Human Gene Patent Case Goes to Supreme Court

Posted: April 16, 2013 at 10:48 pm

By Margaret Steele HealthDay Reporter

MONDAY, April 15 (HealthDay News) -- The question of whether human genes can be patented is at the center of a case to be heard Monday by the U.S. Supreme Court.

The court's decision could have a profound effect on medical research in the country, efforts to fight diseases such as breast and ovarian cancer, and the multi-billion dollar medical and biotechnology industry, experts say.

The U.S. Patent and Trademark Office has been granting patents on human genes for more than 30 years, according to the Associated Press. The current case stems from a 2009 lawsuit filed by the American Civil Liberties Union on behalf of breast cancer patients and health professionals challenging the validity of Myriad Genetics' patents on two genes associated with breast and ovarian cancer risk.

BRCA1 and BRCA2 gene mutations are linked to increased risk of breast and ovarian cancer, and Myriad sells the only BRCA gene test, which gives them a monopoly on a highly profitable business, critics say.

Opponents also say that allowing companies to patent human genes or parts of human genes will hinder potentially lifesaving research to fight diseases such as breast cancer.

"What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes," Karuna Jagger, executive director of Breast Cancer Action, told the AP.

Myriad has the patent on a specific method of isolation and identification of specific BRCA mutations, explained Dr. Iuliana Shapira, director of cancer genetics at North Shore-LIJ Cancer Institute in Lake Success, N.Y.

The way Shapira sees it, patents allow a temporary legal monopoly over the use of an invention, but genes are "not invented" by human intelligence and therefore cannot be patented.

On the other hand, if scientists "edit" the gene, for example removing parts of it or introducing some parts and thus creating "a synthetic gene" -- something that does not exist in nature and has specific functions -- that type of "synthetic gene" is patentable, Shapira said.

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Human Gene Patent Case Goes to Supreme Court

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