Patent Law Practice Center

AMP v. USPTO: The Latest Developments

Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing the latest developments in the AMP v. USPTO case and what the Plaintiffs next move may be.

After the CAFC issued a decision in AMP v. USPTO on July 29, 2011, there was much speculation as to what would be the next move in this compelling case.  A petition for an en banc rehearing or a petition to the Supreme Court to grant a writ of certiorari seemed likely, but instead each party petitioned for a rehearing by the same three-judge panel.  Last week, the CAFC denied both of these without providing any further comments.  However, these petitions provide some insights as to how the parties’ positions on standing as well as the merits are evolving, and are summarized below.

Plaintiffs’ Petition for Panel Rehearing

On August 25, 2011, the Plaintiffs, represented by the ACLU and PubPat, filed a petition for a panel rehearing on both substantive issues and issues of standing.  As to the substantive issues, the Plaintiffs took issue with the majority’s reasoning that isolated DNA does not occur in nature. (more…)

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.”

(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…)