In a case that could have far-reaching implications for medical research and health care based on genetics, groups representing thousands of doctors, scientists and patients went to court Tuesday to argue that no one should be able to patent human genes, a question that has long been controversial in scientific circles.
The case involves a Utah company, Myriad Genetics, and the University of Utah Research Foundation, which in 1994 isolated the DNA sequence for the BRCA1 and later the BRCA2 genes, mutations of which can greatly increase a woman's chance of developing breast and ovarian cancer. Myriad sells a test for the genes.
The American Civil Liberties Union and the Public Patent Foundation, a not-for-profit organization affiliated with Cardozo School of Law in New York, argued before federal district court Judge Robert Sweet that patents on genes are unconstitutional.
The U.S. Patent Office allows genes to be patented as soon as someone isolates the DNA by removing it from the cell, says ACLU attorney Sandra Park. "We're arguing that isolating it does not make it patentable. It's a natural phenomenon, and the Supreme Court has always said natural phenomena are not patentable."
The suit also argues that because every human has these genes, the patents infringe on First Amendment rights of freedom of scientific inquiry and the free exchange of ideas, as well as undermining bodily integrity and a person's right to know about his or her genetic makeup.
The suit is supported by groups such as the American Medical Association, the March of Dimes and the American Society for Human Genetics. It also argues that gene patents make research into tests and cures for cancer more difficult by requiring researchers to obtain licenses from the patent holder.
Myriad strongly disagrees. "Without the patents, there wouldn't have been the financial incentive" to create the tests, says company general counsel Rick Marsh.
The question is whether gene patents stymie research or promote it by making it financially worthwhile.
It really comes down to a question of practicality, says Jonathan Moreno, a professor of bioethics at the University of Pennsylvania. "Is the current intellectual property system the best arrangement between striking the balance between good science, public health and efficiency?"
The suit, filed May 12, is being heard at the U.S. District Court for the Southern District of New York.
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