In a case relating to methods for genotyping a canine breed, the US Court of Appeals for the Federal Circuit upheld a district court’s judgment as a matter of law that the asserted claims were not subject matter eligible under 35 USC § 101. Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH & Co., KG, Case No. 18-2056, (Fed. Cir. Aug. 9, 2019) (Wallach, J).

The claims at issue relate to in vitro methods for genotyping Labrador retrievers in order to discover whether the dog might be a genetic carrier of HNPK, a disease that causes crusts and fissures to appear on a dog’s nose. The disorder is a recessive condition, meaning that a puppy only develops the symptoms of disease if it receives a mutated HNPK gene from both parents. The genetic test disclosed in the patent would allow dog breeders to test Labrador retrievers to determine if they are carrying a mutated HNPK gene.

The Federal Circuit analyzed asserted claims under the Supreme Court’s Alice/Mayo framework, which states that a patent claim falls outside § 101 where (1) it is directed to a patent-ineligible concept, i.e., a law of nature, natural phenomenon or abstract idea, and (2), if so, the particular elements of the claim, considered both individually and as an ordered combination, do not add enough to transform the nature of the claim into a patent-eligible application.

Claim 1 of the patent recited an in vitro method for genotyping a Labrador retriever comprising:

  • Obtaining a biological sample from the Labrador retriever
  • Genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1
  • Detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2

Claims 2 and 3 each depended from claim 1. Claim 2 specified particular genotyping methods that could be used, and claim 3 specified particular primer pairs to be used with the genotyping step.

Under step one of the Mayo/Alice framework, the Federal Circuit found that the claims were directed to a natural phenomenon. The Court acknowledged that the claim required three steps (obtaining a biological sample, genotyping a SUV39H2 gene and detecting the presence of a mutation in said gene), but concluded that taken as a whole, claim 1 is “directed to nothing more than ‘observing or identifying’ the natural phenomenon of a mutation in the SUV39H2 gene.”

Turning to step 2, the Federal Circuit concluded that the claims did not recite an inventive concept that transformed the observation of a natural phenomenon into a patentable invention. The Court relied on expert testimony that the genotyping methods recited were conventional or known laboratory techniques to observe the newly discovered mutation in the SUV39H2 at position 972.

The Federal Circuit also addressed Laboklin’s argument that the district court lacked personal and subject-matter jurisdiction over the patent owner and its exclusive licensor, the University of Bern, which is an instrumentality of the Swiss Confederation, because the University enjoyed sovereign immunity. The Court noted that under the Foreign Sovereign Immunities Act, “a foreign state is presumptively immune from the jurisdiction of United States courts” unless a specified exception applies. Absent an exception, a federal court lacks subject-matter jurisdiction over a claim against a foreign state. However, as the Court further noted, under 28 USC § 1605(a)(2), if a foreign state engages in “commercial activity . . . in the United States,” it operates under an exception to sovereign immunity. Citing Intel v. Commonwealth Sci. & Indus. Research Org. (Fed. Cir. 2006), the Court elaborated that the “acts of (1) obtaining a United States patent and then (2) enforcing its patent so it could reap the profits thereof—whether by threatening litigation or by proffering licenses to putative infringers” constituted commercial activity.

Practice Note: While this outcome is consistent with recent Federal Circuit treatment of diagnostic claims, the Court appears to be divided on the application of the Alice/Mayo framework to patent claims covering medical diagnostics. See, e.g.Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed Cir. July 3, 2019) (an 86-page order denying en banc rehearing with eight separate concurrences/dissents) (IP Update, Vol. 22, No. 2).