In Surprise Ruling, Court Declares Two Gene Patents Invalid

When the ACLU, joined by a long list of medical and genetics groups, sued to invalidate patents on human genes, the lawyers I spoke to for my recent column were almost unanimous in saying the plaintiffs didn't have a prayer, while the scientists said their arguments were compelling. Patents, according to the Constitution, exist to "promote the progress of science," but patents on human genes arguably do the opposite, researchers told me. I figured the lawyers knew better, and assumed the geneticists and the ACLU would lose.

Surprise: in a 156-page decision just handed down, the U.S. District Court for the Southern District of New York ruled that patents on the genes (BRCA1 and BRCA2, both associated with hereditary breast and ovarian cancer) held by Myriad Genetics are invalid.

It's the first time a court has thrown out gene patents, and it raises questions about the validity of the other 40,000 patents on an estimated 2,000 human genes. (There are more patents than genes because the patents cover the form of the gene fished out of the body plus use of the genes, such as genetic testing.)

The ACLU is calling it "a victory for the free flow of ideas in scientific research," crowing that the human genome "was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas." That seemed to be uppermost on the court's mind, with the ruling indicating that the issue in the lawsuit "deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups . . . and those seeking to advance public health."

Joann Boughman, executive VP of the American Society of Human Genetics, which filed an amicus brief in the suit, says that the decision, if it stands, could be momentous. "This could open up research venues in a way that can help patients—and that have been blocked because of the patents," she says. Expect Myriad to appeal, and maybe to prevail: as several of the comments on my column from lawyers argued, the law seems to be on the company's side. But then, the lawyers have been wrong on this case before.