Prometheus: Bound. Myriad: Condemned?

Posted by Doug Pet and Daniel Sharp March 26, 2012
Biopolitical Times

The US Supreme Court today opted not to hear the Myriad gene patent case. Instead, the Supreme Court remanded the case, ordering that the Federal Circuit Court reconsider its previous opinion in light of the high court’s ruling in Mayo Collaborative Services v. Prometheus. Given the similarities between the two cases, this might spell good news for the fight against genetic patenting.

In last week’s ruling, the court opined that patents held by Prometheus Laboratories, whose products test natural drug metabolism in order to determine dosage levels, rely on and “effectively claim the underlying laws of nature themselves,” rendering them invalid under the Patent Act. The validity of Myriad Genetics’ patents on BRCA genes, associated with heritable forms of breast and ovarian cancer, hinges on similar questions of whether human genes are “products of nature” and should thus not be patentable. 

There are many similarities between the Prometheus and Myriad cases. For example, Prometheus’ lawyers argued that since blood analyzed by their tests has been removed from the human body, it should no longer be construed as “naturally occurring.” Myriad has mounted the similarly dubious argument that DNA isolated from a cell is chemically distinct from its natural state in the human body and therefore falls under the purview of invention (patentable) rather than nature (not patentable). 

The American Civil Liberties Union and the Public Patent Foundation, representing several women’s health groups, research organizations, and patients, are litigating the challenge to Myriad’s patent claims. Since they first brought the case to a New York District Court 2009, ACLU has argued that monopolizing the research and testing rights for specific gene variants not only violates patent law but also, in the case of the BRCA genes, poses a major threat to women’s health.

The case has followed a rocky trajectory through the courts, and was most recently decided in favor of Myriad by a three-judge panel on the Federal Circuit of Appeals.  After an appeal to the Supreme Court, the case has been sent back to the same three-judge panel for a second decision. The case has been closely watched, and the most recent decision was covered by a number of major news outlets, including the New York Times, the Wall Street Journal, and Reuters.

Responding to the ruling against Prometheus, ACLU Attorney Sandra Park said, "The decision bodes well for the ultimate outcome" of the Myriad case. Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, remarked:

In light of recent rulings from the court that mere laws of nature cannot be patented, we hope that the lower court will come to the correct conclusion this time around.

Many biotech proponents see things the other way around. Lisa A. Haile, a partner at DLA Piper U.S. and co-chair of the firm’s global life science sector group, opined that

I think the Federal Circuit is going to stick with its original decision…They’re going to say, You’re doing more than just observing the DNA: You have cut it out from its naturally occurring environment now, and you’ve isolated it. I think they’re going to say that that’s enough for the transformation step.

No matter which way the Federal Circuit rules, however, it seems likely that Myriad may still reach the Supreme Court.  As Alex Philippidis of Genetic Engineering & Biotechnology News argues,

[i]t’s fair to say whoever loses in Federal Circuit will push the Myriad case back to the Supreme Court “given the importance of the case and the attention of a number of interested parties,” Paul Rivard, a shareholder with Banner & Witcoff, noted. “I think it’s likely at some point when these issues get back before the Supreme Court that the Supreme Court is going to inject the same concerns they had in Prometheus.

Whatever the ultimate outcome, the Prometheus decision calls attention to one of the most consequential challenges of the biotech age: establishing that the genetic building blocks of life are the shared common heritage of humanity rather than proprietary and exploitable assets. With Prometheus, the Supreme Court took a step in the right direction. Hopefully, the Federal Circuit will follow suit in Myriad. 

Previously on Biopolitical Times: