Opponents of patenting human gene sequences were handed a rare court victory on Monday, when a federal judge refused to dismiss a suit challenging patents for two genes tied to cancers in women.
The case revolves around seven patents relating to human genes BRCA1 and BRCA2, mutations of which have been tied to breast and ovarian cancer. The patents are owned by the University of Utah and licensed to Salt Lake City-based Myriad Genetics. In the late 1990s, Myriad began contacting researchers at the National Cancer Institute and various universities who were working with BRCA1 and BRCA2, demanding they cease their research on the genes and stop testing women for risk-carrying mutations.
Myriad became a lightning rod for critics of human gene patenting, and in May various scientific and medical organizations — backed by lawyers at the American Civil Liberties Union and the Public Patent Foundation — sued Myriad, directors of the University of Utah Research Foundation (UURF), and the U.S. Patent and Trademark Office. Joe Mullin of IP Law & Business previously described the suit in detail in his column.
The plaintiffs claimed that the BRCA1 and BRCA2 patents are invalid because they cover “products of nature,” and they alleged that Myriad’s attempts to enforce the patents by limiting genetic research violated First Amendment protections. In their motions to dismiss, Myriad (represented by Jones Day) and the PTO argued that the suit should be dismissed because the plaintiffs lacked personal and subject matter jurisdiction and because they failed to state a claim for a constitutional violation.
In his 85-page opinion denying the defendants’ motions to dismiss, Manhattan federal district court Judge Robert Sweet explicitly acknowledged the stakes raised by the case. “The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific innovation and biomedical research,” he wrote. “The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of research.” Sweet ruled that the Patent Act did not pre-empt the court’s jurisdiction over the plaintiffs constitutional claims and that the plaintiffs allegations were “plausible, specific, and form a sufficient basis for Plaintiff’s legal arguments.”
The lead ACLU lawyer on the case is Christopher Hansen, and the Public Patent Foundation is represented by its president, Daniel Ravicher. The PTO is represented by Manhattan AUSA Beth Goldman. Myriad and the UURF directors’ lead lawyer, Jones Day’s Brian Poissant, declined to comment on the case other than to say that Myriad “vehemently disagreed” with the plaintiffs’ claims. (Poissant added that he never thought he’d see a case involving the ACLU challenging patents on First Amendment grounds.) The court will next consider motions for summary judgment, which are due in December.
This article first appeared on The Am Law Litigation Daily blog on AmericanLawyer.com.