Biotech Industry at Stake as Court Weighs Human Gene Patents

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Byline: Greg Stohr and Susan Decker Bloomberg News

WASHINGTON -- For 30 years, biotechnology innovators have secured thousands of U.S. patents on genes, defining the legal rights to medical and agricultural products worth hundreds of billions of dollars.

Now the Supreme Court is considering whether that was all a big mistake. The court next week will debate whether human genes can be patented, hearing arguments from doctors, patients and scientists who say patents are stifling clinical testing and research. The group is challenging Myriad Genetics Inc.'s patents on genes linked to breast and ovarian cancer.

A decision against gene patenting would ripple across a host of industries -- including biotechnology, agriculture, industrial microbiology and pharmaceuticals. The case has implications for the growing field of personalized medicine and efforts to map the human brain and discover new uses for embryonic stem cells.

It potentially could bar patents on discoveries outside the DNA context.

"The intellectual framework that comes out of the decision could have an impact on other patents," said Robert Cook- Deegan, a public-policy professor at Duke University and its Institute for Genome Sciences and Policy. Beyond medicine, "this could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications."

The case, which the court will decide by June, is splitting the medical community. Trade groups for the biotechnology, agriculture and drug industries are siding with Myriad. They say gene patents have led to valuable treatments, including Amgen Inc.'s Epogen anemia drug and synthetic insulin developed by Genentech Inc., now part of Roche Holding AG.

Doctor groups such as the American Medical Association are backing the challengers to the patents. They have partial support from the Obama administration, which is urging the court to uphold parts of Myriad's patents and void other aspects.

The administration's stance marks a rejection of the longstanding policy of the U.S. Patent and Trademark Office, which has been awarding human gene patents since 1982.

The dispute comes to the court in an emotionally charged package, with patient advocates accusing Myriad of standing in the way of breast cancer diagnosis and treatment.

The company at one point demanded that the University of Pennsylvania stop clinical testing of cancer patients. Breast cancer patient advocates are planning a demonstration outside the court.

Critics say Myriad's patents effectively give the company ownership rights over a part of the human body.

"There is a strong aversion to patents that cover any aspect of the human body," said Andrew Torrance, who teaches patent and biodiversity law at the University of Kansas and is a visiting scholar at the Massachusetts Institute of Technology.

"It's a gut-level principle. We don't like the thought of humans as property, and we think of patents as property."

More broadly, the case has rekindled a debate over the longstanding concept that patents can't cover "laws of nature." The Supreme Court pointed to that legal principle in 1854 when it invalidated part of Samuel Morse's telegraph patent because it sought to cover the use of electric current to transmit characters or letters.

"Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity," the high court wrote in a 1980 case. "Such discoveries are manifestations of nature, free to all men and reserved exclusively to none."

The Myriad case tests the meaning of that principle against the backdrop of cutting-edge medical and scientific research. In 1994, the Salt Lake City-based company won a race among five research groups to pinpoint the genetic sequences associated with DNA mutations that indicate hereditary risk for breast and ovarian cancer. …