College of American Pathologists




June 13, 2013
© 2013 College of American Pathologists
Special Report
CAP Hails Supreme Court Decision on Gene Patents

June 13, 2013—Genomic medicine achieved a major victory today as the Supreme Court invalidated the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes, on the grounds that human genes are products of nature and therefore ineligible to be patented.

CAP has long opposed the issuing of gene patents and is a co-plaintiff in the case Association of Molecular Pathology et al, vs Myriad Genetics, Inc., which the court decided today.

A quick review of the decision by legal experts at the American Civil Liberties Union (ACLU), states the decision was unanimous and that a straight forward application of the product/law of nature doctrine applied. The decision invalidates patents on genomic DNA, but upholds patents on cDNA, with the caveat that cDNA patents may not be patent eligible where the cDNA is indistinguishable from natural DNA. The court expressed no opinion on whether cDNA is otherwise patentable. ACLU represented the plaintiffs in the case.

Sign up for the College’s exclusive “Supreme Court Gene Patent Decision” Reactor Panel, with experts discussing varying perspectives on the Supreme Court decision and what it means for patient care.

The panel will be held on Wednesday, June 19 at 3 p.m. Eastern Time.

Registration will open later today on

“This is a landmark decision,” said CAP President, Stanley Robboy MD, FCAP. “Genomic medicine has the potential to be a cornerstone of medical testing, treatment, and clinical integration, but the question of ‘who owns your genes’ needed a definitive answer. Now we have it.”

The BRCA1 and BRCA2 genes are indicators for a hereditary predisposition to breast and ovarian cancer. It is thought that only 5% of women carry mutations in these genes that increase their cancer risk. Until the Court’s decision today, a woman could only find out if they carry the mutated gene from a test provided by Myriad at a price of more than $3,000.

By invalidating Myriad’s claims to human genes as well as all naturally occurring mutations of the genes, the Court opened the door for other companies and researchers who can now create their own tests and conduct their own research on the heretofore patented genes. Patient groups and medical groups have voiced concerns for several years that the patents stifled innovation, while the high cost of the tests made it difficult for many women to benefit from the tests that already exist.

“The Supreme Court decision invalidating Myriad Genetics’ patents on BRCA1 and BRCA2, is a huge victory for patients,” said Debra Leonard, MD, PhD, FCAP, Chair of CAP’s Personalized Health Care Committee. “It will allow women to receive life saving, state-of-the-art genetic tests without being forced to trust one provider or one laboratory performing a single test to secure a diagnosis or inform treatment.”

For more information on CAP’s position on genomic medicine and on the case against Myriad Genetics, see CAP’s Video Issue Brief or visit the CAP’s Gene Patent Resource Center.

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