Canine Genetic Testing Patent Dispute Settled


On December 13, 2013, Genetic Veterinary Sciences, Inc. (d/b/a Paw Print Genetics) filed a declaratory judgment action against VetGen, LLC, in the United States District Court for the Eastern District of Washington (Spokane). The lawsuit sought a declaration that Paw Print Genetics was not infringing various claims of patents owned by VetGen. The complaint specifically sought a declaration of non-infringement with respect to U.S. Patent Nos. 6,040,143, 6,074,832, 6,767,707, 6,780,583, and 6,410,237. Each of these patents are titled DNA encoding canine von Willebrand factor and methods of use. In the alternative, Paw Print Genetics also sought a declaration that the claims of the patents are invalid. Both Paw Print Genetics and VetGen offer inherited disease testing to identify carriers and affected dogs for a variety of different canine genetic conditions.

In both dogs and humans, von Willebrand’s disease is a bleeding disorder of variable severity that results from a quantitative or qualitative defect in von Willebrand factor. This clotting factor has two known functions, stabilization of Factor VIII (hemophilic factor A) in the blood, and aiding the adhesion of platelets to the subendothelium, which allows them to provide hemostasis more effectively. If the factor is missing or defective, the patient, whether human or dog, may bleed severely. The disease is the most common hereditary bleeding disorder in both species, and is genetically and clinically heterogenous.

On March 26, 2014, the parties announced that they decided to forego litigation and have reached a settlement related to the patent lawsuit filed by Paw Print Genetics. The terms of the settlement were not disclosed.

Of particular interest in this case is the fact that the Paw Print Genetics CEO, Dr. Lisa Shaffer, cited Supreme Court rulings that call into question the patent eligiblity of claims like those present in the VetGen patents. Those two cases are, of course, Mayo v. Prometheus and AMP v. Myriad Genetics.

“Paw Print Genetics filed the lawsuit, because we strongly believe that we have freedom to operate and conduct these tests based on two recent Supreme Court rulings that reaffirmed long-standing patent laws regarding routine laboratory methods applied to natural phenomena, like DNA and mutations,” said Shaffer. “This settlement furthers our belief that the public should have access and options to affordable and accurate genetic testing for inherited diseases in dogs.”

The Summary of the Invention from the ‘143 patent explains the invention in this way:

The present invention provides a novel purified and isolated nucleic acid sequence encoding canine vWF. A nucleic acid sequence containing the mutation that causes vWD in Scottish terriers, a single-base deletion in exon 4, is also provided. The nucleic acid sequences of the present invention may be used in methods for detecting carriers of the mutation that causes vWD. Such methods may be used by breeders to reduce the frequency of the disease-causing allele and the incidence of disease. In addition, the nucleic acid sequence of the canine vWF provided herein may be used to determine the genetic defect that causes vWD in other breeds as well as other species.

Claim 1 of the ‘143 patent covers:

An isolated nucleic acid comprising a nucleotide sequence encoding the polypeptide of SEQ ID NO. 2.

It would seem that, after the release of the USPTO Myriad/Mayo guidelines, this and many of the other claims in these patents, if not all of the claims, would be deemed to be unpatentable as lacking patent-eligible subject matter by the Office. I can’t help but wonder whether this settlement, which comes so quickly on the heels of the release of the USPTO guidelines, was affected by the position taken by the USPTO in those guidelines.

According to Paul Cole, a UK and European patent attorney, a fair reading of the Myriad and Mayo cases suggests that the USPTO went too far, at least with respect to saying that purification would not create patent-eligible subject matter. He wrote for

It is abundantly clear from study of the opinion in Myriad that the reasons why the BRCA1 gene claim did not survive were that the gene had been defined in terms of its informational content rather than its chemical structure, and that no new utility for the isolated full-length gene had been disclosed. Such an interpretation is wholly consistent with the concession made on behalf of the Petitioners in oral argument.

It does seem that patent practitioners are finally coming to terms with just how awful a decision the Supreme Court made in Mayo and Myriad. After many months of being told that these decisions were not as bad as they seemed, the industry seems to finally be well aware of the negative consequences and how difficult it will now be to obtain patent protection on these and related innovations. This is why I have said and will say again that the Supreme Court overruled Chakrabarty with their decision in Myriad. The fact that there is human intervention and the resulting output is not naturally occurring is no longer dispositive of a patent-eligibility determination.

In any event, Paw Print Genetics will begin offering testing for von Willebrand Disease in April 2014.

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