Can human genes be patented? This question is currently being investigated by the United States Supreme Court.
The decision concerns considering a challenge to patents held by biotechnology company, Myriad Genetics Inc., on two genes that can signal if a woman faces greater risk of developing breast cancer or ovarian cancer. The Supreme Court will review the earlier decision by the U.S. Court of Appeals for the Federal Circuit, which declared that Myriad’s composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patenteligible under Section 101 of the United States Patent Act.
Patients, cancer organizations, medical groups and geneticists, all represented by the American Civil Liberties Union, are challenging the company’s right to the patents. They won a trial court ruling in 2010, but a federal appeals court has twice sided with the Salt Lake City-based company. According to Myriad Genetics, the BRACAnalysis test detects the presence of the BRCA1 and BRCA2 genetic mutations that can help determine a patient’s risk of breast and ovarian cancer and inform about treatment options. In a petition to the Supreme Court, Myriad’s opponents stated that the company’s breast-cancer-gene patents have allowed it to dictate the cost of genetic testing, stopped other laboratories from creating and offering new and improved testing procedures, and made it impossible to obtain second opinions that could better inform patients of their cancer risk.
Could lead to further interpretations
Nordic Life Science Review has spoken to some patent bureaus about this particular case, to investigate what importance it has on the life science business. The concern from the industry is that if the decision goes in favor of the patient organizations, this could result in a further interpretation down the road, leading to a situation where, for example, isolated proteins or antibodies could also be excluded as being patentable. It could possibly affect smaller companies depending highly on investors, which could become cautious about keeping putting money into a seemingly insecure business. According to the patent bureaus, this would however to a great extent depend on how the Supreme Court formulates the court order.
It is possible that the Supreme Court could make the decision to approve the patent. But it is far from an obvious case, particularly after last spring when the high court tightened rules on medical-testing patents. It then ruled against two patents on a method for monitoring a patient’s blood to determine the best drug dosage, in the case of Mayo v. Prometheus Laboratories. A unanimous decision was taken, ruling that Prometheus Laboratories’ methods of dosage calibration for thiopurine drugs for gastrointestinal and non-gastrointestinal autoimmune diseases were ineligible for patenting.
The court decision is expected to be issued during 2013.