Last week Judge Gregory Sleet of the District of Delaware rejected the generic defendants obviousness challenge of Pfizer’s molecule patent for Toviaz®. The defendants based their obviousness defense on the selection of 5-HMT, a metabolite of tolterodine, as a “lead compound.” Tolterodine was already approved to treat overactive bladder as of the critical date. The […]
The Supreme Court will decide what standard the Patent Trial and Appeals Board (“PTAB”) should use to construe claims during Inter Partes Review (“IPR”). Cuozzo Speed Techs., LLC v. Lee. The PTAB currently construes claims using the “broadest reasonable interpretation” standard, rather than the “ordinary meaning” standard used in District Court litigation. In July 2015, […]
On December 1, 2015, a number of amendments to the Federal Rules of Civil Procedure took effect. The amendments primarily concern discovery. Below is an overview of the top three things you need to know. First, the amendments made a couple of changes to Rule 26(b)(1) regarding the scope of discovery. That revision added language […]
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 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 […]
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 […]
PIV certifications do not preclude ANDA filers from seeking inter partes review of Orange Book patents, according to the court in Senju Pharmaceutical Co. v. Metrics, Inc., 14-CV-3962 (D. N.J. Mar. 31, 2015). Plaintiffs Senju and Bausch & Lomb own three patents covering formulations of bromfenac, the active ingredient in Prolensa®. They sued Metrics for […]
In Eli Lilly & Co. et al. v. Mylan et al., No. 14-cv-0389, 2015 U.S. Dist. LEXIS 30175 (S.D. Indiana March 12, 2015), the District Court denied a motion to dismiss for lack of personal jurisdiction. The Issue. Eli Lilly and friends filed a lawsuit against Mylan based on Mylan’s ANDA for Effient®, an anti-thrombotic drug […]