnostics is the exclusive licensee of the '820 patent, covering methods for diagnosing [**3]  neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase ("MuSK"). '820 patent Abstract. Athena also markets a test called FMUSK that functions by evaluating those antibodies. After Mayo Collaborative Services, LLC ("Mayo") developed two competing tests that allegedly practice each step of one or more claims of the '820 patent, Athena accused Mayo of infringing its patent. Mayo moved to dismiss under Rule 12(b)(6), arguing that the asserted claims of the '820 patent  [***1341]  were invalid under 35 U.S.C. § 101. The district court granted  [*747]  Mayo's motion, concluding that the claims were invalid under § 101 for claiming ineligible subject matter. This appeal solely concerns whether claims 6-9 are patent eligible under § 101.

Myasthenia gravis ("MG") is a neurological disorder where patients experience muscle weakness and symptoms including drooping eyelids, double vision, and slurred speech. '820 patent col. 1 ll. 13-23. It was previously discovered that MG is an autoimmune disease caused by a patient generating antibodies against her own acetylcholine receptors. Id. col. 1 ll. 24-26. Antibodies which recognize a person's own proteins as foreign antigens are known as autoantibodies. Id. col. 1 ll. 42-45.

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915 F.3d 743 *; 2019 U.S. App. LEXIS 3645 **; 129 U.S.P.Q.2D (BNA) 1339 ***

ATHENA DIAGNOSTICS, INC., OXFORD UNIVERSITY INNOVATION LTD., MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN E.V., Plaintiffs-Appellants v. MAYO COLLABORATIVE SERVICES, LLC, DBA MAYO MEDICAL LABORATORIES, MAYO CLINIC, Defendants-Appellees

Subsequent History: As Amended February 14, 2019.

Rehearing denied by, Rehearing, en banc, denied by Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333, 2019 U.S. App. LEXIS 19979 (Fed. Cir., July 3, 2019)

US Supreme Court certiorari denied by Athena Diagnostics v. Collaborative, 2020 U.S. LEXIS 24 (U.S., Jan. 13, 2020)

Prior History:  [**1] Appeal from the United States District Court for the District of Massachusetts in No. 1:15-cv-40075-IT, Judge Indira Talwani.

Athena Diagonistics, Inc. v. Mayo Collaborative Servs., LLC, 275 F. Supp. 3d 306, 2017 U.S. Dist. LEXIS 123412 (D. Mass., Aug. 4, 2017)

Disposition: AFFIRMED.

CORE TERMS

natural law, patent, steps, autoantibodies, inventive, label, diagnostic, recite, detecting, district court, conventional, antibody, eligibility, laws of nature, specification, discovery, bodily fluid, immunoprecipitation, ineligible, patients, patent-eligible, epitope, argues, radioimmunoassay, radioactive, man-made, subject matter, iodination, technology, patent law

Civil Procedure, Appeals, Standards of Review, De Novo Review, Patent Law, Subject Matter, Defenses, Demurrers & Objections, Motions to Dismiss, Failure to State Claim, Judgments, Summary Judgment, Motions for Summary Judgment, Reviewability of Lower Court Decisions, Preservation for Review