In a strange ruling by the Court of Appeals for the Federal Circuit, on July 29, 2019, although publicly released on August 9, 2019, in Genetic Veterinary Scis., Inc. v. Laboklin GmbH & Co KG,[1] the Fed Circuit found that in spite of the claimed invention’s “valuable contribution” to the veterinary sciences, it remained outside the protective scope of patent-eligible subject matter under 35 U.S.C. §101. While there were procedural issues addressed in the ruling, this analysis will focus only on the substantive §101 issue.
The University of Bern owns U.S. Patent No. 9,157,114 (‘114), directed to in vitro methods for genotyping Labrador Retrievers to assess whether a particular dog is the genetic carrier for the Hereditary Nasal Parakeratosis (HNPK). The University licensed the ‘114 patent to Laboklin GmbH. Genetic Veterinary Sciences, dba Paw Prints Genetics (PPG) sued the University and Laboklin in the Eastern District of Virginia for declaratory judgment seeking judgment that claims 1-3 of the ‘114 patent were patent-ineligible under §101. The district court granted PPG’s JMOL, which the Laboklin defendants appealed.
The Fed Circuit panel was composed of Judges Wallach, Hughes, and Stoll, with Judge Wallach writing for a unanimous court. He immediately analogized the recent CellzDirect genotyping case, which found certain methods for cryopreserving liver cells for future use as patent-eligible subject matter because the claims were directed to a new tangible and useful result.[2] Both CellzDirect and the current case deal with genotyping of sequences, but here, Judge Wallach noted a difference, and wrote:
Here, the Asserted Claims are not directed to a new and useful method for discovery because they begin and end with the point discovery of the HNPK mutation in the SUV39H2 gene . . . The parties do not dispute that the mutation itself is a naturally occurring phenomenon.
In fact, he noted that Claim 1 of the ‘114 patent is merely “’in vitro method for genotyping a Labrador Retriever’ for detection of the HNPK mutation.” This language only suggests an observation or identification of a natural phenomenon which is not sufficient to warrant patent-eligibility. Judge Wallach further wrote that nothing in Claim 1 suggested that the ‘114 patent was directed to a new method of genotyping the HNPK mutation.
While a positive and valuable contribution, these claims fall short of statutory patentable subject matter.
The judgment of the district court was affirmed.
[1] ___F.3d___ (Fed. Cir. 2019) (slip op.), aff’g 314 F. Supp. 3d 727, 728 (E.D. Va. 2018).
[2] See Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016).