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A Patent on Mother Nature? Court Invalidates Gene Patents

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By Tanya Roth, Esq. on March 31, 2010 12:54 PM

Holding that one cannot patent a "law of nature," United States District Court Judge Robert W. Sweet struck down seven patents held by the biotech company Myriad Genetics, on BRCA1 and BRCA2, the genes whose mutations are connected with breast cancer. The company had asked the court to dismiss the challenge to its patents, arguing that the act of isolating the gene from the body changes it into a patentable material. The court disagreed.

The New York Times reports that the judge, in his Opinion, agreed with critics of gene patents who considered the idea that isolating a gene made it patentable "a 'lawyer's trick' that circumvents the prohibition on the direct patenting of human DNA.

Business interests are concerned about the potential of Monday's decision to have extensive repercussions on the multi-billion dollar industries built on the intellectual property rights of such patents. Kenneth Chahine, a visiting law professor at the University of Utah who filed a friend of the court brief for defendants Myriad, said the decision could also make it harder for new companies to raise money from investors. "The industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection," he said.

The legal ramifications of this decision will depend upon an appeal, which the Times reports is likely. Some experts in the field had expected the court to dismiss the case as the Supreme Court has upheld patents on living organisms since the 1980's.

The practical effects of the decision could be very positive for those who are affected by cancer. One of the individual plaintiffs in the suit, Genae Girard, who has breast cancer and has been tested for ovarian cancer, applauded the decision as "a big turning point." According to the Times, Myriad sells a test costing more than $3,000 that looks for mutations in the two genes to determine if a woman is at a high risk of getting breast or ovarian cancer. Plaintiffs in the case argued the company's monopoly on the test, due to the the patents they held on the genes, kept prices high and prevented women from getting a confirmatory test from another laboratory.

John Ball, executive vice president of the American Society for Clinical Pathology, one of the plaintiffs in the case, called the decision "a big deal." "It's good for patients and patient care, it's good for science and scientists," he said. "It really opens up things."

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