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Athena Diagnostics v. Mayo Collaborative Services Part 2, or: For the Benefit of Us All

February 15, 2019
Post by Oliver P. Couture, Ph.D.

Part 1 of the review of Athena Diagnostics v. Mayo Collaborative reviewed how the Majority Opinion is at odds with precedent and the most recent United States Patent & Trademark Office (USPTO) Subject Matter Guidelines published last month. Part II below examines the dissent from Judge Newman and how it aligns with both precedent and the Guidelines.

As stated in Part 1, at issue in Athena was an admitted novel and non-obvious diagnostic test that worked for the 20% of the population suffering from myasthenia gravis (MG) to be diagnosed.

Judge Newman’s dissent, in her first paragraph, correctly identified the novel and non-obvious diagnostic test as a, “'new and improved technique, for producing a tangible and useful result'”, citing to CellzDirect. She further explained that the claims are not directed to the actual discovery of the antibody in question, but to a new diagnostic for a previously undiagnosable neurological condition, with the claims describing the test.

She further pointed to both the precedence and the statutes to show how the analysis of the Majority Opinion is wrong. She emphasized that the Supreme Court cautioned to not let Alice eviscerate patent law and that the analysis of the claims as a whole was not changed in Mayo/Alice. She also reiterated that 35 U.S.C. 101 was intended to cover a broad range of inventions and there is nothing in the statutes to say that diagnostic methods should be an exception. In her analysis under Mayo/Alice, which is in line with both precedence and the USPTO Guidelines, she found that the claims were not directed to, “a law of nature, but a man-made chemical-biomedical procedure”.

Her dissent, which is in line with both over 150 years of precedence and the Guidelines, should be the analysis under Mayo/Alice. Her analysis still allows for novel and non-obvious diagnostic tests to be patentable, which will benefit everyone, for, as she puts it, “The loser is the afflicted public, for diagnostic methods that are not developed benefit no one”. Anything more, and diagnostic methods will be per se unpatentable.

Oliver P. Couture is an Intellectual Property Attorney in the Biotechnology & Chemical Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information please visit the MVS website or contact Oliver directly via email at oliver.couture@ipmvs.com.


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