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.
New Patent Rules for Genetic Material (Adrian Neal/Stockbyte/Getty Images)
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
Myriad Genetics sells a genetic test that confirms the presence of a BRCA1 or BRCA2 gene mutation under the trademark BRCAAnalysis.
Mutations in the BRCA1 or BRCA2 genes (collectively referred to as BRCA1/2 mutations) are responsible for the majority of
hereditary breast and ovarian cancers. People with mutations in either the BRCA1 or BRCA2 genes have risks of up to 87% for
developing breast cancer and up to 44% for developing ovarian cancers by age 70 (1). Individuals with the mutation who have
been previously diagnosed with cancer also have a significantly increased risk of developing a second primary cancer.
Myriad had exclusive rights to provide the test in the US by virtue of at least seven patents (2), assigned or exclusively
licensed from the University of Utah (3). The Myriad patents cover the genes as isolated from the human body, synthetic, or
man-made genes, fragments of the genes, and use of the genes to perform screens and diagnostic tests. The company did not
enforce its patents against academic researchers (3). Myriad did, however, enforce its patents against the unauthorized commercial
use of its technology. Myriad, for example, sent cease and desist letters to commercial laboratories that offered the diagnostic
tests (3) and enforced its patent rights through litigation (3).
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).