Court Agrees to Allow Early Mylan Prezista Generic

Mylan Pharmaceuticals Inc. can introduce a generic form of Prezista (darunavir) before Janssen Products LP’s patent on the HIV drug expires, according to a settlement agreed to yesterday by the U.S. District Court for the District of New Jersey (Janssen Prods. L.P. v. Lupin Ltd., 2016 BL 79011, D.N.J., Civ. No. 10-5954 (WHW), 3/15/16).

Most litigation-related settlements between brand name and generic drugmakers occur before a court makes an infringement or invalidity decision, reflecting that both parties are still at risk regarding the case’s outcome.

In this case, Mylan lost in district court and was in the middle ...