This article has been corrected to note that the American Civil Liberties Union is not a plaintiff in the case against Myriad and other defendants, but is representing the plaintiffs.
By Turna Ray
Defendants in a high-profile case challenging the patentability of genes have filed motions to dismiss the case, claiming that the plaintiffs, represented by the American Civil Liberties Union, lack standing to bring the suit.
At issue is the lawsuit filed in May by the ACLU on behalf of four scientific organizations — representing more than 150,000 medical professionals, researchers, women's health groups, and individual women — alleging that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad "stifle research that could lead to cures and limit women's options regarding their medical care."
Specifically, the lawsuit challenges the constitutionality of Myriad's patents on the BRCA1 and BRCA2 genes, linked to increased hereditary risk for breast and ovarian cancer [see PGx Reporter 05-13-2009]. According to the ACLU, in patenting genetic sequences, Myriad is hindering the free flow of information and therefore infringing the First Amendment protecting free speech. If the case is ruled in favor of the plaintiffs, it has the potential to impact the entire process of gene patenting.
In a motion-to-dismiss memorandum, the defendants call ACLU's case "a thinly veiled attempt to challenge the validity of patents.
"Other than an overall policy disagreement concerning the legitimacy of gene patents, the plaintiffs have no actual dispute with the Defendants over patent infringement," the defendants state in the memorandum. "If the plaintiffs in this case have standing, then virtually anyone can challenge any patent at any time."
Moreover, the plaintiffs lack standing to bring the suit because they don't have "a concrete plan for infringement," the defendants state. The ACLU, in challenging the patentability of genes, is seeking nothing more than "an advisory opinion in support of an anti-gene patent agenda," according to the defendants.
The defendants assert in the memorandum that "there must be a real controversy, not a mere policy disagreement, to warrant a declaratory judgment," and thus hold that the suit "should be dismissed for lack of subject matter jurisdiction."
In a statement to Pharmacogenomics Reporter, ACLU's Science Advisor Tania Simoncelli said her group will oppose the motion to dismiss the case.
"They have moved to dismiss the case on purely technical grounds," Simoncelli said. "They haven't defended the patenting of genes; they have only argued that we've got the wrong plaintiffs or the wrong defendant or are in the wrong court."
The motion to dismiss the suit is scheduled to be heard on Sept. 30 by the US District Court for the Southern District of New York. The plaintiffs have until Aug. 26 to file their oppositions to the motion to dismiss.
Legal Precedent for Dismissal?
Among other cases, the defendants' memorandum cites MedImmune vs. Genentech, which focused on whether MedImmune could challenge the validity of Genentech's patent for the drug Synagis while simultaneously upholding a license agreement for the patent by making royalty payments to Genentech.
A district court initially dismissed MedImmune's suit for not presenting an "actual controversy" because MedImmune was paying royalties. However, the Supreme Court ultimately overturned the district court's decision, holding that MedImmune was not required to break its contract before suing and that the case did indeed present a controversy.
In the motion to dismiss, Myriad and other defendents cite the 2007 MedImmune decision as precedent that "there must be a real controversy, not a mere policy disagreement, to warrant a declaratory judgment," and argue that since that case, courts have recognized two requirements for standing: the patent owner must have taken some "affirmative action" towards the plaintiff; and the plaintiff must have a "concrete plan to take potentially infringing action."
The motion claims that "neither requirement is met here for any of the plaintiffs. Rather, the plaintiffs essentially seek an advisory opinion declaring the patents invalid, even though there is currently no dispute over potential infringement by any of the plaintiffs."
The defendants note that they "have not had contact with any of the plaintiffs, except for an 11-year-old letter to one of the plaintiffs that has no relevance today." Furthermore, they add, none of the plaintiffs has any concrete plan for infringement."
Incentives or Disincentives of Gene Patenting
In the memorandum, the defendants' discussion of the effect gene patenting has had on research and treatment access in the US is in stark contrast to the experiences relayed by hundreds of researchers, patient groups, and scientists who have signed on to the ACLU suit alleging that Myriad's enforcement of its BRCA patents have stifled research and restricted patients access to cheaper testing alternatives.
"Myriad Genetics and the other Defendants have spent considerable time, effort, and money, in competition with other researchers, to discover the BRCA1 and BRCA2 genes, synthesize DNA corresponding to the genes in test tubes, and identify specific gene mutations that are correlated with breast and ovarian cancer," the memorandum states.
"Using their synthetic tools and discoveries, the inventors engineered diagnostic tests for detecting these mutations in patients. The testing for these mutations has helped thousands of women get information that enabled them to make important choices and take steps to reduce their risk of breast and ovarian cancer."
According to Myriad, without incentivized exclusivity covering diagnostic testing "there would be a much smaller number of women, if any, tested for mutations in the BRCA1 and BRCA2 genes.
"Indeed, but for the prospect of the patent exclusivity, Myriad Genetics would not have been established and funded by investors," the memorandum notes.
Myriad's holds the exclusive rights to perform diagnostic tests on the BRCA1 and BRCA2 genes and the company also holds the rights to future mutations discovered on the BRCA2 gene. The University of Utah is either full or partial owner of the BRCA patents at issue in the lawsuit.
According to the ACLU's lawsuit, Myriad's "monopolistic control" over the BRCA genes hampers clinical diagnosis, serves as a disincentive for research, and allows the company to charge upwards of $3,000 for testing that many women cannot afford. As a result of these practices, "patients whose tests come back with inconclusive results do not have the option to seek additional testing elsewhere," the ACLU charges.
Meanwhile, research by the HHS Secretary's Advisory Committee on Genetics, Health, and Society and Duke University's Center for Genome Ethics has identified cases where patenting has had a negative impact on research. However, according to a draft report released earlier this year, the HHS committee did not find that gene patenting caused "widespread overpricing" of tests or that it systematically impeded patient access. At the same time, SACGHS found that patenting is not necessary as an incentive for genetic research or test development.