the AJMG SEQUENCE
Myriad case heads back to Court of Appeals
Supreme Court remands case after Prometheus decision
The BRCA1 and BRCA2 gene patents are scheduled for further legal review as the U.S. Court of Appeals for the Federal Circuit reconsiders its ruling in Association for Molecular Pathology, et al v. Myriad Genetics (Myriad).
The Supreme Court remanded Myriad after a decision in another case struck down patent claims used in a blood test that helps determine the dosage of a drug used to treat autoimmune diseases. The high court's ruling in Mayo Collaborative Services v. Prometheus Laboratories (Prometheus) says that patent claims must do significantly more than simply describe relationships that occur naturally. A Court of Appeals panel is scheduled to again hear arguments on Myriad on July 20. In July 2011, a Court of Appeals panel upheld Myriad's BRCA patents, ruling that DNA isolated from the body could be patented because it was “markedly different”
Decision and Congressional Action
In its unanimous decision in Prometheus, the Supreme Court said Prometheus's patent claims did little more than describe relationships that occur naturally. Although the claims give physicians instructions, they “add nothing specific to laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field,” the decision says.
Defendants argued that patents promote innovation by assuring protection of investment, while plaintiffs maintained patents impede ability to make further medical discoveries. The decision acknowledges the validity of both arguments, but maintains that Congress, not the court, should resolve the dispute.
Some in Congress have taken unsuccessful action on gene patents. Rep. Debbie Wasserman Schultz (D-Fla.) tried to add an amendment to the 2011 America Invents Act (AIA) that would have established a safe harbor for confirmatory genetic testing where patents exist. The proposed language was somewhat similar to a 2010 recommendation from the now disbanded Department of Health and Human Services' Secretary's Advisory Committee for Genetics, Health, and Society. It suggested that Congress create an exemption to patent infringement for diagnosis and research. Wasserman Schulz successfully added language to AIA mandating that the U.S. Patent and Trademark Office (PTO) report on effective ways to ensure availability of confirmatory diagnostic testing where gene patents and exclusive licensing for primary genetic diagnostic tests exist.
While passing language to ensure confirmatory genetic testing for patented and exclusively licensed genes has proven difficult, it would be more difficult to legislate exclusivity in licensing gene patents, says Robert Cook-Deegan, MD, Research Professor at Duke Institute for Genome Science and Policy. That's because U.S. media reports have generally taken a dim view of gene patenting, he says. “If Congress addresses the issue, it won't go the way patent lawyers want it to. Public sentiment is against them,” he adds.
Meanwhile, the Prometheus ruling is having some effect on the PTO. On March 21, the day after the Supreme Court issued its decision, the PTO issued a preliminary guidance memo that directs patent examiners to deny patent claims that merely invoke laws of nature.
The Court of Appeals has asked the litigants in Myriad to submit briefs on how the Prometheus decision might impact the Myriad case, with a specific focus on patent claim 20. That claim concerns the scientific method for finding a cancer treatment that involves growing a host cell that has been genetically modified to include a BRCA1 gene and testing to see whether any compound particularly inhibits the growth of those cells. “A key question for this claim is whether its breadth effectively extends to cover an abstract idea—namely, using the scientific method to discover a treatment for BRCA1 cancer,” says Bruce Korf, MD, President of the American College of Medical Genetics and Genomics, which is a plaintiff in the case.
Patent lawyer Kevin Noonan, PhD, Partner at McDonnell Boehnen Hulbert & Berghoff, says how the Court of Appeals will rule in the Myriad case is far from clear because Prometheus doesn't answer all the questions in Myriad. But if the court throws out the gene patents, it would overturn many previous decisions, creating problems for biotechnology and diagnostics companies, Noonan says. He calls such a ruling “a nuclear solution” to arguments about gene patents. But because most will expire in 2020, “these arguments … are a time-limited problem,” he says.
Should the Court of Appeals or the Supreme Court ultimately rule in favor of plaintiffs, not all gene patents on isolated genes would be in trouble, Dr. Cook-Deegan says. “Most patents are on genes that produce something, like insulin or growth hormone. They are probably safe,” he says, noting a greater threat to patents on genes used in diagnostics. Companies won't be able to make very broad claims, he explains.
A ruling favorable to plaintiffs won't end legal disputes involving gene patents because diagnostic companies can still sue those laboratories they believe infringe patents, Noonan says. Nothing prevents Myriad from suing labs that perform BRCA tests on claims that aren't included in the lawsuit, he says. If Myriad plaintiffs ultimately prevail, companies still need to recoup the costs of developing tests and would likely favor a strategy of trade secrecy, to the detriment of healthcare, he adds.
Neither Dr. Cook-Deegan nor Dr. Korf expects that the Court of Appeals will have the final word on Myriad. “Regardless of the outcome, I expect the case to be sent back to the Supreme Court in a year or two,” Dr. Korf says.