Genetic Veterinary Sciences, DBA Paw Print Genetics announced today that a federal court in Norfolk, VA ruled as a matter of law following a three-day jury trial that claims 1-3 of a patent related to Hereditary Nasal Parakeratosis (HNPK) owned by the University of Bern, Switzerland and licensed to Laboklin, a German company, is invalid for failing to claim eligible subject matter.
Paw Print Genetics sought clarification from the courts in February 2017, asking for a declaratory judgment after receiving a cease and desist letter from Laboklin. The complaint alleges that claims covering routine and conventional methods of detecting disease (or risk factors for disease) are not eligible for patent protection. The suit alleges that Laboklin’s U.S. Patent No. 9,157,114, simply claims routine and well-known methods of detecting a naturally occurring mutation in a Labrador retriever and is therefore invalid. The Court agreed and decided the matter without submitting the question to the jury because the evidence presented permitted only one outcome.
Two important Supreme Court Rulings support Paw Print Genetics' position that the patent for detecting mutations for canine HNPK is invalid. In March of 2012, the Supreme Court of the United States decided Mayo v. Prometheus, a case concluding that "the processes claimed by the patents effectively claim natural laws or natural phenomena—namely, the correlations between thiopurine metabolite levels and the toxicity and efficacy of thiopurine drugs—and therefore are not patentable”. In another Supreme Court decision issued June, 2013, Molecular Pathology v. Myriad Genetics, the Court concluded that "Myriad did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry." The Court went on to say, "we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."
Paw Print Genetics previously had won a lawsuit involving canine exercise induced collapse (EIC), which received a declaratory judgement of invalidity in March, 2015. In that case, the Honorable United States District Court Judge John R. Tunheim in the U.S. District Court of Minnesota, stated that "Here, the Court concludes that no inventive concept saves the ‘297 Patent from its focus on a patent-ineligible natural law. Because all that it adds to the natural law are well-known genetic detection methods, the Court finds the patent's eight claims to be invalid and will grant PPG's motion for partial summary judgment."Similar to the EIC case, the Honorable United States District Court Judge Henry Coke Morgan, Jr., Senior United States District Judge in the U.S. District Court for the Eastern District of Virginia, Norfolk Division found US Patent ‘114 invalid due to ineligible subject matter. In this case, the patent attempted to pair well-known, conventional methods with a naturally occurring DNA sequence of the SUV39H2 gene. Mutations in theSUV39H2 gene are known to cause HNPK, a disease of Labrador retrievers in which the noses of affected dogs become dry, cracked and susceptible to infections. Testing for the mutation in Labrador retrievers can allow breeders to avoid producing puppies with this condition.
In a statement, Paw Print Genetics' founder and CEO, Dr. Lisa Shaffer said, "This legal declaration that the ‘114 patent for HNPK testing is invalid is a huge victory for dog owners and breeders, allowing them the choice to have accurate, high quality testing performed through our laboratory, ensuring access to everyone seeking testing for their dogs. We are proud to have been the one that fought this battle for all dog owners and breeders who need access to genetic testing for their pets. We will continue to fight for the rights to genetic testing, affordable pricing, and the highest quality standards so that all dog owners and breeders have access to accurate genetic information on their dogs."