May 26, 2016 – Plaintiff Alvogen Pine Brook LLC filed a complaint for declaratory judgment against Noven Pharmaceuticals, Inc. (“Noven”) and Hisamitsu Pharmaceutical Co., seeking a declaration of noninfringement of U.S. Patent Nos. 6,841,716, and 8,231,906. The patents are titled, respectively, “Patch” and “Transdermal estrogen device and delivery.” Noven has listed the ’716 and ’907 patents in the Orange Book, representing that the patents claim the drug approved in its New Drug Application for Minivelle® Transdermal Film, Extended Release. Alvogen seeks a final and nonappealable judgment of noninfringement, which would allow it to obtain FDA approval to market its ANDA product despite not being a first-filer. The case is filed in the United States District Court for the District of Delaware.
By: Katherine E. Adams