ACLU and Myriad File for Panel Rehearing In Challenge to Isolated DNA Patentability

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In a bit of a surprise, the parties in the ACLU v. Myriadcase each filed a petition Aug. 25 for a panel rehearing in the U.S. Court of Appeals for the Federal Circuit, rather than asking for en banc consideration or taking the case directly to the U.S. Supreme Court (Association for Molecular Pathology v. U.S. Patent and Trademark Office, Fed. Cir., No. 2010-1406, petitions for rehearing 8/25/11).

In a divided decision with three separate opinions, the panel ruled July 29 that patents claiming isolated DNA are statutory subject matter under Section 101 of the Patent Act, 35 U.S.C. §101 (147 PTD, 8/1/11).

The plaintiffs' rehearing petition argues that the panel majority erred because “the language of the patents defines the function, not the structure of the patented genes and gene fragments; [and] gene fragments with the altered chemical structure identified by the Court exist in nature.”

The declaratory judgment defendant, Myriad Genetics Inc., on the other hand, seeks to render the case moot, without vacating the panel's opinion on the merits, by removing from the case the only plaintiff ruled to have standing.

Section 101 Holdings by Split Court

The case involves a 2009 declaratory judgment challenge initiated by the American Civil Liberties Union and the Public Patent Foundation 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 ACLU and PUBPAT, acting on behalf of the Association of Molecular Pathology and other medical associations, medical researchers, breast cancer counselors, and women diagnosed with or seeking diagnosis, 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 directed to nonstatutory subject matter under Section 101.

The three panel judges agreed that only one of the method claims at issue was drawn to patentable subject matter, and that claims to cDNA are patent eligible.

They split 2-1, however, as to claims to isolated DNA, with the majority reversing the lower court's ruling. No. 09 Civ. 4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010) (60 PTD, 3/31/10). Each of the judges filed a separate opinion as to those claims, each identifying a different standard for distinguishing patent-ineligible “products of nature.”

The majority agreed at minimum, though, that isolated DNA has “markedly different chemical characteristics” compared to corresponding native DNA in the human body.

Court Finds Only One Researcher Has Standing

The panel reached the Section 101 issues after agreeing that one—and only one—of the researchers had standing to file the suit.

Harry Ostrer, a researcher at New York University School of Medicine, the court held, 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) (6 PTD, 01/10/07)—“a substantial controversy … of sufficient immediacy and reality” and “meaningful preparation” to conduct potentially infringing activity.

The court first distinguished only three of the plaintiffs, all medical researchers and including Ostrer, as subject to Myriad's “affirmative patent enforcement actions,” which occurred in 1998-99.

Of those three, only Ostrer, the court said, “state[d] unequivocally that he will immediately begin [BRCA] testing” if the court ruled the patent claims nonstatutory. The other two said only that they would “consider” resuming BRCA testing, the court noted, defeating their standing claim. Quoting from Lujan v. Defenders of Wildlife, 504 U.S. 555, 564 (1992), the court said that “ ‘some day' intentions” are insufficient to support an “actual or imminent” injury for standing “without … any specification of when the some day will be.”

Myriad Challenges Researcher's Standing

Just before the July 29 court 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 ACLU then submitted a letter to the court asserting that the Montefiore laboratory has the same capabilities as the NYU lab, and that Ostrer still has a “wish to engage in sequencing” BRCA 1 and 2. The court did not discuss either communication in its opinion.

In its rehearing petition, Myriad argues that the controversy existed between Myriad and NYU, and that, “by deciding to start over at a new institution, Dr. Ostrer has severed any nexus he might have had to the Myriad-NYU controversy supposedly created by Myriad's 1998 letter.”

Myriad further argues that the ACLU letter did not establish that Montefiore will allow Ostrer to do the BRCA testing he envisioned and that Ostrer's “wish” to sequence the genes fails to meet the panel's requirement for an “unequivocal” statement of intent.

But Wants Merits Holding Left Intact

“Because the mootness was caused by plaintiff Ostrer's unilateral action,” Myriad's petition continues, “the panel opinion upholding Myriad's patent claims should not be vacated.”

The company relies on the court's ruling in Tafas v. Kappos, 586 F.3d 1369, 92 USPQ2d 1693 (Fed. Cir. 2009) (218 PTD, 11/16/09). Though the issue in the Tafas case was whether to vacate the lower court decision, Myriad said the instant case differed in that the lower court opinion had no precedential value. Therefore, the company said, “the circumstances here are even more compelling” for not vacating the appellate court's decision.

Plaintiffs Say Two More Have Standing

The ACLU petition for the plaintiffs focuses on the isolated DNA patent eligibility aspect of the case, but also devotes two paragraphs to make a case for standing for two other plaintiffs.

First, the plaintiffs argue, if Ostrer has standing, an organization for which he is a member—the American College of Medical Genetics—has organizational standing under Warth v. Selden, 422 U.S. 490, 511 (1975).

Second, the petition counters the court's assertion that only three researchers had received threatening communications from Myriad. Another plaintiff, Ellen Matloff, declared that “she personally had conversations with Myriad in which she was told by Myriad that she and geneticists at Yale would violate Myriad's patents if they performed the tests that she wanted to perform,” the ACLU said.

ACLU, PUBPAT Challenge Patent Eligibility

The plaintiffs' rehearing petition cites a number of errors in the Section 101 analysis performed by both the majority opinion author, Judge Alan D. Lourie, and the concurrence written by Judge Kimberly A. Moore.

The petition repeats the plaintiffs' basic premise that the chemical structure of the isolated DNA is irrelevant for determining whether the DNA is an unpatentable product of nature. “The majority erroneously ignored the language of the claims and erroneously ignored the scientific fact that DNA fragments with identical chemical structure are found in nature,” the ACLU argues further.

In part, the plaintiffs fault the judges for construing the claims at issue in a way that was not discussed in the lower court. For example, Lourie found it important that covalent bonds are broken in isolating the genes at issue, but, the ACLU argues, “The claims have no express limitations to gene fragments that have had their covalent bonds broken by man, and such an inherent limitation is not supported by the specification, the file history, or any argument Myriad made at any time in this matter.”

Even assuming the structural difference of breaking the bonds, the ACLU argues, such events happen to the genes inside the human body.

“Even if the chemical alterations deemed significant by the majority are significant, they result in chemicals that are not markedly different from and are at times identical to those found in nature,” the plaintiffs conclude. “They are thus not patentable subject matter.”

Gregory A. Castanias of Jones Day, Washington, D.C., represents Myriad. The ACLU's Christopher A. Hansen, New York, represents the plaintiffs.

By Tony Dutra

Petitions at http://pub.bna.com/ptcj/101406ACLUPetAug25.pdf and http://pub.bna.com/ptcj/101406MyriadPetAug25.pdf  

The court's opinion is at http://pub.bna.com/ptcj/101406July29.pdf