WASHINGTON, D.C.—The analogy is imprecise, but when theteacher marks an "X" on your test paper and fills in the correct answer, woebetide the student who stubbornly resubmits the same wrong answer. That'sfundamentally what the Federal Circuit Court did in Association for Molecular Pathology v. Myriad Genetics Inc. when itupheld Myriad's patents for the second time, by the same 2-1 margin, and witheach justice articulating the same rationale for his or her decision as thefirst time around.
Its 2-1 ruling came after a U.S. Supreme Court order directing the circuitcourt to reconsider its initial ruling in the light of the Mayo v. Prometheus decision the court handed down last springaddressing the patentability of medical diagnostics. Now, the Supreme Court hasgranted the American Civil Liberties Union's (ACLU)writ of certiorari seeking to invalidate patents for two genesassociated with hereditary breast and ovarian cancer and will hear arguments inthe Myriad case.
The Federal Circuit's intransigence may well reflect itsgenealogy. It was created by Congress with passage of the Federal CourtsImprovement Act of 1982, which merged the U.S. Court of Customs and PatentAppeals and the appellate division of the U.S. Court of Claims.
The originallawsuit charged that the challenged patents are unlawful because genes are"products of nature" and restrict both scientific research and patients' accessto medical care. Myriad had licensed the two patents from the University ofUtah regarding genes BRAC1 and BRAC2. Patients with inherited mutations inthese genes have an increased likelihood of developing breast or ovariancancer. Myriad developed a genetic test called the BRACAnalysis test thatallowed physicians to identify patients at the highest risk of developing suchcancers.
At stake by most analysts' reckoning is the future ofinnovation in companion diagnostics in the United States. Attorney CourtenayBrinckerhoff agrees with many of her legal colleagues about the chilling effectthe Supreme Court's actions will likely create, but she thinks a morecalibrated decision may be in the offing. She foresees the possibility of avacated remand, with some sort of guidance that might create different classesof claims so that some may be eligible, and others not, the judgment being madeon 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 couldresult in different outcomes. Brinckerhoff—a partner with Foley & Lardnerand vice chair of the firm's Chemical, Biotechnology & Pharmaceutical Practiceand a member of the firm's Appellate Practice as well as the Life SciencesIndustry Team—notes, "other countries permit patents of isolated DNA."
Mostother countries don't allow patents of methods but there are ways to reformatclaims. In the end, Europe may provide broader patentability. That said, shebelieves that "if the court leaves room for claims, people will continue toseek patents."But if that proves too difficult, she thinks there may be a movement to greaterreliance on trade secrets. In any event, she sees the decision having atrickle-down effect to the patent office, which issued new guidance to itsexaminers after Mayo and will do thesame in respect to the case now before the court.
According to figures compiled by GlobalData, the market forgenetic testing has experienced double-digit, year-on-year growth in recentyears, and is expected to continue to grow at a CAGR of 10.3 percent throughthe end of this decade. The market for these tests, worth only $426 million in2004, is expected to approach $2 billion by 2018.
"One thing that we do expect to result from these patent decisions is theshifting of diagnostic revenue from small biotech companies to larger, moreestablished diagnostic players. Large companies possessing platformtechnologies will be able to devise their own tests, without the fear of patentinfringement, to compete with more expensive proprietary tests. These companiescan then offer their customers more comprehensive testing at a lower price atthe expense of smaller companies who may have initially developed the testswith the promise of patent protection," states the GlobalData analysis.
Other voices
"Myriad did not invent human genes, and has no right toclaim ownership of them just because they removed them from the body," says DanielB. Ravicher, executive director of PUBPAT. "The government does not have theright to give a corporation the exclusive power to control what we know aboutour own genetic makeup."
Jim Mullen, a San Diego-based, patent prosecutor (andmolecular biologist) with Morrison & Foerster, who counsels clients in thediagnostics and therapeutics fields regarding patent procurement andintellectual property, fears that the ruling in favor of Mayo put all companion diagnostics in danger, with the resultant exodusof technology from the United States to less patent-restrictive nations.
"These patents endanger women who deserve access to the bestpossible care as they make life-changing medical decisions," says Sandra Park,staff attorney with the ACLU Women's Rights Project. "One company should not beable to dictate what testing is available and what research is pursued on twogenes connected to devastating cancers."
Dr. Michael Shuster, co-chair of the Life Sciences Groupwith the law firm Fenwick & West, filed an amicus curiae brief on behalf of the National Venture CapitalAssociation in support of Prometheus' patent claims. He pointed out that aruling in favor of Mayo would put allcompanion diagnostics in danger, setting off a chain reaction that mightplausibly result in the movement of such testing offshore and a loss ofcompetitiveness for the United States.
