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Athena Diagnostics v. Mayo Collaborative Services Part 1, or: How I Learned to Stop Worrying and Love the Inconsistencies

February 12, 2019
Post by Oliver P. Couture, Ph.D.

Part 1 of the review of Athena Diagnostics v. Mayo Collaborative will look at 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 2 will look at the dissent from Judge Newman and how it fits better with both precedent and the Guidelines.

At issue in Athena, were methods for detecting an admitted novel and non-obvious autoantibody in a sample to diagnostic myasthenia gravis (MG). The method could diagnose MG in the 20% of individuals that every current diagnostic for which there was no current diagnostic. This is because the inventors identified a novel MG disease-related protein that could be detected in a patient’s sample using a variety of known in the art protein capture and detection methods.

The District Court dismissed the infringement case due to patent 7,267,820 being directed to ineligible subject matter, and the Federal Circuit upheld the decision. The Federal Circuit Majority Opinion’s analysis, for both Step 1A and 1B of the Mayo/Alice framework, included taking each limitation separately and assessing if it was non-routine step or not novel, and if so, finding them “irrelevant to whether a claim is directed to a natural law”. Under this standard, it is unsurprising that the Federal Circuit ultimately found that the claims are directed to a natural law, as all other limitations were found to be irrelevant as the techniques were known in the art.

The Majority Opinion shows just how inconsistent the precedence has become. This test, which was used to find the claims in Cleveland Clinic and Ariosa invalid, but not CellzDirect, does not consider a claim as a whole. In other words, the Federal Circuit has stopped considering a claim as a whole for diagnostic methods, but not for lab techniques.

Further, the Majority Opinion is inconsistent with the new USPTO Subject Matter Guidelines. Under the new Guidelines, even if an Examiner finds that the claim is directed toward a judicial exception under Step 2A, prong 1, they are then required, under prong 2, to determine if the judicial exception is being used as part of a practical application, without assessing the novelty of the rest of the claim. It is hard to see how a medical diagnostic test is not a practical application. So, even if you can get your claims through the USPTO for a diagnostic under the guidelines, under Athena, citing to Mayo, the claims are likely to be found invalid because, in the words of majority in this case, “Claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself”.

Under this standard, it is hard to see how Mayo/Alice, as it is being applied by the Federal Circuit, is “promot[ing] the progress of science and the useful arts,” or if the courts could more disincentivize development in this area.

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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