“Are your genes patentable?”
Intellectual property law presentation
(Boston Revised 02/15/12) New England Law | Boston: What are the outer limits of patentable subject matter? Do gene patents fall within these limits? Three scientist-attorneys considered these questions as part of an Intellectual Property Law Association (IPLA) presentation concerning the controversial “Myriad” case, held at New England Law | Boston on October 26, 2011.
In the Myriad case, the courts considered whether gene patents constitute patentable subject matter falling within 35 U.S.C. §101 of the Patent Act. Association for Molecular Pathology v. U.S. Patent and Trademark Office involves patents held by biotech firm Myriad Genetics and the University of Utah Research Foundation.
The Myriad case, explained panelist Nicole Parsons, Ph.D., presents a “deceptively simple issue.” Are isolated, purified DNA molecules that are constituents of human genes and methods for using them to detect cancer patentable subject matter under the act?
The U.S. Supreme Court in its 1980 Diamond v. Chakrabarty decision specified three types of non-patentable subject matter: laws of nature, physical phenomena, and abstract ideas. “Everyone’s waiting for the Supreme Court to say a little more about the three exclusions,” said panelist Professor Eileen M. Herlihy.
In Diamond v. Chakrabarty, the Supreme Court distinguished between “…products of nature, whether living or not, and human-made inventions…” The latter could be considered patentable; the former not. It’s indisputable that genes in the human body are naturally occurring products of nature, but Myriad’s scientists took things many steps further. These developments, the firm argues, constitute a transformation in structure and function that makes the genes “compositions of matter” and therefore patentable subject matter.
The plaintiffs–researchers, genetic counselors, patients, women’s health groups, and scientific associations that were represented by the ACLU and the Patent Foundation–countered with the products of nature argument: genes are “common human heritage” they say, which should be freely available to all, rather than the legal property of any one group.
The law school’s October presentation, “Are your genes patentable? The Myriad case and its impact on genes as diagnostic tools,” followed a July 2011 decision by the U.S. Court of Appeals for the Federal Circuit, which overturned an unexpected 2010 decision by the Southern District of New York that had invalidated Myriad’s patents and seemingly those of many similar patent-holders.
The three presenters included Parsons of Finnegan, Henderson, Farabow, Garrett & Dunner, who focuses her practice on patent litigation and strategic client counseling in the biotechnology and pharmaceutical arts, as well as the alternative energy field; Kathleen M. Williams ’92, Ph.D. of Edwards Wildman Palmer LLP, an intellectual property attorney who specializes in complex legal issues surrounding the protection of discoveries in the life sciences; and Professor Herlihy, co-director of the Intellectual Property Institute. Her background in chemistry informed her work as an IP litigator before she joined the New England Law faculty in 2005.
The two courts’ opposing conclusions could suggest that it may be getting more difficult to determine the boundaries of the Supreme Court's exclusions to patentable subject matter. “You’re faced with this new situation, and you have to apply the old wording,” explained Williams. Different judges will make the “leap” differently, she added.
Societal views on what should be patentable may also play a role. Parsons pointed to another contentious area of current law, gay marriage, as an example of “a major societal shift that forces reinterpretation.”
Myriad’s contribution to science may ultimately be surpassed by the importance of the ruling in its case. The ACLU and the Patent Foundation filed a petition for certiorari to the U.S. Supreme Court on December 7, and Myriad has until January 13, 2012, to file opposition. If the High Court decides to take the case it may ultimately say a little more—or perhaps a lot more—about the three types of non-patentable subject matter.