Human-Gene Case at U.S. High Court May Reshape Biotech Landscape

(Bloomberg) — 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 U.S. 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.”

Valuable Treatments

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 including 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 patent 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.

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