There has been speculation about how the Supreme Court’s holding in Prometheus will impact the outcome of the Myriad case. These cases ostensibly address two different types of patents. The Prometheus case addressed the inclusion of laws of nature in patented processes; the Myriad case examines the patentability of a genetic sequence that has been isolated from a gene in nature. The impact of these two patents on innovation in diagnostic research and medical treatment is remarkably similar. This similarity is most likely the driving force behind the Supreme Court’s decision to vacate and remand the Federal Circuit’s decision in Myriad.

 
The patent challenges at issue in each of these cases concern the well established principle, reaffirmed by the Court in Prometheus, that ‘“laws of nature, natural phenomena, and abstract ideas’ are not patentable” Id. at 1293 (citing Diamond v. Diehr, 450 U. S. 175, 185 (1981)). The Court has noted repeatedly that patents on laws or products of nature undermine the balance between rewarding innovation and encouraging further research.  Accordingly, in finding that Prometheus’ patent claim was insufficient to transform a law of nature into a patent-eligible application of such a law, the Court emphasized its concern that “even though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are ‘the basic tools of scientific and technological work’.  And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them….And…threaten to inhibit the development of more refined treatment recommendations that combine Prometheus’ correlations with later discovered features of metabolites, human physiology or individual patient characteristics.” Id. at 1301-1302.

 
The gene sequences at issue in the Myriad case are the very instructions inside each of our cells that determine what proteins are produced. Like the substance of the patents at issue in Prometheus, the BRCA gene sequences contain information derived from nature. The award of patents to Myriad has given Myriad a “double monopoly” on the BRCA 1 and 2 gene sequences, stifling innovation in the field of genetic research, limiting the advent of diagnostic technologies such as multiplex testing and full genome sequencing, and preventing research into breast and ovarian cancer as well as other deadly cancers and diseases. As in the Prometheus case, Myriad discovered the gene sequences at issue using “methods … well known in the art” and engaged in “well-understood, routine, conventional activity previously engaged in by scientists in the field” when isolating the BRCA 1 and 2 sequences. Id. at 1291 (citing Parker v. Flook, 437 U. S. 584, 590 (1978)). The result is that Myriad has claimed a monopoly in a sequence of the human genome that is functionally identical to the information contained in the human body and, in doing so, severely inhibited the development of refined treatments and research into the undiscovered features of these genes.  While the Prometheus case deals with patent processes that contain a law of nature, versus Myriad’s isolation of a gene sequence from nature, the Court’s evident concern with maintaining the proper balance of the patent system, by encouraging diagnostic research and ensuring that information derived from nature is not monopolized to prevent valuable discoveries, is certain to play an important role in the ultimate conclusion of the Myriad case.

Amy co-founded Universities Allied for Essential Medicines in 2002, and continues as a member of its advisory board. Her recent work includes an edited volume, “Access to Knowledge in the Age of Intellectual Property” (Zone Books, 2010), and an article about dynamics of harmonization and counter-harmonization in international intellectual property law, using the pharmaceutical sector in India as a case study.

The ISP is very happy to welcome Amy back to Yale.

More here.

Click here to see “A Conversation with Rachel Maddow”

Monday, March 28, 2011, 9:00am – 10:30am
Yale Law School, Room 127

Rachel Maddow, political analyst and host of the critically acclaimed “Rachel Maddow Show” on MSNBC, will be at Yale Law School on Monday, March 28, for a Q&A with Visiting Associate Professor Amy Kapczynski ’03.

About Rachel Maddow:
Maddow first gained national prominence as a host on Air America Radio, where she worked from its inception in 2004.  In January of 2008, she was named an MSNBC political analyst and soon after, began filling in as guest host for Countdown with Keith Olbermann and Race for the White House.

When The Rachel Maddow Show debuted in August 2008, it was the most successful show launch in MSNBC history, immediately boosting ratings in its time period and drawing national attention.  It was named one of the top shows of the decade by The Washington Post in 2009.  Maddow herself was honored as a “Breakout Star of 2008” by The Washington Post, among the “Best of Television 2008” by The Los Angeles Times, and one of the “Top Ten Political Newcomers of 2008” by Politico.com.

She holds a bachelor’s degree in public policy from Stanford University and a doctorate in political science from Oxford University.

Continental breakfast will be served.  It is free and open to the Yale community.

Co-sponsored by Professor Amy Kapczynski, the Yale Information Society Project, the Outlaws, and the American Constitution Society.