Gass Authors Amici Curiae Brief Supporting Supreme Court Review in Sequenom v. Ariosa

April 26, 2016

David A. Gass, a partner in the biotechnology practice group at Marshall, Gerstein & Borun, served as Counsel of Record for three industry organizations that recently filed an amicus curiae brief in the U.S. Supreme Court, urging the Court to grant a writ of certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc., et al. The industry organizations include the Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Association of University Technology Managers (AUTM).

Sequenom v. Ariosa involves an ongoing debate over the patent-eligibility of biotechnology inventions expressed as processes, in this case a groundbreaking processes for noninvasive prenatal genetic testing. On June 12, 2015, the Federal Circuit affirmed a lower court ruling that U.S. Patent Number 6,258,540, licensed to Sequenom, was not patent-eligible because it allegedly involves a natural phenomenon and fails an eligibility test established by the Supreme Court’s recent Myriad and Mayo decisions for evaluating claims that involve a natural phenomenon. Sequenom petitioned the Supreme Court for review.

The brief, filed on April 20, 2016, states that the growing uncertainty around patent-eligible subject matter threatens to hinder development and commercialization in the biotech industry, especially in the field of biomarker diagnostics. BIO, PhRMA and AUTM maintain, “Biotechnology research and development is expensive and time consuming, and therefore relies heavily on the economic incentives afforded by patent protection. Absent such incentives, research findings may remain idle textbook curiosities, or may be concealed as trade secrets. Neither situation is healthy for innovation.” The brief articulates legal and policy issues deserving consideration by the Supreme Court.

Mr. Gass, a registered patent attorney, assists biotechnology companies, pharmaceutical companies, diagnostics companies, universities, and research institutions to develop and implement IP strategies for the protection and commercialization of life-improving biotechnology inventions. He has previously written on related patent-eligibility issues for Law360 and GenomeWeb and has been quoted on the topic by Law360, Medical Device Daily, and Bloomberg BNA.

BIO is the world’s largest biotechnology trade association, with over 1,100 members worldwide involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

PhRMA is a voluntary, nonprofit association representing the nation’s leading research-based pharmaceutical and biotechnology companies. PhRMA’s mission is to advocate in support of public policies that encourage the discovery of life-saving and life-enhancing new medicines.

AUTM is a nonprofit organization dedicated to bringing research to life by supporting and enhancing the global academic technology transfer profession through education, professional development, partnering, and advocacy. AUTM’s more than 3,200 members represent managers of intellectual property from more than 300 universities, research institutions, and teaching hospitals around the world, as well as numerous businesses and government organizations.