Friday, April 4, 2014

Guidelines for Patentable Subject Matter Eligibility

The National Law Review    April 23, 2014

On March 4, 2014, the U.S. Patent and Trademark Office (USPTO) released a guidance memorandum (the "Guidance") to the Patent Examining Corps providing guidelines for analyzing subject matter eligibility under 35 U.S.C. Section 101 of claims reciting or involving laws of nature/ natural principles, natural phenomena and/or natural products in view of recent Supreme Court decisions, the Association for Molecular Pathology v. Myriad Genetics, Inc. and Mayo Collaborative Services v. Prometheus Laboratories, Inc.

The impact of the Guidelines is significant.  For claims involving natural products (such as active ingredients from natural products or naturally occurring nucleic acids) to be patent eligible, they much be "significantly" or "markedly" different from the natural products and diagnostic methods - the subject matter of many biotechnology and pharmaceutical patent applications as alluded to in our July 10, 2013 webinar regarding Myriad.