September 11, 2015 – On September 10, 2015, Merck Sharp & Dohmne BV (“Merck”) filed a complaint against Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. (collectively, “Teva”) asserting infringement of U.S. Patent No. 5,989,581 (“the ’581 Patent”) in the United States District Court for the District of Delaware. Merck asserts that it is the owner by assignment of all rights and interests related to the asserted patent. The ’581 Patent is titled “Drug delivery system for two or more active substances” and is directed to a drug delivery system for the simultaneous release of two steroid compounds in a fixed physiological ratio over a prolonged period of time. The system comprises a polymer core containing a mixture of two compounds and a thermoplastic polymer skin. According to the Complaint, the action arises from Teva’s filing of an Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug Administration seeking approval to commercially market a generic version of Merck’s NuvaRing® drug product prior to the expiration of the ’581 Patent. The case remains pending.
By: Ketan V. Patel