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By Tony Dutra
• Summary: Federal Circuit announces schedule for new review ofACLU v. Myriad.
• Next Steps: Amicus briefs due June 15; oral arguments scheduled July 20.
Oral arguments for the renewed review of the Myriad case on patent eligibility of isolated DNA will be held July 20, the U.S. Court of Appeals for the Federal Circuit announced April 30 (Association for Molecular Pathology v. United States Patent and Trademark Office, Fed. Cir., No. 2010-1406, appeal reinstated 4/30/12).
The U.S. Supreme Court remanded the case March 26 (58 PTD, 3/27/12) for reconsideration by the appeals court in light of the high court's decision on statutory subject matter, under 35 U.S.C. §101, in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (54 PTD, 3/21/12).
Parties and friends of the court are invited to submit briefs by June 15. Parties' briefs are limited to 20 pages; amici to 15 pages. Briefs are expected to address the question: “What is the applicability of the Supreme Court's decision in Mayo to Myriad's isolated DNA claims and to method claim 20 of the '282 patent?”
The court expressly invited the United States to file an amicus brief.
The Myriad case arose from a 2009 declaratory judgment challenge against patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) for which Myriad Genetics Inc. is the exclusive licensee.
The American Civil Liberties Union and the Public Patent Foundation filed the lawsuit on behalf of the Association of Molecular Pathology and other medical associations, eight individuals involved in medical research, two breast cancer counselors, and six women diagnosed with or seeking diagnosis for cancer.
The plaintiffs argued that nine composition of matter and six method claims of the patents on the BRCA1 and BRCA2 genes--associated with hereditary breast and ovarian cancer--were ineligible for patenting under Section 101.
Three Federal Circuit panel judges agreed that only one of the method claims--Claim 20 of the '282 patent--and all claims to cDNA are patent eligible, but they split 2-1 as to claims to isolated DNA. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011) (147 PTD, 8/1/11).
The majority reversed a lower court's ruling against patent eligibility for such claims. 702 F. Supp. 2d 181, 94 USPQ2d 1683 (S.D.N.Y. 2010).
A week after its surprising unanimous decision rejecting method claim patent eligibility in Mayo, however, the Supreme Court granted the ACLU and PUBPAT's petition for writ of certiorari, vacated the Federal Circuit's opinion, and remanded the case for reconsideration.
In Mayo, the Supreme Court concluded that the steps of the method claims at issue failed to “add enough” to the “inventive concept” of the asserted patents--the correlations between metabolite levels and effectiveness of the drug.
While the court provided no standards for determining when steps provide “enough,” it said that the asserted claims failed because “any additional steps consist of well-understood, 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.”
The high court recognizes three exceptions to patent eligibility under Section 101--laws of nature, natural phenomena, and abstract ideas--often referred to together as “fundamental principles.” The Mayo method claims invoked the law of nature exception.
The five method claims rejected by the Federal Circuit in the Myriad case, on the other hand, were held to be improperly “instead directed to the abstract mental process of comparing two nucleotide sequences.”
The Federal Circuit's April 30 order may have indicated that it will only reconsider the sixth method claim challenged, Claim 20 of the '282 patent, which is directed to “[a] method for screening potential cancer therapeutics.” As in Mayo, this claim at issue uses a “wherein” clause that indicates a correlation: “wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.”
However, the bigger fight in Myriad is on composition of matter claims--isolated DNA and cDNA. Many stakeholders have said that the exception for natural phenomena would then apply, but there is no agreement on whether the law of nature exception should be analyzed differently from the natural phenomenon exception (60 PTD, 3/29/12).
Perhaps significantly, the Federal Circuit's April 30 order also did not ask the parties to address another outstanding issue in the case--whether any of the plaintiffs has standing.
The appeals court originally held that only one plaintiff--Harry Ostrer, a researcher at New York University School of Medicine who was allegedly interested in sequencing the BRCA1 and BRCA2 genes--met the requirements for declaratory judgment standing under the Supreme Court's decision in MedImmune Inc. v. Genentech Inc., 549 U.S. 118, 81 USPQ2d 1225 (2007)--“a substantial controversy … of sufficient immediacy and reality” and “meaningful preparation” to conduct potentially infringing activity.
In its briefing for Federal Circuit rehearing and for Supreme Court review, Myriad argued that even Ostrer should have been denied standing, based on his move to a different lab just before the Federal Circuit's decision.
Christopher A. Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, represents the plaintiffs. Gregory A. Castanias of Jones Day, Washington, D.C., represents Myriad.
By Tony Dutra
Federal Circuit's 2011 decision at http://pub.bna.com/ptcj/101406July29.pdf
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