The unanimous US Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013) (Myriad) held that isolated, naturally occurring genes and gene fragments—a class of discoveries that has been a driver of the biotechnology industry for the last few decades—are not patent-eligible. The plaintiffs and all those who challenged the patents hailed the decision as a victory for medical research, doctors, and patients. The biotechnology industry also declared it a win because the Supreme Court limited its holding, stating only that genes and the information they encode are not patent-eligible simply because they have been isolated from the surrounding genetic material.
Biotechnology executives should closely familiarize themselves with the decision, which overturned decades of patent precedent, and its likely effects on the biotechnology industry and medical research.
BRCA1/2, Myriad Genetics, and Plaintiffs
In 2009, a group of patients, healthcare providers, and researchers, represented by the American Civil Liberties Union (ACLU) and the Public Patent Foundation, filed suit in federal court challenging Myriad's patents covering the BRCA1/2 technology. The ACLU argued that these patents and related technology gave Myriad an improper monopoly over the technology, which stifled research that could lead to cures and limited women's options to obtain second opinions and control their medical care (4).
Myriad argued that isolated DNA is not the same as DNA as it exists in the body (5). Myriad also noted that basic research had not been impeded by its patents and that the US Patent and Trademark Office (USPTO), after public discourse and review, has been issuing patents on isolated DNA for almost 30 years. This patented technology has fueled significant advancements in medicine, agricultural, and industrial products. Myriad also pointed out that its technology, obtained after great effort and investment, has improved individualized patient care (5).