Patent Law Practice Center

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.

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AMP v. USPTO: Myriad wins this battle, but will the war continue?

Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing Friday’s Court of Appeals for the Federal Circuit decision in the AMP v. USPTO case.  He highlights the key points of the decision and why this decision should come as a relief to anyone in the biotechnology industry.

After nearly four months of consideration[1], the Court of Appeals for the Federal Circuit issued a decision in the controversial AMP v. USPTO case on Friday, July 29, 2011.  Weighing in at just over a hundred pages total, the decision includes a majority opinion by Judge Lourie, a concurrence by Judge Moore and a dissent by Judge Bryson.  The main point of contention between the three opinions relates to the patent-eligibility of the composition claims, particularly the claims which recite isolated long DNA sequences.

Standing

The first issue considered by the CAFC was whether the Plaintiffs had standing to sue.  The Plaintiffs were a motley crew of doctors, patients, scientific organizations and advocacy groups.  This wide breadth of Plaintiffs was one of the unusual aspects of this case.  Some Plaintiffs, such as cancer patients, claimed standing based on the fact that they could not afford the costs of the genetic tests or obtain a second opinion, due to Myriad being the exclusive provider for this test in the United States.  The Court quickly dismissed this reasoning, stating that “we fail to see how the inability to afford a patented invention could establish an invasion of a legally protected interest for purposes of standing.”  Citing MedImmune, the Court succinctly stated: “[s]imply disagreeing with the existence of a patent or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court’s requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

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Supreme Court Grants Certiorari In Prometheus V. Mayo (Again)

On Monday, the United States Supreme Court agreed to consider whether to set limits on when inventors can patent medical diagnostic tests.  Our friends at Foley & Lardner sent in this article discussing the history of the case, the issues being considered by the Court and the potential impact this case may have on intellectual property in the personalized medicine space.

On June 20, 2011, the United States Supreme Court granted Mayo’s petition for certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), a case addressing patent eligibility under 35 U.S.C. § 101 of certain method claims relevant to personalized medicine. While the issue under consideration here does not relate to whether isolated genes and other alleged “products of nature” are patent-eligible, the Court in Prometheus will likely address whether and how one can claim methods that take advantage of correlations between an individual’s personal health/genetic make-up and possible health care options.

As discussed in postings on Foley’s Personalized Medicine Bulletin and PharmaPatents blogs, Mayo Collaborative Services filed a second petition for certiorari with the Supreme Court after the Federal Circuit upheld the claims (for a second time) on remand after the Supreme Court’s decision in Bilski v. Kappos (2010). Representative claims in Prometheus include: (more…)

AMP v. U.S.P.T.O.: Oral Argument at the Federal Circuit

Yesterday, the much anticipated oral argument in the AMP v. USPTO aka the Myriad Case took place at the Court of Appeals for the Federal Circuit.  Fortunately for us, Ryan B. Chirnomas, Partner at Westerman, Hattori, Daniels & Adrian attended the argument and has passed along this article summarizing the day’s events.

On April 4, 2011, the Appellant, Appellee and the U.S. Government presented oral argument before the Court of Appeals for the Federal Circuit in AMP v. USPTO, which deals with gene patenting.  The parties in this case are the Association for Molecular Pathology, along with many other medical organizations, doctors and patients on one side, and the U.S.P.T.O., Myriad Genetics, Inc., and the University of Utah Research Foundation on the other side.  Many amicus briefs have been filed as well.  The argument was heard by a panel consisting of Judges Bryson, Lourie and Moore, and was attended by approximately 200 people.   Due to the complexity of the subject matter and the presence of Government, the Court granted each side approximately 30 minutes of argument, instead of the usual 15 minutes.

Interestingly, although the parties seemed eager to discuss the merits, approximately half of the time for the Appellant and Appellee was spent discussing the issue of jurisdiction and standing.  In particular, Judge Moore seemed very interested in this issue.  The Appellants, led by Myriad, argued that there was no immediate controversy between the parties, since Myriad had not contacted any of the parties in over ten years.  However, Judge Moore questioned whether those parties previously threatened by Myriad were still refraining from making and using the claimed subject matter due to a continuing fear of litigation over the past decade.  (more…)