Inter partes review became available on September 16, 2012. Since then, over 3,400 IPR petitions have been filed. The USPTO implemented a first set of changes, or “quick fixes,” in March, and now, the USPTO seeks to improve IPR via a host of additional proposed changes. But will they result in any real change? Only…
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…
The Disposition: On remand from the Supreme Court, the Federal Circuit affirmed its earlier decision finding the claims of Teva’s Orange Book patent for Copaxone invalid as indefinite. See Teva Pharmaceuticals USA, Inc. et al. v. Sandoz, Inc. et al., No. 12-1567 (June 18, 2015). Case History. In its initial review, the Federal Circuit reversed…
Last week, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a district court finding that the asserted claims of a prenatal diagnostic testing method patent are not directed to patent eligible subject matter and are therefore invalid under § 101. The Patent. The patent at issue (the ‘540 patent) involves a technology…
Last week, in Virginia Innovation Sciences (“VIS”) v. Samsung, the Federal Circuit provided some indication of the circumstances under which it would defer to a district court’s evaluation of extrinsic evidence in the post-Teva world. We have previously written about the Supreme Court’s 2015 Teva v. Sandoz opinion, which overturned long-standing precedent, holding that while…
The Ruling. In a 6-2 decision issued Tuesday, the Supreme Court once again disagreed with the Federal Circuit and held that a defendant’s good-faith (but incorrect) belief that a patent is invalid is not a defense to an induced infringement claim. Commil USA, LLC v. Cisco Sys., Inc., No. 13-896. The Court also affirmed that induced…
Last week the Second Circuit upheld an injunction blocking Forest Laboratories (“Forest”) from removing immediate-release Namenda (“Namenda IR”) from the market. The decision prevents Forest from effectuating a so-called “product-hopping” strategy under which it planned to stop selling Namenda IR and switch patients to its newer extended-release product, Namenda XR, prior to entry of a…