After the U.S. Supreme Court last year invalidated human gene patents held by Utah-based Myriad Genetics, the firm’s competitors launched an array of products aimed at cracking Myriad’s stranglehold on the breast cancer gene testing market. Myriad, however, promptly filed a bevy of lawsuits against its challengers, arguing that the high court decision didn’t apply to related patents it held on testing for the BRCA gene mutations linked to cancer risk.
Now, Myriad has won the first round of that fight. Last week, a Houston, Texas, company called Gene by Gene (GBG) retreated from its Myriad challenge, agreeing to stop selling test kits in North America. In return, Myriad and its allies have dropped a lawsuit against GBG that accused the upstart of violating patent law.
Myriad announced the agreement on 7 February on behalf of all involved, including partners who own shares of the BRCA genetic discoveries. These allies include the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche Inc., and the Trustees of the University of Pennsylvania. The settlement remains in force until 12 February 2016 or when the last BRCA testing patent expires—whichever comes first.
In the interim, GBG still has plenty of running room; it will continue to sell BRCA testing outside North America because the patents don’t apply there. In addition, according to GBG’s Chief Scientific Officer David Mittelman, GBG will continue to offer North American clients other genetic information such as personal exome sequencing results that contain data on any BRCA mutations. GBG will do so without providing clients direct access to an interpretation of such results; clients will have to consult a medical professional for that, in compliance with U.S. Food and Drug Administration rules.
GBG is one of many companies entangled in BRCA-related lawsuits with Myriad; the other cases remain unresolved. The companies include: Ambry Genetics of Aliso Viejo, California; Counsyl Inc. of South San Francisco, California; GeneDx of Gaithersburg, Maryland; Invitae of San Francisco, California; LabCorp of Burlington, North Carolina; and Quest Diagnostics of Madison, New Jersey.