FDA Considering New Regulatory Approaches for NGS – Part I


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


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


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

USPTO Releases Revised Subject Matter Eligibility Guidance


On December 15th, 2014, the USPTO released its much anticipated revised subject matter eligibility examination guidance to assist patent examiners to evaluate inventions that may be related to any one of the three judicial exceptions to subject matter eligibility under 35 U.S.C. § 101 – law of nature, natural phenomena, and/or an abstract idea. 2014 Interim Guidance on Patent Subject Matter Eligibility (“Interim Guidance“). The Interim Guidance is to be published in the Federal Register on December 16th, 2014, and is to effective on that date. It is to be applied to all pending and newly filed applications.

This Interim Guidance, unlike the prior guidance of March 2014 (see my prior posts of March 5th and March 7th, 2014), encourages an evaluation of the claim as a whole. In addition, it does not consider a claim that is directed to a combination of natural products as per se ineligible because the individual elements separately are natural products. Continue reading this entry

Another Patent Challenge for Personalized Medicine


The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles ensue and to the benefit of the public, as further jurisprudence will bring more clarity to whether and how diagnostic technologies – critical to personalized medicine – can be patented in the United States.

Health Diagnostic Laboratory, Inc. (“HDL”) will be adding to this jurisprudence.  The company recently alleged that Boston Heart Diagnostic Corp. (“Boston Heart”) is infringing U.S. Patent No. 8,119,358 (the ‘ 358 Patent) entitled “Diabetes-related Biomarkers and Methods of Use Thereof.” Continue reading this entry