Coming around again with gene patents
WASHINGTON, D.C.—The analogy is imprecise, but when the teacher marks an "X" on your test paper and fills in the correct answer, woe betide the student who stubbornly resubmits the same wrong answer. That's fundamentally what the Federal Circuit Court did in Association for Molecular Pathology v. Myriad Genetics Inc. when it upheld Myriad's patents for the second time, by the same 2-1 margin, and with each justice articulating the same rationale for his or her decision as the first time around.
Its 2-1 ruling came after a U.S. Supreme Court order directing the circuit court to reconsider its initial ruling in the light of the Mayo v. Prometheus decision the court handed down last spring addressing the patentability of medical diagnostics. Now, the Supreme Court has granted the American Civil Liberties Union's (ACLU) writ of certiorari seeking to invalidate patents for two genes associated with hereditary breast and ovarian cancer and will hear arguments in the Myriad case.
The Federal Circuit's intransigence may well reflect its genealogy. It was created by Congress with passage of the Federal Courts Improvement Act of 1982, which merged the U.S. Court of Customs and Patent Appeals and the appellate division of the U.S. Court of Claims.
The original lawsuit charged that the challenged patents are unlawful because genes are "products of nature" and restrict both scientific research and patients' access to medical care. Myriad had licensed the two patents from the University of Utah regarding genes BRAC1 and BRAC2. Patients with inherited mutations in these genes have an increased likelihood of developing breast or ovarian cancer. Myriad developed a genetic test called the BRACAnalysis test that allowed physicians to identify patients at the highest risk of developing such cancers.
At stake by most analysts' reckoning is the future of innovation in companion diagnostics in the United States. Attorney Courtenay Brinckerhoff agrees with many of her legal colleagues about the chilling effect the Supreme Court's actions will likely create, but she thinks a more calibrated decision may be in the offing. She foresees the possibility of a vacated remand, with some sort of guidance that might create different classes of claims so that some may be eligible, and others not, the judgment being made on a case-by-case basis.
Brinckerhoff notes that the Mayo case was related to method claims, while Myriad involves a "product of nature," differences that could result in different outcomes. Brinckerhoff—a partner with Foley & Lardner and vice chair of the firm's Chemical, Biotechnology & Pharmaceutical Practice and a member of the firm's Appellate Practice as well as the Life Sciences Industry Team—notes, "other countries permit patents of isolated DNA."
Most other countries don't allow patents of methods but there are ways to reformat claims. In the end, Europe may provide broader patentability. That said, she believes that "if the court leaves room for claims, people will continue to seek patents." But if that proves too difficult, she thinks there may be a movement to greater reliance on trade secrets. In any event, she sees the decision having a trickle-down effect to the patent office, which issued new guidance to its examiners after Mayo and will do the same in respect to the case now before the court.
According to figures compiled by GlobalData, the market for genetic testing has experienced double-digit, year-on-year growth in recent years, and is expected to continue to grow at a CAGR of 10.3 percent through the end of this decade. The market for these tests, worth only $426 million in 2004, is expected to approach $2 billion by 2018.
"One thing that we do expect to result from these patent decisions is the shifting of diagnostic revenue from small biotech companies to larger, more established diagnostic players. Large companies possessing platform technologies will be able to devise their own tests, without the fear of patent infringement, to compete with more expensive proprietary tests. These companies can then offer their customers more comprehensive testing at a lower price at the expense of smaller companies who may have initially developed the tests with the promise of patent protection," states the GlobalData analysis.
"Myriad did not invent human genes, and has no right to claim ownership of them just because they removed them from the body," says Daniel B. Ravicher, executive director of PUBPAT. "The government does not have the right to give a corporation the exclusive power to control what we know about our own genetic makeup."
Jim Mullen, a San Diego-based, patent prosecutor (and molecular biologist) with Morrison & Foerster, who counsels clients in the diagnostics and therapeutics fields regarding patent procurement and intellectual property, fears that the ruling in favor of Mayo put all companion diagnostics in danger, with the resultant exodus of technology from the United States to less patent-restrictive nations.
"These patents endanger women who deserve access to the best possible care as they make life-changing medical decisions," says Sandra Park, staff attorney with the ACLU Women's Rights Project. "One company should not be able to dictate what testing is available and what research is pursued on two genes connected to devastating cancers."
Dr. Michael Shuster, co-chair of the Life Sciences Group with the law firm Fenwick & West, filed an amicus curiae brief on behalf of the National Venture Capital Association in support of Prometheus' patent claims. He pointed out that a ruling in favor of Mayo would put all companion diagnostics in danger, setting off a chain reaction that might plausibly result in the movement of such testing offshore and a loss of competitiveness for the United States.