When Genae Girard received a diagnosis of breast cancer in 2006, she did not expect to run into patent problems.
Girard took a genetic test to see if her genes also put her at increased risk for ovarian cancer, which might require the removal of her ovaries. The test came back positive, so she wanted a second opinion from another test. But there can be no second opinion. A decision by the government more than 10 years ago allowed one company, Myriad Genetics, to own the patent on two genes that are associated with increased risk for breast cancer and ovarian cancer, and on the testing that measures that risk.
On Tuesday, Girard, 39, who lives in the Austin, Texas, area, filed a lawsuit against Myriad and the US Patent Office, challenging the decision to grant a patent on a gene to Myriad and companies like it. She was joined by four other cancer patients, by professional organizations of pathologists with more than 100,000 members and by several individual pathologists and genetic researchers.
The lawsuit was organized by the American Civil Liberties Union (ACLU) and filed in federal court in New York. It blends patent law, medical science, breast cancer activism and an unusual civil liberties argument in ways that could make it a landmark case.
Companies like Myriad, based in Salt Lake City, Utah, have argued that the patent system promotes innovation by giving companies the temporary monopoly that rewards their substantial investment in research and development.
The plaintiffs do not accuse Myriad of being a poor steward of the information concerning the two genes at issue in the suit, known as BRCA1 and BRCA2, but they argue that BRCA testing would improve if market forces were allowed to work.
Harry Ostrer, director of the human genetics program at the New York University School of Medicine and a plaintiff in the case, said many laboratories could perform the BRCA tests faster than Myriad and for less money.
Laboratories like his, he said, could focus on the mysteries still unsolved in gene variants. But if he tried to offer such services today, he said, he would be risking a lawsuit from Myriad.
Christopher Hansen, senior national staff counsel for the ACLU, said the problem was with the patent office, not the company.
He recalled that when he first heard that the office had granted a patent for a gene, “I said that can’t be true.”
Patents are normally not granted for products of nature or laws of nature. The companies successfully argued that they had done something that made the genes more than nature’s work: They had isolated and purified the DNA, and thus had patented something they had created — even though it corresponded to the sequence of an actual gene.
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