New Gene Patent Rules - Pharmaceutical Technology

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New Gene Patent Rules
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders. Includes bonus online coverage.

Pharmaceutical Technology
Volume 37, Issue 8, pp. 14-16

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
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).


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