Orange Book Blog

At the intersection of Patent and FDA Law

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Category: Paragraph IV Cases

  • Federal Circuit Affirms Validity of Takeda’s ACTOS Patent, Rejecting Alphapharm’s Obviousness Arguments

    Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007) In an opinion released today, the Federal Circuit affirmed the validity of Takeda's U.S. Patent No. 4,687,777, which covers pioglitazone HCl (among other compounds).  Pioglitazone HCl is the active ingredient in ACTOS, Takeda's blockbuster drug for the treatment of type 2 diabetes.  The decision is particularly important…

  • Bristol-Myers Squibb and Sanofi-Aventis Prevail Over Apotex in Plavix Case

    Sanofi-Synthelabo et al. v. Apotex, No. 02-2255 (S.D.N.Y. 2007) Following a month-long trial held earlier this year, in an opinion released today a federal district court upheld the validity of Sanofi's U.S. Patent No. 4,847,265.  The '265 patent covers clopidogrel bisulfate, the active ingredient in Plavix.  The court permanently enjoined Canadian generic drug maker Apotex…

  • Pharma News Briefs

    Barr Labs announced Monday that it has amended its paragraph IV certification with respect to Lilly’s Zyprexa Zydis patent to a paragraph III certification, and that Lilly has dropped its related patent suit against Barr.  See also this AP article. FDA Law Blog had this post Tuesday about yet another new study on authorized generics.…

  • Teva Defeats Novartis Motion for Preliminary Injunction in Lotrel Litigation

    Novartis v. Teva, No. 04-4473 (D.N.J. 2007) Yesterday, a federal judge denied a preliminary injunction motion filed by Novartis to protect Lotrel from generic competition.  With the decision, Teva likely resumed shipping its generic version of Lotrel before nightfall.  After all, Teva had already made an initial launch on May 18 – a launch that…

  • Pharma News Briefs

    SCOTUSblog reported on Wednesday that the Supreme Court has denied Pfizer’s emergency application for relief from the Federal Circuit’s ruling in the Norvasc case.  TheStreet.com also has an article on the Supreme Court’s decision. On Tuesday, the Federal Circuit granted Mylan’s motion for summary reversal of the district court decision that had found Pfizer’s Norvasc…

  • District Court Invalidates McNeil’s Formulation Patent on Pepcid Complete, Relying on KSR v. Teleflex

    McNeil-PPC et al. v. Perrigo Co., No. 05-1321 (S.D.N.Y. 2007) In an opinion released Tuesday, Judge William H. Pauley III of the U.S. District Court for the Southern District of New York ruled that McNeil’s patent on the formulation for Pepcid Complete is invalid as obvious, clearing the way for Perrigo Co. to sell its…

  • District Court Finds Apotex and Impax Infringe AstraZeneca’s Formulation Patents on Prilosec

    In re Omeprazole Patent Litigation, No. MDL-1291 (JPML 2007) In a lengthy decision released last Thursday, Judge Barbara S. Jones upheld the validity of AstraZeneca's two formulation patents on Prilosec (U.S. Patent Nos. 4,786,505 and 4,853,230) and found that Apotex and Impax infringe the patents while Mylan and Lek (a division of Sandoz) do not. …

  • Pharma News Briefs

    According to SCOTUSblog, Pfizer filed an emergency plea with the Supreme Court yesterday, asking the Court to delay the effect of the Federal Circuit’s rulings against Pfizer in the Norvasc case.  Separately, Pfizer filed a petition for certiorari and a motion for expedited review of the Federal Circuit’s March 22 decision invalidating three claims of…

  • District Court Explains Dismissal of Merck v. Apotex Fosamax Suit

    Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007) Last month (as we reported then), the U.S. District Court for the District of Delaware granted Merck’s motion to dismiss the patent suit Merck filed against Apotex concerning generic Fosamax.  The court indicated at the time that an opinion would "follow at the court’s earliest…

  • Federal Circuit Denies Pfizer’s Petition for Rehearing in Norvasc Case

    Pfizer v. Apotex, No. 2006-1261 (Fed. Cir. 2007) This afternoon, the Federal Circuit denied Pfizer’s petition for rehearing and rehearing en banc of Pfizer v. Apotex, in which the court invalidated claims 1-3 of Pfizer’s U.S. Patent No. 4,879,303.  The ‘303 patent covers amlodipine besylate, the active ingredient in Norvasc. Three of the twelve judges…