By Tony Dutra
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.
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.
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.
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.
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.”
Nine amicus briefs were filed on or before Jan. 13, all in support of the petitioners. Most echoed the arguments made by the ACLU in the cert petition. Other arguments are listed below.
• AARP. The brief for the retired persons' association was filed by Barbara A. Jones of AARP Foundation Litigation, Pasadena, Calif.
The brief relied on a 19th century case, Kendall v. Winsor, 62 U.S. 322 (1859), for the proposition that “the rights and welfare of the community must be fairly dealt with and effectually guarded” in the patent system.
“Gene patents, such as Myriad's, significantly harm the public interest by maintaining an environment in which patients are unable to obtain a second opinion when other laboratories are precluded from conducting genetic tests due to patents,” the AARP contended.
• Certain Academics in Law, Medicine Health Policy, and Clinical Genetics. Roy Liebman of New York is counsel of record for a brief written by five professors in various disciplines.
Listed as signatories to the brief were: E. Richard Gold, law professor at McGill University, Montreal, Canada; James P. Evans, professor of genetics and medicine in the School of Medicine at the University of North Carolina; Tania Bubela, professor of health and intellectual property law in the School of Public Health at the University of Alberta, Edmonton, Canada; Robert Cook-Deegan, director of genome ethics, law and policy at the Institute for Genome Sciences and Policy at Duke University; and Dianne Nicol, law professor at the University of Tasmania, Australia.
The professors attacked Judge Lourie's reliance during argument on what some stakeholders say represents a defining test for patent eligibility of a composition of matter: the cleavage of a covalent bond.
“There is nothing unique regarding the importance of covalent bonds in chemistry or biology,” the brief argued. “Indeed, other types of bonds—such as the hydrogen bonds linking base pairs on opposing DNA strands that are critical for both replication and transcription and the ionic bonds that link histones to the DNA backbone that are essential to transcription—are at least as important.”
• American Medical Association et al. Lori B. Andrews, professor at the Chicago-Kent College of Law, Chicago, submitted the brief on behalf of major medical associations AMA, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American Osteopathic Association, American College of Legal Medicine, American College of Embryology, and Medical Society of the State of New York.
The brief asked the court to also consider the extent of the research exemption to patent infringement, arguing that the Federal Circuit rendered the exemption “for all practical purposes a nullity” in Madey v. Duke University, 307 F.3d 1351, 64 USPQ2d 1737 (Fed. Cir. 2002).
• Canavan Foundation et al. John L. Hendricks of Hitchcock Evert, Dallas, filed a brief on behalf of Canavan Foundation, Claire Altman Heine Foundation, March of Dimes Foundation, Facing Our Risk of Cancer Empowered, National Association for Pseudoxanthoma Elasticum, and Ovarian Cancer National Alliance.
The brief echoed an argument made by the “certain academics” above as to the impact of Judge Moore's second vote that created the Federal Circuit majority. Moore distinguished DNA sequences by their length, and relied on PTO's longstanding practice of granting patents on isolated DNA. The Federal Circuit decision thus, according to the brief, “overrode the majority of judges on the panel because of expectations settled by administrative, not legal, rules.”
Thus, according to the brief, “the majority opinion represented a two-judge consensus on the ultimate conclusion but not on the legal bases for such conclusion.”
• Cancer Council Australia. Australian organizations and several individuals filed a brief, submitted by Larry James Frierson of Calistoga, Calif. Organizations listed in addition to the Cancer Council Australia were Royal College of Pathologists of Australasia, Human Genetics Society of Australasia, and National Breast Cancer Foundation of Australia.
The brief further questioned the unanimous decision of the Federal Circuit panel that cDNA molecules are patent eligible. “The issue … is the degree of artificiality required to be transformative,” the amici stated. “Is it enough that the cDNA molecule is man-made?”
The brief asserted that the answer was no. “That cDNAs are little more than copies of their natural corresponding counterparts also makes them natural phenomena even though they are artificial.”
• Kaiser Permanente. The health care giant's brief was filed by David C. Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel, Washington, D.C.
Kaiser Permanente is a large a user of Myriad's services, and the brief criticized the patent licensee's practices. One such practice that has received little attention is Myriad's control over the results of the tests that it exclusively provides, an argument apparently attacking the company for failing to abide by the quid pro quo of a patent—the publication of the utility of the composition of matter.
“[I]f clinicians and researchers outside of Myriad were permitted to access and analyze the full information in Myriad's database, they could use it to develop a more complete understanding of the universe of BRCA1 and BRCA2 mutations and variants and the role these genetic factors play in increasing susceptibility to breast and ovarian cancer,” the brief argued.
• Knowledge Ecology International. Krista L. Cox of KEI, Washington, D.C., submitted the brief of the nonprofit organization that claims “expertise in access to medicines and medical technologies.”
The brief described “new incentive and financing models for biomedical innovation and … several mechanisms for stimulating investments and promoting innovation outside of the patent regime.”
• Kali N. Murray and Erika R. George. Two law professors filed a brief with a focus on the standing issue and the link to the First Amendment argument.
“[T]he Federal Circuit failed to appreciate the significant threshold injury suffered by the Petitioners in their communication related to scientific, medical, and public health concerns,” Kali N. Murray, professor at Marquette University Law School, and Erika R. George, professor at the S.J. Quinney College of Law at the University of Utah, said.
“[I]ntellectual property principles are tethered to the First Amendment's right to give and receive information,” they further contended. “Myriad's claims are directed at information so fundamental to medical science and research, that granting them a monopoly would freeze the free flow of basic information and violate First Amendment values.”
• National Women's Health Network et al. The NWHN brief was filed by Debra L. Greenfield of the Center for Society and Genetics at the University of California, Los Angeles. Other organizations listed as amici on the brief were: Generations Ahead, Pro-Choice Alliance for Responsible Research, Asian Communities for Reproductive Justice, Center for Genetics and Society, and Alliance for Humane Biotechnology.
The brief cited a number of studies that have shown a decrease in research on new or improved genetic tests since the PTO began granting patents on isolated DNA. And it was specifically critical of Myriad's practices that prevented add-on research.
• Yale scholars. Five scholars associated with the Information Society Project at Yale Law School, New Haven, Conn., submitted a brief, with resident fellow Priscilla J. Smith, Brooklyn, N.Y., listed as counsel of record.
The brief took up the issue of the patents' impact on research in detail. As with many amici, the brief cited “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests,” an April 2010 publication of the Secretary of Health and Human Services' Advisory Committee on Genetics, Health, and Society (SACGHS), available at http://oba.od.nih.gov/oba/sacghs/reports/SACGHS_patents_report_2010.pdf.
“The ‘inventor class' in genetics and biotechnology are academic and industry researchers whose primary motivations are ‘the desire to advance understanding, help their patients by developing treatments for disease, advance their careers, and enhance their reputations,' ” amici argued, quoting from the SACGHS report. “Gene patents serve only to prevent alternative, and potentially more accurate, tests from being shared in the market.”
ACLU reply at http://pub.bna.com/ptcj/110725ReplyJan20.pdf
ACLU reply at http://pub.bna.com/ptcj/110725ReplyJan20.pdf