August 13, 2019

Federal Circuit Ruling Kills Labrador Retriever Genotyping Patent

Holland & Knight Section 101 Blog
Anthony J. Fuga

The Federal Circuit provided an undesirable reminder to The University of Bern (and many other patent owners): a positive and valuable contribution does not necessarily equate to patentable subject matter.

Here, the Court looked at the university's patent, entitled "Method of Determining the Genotype Relating to Hereditary Nasal Parakeratosis (HNPK) and Nucleic Acids Usable in Said Solution." The patent explained that HNPK is a recessive condition that only passes to a puppy when both parents are carriers of the gene that causes HNPK. Therefore, a test that determines the three genotypes of "free," "carrier" and "affected" would be highly valuable both for dog breeding and for veterinary medicine.

The Court, looking to claim 1, found that the method breaks down into three parts: (1) obtaining a biological sample, which may include a blood or saliva sample; (2) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO 1; and (3) detecting the presence of a replacement of a nucleotide at a specific base pair position.

In short, the claims "simply state that the search for the mutation involves the laboratory examination of Labrador Retriever DNA, which resulted in the revelation of the mutation." This effectively is a claim directed to "nothing more than observing or identifying the natural phenomenon of a mutation in the SUV39H2 gene."

The Federal Circuit contrasted this with the claims in CellzDirect. There, the Court held that the claims were not directed to an observation or detection of the ability of liver cells to survive multiple freeze thaw cycles but, instead, were directed to a "new and improved technique for producing a tangible and useful result."

Here, on the other hand, the 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 gene.

At Step 2 of the Alice inquiry, the Federal Circuit found that the patent claims conduct "conventional detection in a laboratory" and this does not transform the discovery of a natural phenomenon into patent-eligible subject matter. "Rather, similar to the claims at issue in Mayo, a natural phenomenon, together with well-understood conventional activity, is not patent-eligible under § 101."

The appellants argued that the claims do not merely recite the natural phenomenon but instead recite a particular application of the discovery. The Court again contrasted these claims with those from CellzDirect and found that claims here "provide no tangible result save the observation and detection of a mutation in a dog's DNA. While a positive and valuable contribution, these claims fall short of statutory patentable subject matter."

Claim 1 of the asserted patent reads:

1. An in vitro method for genotyping a Labrador Retriever comprising:

a) obtaining a biological sample from the Labrador Retriever;

b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1[;] and

c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.

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