Summary

The US District Court for the Southern District of New York denied a motion to dismiss the lawsuit brought against Myriad Genetics, the US Patent and Trademark Office and the
University of Utah Research Foundation by the Association for Molecular Pathology,
the American Civil Liberties Union and Public Patent Foundation at the Benjamin N. Cardozo School of Law, and others.  This outcome of this lawsuit will significantly impact the patent landscape and business models for companies engaging in genetic testing.

Analysis

On May 12 of this year, the Association for Molecular Pathology, the American Civil Liberties Union and Public Patent Foundation at the Benjamin N. Cardozo School of Law, and others filed a lawsuit against Myriad Genetics, the US Patent and Trademark Office and the University of Utah Research Foundation.  The suit claims that the BRAC gene patents held by the University of Utah and exclusively licensed to Myriad Genetics for breast and ovarian cancer molecular diagnostic tests "stifle research that could lead to cures and limit women's options regarding their medical care."  Since the BRAC tests are only available from Myriad, the plaintiffs believe that this not only limits access to these important tests, but also hinders test development, which typically occurs in a dispersed test environment.

However, the scope of the lawsuit is much greater than the BRAC tests offered by Myriad Genetics.  At the core of this lawsuit is the entire practice of gene patenting.  In a related, recent, development the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) draft report on gene patents recommended that gene patents should be exempt from patent infringement.  If this recommendation is implemented, it would have significant impact on many, if not all companies that offer high value, molecular diagnostic tests.  These include smaller companies such as Myriad Genetics, Genomic Health (NASDAQ: GHDX), but major commercial reference labs such as Quest Diagnostics, LabCorp (NYSE: LH) and leading diagnostic test manufacturers.

For more information on this subject, the companies mentioned above and the high growth molecular diagnostic genetic testing market segments please contact your GLG representative and schedule an individual consult today.

Ken Powell consults with leading institutions through GLG

Ken Powell, President
Ken Powell

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President, Genesis Business Development, LLC

 
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.