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FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

Advocacy > Current Actions > Myriad Genetics vs. Ambry and Gene by Gene

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Newsflash

2/7/2018
FORCE staff and advocates joined stakeholders for a "BRCA Community Perspectives on Data Sharing" workshop in Santa Cruz, CA.

2/6/2018
We joined nearly 40 patient and health care professional organizations in expressing opposition to proposed national right-to-try legislation. Read the letter...

1/17/2018
FORCE submitted comments on a draft CMS Policy on NGS for Medicare Beneficiaries with Advanced Cancer.

1/3/2018
PALS Act moratorium extended to January 2019, preserving insurance coverage of mammograms for women ages 40-49. Read more...

12/20/2018
Court vacates EEOC wellness program rules effective January 1, 2019 signaling end to coercive practices.

Myriad Genetics vs. Ambry and Gene-by-Gene

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Read our declaration that the preliminary injunction sought by Myriad was not in the best interest of the public.

Background

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.

What does this mean for our community?

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 have 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.

Psge updated 07/28/14

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