03/30/20

Vanda v. West-Ward: Swinging Back the Pendulum for Patenting Natural Phenomena

Vanda v. West-Ward: Swinging Back the Pendulum for Patenting Natural Phenomena

Kevin A. Sforza, Ph.D.

Since the Human Genome Project was completed in 2001, the U.S. Patent and Trademark Office granted patent protection to nearly sixty thousand DNA-based patents, about twenty-six hundred of which are for isolated DNA. However, the rulings of two Supreme Court decisions, Mayo in 2012 and Myriad in 2014, put an end to the laissez-faire environment for DNA-based patents. Under those decisions, natural gene and protein sequences are per se ineligible subject matter. The Court’s decisions left the USPTO and many DNA-based patent-holders bewildered. While the Court attempted to define a bright-line rule proscribing natural phenomena, known as the Mayo/Alice framework, its lack of clear guidance on how to apply the test left the lower courts to wrestle with its practical administration. The Supreme Court rightfully aimed to avoid preempting researchers and the public from using natural phenomena, but in doing so gutted the patent incentives for modern research. This Note argues that in a recent decision, Vanda v. West-Ward, the United States Court of Appeals for the Federal Circuit misapplied the Mayo/Alice framework when analyzing a method patent involving a natural relationship. However, the Federal Circuit was justified in redrawing the bounds of patentable subject matter requirements for pro-patent and pro-scientific research reasons. The current patentability statutes under 35 U.S.C. bleed together, and clarifying the requirements may require Congressional and Supreme Court intervention and cooperation. 

101 J. Pat. & Trademark Off. Soc’y 252 (2019)

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