Supreme Court invalidates patents held by Myriad Genetics

The College of American Pathologists applauds today's unanimous Supreme Court decision invalidating the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes. It is a victory for patients and for science.

CAP is a co-plaintiff in the case Association of Molecular Pathology et al, vs Myriad Genetics, Inc., which the court decided today.

"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."