News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Federal Judge Invalidates Myriad’s Patents for BRCA Genes

Pathology labs would generally benefit if Judge Sweet’s ruling is upheld on appeal

It was positive news for many clinical pathology laboratories when a judge ruled against Myriad Genetics and the University of Utah Research Foundation in the federal suit attacking its patents for the BRCA1 and BRCA2 genes. The suit was brought by a group of patients, medical organizations and the American Civil Liberties Union (ACLU).

In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc.,  (NASDAQ:MYGN) of Salt Lake City, Utah.

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Pathologists and Patient Groups Challenge BRCA1 & BRCA2 Gene Patents in Court

Court case will directly affect future development of new pathology and molecular tests

In New York’s Southern District Court, a trial is underway that tests the legality of patenting genes. In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., of Salt Lake City, Utah.

Many experts believe this lawsuit has the potential to produce new case law that addresses the ability of individuals and companies to hold patents on human genes. A ruling in favor of either party in the lawsuit will directly affect the clinical laboratory testing industry and diagnostic tests that utilize gene-based technologies.

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