Myriad Cert Petition Now Fully Briefed; Supreme Court May Decide (to take up Gene Patent Case) by Feb. 20

by jeeg 13. February 2012 22:21

Petitioners challenging the patent eligibility of isolated DNA filed a reply brief Jan. 20, rejecting the respondent patent owner's call for the U.S. Supreme Court to deny review of the case for lack of standing (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 11-725, reply filed 1/20/12).

The reply brief, filed by the American Civil Liberties Union and the Public Patent Foundation, argued that Myriad Genetics Inc. failed to inform the high court that the U.S. Court of Appeals for the Federal Circuit had already rejected the standing challenge.

Nine briefs were filed by friends of the court urging the high court to take the case. These amicus briefs focused on the merits of the case, arguing that allowing patents on genetic materials is bad public policy.

The Supreme Court will consider the petition at its Feb. 17 conference and may decide on Feb. 20 whether to accept the case for review.

Section 101 Holdings by Split Court

The case involves a 2009 declaratory judgment challenge initiated by the ACLU and PUBPAT 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.

A Federal Circuit panel agreed that one of six method claims at issue was drawn to patentable subject matter, and that claims to cDNA are patent eligible. 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).

They split 2-1, however, as to claims to isolated DNA, with the majority reversing the lower court's ruling against patent eligibility for such claims. No. 09 Civ. 4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010).

Judge Alan D. Lourie wrote the majority opinion; Judge Kimberly A. Moore wrote a concurrence. They agreed at minimum that isolated DNA has “markedly different chemical characteristics” compared to corresponding native DNA in the human body, reciting the court's standard set in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980).

However, they identified different standards for distinguishing patent-ineligible “products of nature,” and Moore gave weight to the expectations of the industry and the patent community in light of the longstanding standards of the Patent and Trademark Office. In dissent, Judge William C. Bryson described yet another approach.

The panel rejected both parties' rehearing petitions. Neither party filed for an en banc rehearing.

Petition Says Structure and Function Must Differ

The ACLU and PUBPAT filed the petition for certiorari Dec. 7. The question presented as to the isolated DNA patent eligibility holding is simply, “Are human genes patentable?”

The petition, written by the ACLU's Christopher A. Hansen, New York, broadened the scope of the challenge to date slightly, focusing on the Section 101 requirement of a “new and useful” composition of matter. The challengers thus concluded that the “useful” requirement meant that the function of the isolated DNA—not just its chemical structure—must be markedly different from what appears in the human body.

The plaintiffs also reprised an argument that had initially been brought against the PTO as a separate defendant: “Patents on isolated DNA, whether small segments or whole genes, also violate the First Amendment because they block scientific inquiry into the patented DNA.” The petitioners contended that DNA patents “grant control over a body of knowledge and pure information.”

The petition also asked the court to reverse the Federal Circuit's opinion as to the requirements for standing in the case. The appeals court held that only one plaintiff—Harry Ostrer, a researcher at New York University School of Medicine—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.

However, just before the Federal Circuit's July 29 decision, Myriad notified the court that Ostrer was planning to leave NYU at the end of August and move to the Montefiore Medical Center at the Albert Einstein College of Medicine. The Federal Circuit's opinion made no mention of that fact, and its denial of Myriad's petition for rehearing was likely based on a letter from Ostrer that the position change did not alter his desire to perform allegedly infringing activities.

The ACLU's cert petition did not address Ostrer's status, instead arguing that standing could be based on two other plaintiffs among the various medical associations, medical researchers, breast cancer counselors, and women diagnosed with or seeking diagnosis who filed the initial complaint.

Myriad's Counters ACLU's Assertions

Gregory A. Castanias of Jones Day, Washington, D.C., represents Myriad and filed the brief in opposition Jan. 13.

Myriad faulted the petitioners for their characterization of the similarity between the isolated DNA and DNA molecules in the body. Citing Lourie's majority opinion, the company listed the structural differences: “chemically-severed backbones, significantly fewer nucleotides, and the free-standing nature of isolated DNA molecules.”

The brief attacked the petitioners for their characterization of Myriad's actions in enforcing its patent rights as well. Throughout litigation, the ACLU used Myriad's purported threats to researchers to cease investigating the BRCA1/2 genes to support a policy argument of why DNA patenting should be banned.

“Contrary to petitioners' cursory assertions,” Myriad contested, “neither Myriad nor the existence of the challenged patents hinder research of BRCA1/2.” The brief cited evidence of thousands of research studies and papers on the genes.

And as to the ACLU's additional policy argument that having an exclusive licensee is detrimental to the need for second opinions in health matters, Myriad countered, “the record shows that there are multiple laboratories that provide ‘second opinions' regarding BRCA1/2 test results for deleterious mutations.”

Finally, Myriad continued its challenge to Ostrer's standing. “Here, substantial questions regarding Dr. Ostrer's stake (if any) in this case would also have to be resolved at the outset, before the Court could reach the merits of the § 101 issue,” Myriad argued.

ACLU, PUBPAT Reply

The ACLU and PUBPAT replied Jan. 20.

Reaffirming the assertion that Ostrer had standing, the brief quoted a declaration by Ostrer expressing “the strong desire for my [Montefiore] lab to provide [BRCA1/2] sequencing services.”

Ostrer's declaration also rejected Myriad's contention that a purportedly threatening letter from Myriad implicated NYU's standing, not Ostrer's, the brief noted, quoting Ostrer's statement that he “cannot reconcile that argument” with the fact that Myriad's letter was addressed to him. According to Ostrer, “I felt personally threatened then and I continue to feel so today,” the brief said, again quoting Ostrer's declaration.

The ACLU/PUBPAT brief also criticized Myriad for attempting to resurrect in its Supreme Court briefing a redressability argument. In the appeals court and in its opposition to the cert petition, Myriad asserted that the petitioners will still be subject to an infringement complaint on other claims, such as those directed to primers and probes. “Myriad does not mention that its argument was raised and rejected by the Federal Circuit,” the reply brief noted.

The petitioners also refuted Myriad's claim to have engaged in extensive research on BRCA1/2, arguing that the patent owner's published papers simply mentioned those genes.

Finally, the ACLU contended that Myriad was “simply wrong” in arguing that the case is not important because isolated DNA sequence patents are now foreclosed by the publication of the whole genome. The petitioners' brief cited an academic paper stating that “gaps in genome identification remain,” and, noting a recently issued U.S. patent (7,928,212), added, “patents on genes are still being sought and granted.”

Tony Dutra, BNA

 

 

 

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