Suit over gene patents is ongoing

A federal judge in New York has denied requests by Salt Lake City-based Myriad Genetics Inc., the directors of the University of Utah Research Foundation and the U.S. Patent and Trademark Office to dismiss a lawsuit over patents for two human genes and their mutations that can indicate if a woman is at risk for breast or ovarian cancer.

Judge Robert W. Sweet of the U.S. District of Southern New York wrote in an 85-page ruling made public Monday that the case law the attorneys used to argue that the Manhattan courtroom was not the proper jurisdiction to hear such a case and that the lawsuit against them failed to state a legal claim were incorrect interpretations of prior judicial decisions.

"The widespread use of gene-sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research," Sweet wrote.

Myriad Genetics officials declined Wednesday to comment on the judge's decision. "We have a policy of not commenting on pending litigation," said Suzanne Barton, the company's director of investor relations.

However, she said the company will continue to defend itself.

The genes at issue are called BRCA1 and BRCA2, located in Chromosome 17 of human cells. In the 1990s, Utah researchers found the BRCA genes, named after the first two letters in "breast" and "cancer," and determined that they correlated with breast-cancer susceptibility. The researchers formed Myriad and obtained patents on the gene, which is allowed by the U.S. Patent Office if the gene is "isolated and purified," which means it must be separated from other contents of the cell.

The defendants are being sued by a handful of groups, including breast-cancer patients, the American Society for Clinical Pathology and the American Civil Liberties Union Foundation.

Patients, in affidavits submitted to the court, said that Myriad is the only company that performs genetic testing on women to determine if they have the gene. They cannot get second opinions from other researchers. Some said Myriad's prices were too high to get tested.

Physicians and scientists claim that they cannot conduct further research on the genes, because Myriad holds the patent.

The plaintiffs, who filed the original suit May 12, believe the patents are illegal under the 1954 Patent Act, as well as the First and 14th amendments.

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