In December of 2013, Paw Print Genetics, a division of Genetic Veterinary Sciences, Inc., filed a complaint seeking a declaratory judgment for a patent held by Canine EIC Genetics, LLC, a company based in Minnesota, over the genetic screening of dogs for a disorder known as exercise-induced collapse (EIC).
Two recent Supreme Court Rulings support Paw Print Genetics' position that the patent for detecting canine EIC is invalid. In March of 2012, the Supreme Court 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 13, 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."
These two Supreme Court decisions in 2012 and 2013 changed the guidelines and procedures at the United States Patent and Trademark Office ("USPTO") regarding what kinds of methods and inventions are eligible for patent protection. According to the Supreme Court, the USPTO had been allowing patent claims to issue for subject matter that is not eligible for patent protection.
Under the new USPTO rules for eligibility, claims covering routine and conventional methods of detecting disease (or risk factors for disease) are not eligible for patent protection. Many claims like this that issued under the old rules are now invalid. In addition, claims to naturally occurring nucleic acids (DNA or genes) are not patentable merely because they have been isolated.
Paw Print Genetics sought clarification from the courts after receiving numerous questions about the patent for EIC from customers who were unaware of the recent Supreme Court's decisions. In view of these customer inquiries and general confusion in the market regarding the validity of patents covering routine or conventional methods for detecting a mutation or other naturally occurring abnormality, Paw Print Genetics sought a declaration of its rights to conduct testing for EIC.
The recent judgment by the Honorable United States District Court Judge John R. Tunheim in the U.S. District Court of Minnesota, states 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."
In a statement, Paw Print Genetics' founder and CEO, Dr. Lisa Shaffer said, "We are thrilled today to have a legal declaration that the patent held for EIC testing is invalid. This allows the public to choose laboratories that they know will provide accurate, high quality testing. We are proud to have been the one that fought this battle for all dog owners who seek open access and choice for genetic testing for their pets."