Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

Category: Paragraph IV Cases

  • District Court Dismisses Merck’s Fosamax Suit Against Apotex, Despite Apotex’s Opposition

    Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007) A year ago, Merck sued Apotex alleging that Apotex’s ANDA for generic Fosamax infringed nine patents on pharmaceutical formulations of alendronate, the active ingredient in Fosamax.  Apotex answered with counterclaims of patent invalidity and noninfringement.  Then, after Merck reviewed portions of Apotex’s ANDA, Merck granted…

  • OBB News Briefs

    Norvasc update: FDA Law Blog reports that the district court has extended FDA’s deadline and that Zydus has filed a new citizen petition. Pharmalot reports on Barr Labs’ efforts to protect its Seasonale oral contraceptive from generic competition. The WSJ Health Blog summarizes today’s front-page WSJ article on Amgen’s recent troubles. The Business Standard and…

  • Pfizer and Mylan Fight to Defend Norvasc Exclusivity; Apotex, Teva and Others Battle for FDA Approval

    A dozen companies have submitted letters in response to FDA’s March 29 request for "comments from interested parties" on Norvasc (amlodipine besylate) exclusivity issues.  Last week, as we reported here, FDA promised the U.S. District Court for the District of Columbia that by Wednesday, April 11, it will decide whether to approve any ANDAs for…

  • Federal Circuit Allows Declaratory Judgment Jurisdiction for Generic Drug Patent Challenges

    Teva Pharms. USA v. Novartis Pharms. et al., No. 06-1181 (Fed. Cir. 2007) For the second time in as many days, the Federal Circuit has decided a case with broad implications for innovator and generic drug companies.  The decision today, in Teva v. Novartis, opens the door to many more lawsuits by generic drug companies…

  • Merck Prevails in Patent Term Extension Case at Federal Circuit

    Merck & Co. v. Hi-Tech Pharmacal, No. 06-1401 (Fed. Cir. 2007) The U.S. Court of Appeals for the Federal Circuit held today that a patent term extension under 35 USC 156 may be applied to a patent that is subject to a terminal disclaimer under 35 USC 253, handing a victory to Merck in its…

  • OBB News Briefs

    Adams Respiratory and Mutual Pharma settle guaifenesin patent litigation: press release FTC subpoenas Cephalon over Provigil patent litigation settlements: AP; Phil. Bus. J. Glenmark first to file Zetia ANDA with paragraph IV certification: Bloomberg Senate holds hearing on pediatric exclusivity: Reuters Takeda awarded $16.8 million in fees in pioglitazone patent case: NY Law J.; Reuters

  • Mylan Obtains Injunction Preventing FDA from Approving Any Other Generic Norvasc Until April 13

    Mylan Laboratories announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007.  Mylan launched its generic Norvasc last week and, with the exception of Pfizer’s authorized generic, currently has the only generic…

  • Mylan Launches Generic Norvasc; Other Generics to Follow Soon?

    Mylan announced in a press release today that it has launched its generic Norvasc (amlodipine besylate).  Mylan’s generic launch follows the Federal Circuit’s decision yesterday, invalidating Pfizer’s patent on Norvasc.  The case presents some very interesting issues involving the interaction between patent rights, pediatric exclusivity, and 180-day exclusivity. Last month, Mylan lost its patent challenge…

  • Federal Circuit Invalidates Pfizer’s Norvasc Patent; Mylan’s Generic Expected to Launch Soon

    Pfizer v. Apotex, No. 2006-1261 (Fed. Cir. 2007) The U.S. Court of Appeals for the Federal Circuit invalidated Pfizer's patent on Norvasc today, clearing a major hurdle for Mylan in its bid to launch a generic version of Norvasc.  The FDA has already granted final approval to Mylan's ANDA for generic Norvasc and Mylan, as…

  • Pfizer Defeats Teva in Celebrex Case

    Pfizer et al. v. Teva Pharms. USA, No. 04-754 (D.N.J. 2007) In a 201-page opinion released today, Judge John C. Lifland of the U.S. District Court for the District of New Jersey found all three of Pfizer's patents on Celebrex (celecoxib) valid, enforceable, and infringed by Teva, who had sought to market a generic version…