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 …
By Kurt R. Karst – On the same day that the Senate Judiciary Committee held a hearing on “Oversight of the Enforcement of the Antitrust Laws,” at which Federal Trade Commission (“FTC”) Chairman Jon Leibowitz and U.S. Department of Justice (“DOJ”) Assistant Attorney General …
By Kurt R. Karst – FDA's recent approval of an ANDA submitted by Perrigo R&D Company ("Perrigo") for a generic version of the over-the-counter drug MONISTAT 1 Combination Pack (1200 mg miconazole nitrate vaginal insert and 2% miconazole nitrate cream) contains some interesting language …
By Kurt R. Karst – Earlier this year, the U.S. Patent and Trademark Office (“PTO”) denied an application for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,869,939 (“the ‘939 patent”). The ‘939 patent is one of four patents listed in FDA’s Orange Book …
By Kurt R. Karst – Last week’s 29-page decision by the U.S. District Court for the Eastern District of Pennsylvania in In re Budeprion XL Marketing & Sales Litigation is yet more affirmation that lower courts are broadly reading and applying the U.S. Supreme Court’s …
By Kurt R. Karst – Earlier this week, we reported on the latest in the ongoing saga 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) – an order from the U.S. …
By Kurt R. Karst – In a somewhat unusual move, the U.S. Supreme Court has asked the U.S. Department of Justice (Solicitor General of the United States) to weigh in on generic drug preemption. The move signals that the Court has continued interest in this …
By Kurt R. Karst – Late last Friday, in a case that is full of twists and turns, the U.S. District Court for the Eastern District of Virginia (Alexandria Division) added another twist (or turn) and ordered the U.S. Patent and Trademark Office (“PTO”) to …
By Kurt R. Karst – Last fall, we reported on a decision from Judge Richard E. L. Strauss of the Superior Court of California, County of San Diego, in which he granted motions for summary judgment ruling that Bayer AG and several generic drug …
By Kurt R. Karst – Late on May 17th, the U.S. Court of Appeals for the District of Columbia Circuit denied, in separate orders (here and here), FDA’s petition for panel rehearing and rehearing en banc of the D.C. Circuit’s March 2, 2010 decision in Teva …
By Kurt R. Karst – FDA’s recent decision to approve Sandoz Inc.’s (“Sandoz’s”) ANDA No. 40-445 for a generic version of King Pharmaceuticals, Inc.’s (“King’s”) SKELAXIN (metaxalone) Tablets, 800 mg, with a period of 180-day exclusivity is one of the few cases in which …
By Kurt R. Karst – The growing application backlog and median time for ANDA approval by FDA’s Office of Generic Drugs (“OGD”) has been a thorn in the side of the generic drug industry for quite some time now. As we previously reported, the …
By Kurt R. Karst – On May 10, 2010, a 3-judge panel of the U.S. Court of Appeals for the Federal Circuit (Circuit Judges Newman, Rader, and Linn) issued its unanimous decisions in two cases that should solidify as to when a patent covering …
By Kurt R. Karst – Last week’s decision by a 3-judge panel of the U.S. Court of Appeals for the Second Circuit in In re: Ciprofloxacin Hydrochloride Antitrust Litigation affirming a 2005 decision by the U.S. District Court for the Eastern District of New York …
