After nearly five years of litigation with Par and Alkermes, TWi can finally launch its generic version of Megace ES® (megestrol acetate). On remand from the Federal Circuit following an initial finding of invalidity, the District of Maryland held that the asserted claims are invalid for obviousness and lack of enablement, and denied the plaintiffs’ motion…
A recent filing in the Eastern District of Texas highlights the importance of investigating patent ownership issues before initiating a lawsuit or as part of defending against a lawsuit. Earlier this month, accused infringer Eli Lilly filed a motion to dismiss for lack of subject-matter jurisdiction under Fed. R. Civ. P. 12(b)(1), contending that Plaintiff…
On July 22, 2015, the Patent Trial and Appeal Board rejected Amneal Pharmaceuticals LLC’s America Invents Act (AIA) challenge to Endo Pharmaceuticals’ patent related to Opana ER. The patent at issue (the ‘216 patent) relates to oral controlled-release pharmaceutical formulations comprising oxymorphone and methods of using it for sustained pain relief. In its Final Written…
The Federal Circuit handed down a decision interpreting the Biologics Price Competition and Innovation Act (BPCIA) in a way that effectively grants branded biologics an additional six months of exclusivity. However, in a win for biosimilar applicants, the Federal Circuit also held that the statutory directive to disclose abbreviated application and manufacturing information to the…