Hatch-Waxman

By Kurt R. Karst –    For years now, folks (of the Hatch-Waxman type) have clamored for a full list of 180-day exclusivity decisions.  FDA has not put together such a list, so we decided to try and put together our own list – the …

By Kurt R. Karst –    FDA’s recent denial of a citizen petition concerning labeling carve-out issues related to the approval of generic versions of LYRICA (pregabalin) – which, by the way, contains some of the most useful insight in years into FDA’s thinking on …

By Kurt R. Karst –    On August 3rd, Judge Claude Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) granted  The Medicines Company’s (“MDCO’s”) Motion for Summary Judgment in a long-running dispute (involving all three branches of the federal …

By Kurt R. Karst –    On Thursday, the U.S. Senate Committee on Appropriations approved the inclusion of the “Preserve Access to Affordable Generics Act” in the report (Senate Report No. 111-238; pages 144-148 & 150-151) accompanying the Fiscal Year 2011 Financial Services and General …

By Kurt R. Karst –  Earlier today, the U.S. Court of Appeals for the Federal Circuit denied Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd.’s (“Sun”) Petition for Panel Rehearing and Rehearing en banc of an April 14, 2010 Federal Circuit decision in …

By Kurt R. Karst –    Earlier this week, the U.S. District Court for the District of Columbia denied Sanofi-Aventis’s Motion for Summary Judgment and granted Cross-Motions for Summary Judgment (here and here) filed by FDA and intervenor-defendants last fall in a dispute over FDA’s approval of applications …

By Kurt R. Karst –    As we thought might happen, Sanofi-aventis U.S. L.L.C. (“Sanofi”) sued FDA over the Agency’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection).  (On the …

By Kurt R. Karst – Earlier today, FDA issued its long-awaited response (45 pages) to a February 2003 citizen petition submitted to the Agency on behalf of Aventis Pharmaceuticals, Inc. (“Aventis”) concerning the approval of generic versions of the company’s anti-coagulant drug LOVENOX (enoxaparin sodium …

By Kurt R. Karst –    Last week, the U.S. Court of Appeals for the Federal Circuit denied Lupin Pharmaceuticals, Inc.’s (“Lupin’s”) Petition for Rehearing en banc of a May 10, 2010 panel decision in Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc. in which the Court affirmed …

By Kurt R. Karst –    Although it took a little longer than we expected, late last week, Graceway Pharmaceuticals, LLC (“Graceway”) sued FDA in the U.S. District Court for the District of Columbia requesting declaratory and injunctive relief with respect to the Agency’s January 2010 denial …

By Kurt R. Karst – With all of the hubbub over Patent Use Codes (“PUCs”) since the U.S. Court of Appeals for the Federal Circuit issued its April 2010 decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. addressing whether the patent delisting counterclaim …

By Kurt R. Karst –    Earlier today, a 3-judge panel (Judges Tatel, Griffith, and Kavanaugh) of the U.S. Court of Appeals for the District of Columbia Circuit issued a 2-page per curiam judgment (without memorandum) affirming the U.S. District Court for the District of …

By Kurt R. Karst –    Late Thursday, the U.S. House of Representatives passed a package of amendments (beginning on page 74) to the War Funding Bill (H.R. 4899) that included the “Preserve Access to Affordable Generics Act,” which is intended to curb patent settlement …

By Kurt R. Karst –    With all of the FDA-related amendments being introduced for consideration to the Tax Extenders Act (H.R. 4213), including the Preserve Access to Affordable Generics Act to address patent settlement agreements and an amendment to legislatively extend a patent covering …

By Kurt R. Karst –    Since shortly after the enactment of the Hatch-Waxman Amendments in 1984, FDA has recognized an NDA sponsor’s ability to relinquish or selectively waive exclusivity, such as 5-year new chemical entity exclusivity and 3-year new use exclusivity, even though  the …