FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.
Read our declaration that the preliminary injunction sought by Myriad was not in the best interest of the public.
On June 13, 2013, in a highly-publicized case, the United States Supreme Court unanimously ruled that the Myriad Genetics' patents on the BRCA1 and BRCA2 genes were invalid. FORCE filed an amicus brief in support of the ACLU and testified to the Patent and Trademark Office about the burden that gene patents placed on members of our community.
Subsequently, several laboratories, including Ambry Genetics, Gene-by-Gene, and others began offering genetic tests for BRCA1 and BRCA2 mutations at a lower cost than Myriad's tests.
In July 2013, Myriad sued both companies, alleging that their BRCA tests infringe on patents that were not invalidated by the Supreme Court decision. Myriad then sought a preliminary injunction, asking the court to block Ambry and Gene-by-Gene from conducting any BRCA testing until the patent infringement case is resolved — a delay that could take many months. Myriad must prove to the court — among other things — that the granting of a preliminary injunction is in the public interest.
In February 2014, Gene-by-Gene became the first genetic diagnostic company to settle with Myriad. Under the terms of the agreement, Gene-by-Gene immediately ceased "selling or marketing" BRCA gene tests as standalone tests or as part of a wider panel in the U.S. This settlement has little to do with the merits of the case, and more to do with the financial resources needed to engage in an ongoing court battle.
On March 10, 2014, the court ruled against Myriad and its co-plaintiffs’ request for a preliminary injunction against Ambry Genetics. Myriad's patent lawsuit against other labs can continue but until a final ruling or settlement is made, competing laboratories may continue to offer BRCA testing.
Myriad appealed this decision. On December 17, 2014 the company lost its court appeal to block competitors from doing BRCA testing. The U.S. appeals court upheld a trial judge’s decision to allow competing tests to remain on the market and reiterated that the patents on the BRCA tests never should have been issued.
FORCE believes that competition in the genetic testing marketplace is good for consumers. It has already resulted in lower costs for BRCA testing and has enabled the invent of multiplex testing, an approach which screens for numerous cancer susceptibility mutations. We have long advocated against exclusive gene patents, and testified twice before the United States Patent and Trademark Office about the negative impact of exclusive gene patenting on research, clinical care, and access to genetic testing. FORCE submitted a declaration stating that in our view, an injunction to prohibit competing labs from performing BRCA testing is not in the best interest of the HBOC community or the general public.