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Ruling in Genetics Patent Case May Unlock the Code to New Competition

Yesterday, Judge Robert Sweet, a New York district judge, ruled that the patents held by Salt Lake City- based Myriad Genetics on the BRCA1 and BRCA2 genes, which identify a woman's proclivity to breast and ovarian cancer, are invalid because they "are directed to a law of nature" and therefore cannot be patented.

The ruling sided with the American Civil Liberties Union, which filed a suit last May on behalf of the Association of Molecular Pathology and the American College of Medical Genetics. The groups argued that the patents gave Myriad too much control over their gene tests for which the company charges $3000 and forbids other organizations from developing alternative tests. The groups believed that this discouraged other scientists from researching newer options on screening tests, which they say impedes future investment in research and ultimately limits women's medical care options.

According to the Washington Independent, "researchers interested in any type of research on the BCRA1 and BCRA2 genes - which are associated with a 500 percent higher risk of developing breast or ovarian cancer - had to get (and often pay for) the company's permission to perform their research."

According to Business Week, the judge's ruling stated that:

Patents aren't allowed for rules of nature, natural phenomena or abstract ideas, although the U.S. Patent and Trademark Office has said genes can be patented if they are "isolated from their natural state and purified."

Sweet said that Myriad simply identified something that occurred in the body, and that the comparisons of DNA sequences are "abstract mental processes" and neither are eligible for patent protection.

"The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent," Sweet ruled.

This ruling is important because it now opens up the options for research in alternative tests. This is especially important given that a recent study published in The New England Journal of Medicine found that the addition of genetic information only modestly improved assessment in an analysis of 5600 cases of breast cancer. So in other words, more research is very much needed.

According to The Wall Street Journal, Judge Sweet's ruling "doesn't bind other federal courts, and other judges may or may not adopt the decision in similar cases." The New York Times also reported that the ruling is likely to be appealed, but "if upheld [it] could throw into doubt the patents covering thousands of human genes and reshape the law of intellectual property." Currently, about 20 percent of human genes are patented.

The Times also reported that Myriad had asked the court to dismiss the case because "the work of isolating the DNA from the body transforms it and makes it patentable." The company argued that such patents have been granted for decades since the Supreme Court upheld patents on living organisms in 1980. But in court filings, the ACLU said that in granting the patents, the USPTO "went beyond what was allowed" in the 1980 decision. Daniel Vorhaus of The Genomics Law Report, offers an in depth legal analysis of the case.
Whether or not Myriad wins its appeal, this case, has already already had an enormous impact on the company. Yesterday, it's stock price plummeted. The ruling will continue to impact the genetics business by raising big questions about intellectual property and company-based genetic research.

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