This article has been updated with a comment from Myriad and one of the additional plaintiffs.
NEW YORK (GenomeWeb News) – The American Civil Liberties Union and the Public Patent Foundation at the Benjamin N. Cardozo School of Law, along with a number of other plaintiffs, filed a lawsuit yesterday alleging that the BRCA gene patents "stifle research that could lead to cures and limit women's options regarding their medical care."
The suit was filed in the US District Court for the Southern District of New York against Myriad Genetics, the US Patent and Trademark Office, and the University of Utah Research Foundation, which holds the patents to the BRCA1 and BRCA2 genes. The research foundation exclusively licensed the rights to perform diagnostic tests on the genes to Myriad, which provides genetic testing for ovarian and breast cancer.
Myriad also is co-owner of several of the patents challenged in the suit. In total, the plaintiffs are challenging the legality and constitutionality of four categories of claims in seven US patents.
"Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights," Anthony Romero, executive director of the ACLU, said in a statement.
"The government should not be granting private entities control over something as personal and basic to who we are as our genes," he said. "Moreover, granting patents that limit scientific research, learning and the free flow of information violates the First Amendment."
Myriad said in a statement sent to GenomeWeb Daily News that it has not yet been served with the suit but understands that the core issue surrounds the patenting of genes.
"Since a landmark US Supreme Court decision in 1980 relating to gene patenting, the USPTO has granted tens of thousands of genetic and genetic related patents which cover a large number of life-saving pharmaceutical and diagnostic products," the firm said. "Myriad strongly believes that its patents are valid and enforceable and will be upheld by the courts."
The lawsuit claims that Myriad maintains a monopoly over any genetic testing to determine the presence or absence of mutations on the human BRCA1 or BRCA2 genes. The ACLU said in a statement that this monopoly "hampers clinical diagnosis and serves as a disincentive for research because Myriad not only has the right to enforce its patents against other entities but also has the rights to future mutations discovered on the BRCA2 gene."
According to the lawsuit, Myriad's exclusive rights also have "resulted in a disparity in the amount of information known about genetic mutations in BRCA1 and BRCA2 in ethnic groups other than Caucasians."
In addition, the ACLU said that the patents have several negative consequences for patients, including women not being able to afford Myriad's BRCAnalysis test, which could cost patients as much as $3,000, depending on insurance coverage. It also said that patients can't get a second opinion on their test results, and patients who receive an inconclusive result do not have an option to seek additional testing elsewhere.
The ACLU's lawsuit is, in effect, challenging the entire practice of gene patenting, and the outcome of the case could have wide-reaching effects for the research and genetic diagnostics fields. The organization noted that around 20 percent of human genes currently are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, and asthma.
The ACLU also believes it is the first to apply the First Amendment to a gene patent challenge.
Other plaintiffs in the lawsuit include the Association for Molecular Pathology, the American College of Medical Genetics, the American Society for Clinical Pathology, the College of American Pathologists, advocacy group Breast Cancer Action, several medical geneticists, and others representing women and scientific associations.
"Gene patenting creates an obstacl course that will make true genomic analysis not only cost-prohibitive, but impossible, given that no single laboratory will ever own the rights to offer comprehensive testing," Bruce Korf, president of the American College of Medical Genetics, said in a statement.
The lawsuit comes several months after the European Patent Office decided that Myriad's patent covering the BRCA1 gene be maintained but in an amended and more limited form.