Could SCOTUS Prometheus ruling be the end of human gene patents?

The Mayo Clinic and its lawyers at Mayer Brown weren't the only ones to welcome the U.S. Supreme Court's ruling Tuesday that Prometheus Laboratories cannot patent a medical test that relies on correlations between drug dosages and treatment. Lawyers at the American Civil Liberties Union see the high court's unanimous decision as a good omen for their own case challenging the patentability of human genes.

The plaintiffs in both cases have relied on the same argument: that the patents in dispute are naturally occurring phenomena that do not qualify for patent protection. The Supreme Court bought that argument wholeheartedly in Mayo's case.

"We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. Those claims are consequently invalid," wrote Justice Stephen Breyer. Just as Einstein could not have patented E=mc2 and Newton could not have laid claim to the law of gravity, Breyer wrote, so Prometheus cannot patent a test kit that correlates a patient's blood chemistry with the best drug dosages for treatment. The decision overturned a ruling by the U.S. Court of Appeals for the Federal Circuit upholding Prometheus's patents.

"We were really pleased with the Prometheus decision," said Sandra Park, an ACLU attorney fighting on behalf of a host of researchers and breast cancer patients to invalidate Myriad Genetics' right to patent isolated breast cancer genes. "The decision bodes well for the ultimate outcome of the Myriad case," she said.

Last summer, a three-judge panel of the Federal Circuit Court of Appeals issued a fractured decision upholding Myriad's right to patent isolated human genes -- BRCA1 and BRCA2 -- that are linked to most inherited forms of breast and ovarian cancers. (All three judges wrote separate opinions; two of them backed Myriad.) The ACLU has filed a petition asking the Supreme Court to review the Federal Circuit's decision, but the court has not yet decided whether to grant cert. That decision is expected in coming weeks, Park said.

In the meantime, ACLU attorneys are examining the Prometheus decision for any clues about the high court's thinking. Park said many of the Supreme Court's points in the Prometheus decision are directly relevant to the Myriad case, in which the ACLU has argued that patents on genes prevent clinicians and researchers from improving their testing methods and conducting further research.

That point was featured front and center in the Prometheus decision on Tuesday: "The court has repeatedly emphasized ... that patent law not inhibit further discovery by improperly tying up the future use of laws of nature," Breyer wrote. The Supreme Court also rejected arguments by Prometheus' counsel at Latham & Watkins that because blood is removed from the patient and analyzed, it is transformed from a naturally-occurring phenomenon. A similar concept buttressed the Federal Circuit majority in the Myriad case, which found that when DNA is removed from a human cell, the ends of the gene are chemically changed, making it patentable. The ACLU claims that those ends are constantly being broken and reformed in the human body, and are therefore still a natural phenomenon and not patentable.

The Prometheus decision also seemed to respond directly to the Federal Circuit majority's reasoning in the Myriad case that courts cannot disrupt companies' IP rights in human genes, given the U.S. Patent and Trademark Office's longstanding policy of granting such rights. The Supreme Court in Prometheus concluded that it is not up to the court to weigh different groups' interests. Just as patent protection gives companies monetary incentives to create, invent and discover new technology, it also obstructs the flow of information that would otherwise spur innovation, the court noted.

"We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable," Justice Breyer wrote.

Myriad disputed the ACLU's take on the Prometheus ruling, drawing a distinction between the method claims in that case and the composition-of-matter claims in the gene patent suit. "There's no relationship from this ruling that can be applied to the Myriad case," a company spokeswoman said. A March 21 report drafted by Myriad adviser Cowen and Company, detailing a call with patent consultants, described the Prometheus ruling as "surprisingly narrow." The memo did note that the Supreme Court ruling could place isolated gene claims at increased risk, but said the justices may want to avoid the "extremely broad" implications of that finding.

Gregory Castanias and Brian Poissant of Jones Day, who represented Myriad at the Federal Circuit, did not respond to requests for comment.

by Terry Baynes, Thomason Reuters News & Insights
March 21st, 2012