Canada Joins the Gene Patenting Debate

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Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal Court asserting that 5 patents[1] assigned to Defendants (collectively the “Long QT Patents”) for compositions and methods useful in the diagnosis and/or assessment of Long QT syndrome (“Long QT”) in human patients are invalid and/or unenforceable. Continue reading this entry

Federal Circuit’s Post-Alice Eligibility Analysis of Business Methods

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The Federal Circuit in Ultramercial, Inc. v. WildTangent, Inc., held that an “entrepreneurial” multi-step process for distributing copyrighted media products over the Internet to consumers is not patent-eligible under 35 U.S.C. § 101 even though the specific method of advertising and content distribution was neither previously known nor employed on the Internet. Although the patent in question is directed to a consumer-related business method, the Federal Circuit’s analysis of business-related discoveries is a must read for its view of patenting any technology that might be categorized as an “abstract idea” such as the analysis of patient-related data and management of clinical trials in the field of personalized medicine. Continue reading this entry

Supreme Court Asked to Review Standing in Stem Cell Challenge

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The Public Patent Foundation and Consumer Watchdog (collectively “CW”) petitioned the U.S. Supreme Court on October 31, 2014, seeking reversal of the Federal Circuit’s dismissal of its appeal from a decision of the USPTO that upheld the validity of Wisconsin Alumni Research Foundation’s (WARF’s) patent regarding in vitro cultured human embryonic stem cells. The case will decide if a third party challenger, lacking a specific injury related to the underlying dispute, has standing to challenge the USPTO’s inter partes reexamination decision in the courts. Continue reading this entry

Myriad’s Continuing Patent Debate

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On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. If you missed oral argument, the parties’ Supplemental Briefs filed in late September set forth some of the key points raised during oral argument. My prior post of September 29, 2014 summarizes the status of the dispute and the parties’ positions on patent-eligibility.

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FDA Issues Draft Guidance for Regulation of LDTs

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On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance“). The publication of the draft Guidance is the next step in FDA’s implementation of its risk based approach to oversight of LDTs. In addition to noting FDA’s intention for bringing under its review many devices or tests that previously were exempt under the FDA’s enforcement discretion, the FDA’s draft Guidance also imposes new requirements, such as registration and notice, for all LDTs. Continue reading this entry