US Supreme Court To Hear Gene Patenting Case Starting On Monday

redOrbit Staff & Wire Reports – Your Universe Online

The US Supreme Court will hear oral arguments on Monday in a case that could determine whether or not human DNA can be patented, which could have a tremendous impact on genetic research, one way or the other.

According to Reuters reporter Sharon Begley, “The US Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities and others that have discovered and decoded them.”

Those patents cover approximately 40 percent of the entire human genome, according to recent research conducted by Dr. Christopher E. Mason of Weill Cornell Medical College and Dr. Jeffrey Rosenfeld, an assistant professor of medicine at the University of Medicine & Dentistry of New Jersey.

The validity of these patents was challenged in a 2009 lawsuit by the American Civil Liberties Union (ACLU) and the Public Patent Foundation, Begley said. The focus of that lawsuit was seven patents pertaining to a pair of genes linked to breast and ovarian cancer, BRCA1 and BRCA2.

Those patents are currently held by Myriad Genetics, but the ACLU and the Public Patent Foundation argue that since DNA is a natural product, it cannot be patented under the US Patent Act.

Conversely, Myriad claims that the patents that they hold are for genes that have been “isolated,” thus making them the products of “human ingenuity” and thus patentable, Reuters said. While a federal judge sided with the ACLU and the Public Patent Foundation, that ruling was overturned by a US appeals court.

“As scholars debate the legal questions, two parallel issues have emerged: whether patenting genes thwarts scientific research, and whether it harms patients,” Begley said. “A coalition of researchers, genetic counselors, cancer survivors, breast cancer support groups, and scientific associations representing 150,000 geneticists, pathologists and laboratory professionals argue that gene patents can be problematic on both counts.”

“The American Medical Association, the American Society of Human Genetics, the March of Dimes and even James Watson (co-discoverer, in 1953, of the double helix), among others, have filed briefs asking the court to invalidate Myriad’s patents on genes called BRCA1 and BRCA2,” she added. “On the other side are Myriad and industry groups such as the Biotechnology Industry Organization (BIO) and the Animal Health Institute, which say that if gene patenting is ruled invalid, companies — with no guarantee they could profit from their discoveries — would stop investing in genetics research, to the detriment not only of patients but the economy.”

According to Karen McVeigh of The Guardian, the 4,000-plus genes currently covered by at least one patent constitute nearly one-fifth of the entire human genome. Some of the genes have been linked to diseases like Alzheimer’s disease and colon cancer, and they are held by a variety of institutions, including research laboratories, universities, and others looking to keep them widely available by blocking commercial companies from obtaining them.

“The overabundance of gene patents is a large and looming threat to personalized medicine,” Mason told Begley on Sunday. “How is it possible that my doctor cannot look at my DNA without being concerned about patent infringement? Individuals have an innate right to their own genome, or to allow their doctor to look at that genome, just like the lungs or kidneys.”

Mark Capone, president of Myriad’s laboratory division, countered by claiming that permitting DNA to be patented as intellectual property rewards research and thus helps patients. Capone told Reuters that research had not been hampered by his company´s patents, and that the 10,000 papers on the BRCA genes that had been published by an estimated 18,000 scientists worldwide served as proof of that.

Capone added that those statistics made those genes among the most studied genetic material in the world, and that they had been able to “to save thousands of patients’ lives” by telling them that they had cancer-causing BRCA mutations. Both arguments will be presented to the US Supreme Court starting on Monday.

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