Civil liberties group files landmark gene patenting case

The American Civil Liberties Union (ACLU) has filed a lawsuit against Myriad Genetics that could lead to one of the most important legal battles in the history of biotechnology.

NEW ROCHELLE, NEW YORK – The American Civil Liberties Union (ACLU) has filed a lawsuit against Myriad Genetics that could lead to one of the most important legal battles in the history of biotechnology.

The ACLU claims that the patenting of two human genes linked to breast and ovarian cancer – BRCA1 and BRCA2 – will inhibit medical research. It also says that the patents are invalid and unconstitutional.

Patenting genes has been a controversial business for nearly thirty years, with a series of legal challenges. But this case is unusual in terms of the sheer number of plaintiffs – four scientific organisations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women’s health groups, genetic counselors and individual women.

It also takes a particularly hard line on the issue. For while the lawsuit specifically centers on the patentability of two cancer-related genes, the ACLU says it plans to challenge the entire concept of patenting genes. “Patents are meant to protect inventions, not things that exist in nature like genes in the human body,” said Chris Hansen, a staff attorney with the ACLU. “Genes isolated from the human body are no more patentable than gold extracted from a mountain.”

According to the ACLU, the decision of the US Patent and Trademark Office (PTO) to grant patents on the BRCA genes to Myriad Genetics means that Myriad’s lab is the only place in the country where diagnostic testing can be performed. Myriad’s monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results, it says, and allows Myriad to charge over $3,000 for tests.

“Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights,” said Anthony D Romero, Executive Director of the ACLU. “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.”

Players and commentators on the biotech industry are lining up to take sides in the debate. “This is going to turn into one of the watershed events in the evolution of the bioindustry,” says John Sterling, Editor in Chief of Genetic Engineering & Biotechnology News (GEN). “What we have here is one group, the ACLU and its allies, contending that gene patents stifle life science research and potentially harm the health of thousands of patients. On the other side are biotech companies who maintain that without gene patents research incentives are seriously diminished and innovation is smothered.”

Kenneth I Berns, Editor in Chief of Genetic Testing and Molecular Biomarkers, which is the official journal of the Genetic Alliance, says the “patenting of human genes is a bad idea, and healthcare in the US would be enhanced if the ACLU suit prevails.”

Yvonne Cripps, the Harry T Ice Professor of Law at Indiana University Maurer School of Law, who specializes in intellectual property law and biotechnology, said the patents held by Myriad are vulnerable, but that this does not reduce the need for a constitutional challenge.

“The patents have already been questioned internationally because of their fundamental importance. Various Canadian state governments effectively ignore these patents on unmodified human breast cancer genes because they affect, in various ways, access to potentially life-saving medical treatment,” she said in a statement. “In my opinion, they may ultimately be thought to be relevant to the 14th Amendment’s protection for life and liberty.”

But William Warren, partner at law firm Sutherland, thinks the ACLU, in this case, has chosen its weapons unwisely. “The ACLU unexpectedly based its invalidity challenge on claims to unpatentable subject matter,” he says. “The ACLU might have instead considered challenging the Myriad patents for obviousness.”