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University of Utah v. Ambry Genetics

Last Update: September 29, 2014

What's at Stake

On July 9, 2013, Myriad Genetics, along with the University of Utah Research Foundation, Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, and Endorecherche, Inc. filed lawsuits against Ambry Genetics and Gene by Gene, two laboratories that began or have proposed to begin offering genetic testing of the BRCA 1 and 2 genes.

These cases arose in the aftermath of a unanimous Supreme Court decision invalidating patent claims held by Myriad Genetics that created a monopoly on clinical testing of the BRCA1 and BRCA2 genes. Myriad asserted patent claims that were not challenged in the Supreme Court litigation.

Myriad moved for a preliminary injunction to stop the laboratories' testing of the BRCA genes. The ACLU, ACLU of Utah, Public Patent Foundation, Association for Molecular Pathology, Breast Cancer Action, and AARP filed an amicus brief in the district court opposing the preliminary injunction. The brief argues that the patent claims are invalid under prevailing precedent and that the public interest would be undermined by the imposition of a preliminary injunction, because of the limitations that would be placed on genetic testing and scientific development. In March 2014, the district court judge denied Myriad's motion for preliminary injunction, concluding that there are substantial questions about whether Myriad's patent claims monopolize products and laws of nature, in violation of Section 101 of the Patent Act.

Myriad filed an appeal in the U.S. Court of Appeals for the Federal Circuit. The ACLU and others filed two amici briefs.

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