Tag Archives: Genetic Tests

Federal Circuit Invalidates Another Diagnostic Patent

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In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal Circuit held that Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 Patent) was invalid under 35 U.S.C. § 101, for failing to claim patent-eligible subject matter. The Court’s decision is yet another application … Continue reading this entry

FDA Considering New Regulatory Approaches for NGS – Part II

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The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding its regulation of next generation sequencing (“NGS”). Specifically, the agency seeks public comment and feedback on the issues and questions raised in its discussion … Continue reading this entry

FDA Considering New Regulatory Approaches for NGS – Part I

fda
The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding its regulation of next generation sequencing (“NGS”). Specifically, the agency seeks public comment and feedback on the issues and questions raised in its discussion … Continue reading this entry

China Issues Human Genetic Resources Management Regulations

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the management of its human genetic resources. The regulations apply to the collection, preservation, research, development, immigration and other activities involving human genetic material. The Draft … Continue reading this entry

Fed. Cir. Denies Myriad's Petition for Rehearing in Gene Patenting Case

We previously reported that the ACLU and Myriad each filed a Petition for Panel Rehearing with the Federal Circuit for review of the July 29, 2011 decision, Assn. Molec. Path. et al. v. USPTO et al. This dispute, now known as the “gene patenting case,” reviewed whether isolated genetic material and diagnostic tests that rely on … Continue reading this entry

Subject Matter Jurisdiction Challenged in Supreme Court's Review of Mayo v. Prometheus

An international intellectual property association filed an amicus curie brief urging the U.S Supreme Court to dismiss the dispute and issue presented in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 131 S.Ct. 3027 (2011), arguing that the district court and Federal Circuit lacked subject matter jurisdiction. The amici argued that for reasons that are not … Continue reading this entry