The US Supreme Court unanimously decided Thursday that human genes cannot be patented, in a landmark decision that is seen as a major win for researchers and patients, who have argued that allowing patents on human genes impedes research and harms patients’ ability to find out their risk for disease.
Companies, on the other hand, have argued that upholding a challenge to such patents could irrevocably harm the foundation of the biotechnology industry, slowing innovation and the development of genetic tests and treatments.
In the case, the Association for Molecular Pathology and a number of other parties, including scientists and patients, challenged the patents that Utah-based biotechnology company Myriad Genetics holds on breast cancer risk genes. Those genes have recently been catapulted into the national spotlight by actress Angelina Jolie’s revelation that she had her breasts removed after discovering she had a high genetic risk of developing breast cancer. The patents that have been struck down by the court gave Myriad the exclusive right to test for mutations in the genes, BRCA1 and BRCA2.
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” justice Clarence Thomas wrote on behalf of the court. The court decided that synthetically-generated strands of DNA, called cDNA, however, are eligible for patent protection.
“Myriad did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA,” Thomas wrote. “It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself” make the work patent eligible.
In a brief filed earlier this year that officially sided with neither party, Eric Lander, director of the Broad Institute, a genetics research center in Cambridge, argued that the negative impacts on the biotechnology industry would be less than what was being projected, and that the impact on research was real. He suggested that it might be informative to think about the effects such restrictive patents would have had on other fields that have since rushed ahead, such as AIDS research.
“The patent holder would have been legally entitled to use his patent to block anyone from observing, characterizing or analyzing the virus by any means whatsoever. Scientists would not have been able to rapidly learn the secrets of this insidious virus; drug developers would not have been able to develop life-saving drugs; technologists would not have been able to develop effective diagnostics; and patients would not have been able to know their HIV status,” Lander wrote. “To their credit, the discoverers of HIV obtained appropriately narrow patents that do not exclude others from observing, characterizing and analyzing naturally occurring HIV.”
