Lawsuit Challenges Status of BRCA Genes

The American Civil Liberties Union (ACLU), in conjunction with several other plaintiffs, has filed a lawsuit alleging that the owners of the BRCA gene patents "stifle research that could lead to cures and limit women's options regarding their medical care.”

The lawsuit, filed against Myriad Genetics, alleges that the company “maintains a monopoly” over the ability to perform genetic tests that determine the presence or absence of mutations on the BRCA1 or BRCA2 genes. The ACLU claims that this monopoly inhibits diagnosis, prevents research, and limits the amount of information known about the BRCA genes in “ethnic groups other than Caucasians.” In addition, the lawsuit alleges that there are “negative consequences” to the ownership that include the inability of women to pay for Myriad’s BRCAnalysis test and that women may be unable to get second opinions on their diagnoses.

"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," Myriad said in a statement to GenomeWeb Daily News. "Myriad strongly believes that its patents are valid and enforceable and will be upheld by the courts."

The US Patent and Trademark Office and the University of Utah Research Foundation were also named as defendants in the lawsuit. The Research Foundation exclusively licenses the rights to perform diagnostic tests on the genese to Myriad. The Public Patent Foundation at the Benjamin N. Cardozo School of Law and several other plaintiffs collectively filed the lawsuit.

"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. "The government should not be granting private entities control over something as personal and basic to who we are as our genes. Moreover, granting patents that limit scientific research, learning and the free flow of information violates the First Amendment."