Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

Category: Validity–Novelty

  • Cadence Prevails Over Exela in OFIRMEV® (Acetaminophen) ANDA Litigation

    Cadence Pharms., Inc. v. Exela Scis., LLC, No. 11-733-LPS (D. Del.)     by Dunstan H. Barnes On November 22, 2013, the U.S. District Court for the District of Delaware issued a Final Judgment and Permanent Injunction barring Exela from manufacturing a generic version of OFIRMEV®, which is an injectable liquid acetaminophen composition.  Judge Leonard Stark…

  • Invalidity Due to Public Use in ANDA Cases

    Pronova Biopharma Norge v. Teva Pharms., No. 2012-1498 (Fed. Cir.)     by Aaron F. Barkoff It is not unusual for a defendant in an ANDA case to assert invalidity due to prior public use, but it is rare that such a defense succeeds.  In a unanimous decision last week, the Federal Circuit held the asserted claims of…

  • OBB News Briefs: First-Inventor-to-File Rules; Myriad oral argument; Lyrica decision

    On Friday morning, the USPTO pre-published its proposed rule changes implementing the provisions of the America Invents Act that convert the U.S. patent system from a "first to invent" to a "first inventor to file" system.  The proposed rules (available here) were scheduled to be published in the Federal Register on Monday, but were withdrawn…

  • Federal Circuit Affirms Invalidity of Teva’s Patent on Rosuvastatin Formulation

    Teva Pharm. Indus. Ltd. v. AstraZeneca Pharms. LP, No. 2011-1091 (Fed. Cir.) In a precedential opinion filed today, the Federal Circuit affirmed the invalidity of Teva's U.S. Patent No. RE39,502 under 35 U.S.C. § 102(g)(2).  Teva's '502 patent claims a rosuvastatin formulation comprising "a stabilizing effective amount" of crospovidone.  This post describes the district court decision and provides…

  • Federal Circuit Affirms Validity of Argatroban Patent

    Mitsubishi Chemical Corp. v. Barr Labs., No. 2010-1432 (Fed. Cir. 2011) Mitsubishi Chemical owns U.S. Patent No. 5,214,052, which claims a "method for dissolving an arginineamide, comprising dissolving [argatroban] and/or its salt in a solvent containing ethanol, water and a saccharide"; and a "pharmaceutical composition for injection, comprising [argatroban] and/or its salt together with ethanol,…

  • AstraZeneca Defeats Teva’s Claim That Crestor Infringes Teva’s Patent

    Teva Pharm. Indus. v. AstraZeneca Pharms., No. 08cv4786 (E.D. Pa. 2010) Here's something you don't see every day:  an ANDA filer suing a brand-name drug manufacturer for patent infringement, claiming that the brand-name drug infringes the ANDA filer's patent. In late 2007/early 2008, AstraZeneca ("AZ") filed suit against nine different ANDA filers, including Teva, who…