by Dennis Crouch
Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)
There is a lot to unpack in this decision, and so this is just a small discussion of an important Federal Circuit opinion – DC
Mayo is involved in another diagnostic method patent dispute — and again has come out on-top with a finding that the asserted patent claims are ineligible under 35 U.S.C. 101. That district court finding has now been affirmed on appeal, although subject to a strong dissent from Judge Newman.
The named inventors on Athena’s patent were working on a subset of Myasthenia gravis (MG) patients who did not exhibit the usual acetylcholine receptor antibodies. The researchers discovered that these patients were instead generating excess antibodies to a muscle-specific tyrosine kinase (MuSK) that the body uses in neuromuscular junctions. So, the key discovery here was the relationship between MuSK autoantibody production and MG.
The patent at issue is not directed a this relationship per se, but rather a method for diagnosing MuSK related disorders by looking for those MuSK autoantibodies. The particular claims at issue include a basic diagnostic method involving: mixing a person’s “bodily fluid” with a labeled antigen to the MuSK antibodies; immunoprecipitating any MuSK complexes from the fluid; and then looking for the label in the precipitate. Some claims indicate that the label is a radioactive iodine isotope.
Conventional Techniques: As we get into the eligibility analysis, it makes sense to note here that the claimed method is basically the one that any biochem PhD researcher would have come up with after learning about the importance of the MuSK autoantibody — i.e., it probably would be obvious if the relationship between MuSk and MG were in the prior art. However, the claimed method does involve creating non-naturally-occurring labeled antigens and then causing a chemical reaction that does not naturally-occur.
Under Mayo v. Prometheus, 566 U.S. 66 (2012) a law of nature may not be patented. In that case, the provided an example of a law of nature — the correlation between the a blood metabolite and the appropriate treatment dosage. The court explained explain that it is proper to have a claim “directed to” a law of nature, so long as the claim also includes “something more” such as an inventive practical application. In other words: “Laws of nature are not patentable, but applications of such laws may be patentable.” Athena.
Here, the Federal Circuit agreed with the lower court that the claims at issue are directed to a law of nature: “the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG.” This correlation exists in nature, even if only recently discovered by humans, and “there can thus be no dispute that it is an ineligible natural law.”
Here, although the claims include “certain concrete steps,” the court still determined that they were – as a whole – directed to the abstract idea “because the claimed advance was only in the discovery of a natural law, and . . . the additional recited steps only apply conventional techniques to detect that natural law.” To support this conclusion, the court cited to portions of the specification explaining that “the actual steps [are] known per se in the art” or are “standard techniques in the art.”
Regarding the required creation and use of a man-made molecule. The court held that “the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.” I will note here that the molecule itself would likely be eligible — to the extent they were created by the researchers.
In its analysis, the court also distinguishes its recent decision in Vanda, which found a method of treatment based upon genotype to be eligible.
We consider it important at this point to note the difference between the claims before us here, which recite a natural law and conventional means for detecting it, and applications of natural laws, which are patent-eligible. See Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1133–36 (Fed. Cir. 2018) (holding that method of treatment by administering drug at certain dosage ranges based on a patient’s genotype was not directed to a natural law). 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. But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law.
Within step-one of the Mayo/Alice analysis the court basically answered step-two as well — does the claim include “something more.” Here, the court appears to have added the notion that step-one should focus only on the claim as a whole while step-two includes an element-by-element analysis. Regardless, the court found that the application steps were all simply recitations of steps known in the art.
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. . . . [A]pplying standard techniques in a standard way to observe a natural law does not provide an inventive concept.
Although conventionality can now be seen as an issue of fact, the court found that it was effectively admitted within the specification.
Judge Lourie penned the majority opinion and was joined by Judge Stoll. Judge Newman wrote in dissent. Judge Newman argued that the claims should be seen at face value:
The claims … preparation of the new radioactive entities and their chemical reactions to detect autoantibodies to the protein muscle-specific tyrosine kinase (MuSK).
This, according to Judge Newman is “not a law of nature.”
Note here Footnote 4 from the majority opinion — agreeing with the dissent that “the public interest is poorly served by adding disincentive to the development of new diagnostic methods” and lamenting their inability to act. “Our precedent leaves no room for a different outcome here.”