Cancer-Linked Gene Patents Denied

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Guest blogger: Justin R. Jensen, Esq

Patents on two genes linked to breast and ovarian cancer were struck down Monday by a Federal judge. If the 152-page decision is upheld, patents covering thousands of human genes may also be invalidated.

Certain variations of the BRCA1 and BRCA2 genes lead to an increased risk for breast and ovarian cancer. Women with BRCA1 or BRCA2 mutations have about a 60% risk of being diagnosed with breast cancer in their lifetimes.

Genetic screening can identify the problem before the onset of cancer, but Myriad Genetics holds the patent to the gene and is the only seller of a test costing more than $3,000. Plaintiffs in the case argued that Myriad’s monopoly on the test kept its prices unreasonably high and prevented women from getting a second opinion.

U.S. District Court Judge Robert W. Sweet found the patents were “improperly granted” as they involved a “law of nature.” Multi-billion dollar industries have been built on the 20 percent of human genes that have been patented; industries that may soon cease to exist.

Opponents argue that such patents had been granted for decades, and it was widely predicted the court would throw out the suit. Edward Reines, a patent lawyer for biotech firms uninvolved in the case, noted “The genetic tools to solve the major health problems of our time have not been found yet… These are the discoveries we want to motivate by providing incentives to all the researchers out there.”

Patients and scientists have found reason to rejoice, however: cheaper and more available testing for breast cancer now, and less obstacles to genetic research in the future. “This could open up research venues in a way that can help patients—and that have been blocked because of the patents,” says Joann Boughman, executive VP of the American Society of Human Genetics.

ACLU staff lawyer Chris Hansen said: “The human genome, like the structure of blood, air or water, 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.”

Mary-Claire King, the University of Washington scientist who discovered BRCA1, cheered the ruling as “very good news for women who are potential carriers.” Patenting a gene “makes no sense,” King said. “It’s like patenting one’s thumb.”

While the law seems to be on Myriad’s side on appeal, for now the ruling appears to be a victory for patients and scientists. If it stands, it could well reshape the future of medicine.