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USPTO Update on Patent-Eligibility for Life Science Inventions

On August 2nd 2017, the USPTO hosted a Bicoastal Biotechnology/Chemical/Pharmaceutical Customer Partnership that focused on the USPTO’s current thinking on patent-eligibility. The meeting followed the USPTO’s June 25th, 2017 publication of its report “Patent Eligible Subject Matter: Report on Views and Recommendations from the Public” (“Report”) which summarized the case law, international approaches to defining … Continue reading this entry

More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is a national effort to dramatically accelerate efforts to prevent, diagnose and treat cancer that take advantage of recent advances in molecular medicine … Continue reading this entry

Breakthrough Business Solutions to Advance Personalized or Precision Medicine

In today’s era of unprecedented opportunities and complexity within personalized medicine, it has become critical innovators in the space to adopt a collaborative approach with outside experts in order to quickly and affordably bring new products and services to market. And, as it turns out, collaboration may also be the key to achieving mainstream clinical … Continue reading this entry

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing insight into the diagnosis, prediction and treatment of disease, and will continue to do so as more genetic information is collected and … Continue reading this entry

Supreme Court Declines Sequenom Review

Last week the United States Supreme Court denied Sequenom’s petition to review the Federal Circuit’s holding in Sequenom Inc. v. Ariosa Diagnostic Inc., 788 F.3d 1371 (2015) that claims directed to detecting fetal DNA in maternal blood were invalid for failing to recite patent eligible subject matter. Therefore by default, the Court let stand the … Continue reading this entry

Data Transmission, Personalized Medicine, and Privacy

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of January 26, 2016) has rolled out a program to collect health data from one million volunteers to inform and guide future research. Consumers … Continue reading this entry

Federal Circuit Invalidates Another Diagnostic Patent

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