ACLU Files Cert Petition in Myriad Case Asking ‘Are Human Genes Patentable?'

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As expected, the American Civil Liberties Union filed a petition for writ of certiorari in the case challenging the patent eligibility of claims on isolated DNA (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., docket number not available, review sought 9/25/12).

The petition asks three questions:

(1) Are human genes patentable?

(2) Did the U.S. Court of Appeals for the Federal Circuit err in upholding a method claim by Myriad Genetics Inc. that is irreconcilable with the Supreme Court's ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (54 PTD, 3/21/12)?

(3) Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and the Supreme Court's decision in MedImmune Inc. v. Genentech Inc., 549 U.S. 118, 81 USPQ2d 1225 (2007) (06 PTD, 1/10/07), that petitioners who have been indisputably deterred by Myriad's “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?


The petition appeals a 2-1 decision by the Federal Circuit that isolated DNA claims of patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) exclusively licensed to Myriad are patent eligible under 35 U.S.C. §101. Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 103 USPQ2d 1681 (Fed. Cir. Aug. 16, 2012) (159 PTD, 8/17/12).

That decision followed a remand by the Supreme Court for reconsideration of a 2011 Federal Circuit decision (147 PTD, 8/1/11). Each of the three judges participating in the Aug. 24 panel ruling wrote an opinion that largely ignored the possibility of applying the Mayo opinion, which related to method claims, to the claims related to genetic materials.

The second question presented relates to the only method claim that the Federal Circuit held, unanimously, was patent eligible under Section 101. Again, though, the Mayo opinion did not change the views of the appellate court.

The issue referenced in the third question applies to the Federal Circuit's conclusion that only one of the plaintiffs, a researcher who was allegedly interested in sequencing the genes covered by the patents, met the requirements for declaratory judgment standing.

The ACLU and the Public Patent Foundation filed the lawsuit originally on behalf of the Association of Molecular Pathology and other medical associations, individuals involved in medical research, breast cancer counselors, and women diagnosed with or seeking diagnosis for cancer.

Christopher A. Hansen, staff attorney with the ACLU Speech, Privacy, and Technology Project, submitted the petition on behalf of the plaintiffs.

Gregory A. Castanias of Jones Day, Washington, D.C., represented Myriad.

By Tony Dutra  

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