A federal district court said that the ACLU et al. suit challenging the patentability of gene patents can go forward. The American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole host of others have filed a lawsuit challenging patents on two human genes associated with breast and ovarian cancer claiming that the patents are illegal and restrict both scientific research and patients’ access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are “products of nature.”
The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The plaintiffs in the lawsuit include several patients and more than a dozen universities, genetic specialists and medical associations, such as the Association for Molecular Pathology and the American College of Medical Genetics.
The challenged patents cover diagnostic tests for mutations along the genes, known as BRCA1 and BRCA2, which are responsible for most cases of hereditary breast and ovarian cancers. The patents, held by Myriad Genetics, have been a source of contention since Myriad’s lab is the only place in the country where the diagnostic testing can be performed.
While far from over, the district court judge denied a motion filed by the US Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation to dismiss a lawsuit for lack standing to sue the USPTO, lack of subject matter jurisdiction, and because the action is barred by the sovereign immunity.
The judge felt that there was enough to get over the challenges saying that the plaintiffs had the necessary standing to bring their claims against the defendants and that the facts alleged in the case are plausible, specific, and form a sufficient basis for the plaintiff’s legal arguments. The court also denied motions by the defendants to dismiss the case based on jurisdictional and other issues.
The court’s opinion stated:
“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 biomedical research… The novel circumstances presented by this action against the USPTO, the absence of any remedy provided in the Patent Act, and the important constitutional rights the Plaintiffs seek to vindicate establish subject matter jurisdiction over the Plaintiffs’ claim against the USPTO.”
The ACLU’s lawsuit is, in effect, challenging the entire practice of gene patenting so the case could have wide-reaching effects for the research and genetic diagnostics fields. A draft report by the NIH shows that around 20 percent of human genes currently are patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, and asthma, and corresponding to 4,382 of the 23,688 genes as of 2007. The genes found in the claims of over 4,270 patents.
While it is surprising that the suit is still in existence, I think the district court judge is allowing the plaintiff’s to at least make their best case. Eventually, the suit will probably sputter out for lack of merit. Even if semi-successful on some issues, a fight over the patentability of isolated genes is misplaced and is not likely to change the overall landscape of diagnostic and therapeutic costs. Very often, patents are obtained not just on the isolated gene but also on methods of use and as part of more complex assays or kits. Preventing just one kind of claim might provide some additional competition in the marketplace but any impact would likely be muted.
A copy of the complaint is available here: myriad-brca1-complaint (pdf)
A copy of the court’s decision is available here: MTD_decision (pdf)