Paw Print Genetics, a division of Genetic Veterinary Sciences, Inc., filed two complaints seeking a declaratory judgment in the United States District Court for the Eastern District of Washington at Spokane. The first complaint stems from a dispute between Paw Print Genetics and VetGen, LLC, a company based in Michigan, over the screening of dogs for von Willibrand's disease (vWD), a disorder that is associated with abnormal blood clotting. The second complaint involves a dispute between Paw Print Genetics and Canine EIC Genetics, LLC, a company based in Minnesota, over the screening of dogs for a disorder known as exercise-induced collapse (EIC).
There are three main types of vWD that result in a bleeding disorder of variable severity. It is important to screen dogs for the mutations that cause vWD, especially prior to any surgery such as spaying and neutering. The canine is an excellent model for this disease, which was clinically identified in humans by Erik von Willibrand in 1926. The mutations that cause the various types of human vWD were identified in the 1980s and 1990s after the causative gene, the von Willibrand factor gene, was cloned in 1985. vWD has been widely recognized as one of the most prevelant bleeding disorders in dogs. Prior to the identification of the specific mutations in canine vWF, the vWF antigen was being measured in plasma obtained from blood, demonstrating the known relationship between the disease and the vWF. VetGen has taken the position that the patents that they own cover methods of testing for canine vWD mutations and that anyone practicing these methods are infringing.
Canine EIC is a genetic disorder typically associated with Labrador Retrievers but can be observed in other breeds. Dogs who suffer from EIC usually develop signs of an episode five to fifteen minutes after initiation of strenuous exercise. At the beginning of an EIC episode, the dog starts to lose coordination and develops a wobbly gait, which soon progresses to a loss of control of the hind legs. In some cases, the entire body is unable to move during an EIC episode. The collapse period usually lasts five to ten minutes. After thirty minutes, the dog will usually be fully recovered. Dogs affected with EIC usually cannot continue with intense strenuous exercise, but can live relatively normal lives as house pets. Genetic testing for EIC presents the most useful approach for those who seek to identify service or working dogs for training in a vocation that will require strenuous exercise.
Two recent Supreme Court Rulings support Paw Print Genetics' position that certain patents for detecting vWD and canine EIC are 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".
Notably, the Court went on to state: "… the claims inform a relevant audience about certain laws of nature; any additional steps consist of wellunderstood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities."
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. Any 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 believes that the existence of patents issued under old USPTO rules for eligibility, like the ones covering routine or conventional methods for detecting canine EIC or vWD, creates an incorrect perception in the public that only certain parties can test for these diseases. Indeed, Paw Print Genetics has received several questions about these patents from customers who were unaware of the Supreme Court's decisions in Mayo v. Prometheus and Molecular Pathology v. Myriad Genetics or unaware of the change in USPTO examination guidelines following these 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 seeks a declaration of its rights to conduct testing for vWD and EIC.
In a statement, Paw Print Genetics' founder, Dr. Lisa Shaffer said "it was a difficult decision to take legal action against these patents, but ultimately, this is about fair and equal access for the public to affordable and accurate tests for the existence of mutations that are known to cause very serious diseases in dogs. Given the need for accuracy and quality in tests like this, including the need for second and even third opinions from independent labs, the public has a right to choose laboratories they know will provide accurate, high quality testing results," she said. "In the end, these lawsuits are about providing access to the very best care for animals."