Natural Genes Not Patentable, Says Supreme Court

Los Angeles –  The U.S. Supreme Court ruled unanimously in a landmark case Thursday that natural human genes cannot be patented.  The case, Association for Medical Pathology v. Myriad Genetics, was originally brought in federal court in the Southern District of New York in 2010, but made its way through appeals to the nation’s top court.

The ruling came in a contentious battle over two genes that were identified as markers for increased risk of breast cancer and patented by biological research company Myriad Genetics.  Myriad Genetics held a patent for both the natural form of the gene isolated from the rest of the genome, and also the synthetic version of the gene, known as cDNA.  The justices ruled that while Myriad Genetics could continue to patent synthetic versions of the genes they isolate, patents for naturally occurring genes in the body could not be enforced.

This decision by the Justices has broad implications, as more than 20 percent of the human genome has been patented in the last 30 years.  This decision has helped to update the parameters for determining what is eligible for patent protection in the advanced field of biotechnology where there is an increasingly fine line between what is natural or synthetic.

This fight over gene patents was particularly contentious because Myriad Genetics’ patent meant that no other companies could pursue research on these genes.  From its research into the genes, Myriad has developed two tests to identify potential abnormalities of these genes that could lead to cancer.  The company’s patent meant that no other companies could develop tests of their own.

Myriad Genetics’ two tests consist of one basic test, BRAC, that is widely available and BART, a more advanced test that can cost thousands of dollars.  Plaintiffs in the case alleged that this second, more advanced test was only available if the patient had a strong history of cancer, or had the ability to pay for the test out of pocket.

Actress Angelina Jolie recently spoke out about her decision to undergo a double mastectomy after the results of her BART test showed that she was genetically disposed to breast cancer.  Advocates argue that this test should be more widely available so that all women at risk could have the opportunity to take this test, regardless of their ability to pay.

The Supreme Court’s ruling means that the field is now open for other companies to develop their own, potentially cheaper, versions of the test.

The scientific community has long been divided over the role of patent protection for inventions versus discovery for the public good.  Myriad Genetics argued that it spent years and millions of dollars pursuing this research, and having patent protection would have helped to recoup its costs and would justify further expenditures.  Genetics corporation advocates fear that this decision could stymie future genetics research because of the enormous cost and lack of protection over the results.  Other genetic researchers, however, are excited for the opportunity to research these genes that had long been off-limits due to patent protection.