TESTING UPDATE COURT RULING INVALIDATES PATENT ON NONINVASIVE TEST FOR DOWN SYNDROME Decision cites landmark Supreme Court ruling in Myriad Genetics case recent legal decision invalidates the patent on technology used in noninvasive prenatal tests that detect Down syndrome and opens up the market for diagnostic tests that use cell-free fetal DNA (cffDNA) circulating in mothers’ blood. But a higher court could overturn this ruling. Currently marketed tests that noninvasively detect trisomies 13, 18, and 21 and fetal sex rely on cffDNA, which has the potential to help determine if parents carry mutations for single gene disorders and identify these conditions in fetuses. The decision by Judge Susan Illston of the United States District Court in Northern California denied a bid by San Diego-based Sequenom, Inc. for summary judgment against Ariosa Diagnostics of San Jose, California. Ariosa also markets a noninvasive test for Down syndrome that uses cffDNA, as do other companies. At issue are patents on claims to diagnostic methods, licensed exclusively to Sequenom, for amplifying and detecting paternally inherited nucleic acid in the fetal DNA. Judge Illston’s ruling says methods claimed in Sequenom’s patents apply established scientific procedures to cffDNA, and their application to naturally occurring cffDNA is the only innovative portion of the claims. “It appears that the effect of issuing the patent was to wholly preempt all known methods of detecting cffDNA at that time,” Judge Illston writes. “Accordingly, the court concludes that the claims at issue pose a substantial risk of preempting the natural phenomenon.” Although the patents at issue do not lay claim to a gene, Judge Illston’s decision cites legal arguments made in a June 2013 U.S. Supreme Court case that involved BRCA1 and BRCA2 and invalidated gene patents, and the high court’s 2012 Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision. In the Mayo decision, the Supreme Court invalidated patent claims on a

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A recent court decision strikes down a patent on a method of detecting paternally inherited nucleic acid in fetal DNA and identifying certain trisomies in fetuses.

relationship between the concentrations of blood metabolites and response to a therapeutic drug, saying the claim relied on a law of nature. The Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. last June ruled that patents on naturally occurring genes are invalid because DNA segments used to detect mutations are products of nature and not patent-eligible merely because they have been isolated. “This decision [by Judge Illston] is in the best interest of patients and the public,” says James P. Evans, MD, PhD, Professor of Genetics and Medicine at University of North Carolina at Chapel Hill and chair of the gene patent task force implemented by the disbanded Department of Health and Human Services’ Secretary’s Advisory Committee on Society, Health, and Genetics. “The decision will expand research opportunities for this promising avenue.”

Headed for an Appeal Sequenom filed a petition to appeal the district court decision with the U.S. Court of Appeals for the Federal Circuit on December 2, 2013. Both Dr. Evans and patent lawyers familiar with the district court ruling on the cffDNA patent

contend that it will likely be overturned, at least in part. Whether Judge Illston’s ruling is overturned “totally depends on what judges are on the [appeals court] panel,” says Kevin Noonan, PhD, partner with McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, while Dr. Evans describes the appeals court as “patent-friendly.” “Stay tuned,” says Robert CookDeegan, MD, from the Sanford School of Public Policy at Duke University in Durham, North Carolina. Since the Myriad ruling did not explain how much a gene must be altered to warrant a patent and the Mayo decision did not clearly stipulate how to distinguish patentable methods from “laws of nature,” rulings by lower courts may begin to fill that gap.

Fight Over Breast Cancer Gene Patents Meanwhile, legal battles over BRCA1 and BRCA2 tests rage as Myriad aggressively protects its patents on testing methods. Representatives of Myriad Genetics hinted the company may file lawsuits against competitors shortly after the June 2013 Supreme Court ruling, announcing it still had 500 valid and enforceable claims in 24 patents underlying its test. Starting last July, Myriad made good on those threats by filing a lawsuit against Ambry Genetics and other genetics companies, accusing them of patent infringement. A declaratory judgment by one court in any of these cases will not affect rulings in the others, says Dr. Noonan, who contends that the Supreme Court’s decision in Myriad has not necessarily cleared the way for competitors marketing BRCA1 and BRCA2 tests. But, Dr. Evans disagrees, calling Myriad’s suits against its competitors “a rear-guard action that’s doomed to failure and mostly an effort by Myriad to keep its stock price up.” DOI: 10.1002/ajmg.a.36419

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Court ruling invalidates patent on noninvasive test for down syndrome: decision cites landmark Supreme Court ruling in Myriad Genetics case.

Court ruling invalidates patent on noninvasive test for down syndrome: decision cites landmark Supreme Court ruling in Myriad Genetics case. - PDF Download Free
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