Amici File Seven Briefs Supporting ACLU Challenge to Isolated DNA Patent Eligibility

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Seven briefs were filed as of Oct. 31 by friends of the court urging the Supreme Court to grant review in the case challenging patents on isolated DNA (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 12-398, amicus briefs filed 10/31/12).

The petition for certiorari, filed Sept. 25 (186 PTD, 9/26/12), appeals a 2-1 decision by the U.S. Court of Appeals for the Federal Circuit that isolated DNA claims of patents exclusively licensed to Myriad Genetics Inc. are patent eligible under 35 U.S.C. §101.

That decision followed a remand by the high court to reconsider the case in light of the Supreme Court's Section 101 ruling in Mayo v. Prometheus. However, the three opinions by the Federal Circuit panel members did not change much on remand, and the net impact of Mayo on each opinion was minimal.

The organizations behind the challenge, the American Civil Liberties Union and the Public Patent Foundation, asked the high court a second time to consider the question, “Are human genes patentable?”

Myriad filed its brief in opposition Oct. 31, chastising the plaintiffs for that phrasing. The patent owner accused the petitioners of “a misunderstanding of basic scientific principles, well-established case law, and the nature of the composition claims at issue.”

The amici supporting the ACLU's petition--headed by the American Medical Association--cited broad support in the medical services community to barring patents on human genetic materials.

In general, the amici put forth policy arguments, contending that the patent incentive is not necessary for innovation in gene-related technology development, and that patents inhibit rather than promote further developments.

Challenge Began in 2009.

The case arose from a 2009 declaratory judgment challenge filed by the ACLU and PubPat, on behalf of the Association of Molecular Pathology and other medical associations, individuals involved in medical research, breast cancer counselors, and women diagnosed with or seeking diagnosis for cancer (91 PTD, 5/14/09).

They argued that particular claims in patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) on isolated DNA, cDNA, and methods related to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer were ineligible for patenting under 35 U.S.C. §101.

In its first decision, the Federal Circuit agreed that only one of the method claims and all the claims to cDNA are patent eligible, but the court was divided 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) (150 PTD, 8/4/11).

A week after unanimously rejecting method claim patent eligibility in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 USPQ2d 1961 (2012), the Supreme Court granted the ACLU's petition for writ of certiorari in the instant case, vacated the Federal Circuit's opinion, and remanded the case for reconsideration.

On remand, however, the appeals court panel came to the same conclusions, with all three judges writing essentially the same opinions that they had penned the first time. 689 F.3d 1303, 103 USPQ2d 1681 (Fed. Cir. 2012).

Amici Express Common Themes.

Each of the seven amicus brief filers also filed a brief in support of the ACLU's initial petition to the high court.

From a jurisprudential standpoint, most attempted to construe in the petitioners' favor the Supreme Court's 32-year-old opinion differentiating an unpatentable “product of nature” from “a nonnaturally occurring manufacture or composition of matter … with markedly different characteristics from any found in nature,” in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980).

However, their focus was on policy arguments. Most of the briefs 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,' ” according to the SACGHS report. “Gene patents serve only to prevent alternative, and potentially more accurate, tests from being shared in the market.”

But Each Brief Offers Different Focus.

Following is a list of the seven briefs filed, the amici in support, and their specific arguments.

• AARP. The brief for the retired persons' association was filed by Barbara A. Jones of AARP Foundation Litigation, Pasadena, Calif.

Copying a policy argument that it made when the ACLU first filed for cert, the AARP said, “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 current brief was updated to extend this argument in light of what the Federal Circuit said in its decision on remand. The majority said the case “is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion.”

“Unfortunately, that is precisely what this case is about,” the AARP brief said, “and the Federal Circuit committed reversible error by refusing to even consider the public health consequences of its decision.”

• Academics in Law, Medicine, Health Policy and Clinical Genetics. “This Court, in Mayo, provided a clear understanding of the independent role played by the exception to patentable subject matter implicit in §101 relating to laws of nature, natural phenomena, and abstract ideas,” according to six multi-discipline professors.

“[T]he Federal Circuit not only ignored this Court's discussion of the underlying purpose of the exception in Mayo but flatly contradicted it,” they argued.

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; Dianne Nicol, law professor at the University of Tasmania, Australia; and Julian Kinderlerer, professor of intellectual property law at the University of Cape Town, South Africa.

• American Medical Association et al. Lori B. Andrews, professor at the Chicago-Kent College of Law, Chicago, submitted a 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, and Medical Society of the State of New York.

This time around, these parties deleted a request that the court also consider the extent of the research exemption to patent infringement, an argument 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).

The amici now replaced that argument with a broader reliance on the SACGHS report. “Gene sequence patents are not necessary to incentivize the discovery of genes and the development of genetic tests,” according to the brief.

The brief also followed the AARP policy approach, focusing on the issue of unavailability of a second opinion.

“In this case, because Myriad has exclusive use of the BRCA1 and BRCA2 gene sequences, no woman can get an independent second opinion about her condition before deciding to have her healthy breasts or ovaries removed in order to avoid cancer,” according to the AMA. “As a result, women may have their breasts or ovaries removed unnecessarily when they receive a false positive result on a BRCA1 or BRCA2 test because they do not have access to an independent confirmatory test.”

• 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.

That brief, too, faulted the Federal Circuit for “simply wav[ing] off this Court's admonitions to take guidance from Mayo.”

Amici noted that the Supreme Court remanded the Myriad case on the basis of the ACLU's cert petition challenging composition of matter claims only, and not method claims, as were at issue in Mayo. Yet, the Federal Circuit's majority opinion on remand held that “Mayo does not control the question of patent-eligibility of [isolated DNA] claims. They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter in §101.”

Canavan characterized the question in Mayo as whether “the patent claims add enough to their statements of [medical diagnostic] correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws.”

“The correlative question in this case,” Canavan said, “is whether the process of isolating DNA and the attendant changes that occur at the terminal ends of an isolated gene make it different enough to transform it in any defining way.”

• Cancer Council Australia et al. Luigi Palombi, a professor at the University of Sydney Law School in Australia, authoreda brief listing amici including the Cancer Council Australia, 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.”

• National Women's Health Network et al. Debra L. Greenfield of the Institute for Society and Genetics at the University of California, Los Angeles, filed a brief on behalf of the National Women's Health Network, Reproductive Health Technologies Project, Disability Rights Legal Center, Forward Together, the Center for Genetics and Society, the Pro-Choice Alliance for Responsible Research, Alliance for Humane Biotechnology, and two doctors, G. Michael Roybal and Anne L. Peters.

These amici modified their arguments the second time around more than the others. Their prior focus was on studies that have shown a decrease in research on new or improved genetic tests since the PTO began granting patents on isolated DNA. Though they particularized their attack to Myriad to some extent in that earlier brief, the current brief extended that focus, criticizing Myriad's test for its limitations, inaccuracy, and cost, and contending that newer, better technologies are preempted by Myriad's assertion of its patent rights.

The brief also addressed the “inventive concept” requirement the Supreme Court added to its jurisprudence in Mayo. “Claims to isolated DNA/cDNA molecules do not rest on inventive concepts,” the amici said. “The claim terms indicating isolation or synthesis do not add anything of significance to render these laws and products of nature patent-eligible.”

• Kali N. Murray and Erika R. George. Two law professors filed a brief that was not available to BNA for this report.

In January, their brief made a First Amendment argument, tied to a standing question in the case, addressing the policy issue here.

“[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.”

By Tony Dutra  


ACLU petition at http://pub.bna.com/ptcj/ACLUCertPetition12Sep25.pdf

Myriad brief at http://pub.bna.com/ptcj/120398Myriad12Oct31.pdf

Amicus briefs at --

• AARP: http://pub.bna.com/ptcj/120398AARP12Oct31.pdf

• Academics: http://pub.bna.com/ptcj/120398Academics12Oct26.pdf

• AMA: http://pub.bna.com/ptcj/120398AMA12Oct31.pdf

• Canavan: http://pub.bna.com/ptcj/120398Canavan12Oct31.pdf

• Cancer Council Australia: http://pub.bna.com/ptcj/120398CCA12Oct31.pdf

• NWNH: http://pub.bna.com/ptcj/120398NWHN12Oct24.pdf