President Obama Revisits Interest in Personalized Medicine

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President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported by the Personalized Medicine Coalition, President Obama stated:

“21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine – one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.” 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 paper “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests – Preliminary Discussion Paper” (“FDA Discussion Paper”) (attached here). My post of December 28th, 2014 highlighted FDA’s issues and concerns regarding the analytical performance of NGS. This post will address FDA’s issues and concerns relating to the clinical performance of NGS. Continue reading this entry

FDA Considering New Regulatory Approaches for NGS – Part I

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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 paper “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests – Preliminary Discussion Paper” (“FDA Discussion Paper”) (copy here). This post will highlight FDA’s issues and concerns regarding the analytical performance of NGS. Part II will address the agency’s issues and concerns as they pertain to the clinical performance of NGS. Continue reading this entry

An Early Test for the USPTO’S Eligibility Analysis

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Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter EligibilityInterim Guidance” reviewed in my prior post of December 16th, 2014). The Interim Guidance replaced the March 2014 Guidance that was much-criticized for its expansive application of U.S. Supreme Court jurisprudence relating to the judicial exceptions to patent-eligibility: abstract ideas, laws of nature and natural phenomenon. Unlike the March 2014 Guidance (that was not circulated to the public for comment prior to its issuance), the Interim Guidance notes that the USPTO’s analysis of patent-eligibility will be an iterative process continuing with “periodic supplements based on developments in patent subject matter eligibility jurisprudence and public feedback.” Interim Guidance at page 4. Embedded within footnote 5 of the Interim Guidance, the USPTO references an appeal pending before the Federal Circuit – University of Utah Research Foundation v. Ambry Genetics Corp. (In re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litigation), No. 14-1361 (Fed. Cir. Filed Mar. 18, 2014 (“Myriad II”) that may impact the USPTO’s Interim Guidance. Interestingly, the next day on December 17th, 2014 the Federal Circuit issued its Myriad II decision (attached here) holding that Myriad’s asserted claims were not patent-eligible. The decision is interesting not only because it evaluates yet more claims from Myriad’s impressive patent portfolio but also because it provides an early test of the USPTO’s Interim Guidance. Continue reading this entry

Fetal Diagnostics Patent Claims Fall in Inter Partes Review

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Post grant inter partes review proceedings have lowered the hurdle to invalidate U.S. patents. The “broadest reasonable construction” of the claims and the lower burden to prove invalidity (by a preponderance of the evidence) of inter partes review proceedings have resulted in many successful challenges. Indeed, the Patent Trial and Appeal Board (PTAB) of the USPTO recently invalidated all challenged claims of a patent claiming methods to diagnose fetal abnormalities. In Ariosa Diagnostics v. The Board of Trustees of the Leland Stanford Junior University (IPR2013-00308) (“Decision”) the PTAB invalidated 13 claims of U.S. Patent No. 8,296,076 entitled “Noninvasive Diagnosis of Fetal Aneuoploidy by Sequencing” (“the ‘076 Patent”) assigned to the Board of Trustees of the Leland Stanford Junior University (“Stanford”). Continue reading this entry