Supreme Court will rule on whether patents for BRAC1 and BRAC2 genes are valid

BMJ 2012; 345 doi: (Published 05 December 2012) Cite this as: BMJ 2012;345:e8266
  1. Clare Dyer
  1. 1BMJ

The US Supreme Court is to decide whether isolated sequences of genes associated with breast and ovarian cancer may be patented, in a case with far reaching implications for genetic research and healthcare.

The case will decide the validity of US patents held by Myriad Genetics and the University of Utah Research Foundation on the BRCA1 and BRCA2 genes, which give them a monopoly on commercial screening for the genes, which can increase the risk of cancer.

The long running lawsuit has been brought by the American Civil Liberties Union and the Public Patent Foundation on behalf of the Association of Medical Pathology, other medical and professional associations, researchers, women’s health groups, and patients. They argue that the genes are products of nature and therefore cannot be patented.

In March 2010 a federal district court held that the patents were invalid, but the ruling was overturned 2-1 in July 2011 by the appeals court of the federal circuit.

The US Supreme Court directed the appeals court to reconsider the issue in the light of a Supreme Court ruling in a different case that a test to determine drug doses for certain autoimmune disorders was a natural phenomenon and not patentable. The court said in that case that for something to be patentable it must add enough to a natural phenomenon to make it different from anything found in nature.1

But last August the appeals court reaffirmed its original decision, holding that the isolated cells had been “transformed” and that the method of isolation included steps that did not occur naturally.

The president of the Association of Medical Pathology, Iris Schrijver, said in a statement last September when the association petitioned the Supreme Court to hear the case, “Gene patents prevent pathologists from reading their patients’ DNA sequences to assess their risks for disease, their prognoses, or their potential responsiveness to therapy. The result of this lack of competition is increased test costs; decreased patient access; reduced innovation in the development of new test methods; and dramatically reduced knowledge dissemination.”

In their petition to the Supreme Court the plaintiffs said that the patents “have allowed [Myriad] to dictate the cost of genetic testing, stopped other laboratories from creating and offering new and improved testing, and made it impossible to obtain second opinions that could better inform patients of their cancer risk.”

Myriad, based in Salt Lake City, Utah, also refuses to allow public access to its database.2 In a statement to Fox News after the Supreme Court announced that it would hear the appeal, the company’s chief executive, Peter Meldrum, said that Myriad’s test had helped nearly one million people learn about their risk of hereditary cancer. “The discovery and development of pioneering diagnostics and therapeutics require a huge investment, and our US patent system is the engine that derives this innovation,” he added.

The Supreme Court will hear arguments next March and give its decision in June.


Cite this as: BMJ 2012;345:e8266