Supreme Court Will Weigh Patent Eligibility Of Claims on Human DNA in Myriad Case

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By Tony Dutra and W. Randy Kubetin – Dec 14, 2012

The U.S. Supreme Court will decide the patent eligibility of claims on isolated DNA, granting a petition for certiorari Nov. 30 in Association for Molecular Pathology v. Myriad Genetics Inc., (U.S., No. 12-398, review granted 11/30/12).

Parties on both sides of the case reacted as might be expected, and one attorney said the decision looks to be another blockbuster similar to recent Supreme Court decisions in other cases in the life sciences and biotechnology fields.

The cert petition appealed 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.

The court certified only the first question presented: “Are human genes patentable?”

The petitioners, led by the American Civil Liberties Union and the Public Patent Foundation, had two other questions, which the high court will not consider.

For the first, claims directed to methods of genetic diagnostic testing are at issue in the case as well, although the appeals court was unanimous in finding only one claim—on a “method of screening potential cancer therapeutics”—patent eligible.

The petition asked: Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289 (2012) (6 LSLR 404, 4/6/12).

The appeals court also agreed unanimously that only one plaintiff—a researcher who was allegedly interested in sequencing the genes covered by the patents—had declaratory judgment standing. Those deemed to lack standing included medical associations, other individuals involved in medical research, breast cancer counselors, and women diagnosed with or seeking diagnosis for cancer.

The petitioners had asked: Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision in MedImmune Inc. v. Genentech Inc., 549 U.S. 118 (2007) (4 LSLR 1168, 12/17/10), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

The case arose from a 2009 declaratory judgment challenge filed by the ACLU and PubPat (3 LSLR 512, 5/22/09).

They argued on behalf of the plaintiffs 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 Section 101.

In its first decision July 29, 2011, 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 (5 LSLR 831, 8/12/11).

Then on March 26, a week after unanimously rejecting method claim patent eligibility in Mayo v. Prometheus, 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 (6 LSLR 402, 4/6/12).

On remand Aug. 16, 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, including as to the patent eligibility of the method claims asserted. Association for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012) (6 LSLR 857, 8/24/12).

The ACLU wasted little time, petitioning again for certiorari Sept. 25 (6 LSLR 995, 10/5/12).

Myriad filed its opposition brief Oct. 31 (6 LSLR 1131, 11/16/12), mostly devoted to disputing the phrasing of the first question presented—“Are human genes patentable?”

The case is not about patenting “native” human genes, Myriad said. “The challenged composition claims are instead narrowly drawn to specific, defined DNA molecules, isolated by human scientists in laboratories, that do not naturally occur.”

Seven additional briefs were filed as of Oct. 31 by friends of the court urging the Supreme Court to grant review (6 LSLR 1132, 11/16/12). 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.

Notably, the medical services community, led by the American Medical Association, submitted a brief on behalf of several associations asking the high court to overturn the Federal Circuit’s ruling.

Sandra Park, a staff attorney with the ACLU Women’s Rights Project, said in a Nov. 30 ACLU blog entry that by invalidating Myriad’s gene patents, “the Supreme Court would ensure that the patent system fulfills its constitutional mandate ‘to promote the progress of science.’” Patents on human genes, she said, “would no longer stand in the way of deepening our knowledge of the human genome and using these discoveries to improve how we diagnose and treat diseases.”

According to Park, Myriad has enforced its patents on the genes so that it has a monopoly on BRCA genetic testing. She predicted the following impacts from a Supreme Court ruling against human gene patents:

  • Gene patent holders could not threaten or shut down other laboratories from offering genetic testing.

  • Gene patent holders could not prevent others from providing genetic testing that draws on new developments in genetic research.

  • Patients would not be barred from getting a second opinion or testing at a lower cost because a patentholder has a monopoly on a gene.

  • Genetic testing could be offered that screens multiple genes for certain conditions, giving patients and doctors a better understanding of how genetic factors might affect diagnosis and treatment.

  • No single laboratory could use its patents to control most of the data about a gene.

  • Universities, laboratories, and biotechnology companies could develop (and patent, if they choose) new tests, drugs, and other inventions based on genetic information and sequencing without fear of being accused of patent infringement.

In a Nov. 30 statement responding to the Supreme Court ruling, Peter Meldrum, president and chief executive officer of Myriad, said, “Two previous decisions by the Federal Circuit Court of Appeals confirmed the patentability of our groundbreaking diagnostic test.”

“Myriad devoted more than 17 years and $500 million to develop its BRACAnalysis test,” Meldrum added. “The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our U.S. patent system is the engine that drives this innovation. This case has great importance for the hundreds of millions of patients whose lives are saved and enhanced by the life science industry’s products.”

He said the test is widely available for all women with a family history of cancer and is cost-effective for both patients and the health care system. Health economic studies conclude that Myriad’s genetic tests are fairly priced, he said, and about 1 million women already have benefited from taking the BRACAnalysis test.

In addition, Meldrum said, Myriad has supported research on its patented BRCA1, BRCA2 genes by more than 18,000 scientists, resulting in more than 9,000 published research papers. Myriad also has facilitated research through a partnership with the National Institutes of Health and provided at-cost testing for nearly 6,000 researchers receiving NIH grants.

Additionally, Myriad has established a Financial Assistance Program that provides coverage at no charge to low-income patients who lack insurance, he said.

Overall, Meldrum said, “approximately 95 percent of all patients in the United States have access to BRACAnalysis either through private insurance, Medicare, or Medicaid. The average out-of-pocket cost to a patient is less than $100. Even though Myriad automatically retests all positive results to confirm the findings at no additional charge to the patient, second-opinion testing is also available for all patients.”

The Supreme Court’s ruling “apparently represents yet another of a series of interventions into the patent law system by the United States Supreme Court,” J. Mark Waxman, a partner with Foley & Lardner in Boston, told BNA in a Dec. 2 email. “This decision will, as have the others in the very recent past, reframe the patent system in the gene-based technology area. Put differently, this decision looks to be another blockbuster.”

D. Christopher Ohly, a partner with Schiff Hardin in Washington, said in a Nov. 30 email to BNA that by taking the Myriad case, the Supreme Court may “smooth the edges between its precedents” in cases involving the patent eligibility of processes versus those involving products, “at least in cases in which natural laws are involved in challenged patent claims.”

The Federal Circuit declined the opportunity to extend the reasoning of Prometheus, which dealt with diagnostic methods, to the Myriad case, which involves a gene segment product, Ohly said.

“The Federal Circuit did so,” he said, “in part, because the Supreme Court jurisprudence in each area is different. The Myriad decision turned on the molecular difference in a segment of DNA that was ‘isolated’ by man made processes, from the same segment as it may be found in its natural state as part of a much longer DNA molecule.

“This decision looks to be another blockbuster.” — J. Mark Waxman, Foley & Lardner

“According to the majority, when the isolated DNA segment was cleaved from the longer strand, and covalent bonds at each end of the isolated segment were broken, a new molecule was formed that is sufficiently different from the same segment in its previous, natural state, to allow it to be eligible for patenting,” he said.

“It remains to be seen whether this difference, which may be as small as a single atom on each end of the isolated segment, will be enough to allow the Supreme Court to agree with the Federal Circuit, Ohly said. “It may be that the Supreme Court has granted certiorari to reverse and hold that the difference is insufficient to warrant issuance of a patent that may, to some undefined extent, preempt competition and even further research. If so, the Supreme Court will be required to define more precisely than it did in Prometheus what is different ‘enough’ from natural law, or a product that reflects natural law, to warrant issuance of a patent.

“It is at least arguable that the broad question presented by the parties in Myriad could have been avoided by insistence by the Court that issues of patent eligibility, under Section 101 of the Patent Act, be considered along with issues of anticipation and obviousness, or written description, under Sections 102, 103 and 112,” Ohly said. “This may be so, especially given the District Court’s unchallenged claim construction, which was not even mentioned in the Federal Circuit’s two opinions in Myriad.

“Issues of novelty, which are apparent in consideration of patent eligibility under Section 101, are more comfortably handled by the courts in the context of challenges based on obviousness and anticipation. While analyses of patent eligibility under Section 101 may typically have been conducted first, as a threshold matter, it is not necessary that this order be kept. Nor is it necessary for the courts to permit parties to avoid consideration of obviousness or anticipation, simply by crafting their pleadings to avoid challenges to patents under Sections 102 and 103,” Ohly said.

Ronald M. Daignault, a partner with Robins, Kaplan, Miller & Ciresi in New York, said that by limiting consideration to the question, “Are human genes patentable?” the Supreme court decision lends greater predictability to the other areas of patentable subject matter the Federal Circuit considered in Myriad.

“The Federal Circuit found the method claims of analyzing/comparing BRCA1 gene sequences to determine whether there is an alteration in the sequence were not patentable subject matter. That holding stands and appears consistent with the Supreme Court’s decision in Mayo v. Prometheus,” Daignault told BNA in a Dec. 3 email.

“In fact, just two weeks ago in PerkinElmer v. Intema [Fed. Cir., No. 2011-1577, 11/20/12; 6 LSLR 1179, 11/30/12], the Federal Circuit relied on Mayo and pointed to the panel’s decision in Myriad to find that screening methods of determining the risk of Down’s syndrome were not patentable subject matter, as the claims at issue involved insignificant mental steps concerning laws of nature. Thus, greater clarity of patent ineligibility may be emerging in this area,” he said.

As to the other method claims in Myriad—methods for screening potential cancer therapeutics with transformed host cells—the Federal Circuit held that those methods were patent eligible subject matter. Granting certiorari should not affect that ruling either.

According to Daignault, “devoid of context, there is room for potential mischief in the broad question, ‘Are human genes patentable?’ Both parties and amici will address that question from different perspectives in varying contexts. In the end, it will be interesting to see what the Supreme Court will say its holding is as opposed to dicta.”

Deborah L. Lu, a partner with Vedder Price in New York, said the Supreme Court’s denial of cert on the approval of diagnostic method patents indicates that it did not wish to deal with that issue, and that the Federal Circuit’s decision in Mayo already has narrowed the scope of diagnostic patents.

She expressed hope that the high court would clarify the question of whether human genes are patentable, but that in her opinion, it would be a mistake to overturn the Federal Circuit in this case.

Regardless of the outcome, she said, the question of human gene patentability could remain clouded given that many primate, mammalian, and even bacterial genes have identical sequences to human genes. “I am thinking along the lines of conserved sequences,” she told BNA in a Dec. 3 email. A large percentage of human DNA is homologous to a primate and to a mouse, and some human genes include retroviral DNA, Lu said.

“So let’s suppose for the sake of argument that the Supreme Court holds that human genes are not patentable,” Lu said. “I could always argue that a sequence, although present in a human, is not a human gene because it is also present in a non-human animal. In that instance, what about retrovirus genes? If they are present in a human, does it make that gene a human gene? I think it’s a stretch for someone to argue that cytomegalovirus (CMV) is a human gene but could it be classified as one because it is present in many, many humans?”

Summing up, Courtenay C. Brinckerhoff of Foley & Lardner, Washington, told BNA in a Nov. 30 email, “The Supreme Court’s decision to grant certiorari creates a cloud of uncertainty over isolated DNA claims that read on human genes, at least until the Court renders its decision, which could come before the end of the Court’s current term, in June 2013.”

Gregory A. Castanias of Jones Day, Washington, represents Myriad. Christopher A. Hansen, staff attorney with the ACLU Speech, Privacy, and Technology Project, represents the petitioners.

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