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Supreme Court Will Weigh Patent Eligibility of Human DNA in Myriad Case

Monday, December 3, 2012

The U.S. Supreme Court will decide the patent eligibility of claims on isolated DNA, granting a petition for certiorari Nov. 30 in Association for Molecular Pathology v. Myriad Genetics Inc.,( U.S., No. 12-398, review granted 11/30/12).

The petition appealed a 2-1 decision by the U.S. Court of Appeals for the Federal Circuit that isolated DNA claims of patents exclusively licensed to Myriad Genetics Inc. are patent eligible under 35 U.S.C. §101.

The court certified only the first question presented: “Are human genes patentable?”

The petitioners, led by the American Civil Liberties Union and the Public Patent Foundation, had two other questions, which the high court will not consider.

For the first, claims directed to methods of genetic diagnostic testing are at issue in the case as well, though the appeals court was unanimous in finding only one claim--on a “method of screening potential cancer therapeutics”--patent eligible.

The petition asked: Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (55 PTD, 3/22/12).

The appeals court also agreed unanimously that only one plaintiff--a researcher who was allegedly interested in sequencing the genes covered by the patents--had declaratory judgment standing. Those deemed to lack standing included medical associations, other individuals involved in medical research, breast cancer counselors, and women diagnosed with or seeking diagnosis for cancer.

The petitioners had asked: Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this 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?

Challenge Began in 2009.

The case arose from a 2009 declaratory judgment challenge filed by the ACLU and PubPat.

They argued on behalf of the plaintiffs that particular claims in patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) on isolated DNA, cDNA, and methods related to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer were ineligible for patenting under Section 101.

In its first decision July 29, 2011, the Federal Circuit agreed that only one of the method claims and all the claims to cDNA are patent eligible, but the court was divided as to claims to isolated DNA.

Then on March 26, a week after unanimously rejecting method claim patent eligibility in Mayo v. Prometheus, the Supreme Court granted the ACLU's petition for writ of certiorari in the instant case, vacated the Federal Circuit's opinion, and remanded the case for reconsideration.

On remand Aug. 16, however, the appeals court panel came to the same conclusions, with all three judges writing essentially the same opinions that they had penned the first time, including as to the patent eligibility of the method claims asserted. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303, 103 USPQ2d 1681 (Fed. Cir. 2012).

Briefing Completed.

The ACLU wasted little time, petitioning again for certiorari Sept. 25.

Myriad filed its opposition brief Oct. 31, mostly devoted to disputing the phrasing of the first question presented--“Are human genes patentable?”

The case is not about patenting “native” human genes, Myriad said. “The challenged composition claims are instead narrowly drawn to specific, defined DNA molecules, isolated by human scientists in laboratories, that do not naturally occur.”

Seven additional briefs were filed as of Oct. 31 by friends of the court urging the Supreme Court to grant review. In general, the amici put forth policy arguments, contending that the patent incentive is not necessary for innovation in gene-related technology development, and that patents inhibit rather than promote further developments.

Notably, the medical services community, led by the American Medical Association, submitted a brief on behalf of several associations asking the high court to overturn the Federal Circuit's ruling.

Gregory A. Castanias of Jones Day, Washington, D.C., represents Myriad. Christopher A. Hansen, staff attorney with the ACLU Speech, Privacy, and Technology Project, represents the petitioners.


Federal Circuit's opinion at http://pub.bna.com/ptcj/10140612Aug16.pdf

ACLU petition at http://pub.bna.com/ptcj/ACLUCertPetition12Sep25.pdf

Myriad opposition brief at http://pub.bna.com/ptcj/120398Myriad12Oct31.pdf

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