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Human Gene Patent Case Goes to Supreme Court

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.

"Some synthetic genes are used by the biotechnology industry to make therapeutic antibodies, such as Rituxan (used to treat lymphoma) or Herceptin (used to treat breast cancer)," Shapira said. "These synthetic genes have patents that nobody disputes."

Some of the opposition's concerns are overblown and some are simply incorrect, according to Mark Capone, president of Myriad Genetics Laboratories, Inc., a subsidiary of Myriad.

"Myriad cannot, should not and has not patented genes as they exist in the human body on DNA," Capone told the AP. "This case is truly about isolated DNA molecules, which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent."

However, the ACLU contends that isolating the DNA molecules doesn't stop them from being DNA molecules, and that these molecules are not patentable. That position appears to have the support of the Obama administration, the AP reported. In court papers, Solicitor General Donald Verrilli said artificially created DNA can be patented, while "isolated but otherwise unmodified genomic DNA is not patent-eligible."

Dr. Barbara Pober, a professor of medical sciences at Quinnipiac University's Frank H. Netter MD School of Medicine, agreed that the Myriad genes should not have been patented. "Genetic sequencing in the laboratory, as performed by Myriad Genetics, does not involve sufficient alteration or modification of the gene to warrant the protections afforded to a patented product," she said.

"In fact, patenting genes inhibits dissemination of genetic information to patients, as well as innovation and technology by eliminating the ability of both small and large laboratories to develop genetic tests," she added. As a result, consumers and hospitals pay more for tests and wait longer for the results, she said.

Whatever the ruling, the implications will be significant in terms of shaping laws governing biotechnology and medical innovations, one expert said.

"The intellectual framework that comes out of the decision could have a significant impact on other patents -- for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature," Robert Cook-Deegan, director for genome ethics, law and policy at Duke University, said in a statement, the AP reported.

"This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications," he explained.

Current research would come to a halt, others contend. Biotechnology Industry Organization said in a friend of the court brief that invalidating the current patent law "would chill a wide range of important activities that benefit society," according to The New York Times.

Others are less convinced that the ruling will have an enormous impact, especially since the Myriad patents will expire over the next two years. Dr. James Evans, a professor of genetics and medicine at the University of North Carolina, Chapel Hill, told the Times that the significance of the nine justices' decision "will be much more ideological than it will be practical."

More information

The U.S. National Cancer Institute has more on genes and breast cancer.

SOURCES: Iuliana Shapira, M.D., director, cancer genetics, North Shore-LIJ Cancer Institute, Lake Success, N.Y., and investigator, Feinstein Institute for Medical Research in Manhasset, N.Y.; Barbara R. Pober, M.D., professor, medical sciences, Frank H. Netter M.D. School of Medicine, Quinnipiac University, Hamden, Conn.; April 15, 2013, New York Times and Associated Press

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