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Myriad Genetics vs. Ambry and Gene by Gene

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Read our declaration that the preliminary injunction is not in the best interest of the public.

Stay tuned for updates on this case after the September 11 & 12 hearings on the injunction.

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Update on preliminary injunction

Read below (at the bottom of this article) for a March 10, 2014 update on Myriad Genetics vs. Ambry and Gene by Gene case.

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 place on members of our community.

Subsequently, several laboratories, including Ambry Genetics and Gene by Gene, began offering genetic tests for BRCA1 and BRCA2 mutations at a lower cost than Myriad’s test.

In July, Myriad sued both companies, alleging that their BRCA tests infringed 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.

What does this mean for our community?

  • Myriad's patent infringement lawsuit could take months before a final ruling is made. In the meantime, if the preliminary injunction is granted, Ambry and Gene by Gene will no longer be able to offer BRCA testing until the patent infringement case has concluded.
  • Competition in genetic testing for BRCA mutations has made the test less expensive and more accessible for patients. If Myriad’s preliminary injunction is successful, it could set the clock back on BRCA testing options to where things stood before the Supreme Court ruling.

FORCE believes that competition in the genetic testing marketplace is good for consumers and will result in lower BRCA testing costs. 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 has 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. FORCE may be called to testify about this issue in a hearing scheduled for September 11 and 12, 2013.

Update on preliminary injunction

March 10, 2014, Judge Shelby ruled against Myriad and its co-plaintiffs request for a preliminary injunction. Myriad's patent lawsuit against other labs can continue but until a ruling or settlement is made, other competing laboratories may continue to offer testing for BRCA.

 

Page updated 03/10/14


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