Hatch-Waxman

By Kurt R. Karst –    Do you have an ANDA prior approval supplement pending at FDA?  How long has it been pending – 6 months?  One year?  18 months?  Well it might still some time until there is any action on it.  Over the …

By Kurt R. Karst –    It was not a question of whether ViroPharma Incorporated (“ViroPharma”) would sue FDA in connection with the approval of ANDAs for generic versions of the company’s antibiotic drug of last resort, VANCOCIN (vancomycin HCl) Capsules, but when.  In addition …

By Kurt R. Karst –    Earlier today (September 9th), in a notice filed with the U.S. District Court for the Eastern District of Virginia (Alexandria Division), the government informed the court that “the Solicitor General has, at this time, elected against appeal” of Judge …

By Kurt R. Karst –    Earlier this week, the U.S. Court of Appeals for the Second circuit denied without comment a Petition for Rehearing and Rehearing En Banc filed on behalf of certain plaintiffs-appellants in In Re Ciprofloxacin Hydrochloride Antitrust Litig,, an antitrust challenge to …

By Kurt R. Karst –       A recent report issued by Morgan Stanley, titled Pharmaceuticals – Potential Selective Upside for Industry post Prandin Ruling, predicts “increasing probability for the innovative pharmaceutical industry to successfully delay US generic approval of select innovative drugs” following a pair of rulings …

By Kurt R. Karst –       The long-running dispute over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) may be far from over.  On September 1st, APP Pharmaceuticals, LLC, which previously submitted an amicus brief …

By Kurt R. Karst –    Some drugs, it seems, are destined for Hatch-Waxman controversy and lore.  Eisai, Inc.s’ ARICEPT (donepezil HCl) Tablets is one of those drugs.  As the battle over pre-Medicare Modernization Act shared 180-day exclusivity takes off – with a recent citizen …

By Kurt R. Karst –    When we attended the August 17th hearing in Sanofi-aventis U.S. L.L.C.’s (“Sanofi’s”)  challenge to FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s LOVENOX (enoxaparin sodium injection), it seemed as …

By Kurt R. Karst –    When does a patent expire?  When does pediatric exclusivity begin and end?  And when can FDA approve ANDAs (or 505(b)(2) applications)?  These are some interesting questions touched on in some recent court decisions.  But before we get to those …

By Kurt R. Karst –    A recent analysis of the Congressional Budget Office’s (“CBO’s”) cost estimate of legislation intended to curb patent settlements (or what opponents call “pay-for-delay” or “reverse payment” agreements) criticizes the estimated savings as “significantly overstated.”  As we recently reported, in late …

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 …