Policy Archive Successful Effort
Supreme Court Rules Gene Patents Unlawful
In 2009, the American Civil Liberties Union (ACLU) filed a lawsuit challenging Myriad Genetics' patents on the BRCA genes. On April 15, 2013 the U.S. Supreme Court heard oral arguments, and ultimately ruled unanimously that the patents on the BRCA1 and BRCA2 genes were invalid. This landmark ruling represented the culmination of the legal tug-of-war between Myriad and the plaintiffs, including the ACLU as well as individual, advocacy, and health care professional groups.
FORCE strongly supported the stance that exclusive gene patents had negative effects on the scientific, medical and patient communities, and filed an Amicus (Friend of the Court) brief on behalf of the plaintiffs. In addition, a FORCE representative testified before the U.S. Patent and Trademark Office and served as an expert witness on how the exclusive BRCA gene patents influenced research and access to care.
The abolishment of gene patents has fostered competition and substantial growth in the genetic and genomic testing marketplace. Costs for genetic testing have plunged while the growth of multigene panel tests has accelerated quickly enabling the identification of individuals who carry not only BRCA mutations, but also many "new" genetic mutations which cause increased risk of breast, ovarian, and related cancers. In addition to allowing more high-risk individuals to be proactive with their health, the new landscape is fostering a more personalized approach to cancer treatment with the development of therapies that target tumors based on their unique biology.
7/1/2021 - Effective today, North Carolina's Medicaid program will cover genetic counseling and BRCA mutation testing for those who have "higher than average risk" for the development of certain cancers based on specific personal and/or family history of the disease.
6/30/2021 - FORCE added its support to a letter sent to Senate HELP Committee leadership urging the prioritization of diagnostics reform on behalf of the In-vitro Diagnostics (IVD) Reform Coalition and the communities it represents.
5/21/2021 - Joined the Defense Health Research Consortium in a letter asking House and Senate leadership to continue support for the defense health research programs funded through the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP).