Myriad Genetics, USPTO File Summary Judgment Motions in Gene Patent Case
Two of the defendants in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the frontal attack on Myriad Genetics’ breast cancer gene patents organized by the American Civil Liberties Union, have now filed their own summary judgment motions. (Click through to read the memorandum in support of Myriad Genetics’ motion (pdf) filed on December 23 and the memorandum in support of the PTO’s motion (pdf) filed on December 24). As we explained in an earlier post, a summary judgment motion seeks to convince the trial judge that the facts are so clear-cut that there is no reason to go ahead with the trial—in legal jargon, that there is “no issue of material fact” that needs to be tried. This is the rare case in which both sides have asked for summary judgment (the plaintiffs filed their motion and supporting memorandum (pdf) back on August 26). The filings by both sides are not a surprise here, however, since the facts surrounding the challenged patents are largely undisputed and the real question is how to apply patent law to those facts.
Myriad argues that striking down its patents on isolated genes under the “product of nature” ban would upset a “long and consistent line of authority” that dates back to the early twentieth century and includes the Supreme Court’s 1981 Chakrabarty decision. Myriad also argues that its patents on diagnostic and therapeutic screening methods satisfy the standards established by the Federal Circuit’s recent Prometheus and Bilski decisions. Finally, Myriad counters the plaintiffs’ argument that its patents monopolize information in a way that violates the First Amendment by arguing that its patents cover not information, but chemical compositions (the genes) and physical laboratory testing (the various methods).
The PTO’s motion is different, since the claims against it are that it has violated the Patent Clause of the Constitution (Article I, section 8, clause 8 ) and the First Amendment by issuing the challenged patents. The PTO contends that it is following the mandate of Congress in allowing such patents, and that Congress can interpret the Patent Clause in any way that is rational. In response to the First Amendment claim, the PTO argues that the courts have tolerated patents that have incidental effects on speech and information since the days of Samuel Morse’s patent on the telegraph and Alexander Graham Bell’s patent on the telephone.
Back on November 2, the New York district judge denied the defendants’ motions to dismiss the plaintiffs’ complaint. Does that make it likely that the defendants summary judgments motions will also be rejected? Not necessarily—the motions to dismiss were based on some highly technical procedural arguments, including the jurisdiction of the federal courts and whether private parties who are threatened by particular patents have “standing” to sue the PTO for issuing them. While the ruling on that last issue was potentially significant—if it stands up on appeal—it is extremely rare for a district court to dismiss a complaint at the very outset of a case. So the denial of the motion to dismiss is not a good basis for predicting the outcome on summary judgment. We shouldn’t have to wait too long either way, since the court will hear oral arguments on all the summary judgment motions on January 21.
A final point worth noting is that the summary judgment motions on both sides have elicited extensive support in the form of declarations (or affidavits) and amicus curiae (friend of the court) legal briefs. Most of these filings have been predictable; the Biotechnology Industry Organization, for example, has supported Myriad and opposed the plaintiffs’ motion (pdf). But not all—Genetic Alliance, a leading nonprofit genetic advocacy group, whom we might expect to oppose Myriad’s gene patents, has filed an amicus brief (pdf) “in opposition to certain positions of the plaintiffs.” Genetic Alliance argues that “the specific remedies proposed by plaintiffs are both legally untenable and undesirable as public policy, because they would diminish the promise of genetic research for patients and negatively affect other areas of medicine.”
Read More: Follow all of the Genomics Law Report’s coverage of the ongoing ACLU/Myriad litigation right here.
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you mention that it is somewhat surprising that genetic alliance supports industry in this suit. are you aware that the ceo of genetic alliance, sharon terry, is an “inventor” on the patent for
the PXE (pseudoxanthoma elasticum) gene? and that her husband, patrick terry, is a co-dounder of genomic health, a private for-profit diagnostics company that makes and markets Oncotype DX, a breast cancer test?
William -
I can’t speak for John but I am aware that Ms. Terry is one of the inventors on the PXE gene. I believe that the rights are held by the non-profit PXE foundation that Ms. Terry helped to form.
Your comments suggest that there may be some type of financial conflict of interest behind Genetic Alliance’s support of the Myriad position in the AMP/Myriad litigation. I can’t speak for John, or for Genetic Alliance, but I think extensive experience demonstrates fairly conclusively the importance of patient advocacy and improved clinical outcomes for both GA and Ms. Terry. It’s interesting to me, therefore, that while some patients and advocacy groups have lined up to support AMP and the ACLU, Genetic Alliance has considered the issue and decided that, on balance, the patent status quo is worth preserving over the alternative the plaintiffs propose.
You may be interested to read the position statement released yesterday by Genetic Alliance: http://geneticalliance.org/pr.AmicusBriefPatenting
Thanks.
- Dan