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    • Sanofi Seeks Summary Judgment in Generic LOVENOX Dispute; Administrative Record Highlights Disagreements at FDA Over Generic ApprovalDecember 14th, 2010

      By Kurt R. Karst –  When we last left you in the battle over FDA’s approval of a generic version of sanofi-aventis U.S. L.L.C.’s (“sanofi’s”) blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection), Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia denied …

    • Apotex Cert Petition on 180-Day Exclusivity Forfeiture Decision is DOA, Says Teva in Opposition BriefDecember 13th, 2010

      By Kurt R. Karst –       Last Friday, Teva Pharmaceuticals USA, Inc. (“Teva”) filed its opposition brief to Apotex, Inc.’s (“Apotex’s”) Petition for Writ of Certiorari, which Apotex filed with the U.S. Supreme Court in October asking for a review of the U.S. Court of Appeals for …

    • Supreme Court Will Review Generic Drug Preemption CasesDecember 10th, 2010

      By Kurt R. Karst –       Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501).  As we previously reported, the petitions presented almost identical questions for the …

    • Bright “Orphan” Ideas BlossomDecember 10th, 2010

      This week, the Republican Steering Committee selected Congressman Fred Upton (R-MI) to succeed Congressman Henry Waxman (D-CA) as Chair of the House Energy and Commerce Committee in the next Congress.  In August 2008, at the Democratic National Convention in Denver, Hyman, Phelps & McNamara’s Frank …

    • Drug Purchasers Petition U.S. Supreme Court to Consider CIPRO Patent Settlement CaseDecember 8th, 2010

      By Kurt R. Karst –       Speculation was running high that the U.S. Supreme Court would be petitioned on whether a patent settlement agreement (what opponents call “pay-for-delay” agreements or “reverse payments”) involving manufacturers of Ciprofloxacin HCl (CIPRO) is per se lawful under the Sherman Act after …