In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit affirmed a decision from the District of Massachusetts invalidating patent claims directed to diagnosing certain disorders by detecting certain autoantibodies in a bodily fluid using standard laboratory techniques, even though the link between the disorders and the autoantibodies had not been previously discovered.

Practical Result

Medical diagnostic patents continue to be closely scrutinized in the wake of the Supreme Court’s landmark ruling in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014).  The Athena case highlights the conditions under which patentability may be precluded under 35 U.S.C. §101 for diagnostic methods that make use of new discoveries relating to how the human body reacts to disease.  Ultimately, patentability will hinge upon whether such diagnostic methods represent an innovation other than the discovery itself, regardless of whether the claimed method steps are considered to preempt that discovery.

Decision Details

Athena filed a patent infringement complaint against Mayo based upon U.S. Patent No. 7,267,820 (the “‘820 Patent”).  The ’820 Patent resulted from the discovery that certain patients suffering from the neurological disorder myasthenia gravis (“MG”) generate autoantibodies to a membrane protein called MuSK.  The inventors discovered this association and, based upon it, patented a method for diagnosing patients.  Claim 9, depending from claims 1, 7 and 8, is the most specific claim at issue (and thus the claim most likely to survive an invalidity challenge):

A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK); comprising contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to muscle specific tyrosine kinase (MuSK); wherein said label is a radioactive label; wherein said label is 125I.

Simplifying it into its basic elements, claim 9 recites

• a method for diagnosing disorders relating to MuSK by detecting MuSK antibodies,
• by a process that includes
  • contacting MuSK having a radioactive 125I label with bodily fluid,
  • immunoprecipitating an antibody/MuSK complex from the bodily fluid, and
  • monitoring for the label on the complex.

Mayo moved to dismiss Athena’s complaint under Rule 12(b)(6), arguing that the asserted claims are invalid under §101.  The District Court agreed with Mayo, and Athena appealed.

As required by Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014), the Federal Circuit applied a two-part test to assess validity of claims allegedly directed to laws of nature: (1) whether the claims are indeed directed to a law of nature, and if so, (2) whether the limitations of the claim apart from the law of nature, considered individually and as an ordered combination, transform the nature of the claim into a patent-eligible application as amounting to something significantly more than a patent of the natural law itself.

Addressing the first Alice inquiry, the Court found the claims to be directed to a natural law: the correlation between the presence of naturally-occurring MuSK autoantibodies in a bodily fluid and MuSK-related disorders such as MG.  Athena argued that the claims are directed to an innovative laboratory technique rather than a natural law, but the Court disagreed because the claimed process steps are routine laboratory methods.  Indeed, Athena’s only admitted innovation was the discovery of the link between MuSK autoantibodies and certain disorders such as MG.  The claimed process steps are described in the ‘820 patent as being known in the art.  Athena also argued that the claims would not preempt any natural law because of the specificity of the claimed process steps.  Importantly, the Court noted that “[p]reemption is sufficient to render a claim ineligible under §101, but it is not necessary.”

Having found the claims to be directed to a natural law, the Court turned to the second Alice inquiry, finding the claim steps not drawn to the natural law to require only standard techniques to be applied in a standard way.  “Because the specification defines the individual immunoprecipitation and iodination steps and the overall radioimmunoassay as conventional techniques, the claims fail to provide an inventive concept.”  In so holding, the Court rejected Athena’s arguments that the claimed steps amounted to significantly more than the natural law because they had not been previously applied to detect MuSK autoantibodies, and further, that they made use of a man-made molecule (i.e., labeled MuSK).  Individually and collectively, the claimed steps were found not to represent an inventive application beyond the discovery of the natural law itself because they were each known, conventional techniques.