Orange Book Blog

At the intersection of Patent and FDA Law

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Category: Paragraph IV Cases

  • Bayer Prevails Over Dr. Reddy’s at Trial in Avelox Case

    Bayer AG v. Dr. Reddy’s Laboratories, Ltd., No. 04-179 (D. Del. 2007) Last Thursday, the U.S. District Court for the District of Delaware held that two Bayer patents on Avelox (moxifloxacin hydrochloride) are valid and enforceable, and infringed by Dr. Reddy’s ANDA for a generic version of Avelox.  The Opinion and Order follow a week-long bench trial held in…

  • Paddock Labs Prevails Over Schwarz Pharma in Univasc Case at Federal Circuit

    Schwarz Pharma v. Paddock Labs, No. 2007-1074 (Fed. Cir. 2007) In a decision released this morning, the Federal Circuit affirmed a 2006 district court decision granting summary judgment of noninfringement of U.S. Patent No. 4,743,450 in favor of Paddock Labs.  The ‘450 patent, owned by Warner-Lambert and exclusively licensed by Schwarz Pharma, covers pharmaceutical compositions…

  • Federal Circuit Affirms Injunction Against Apotex in Depakote Case, But Finds Apotex Was Not in Contempt

    Abbott Labs v. Torpharm and Apotex, No. 2007-1019 (Fed. Cir. 2007) In 1997, Apotex filed an ANDA for generic Depakote (divalproex sodium), Abbott’s blockbuster treatment for bipolar disorder, migraine headaches, and epilepsy.  Abbott responded by filing suit against Apotex for infringement of U.S. Patent Nos. 4,988,731 and 5,212,326, which claim an oligomer containing about 4…

  • Pharma News Briefs

    The Supreme Court this morning denied Pfizer’s cert petition in the Norvasc case (AP story).  Although the Federal Circuit’s March 22 decision is controversial, the denial of Pfizer’s cert petition is not surprising, given that the Court had previously denied Pfizer’s motions for an emergency stay and for an expedited appeal. Late last Friday the…

  • Pfizer Wins Appeal of Summary Judgment Ruling in Neurontin Case

    In re Gabapentin Patent Litigation, No. 2006-1572 (Fed. Cir. 2007) Last Friday, the Court of Appeals for the Federal Circuit reversed a 2005 district court ruling granting summary judgment of noninfringement to several companies who sought to market generic versions of Pfizer’s epilepsy drug Neurontin (gabapentin).  The district court had ruled on summary judgment that…

  • Pharma News Briefs

    FDA Law Blog has a great post about a very interesting district court decision concerning Apotex’s attempt to market generic Prilosec before AstraZeneca’s pediatric exclusivity expires. Congress passed FDA reform legislation this week, albeit without provisions for biosimilars.  (AP article; FDA Law Blog; PhRMA release). In the Pipeline is a great blog by a medicinal…

  • No Second Bite at the Apple for Apotex in Acular Litigation; Roche Prevails Again

    Roche Palo Alto LLC v. Apotex, Inc., No. C05-02116-MJJ (N.D. Cal. 2007) Apotex suffered a loss last week in its effort to relitigate the validity of U.S. Patent No. 5,110,493, which covers Roche's ketorolac tromethamine (KT) ophthalmic solution (i.e., Acular®).  The U.S. District Court for the Northern District of California granted Roche's motion for summary…

  • Pharma News Briefs

    The Federal Circuit reissued its July 11 opinion in Daiichi Sankyo v. Apotex as a precedential opinion, one day after denying Daiichi's petition for rehearing.  According to Hal Wegner, a major reason for making the decision precedential was Prof. Joseph Scott Miller's Rule 47.6(c) filing. Biosimilars legislation is "off the table" for now.  The FDA…

  • Teva Wins in District Court, Launches Generic Famvir, Then is Enjoined by Federal Circuit the Next Day

    Novartis Pharms. v. Teva Pharms. USA, No. 05-1887 (D.N.J. 2007) Novartis and Teva have been in litigation over Teva’s ANDA for generic Famvir (famciclovir), Novartis’s antiviral treatment for herpes, since 2005.  Teva was prepared to launch its generic famciclovir product on August 24, 2007–the day the 30-month stay expired.  To prevent such an at-risk launch,…

  • Federal Circuit Invalidates Aventis’s Altace Patent on Obviousness Grounds, Handing Victory to Lupin

    Aventis Pharma and King Pharms. v. Lupin, No. 2006-1530 (Fed. Cir. 2007) The Court of Appeals for the Federal Circuit today reversed a district court trial verdict that held the asserted claims of Aventis's patent on Altace not invalid, finding instead that the claimed invention would have been obvious.  The patent in suit was U.S.…