Myriad Genetics Maintains BRCA1 and BRCA2 Patents, Appellate Court Rules

On August 16, the US Federal Circuit Court of Appeals ruled 2-1 to uphold its original decision that Myriad Genetics has the right to hold the patent to the BRCA1 and BRCA2 genes.

The decision comes after the US Supreme Court remanded the case of The Association for Molecular Pathology, et al., v. Myriad Genetics, Inc., et al (Docket No. 11-725) to the appeals court in March. In that case, the right of Myriad Genetics and the University of Utah to hold the patents for the genes was challenged.

Those two genes are closely associated with an increased risk of developing breast and ovarian cancer. Critics claimed that the genes and their subsequent mutations were naturally occurring. Myriad and the University of Utah argued that the genes had been isolated, and the isolated genes did not occur naturally. Currently, Myriad manufactures the only test available that identifies both genes.

“Everything and everyone comes from nature, following its laws,” wrote Circuit Judge Alan Lourie on behalf of the court majority. “But the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”

In March 2010, a US District Court in New York ruled against Myriad, stating that the genes could not be patented. Then, last July, the appellate court reversed that decision. The Supreme Court asked the appellate court to reconsider its decision in light of a ruling it made in a different case in March of this year. The case cited by the highest court was Mayo Collaborative Services, Mayo Medical Laboratories, et al., v. Prometheus Laboratories, Inc. (Docket No. 10-1150), which concerned a blood test used by doctors on patients who take thiopurine drugs to treat gastrointestinal and nongastrointestinal autoimmune diseases. The test is used to identify thiopurine metabolites that are formed when the drugs are broken down in the body, and to determine if a prescribing physician should raise or lower the dosage. The US Supreme Court ruled against Prometheus, stating that the claim made by the company was a law of nature and could not be patented.

The appellate court sought to distinguish between the Prometheus case and the Myriad case and determined that, while the process by which drugs are broken down in the body is natural, the isolation of DNA strands is not.

“Unlike Prometheus, the claims to short isolated strands of DNA are not directed to the relationship between the mutation and cancer, but rather to a new tool that can be used to determine if that relationship exists,” Lourie wrote. “The short isolated DNA sequences have markedly different properties which are directly responsible for their new and significant utility.”

BRCA1 and BRCA2 are studied extensively in oncology in terms of their value in diagnostic and treatment strategies, and critics claimed that Myriad had set out to create a monopoly because the company made the only test available for the genes, and had the ability to restrict other researchers from being granted access to the genes. The original lawsuit was filed by the Association for Molecular Pathology (AMP), the American Civil Liberties Union (ACLU), and the Public Patent Foundation against the US Patent and Trademark Office and Myriad in 2009.

“We are very pleased with the favorable decision the Court rendered today, which again confirmed that isolated DNA is patentable,” said Peter Meldrum, president and CEO of Myriad Genetics, in a statement released on Aug. 16. “Importantly, the Court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity.”