Myriad Tries to Circumvent Patent Eligibility Decision by Reviving Standing Challenge

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By Tony Dutra  


• Summary: In the case that could upend DNA patent eligibility, Myriad makes one more attempt to get the action dismissed for lack of standing.  

The scheduling of further substantive debate in the case challenging DNA patenting faced another hurdle May 30, as Myriad Genetics Inc. once again sought to defeat the challengers based on a lack of standing (Association for Molecular Pathology v. U.S. Patent and Trademark Office, Fed. Cir., No. 2010-1406, pleading 5/30/12).

The case is on remand from the U.S. Supreme Court (60 PTD, 3/29/12) for reconsideration by the U.S. Court of Appeals for the Federal Circuit 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(55 PTD, 3/22/12).

Briefing for the parties and friends of the court on the merits of the patent eligibility questions is due by June 15, with oral arguments scheduled for July 20 (83 PTD, 5/1/12).

However, in a May 30 “suggestion of mootness, or, in the alternative, motion to remand,” Myriad maintained its earlier argument that the only plaintiff the Federal Circuit previously held had standing is no longer in the same position.

The Challenge in Myriad.

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 is the exclusive licensee (91 PTD, 5/14/09).

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 and all claims to cDNA are patent eligible, but they split 2-1 as to claims to isolated DNA. 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011)(150 PTD, 8/4/11)

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)(61 PTD, 4/1/10).

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.

Researcher With Standing Changes Labs.

On remand, the Federal Circuit issued its scheduling order April 30. The order did not ask the parties to address 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) (06 PTD, 1/10/07)--“a substantial controversy … of sufficient immediacy and reality” and “meaningful preparation” to conduct potentially infringing activity.

In its briefing for Federal Circuit rehearing (172 PTD, 9/6/11) 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.

The Federal Circuit denied the rehearing motion without comment. The Supreme Court took no notice of the standing question.

Myriad Revives Standing Question.

Myriad's May 30 pleading mostly repeated arguments that it presented previously.

In general, Myriad argued that its prior communications--an offer of a license in 1998--were directed to NYU and that Ostrer's standing thus is based solely on his position at NYU. The company claims it has had no such communications with Ostrer's new lab location, the Albert Einstein College of Medicine and Montefiore Medical Center.

“Dr. Ostrer … voluntarily severed his connection with NYU, and by doing so he changed all of the relevant facts and circumstances that led this Court to conclude that he alone had a justiciable controversy,” Myriad said.

Myriad acknowledged a supplemental declaration filed by Ostrer before the earlier rehearing denial, wherein Ostrer committed to BRCA1/2 testing at Montefiore. However, the patent owner contended, “there must be an actual controversy--a bilateral dispute [with Montefiore]--requiring immediate resolution by a judicial ruling.”

Despite its prior briefing on the issue, Myriad still argued that its jurisdictional challenge has not yet been addressed. “Neither this Court's denial of Myriad's rehearing petition, nor the Supreme Court's order granting plaintiffs' petition … decided any of the issues raised in those proceedings.”

The pleading closed with a description of Ostrer's new position at Montefiore and raised questions about Ostrer's ability to provide the services that he committed to in the declaration. Myriad thus asked that, at the least, the appeals court should remand the case to the district court for a factual determination on Ostrer's current status.

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 plaintiffs.

By Tony Dutra  

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