Class Action Challenging Patents on|Breast Cancer Genes Can Proceed

MANHATTAN (CN) - A federal judge has allowed a class action to proceed against the U.S. Patent Office and Myriad Genetics that argues the company's patents on two human genes associated with breast and ovarian cancer are unconstitutional. Organizations that represent more than 150,000 researchers, pathologists, breast cancer groups and individual women say the patents on the BRCA1 and BRCA2 genes interfere with the free flow of knowledge, and that genes are products of nature that cannot be patented. As many as 20 percent of human genes may already have been patented.

U.S. District Judge Robert W. Sweet denied the motion to dismiss, writing, "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 woman facing the specter of breast cancer, but also for the future course of biomedical research."

Researchers in 1990 identified the BRCA1 and BRCA 2 genes as having a correlation with breast cancer susceptibility. The researchers subsequently formed Myriad and patented the genes.

They discovered that although everyone carries BRCA genes, certain mutations in the genes are correlated with an increased risk of breast and ovarian cancer, and may be associated with other cancers, such as those of the prostate and pancreas.

The plaintiffs say 5 percent to 10 percent of women who develop breast cancer are likely to have mutation in their BRCA 1 or BRCA2 genes, predisposing them to the disease.

A positive test result can have a "substantial impact on a woman's medical decisions and health," the plaintiffs say. They say women will be able to obtain earlier and more vigilant screening for breast and ovarian cancers if the patents-in-suit were lifted, and doctors could freely conduct BRCA gene tests.

The complaint also names the University of Utah Research Foundation as a defendant. The university, along with Myriad, based in Salt Lake City, holds the patents for BRCA1 and BRCA2 genes.

Myriad is the sole clinical provider of full sequencing of the BRCA genes in the United States. This means that although other doctors may conduct tests to gauge patients' susceptibility to cancer, they must send the samples to Myriad. This prevents many people from access to screening for BRCA1 and BRCA2, the plaintiffs say.

One of the individual plaintiffs is a 43-year-old single mother who was diagnosed with cancer in both breasts. Her oncologist recommended she get BRCA 1 and 2 testing to determine whether she should consider further surgery to reduce her risk of ovarian cancer.

Myriad refused to accept her insurance and she was unable to pay for the tests out of pocket. The tests still have not been done, according to the complaint.

Another plaintiff had to wait for 2 years for Myriad to complete the tests, though she was diagnosed with aggressive breast cancer. This 32-year-old finally received her test results, which came back reading, "Genetic variant of uncertain significance." She says the tests did not examine all types of genetic mutations.

Numerous other women claim that they are prevented from getting tests results that could help them make informed decisions about medical treatment. The plaintiffs all argue that if the patents-in-suit were lifted, they could get genetic testing at labs other than Myriad.

Doctors in the plaintiff class, including the director of human genetics at NYU's Langone Medical Center, say they could perform the same or more thorough tests than Myriad, perhaps at less cost.

Researchers from the University of Pennsylvania, Yale and the Emory University School of Medicine say they would send samples to different labs if they could.

The complaint says Myriad should never have been granted patents-in-suit "over products of nature, laws of nature, natural phenomena, abstract ideas, and basic human knowledge," and that the patents violate the First Amendment's protections for freedom of thought.

Judge Sweet found that the plaintiffs have standing to sue. He concluded his 88-page opinion by writing that the facts alleged in the complaint are "plausible, specific, and form a sufficient basis for plaintiffs' legal argument."

Plaintiffs include the American Society for Clinical Pathology, the College of American Pathologists, Breast Cancer Action, and several leading, university-affiliated scientists.

Drug companies and some entrepreneurial scientists say genetic patents, and their offer of profits, stimulate research. The opposing argument, as in this case, is that patents, once granted, can freeze research, at great human cost.

Judge Sweet gave the defendants until Dec. 2 to submit a motion for opposition to summary judgment, and gave the plaintiffs until Dec. 9 to respond. He will hear arguments on the motions on Dec. 11.

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