by Dennis Crouch
In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit reaffirmed its general ruling that newly invented diagnostic methods will generally be seen as directed toward unpatentable natural laws absent some new machinery for performing the method. Athena’s patented method is a three-step process for identifying MuSK antibodies in body fluid (such as blood): Mixing labelled MuSK with the body fluid; immunoprecipitating any antibody/MuSK complex from the fluid; and monitoring for the label in the left-over precipitate. The test is important because the existence of MuSK helps diagnose a particular form of Myasthenia gravis (MG).
In its decision, the Federal Circuit found that the core discovery here is the relationship between MuSK antibodies in the body and MG. That relationship though is a natural law. The court then looked to the particular steps in the method and found no inventive concept. Even though the claims required specific chemical reactions, the specification also made clear that development of the particular steps would be within reach of one skilled in the art — once they understand that MuSK is important. The Federal Circuit decision was penned by Judge Lourie and joined by Judge Stoll. Judge Newman wrote in dissent. A 7-5 court then denied Athena’s petition for en banc rehearing — writing effectively that its hands were tied by Mayo & Alice. The Athena denial is interesting because it includes eight opinions (seven substantive) that generally lament the current situation.
Athena then filed a petition asking the Supreme Court to take-up the case on the following question:
Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter,where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.
[Petition]. Now, 11 amici briefs have filed in support of review. Each of the briefs have lots to say, but I have included below one thought from each that I see as an important contribution:
- Professors Jeffrey A. Lefstin and Peter S. Menell (Congress intended for patents to cover practical applications of scientific discoveries; We should all reread the original cases on the topic from England – Nielson)
- Chicago Patent Attorneys (Noonan) (the court should focus on preemption)
- Intellectual Property Law Association of Chicago (The test here is unduly biased against methods)
- The Chartered Institute of Patent Attorneys (UK) (Athena conflicts “with international treaties to which the United States is a party, as well as established international practice”)
- Biotechnology Innovation Organization (BIO) (The Federal Circuit has created a heightened inventive concept test for diagnostic methods)
- Freenome Holdings, Inc. and New Cures For Cancers, Inc. (Alice and Mayo are inconsistent with Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176 (1980)).
- New York Intellectual Property Law Association (The Mayo test was not intended as the exclusive test)
- Blaine Laboratories, Inc. (See Henry Schein, Inc. v. Archer & White Sales, Inc., 139 S.Ct. 524 (2019) (judicial exceptions to broad statutes are inappropriate))
- Pharmaceutical Research and Manufacturers of America (PhRMA) (patent eligibility for diagnostic methods is a critical incentive for advancement in the field).
- Intellectual Property Owners Association (Look to the USPTO guidance to see the trouble — especially its diagnostic method examples)
- Honorable Paul R. Michel (ret.) (“Never before has the Federal Circuit been so splintered on a fundamental doctrine of patent law.”)
These are very interesting and important briefs. Yes, they show support, but they also include useful legal analysis.
Mayo’s responsive brief is due on November 22, 2019 with any amici in support of the current-state-of-affairs due shortly thereafter.