Orange Book Blog

At the intersection of Patent and FDA Law

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Month: August 2006

  • Authorized Generics Brown Bag Lunch, Sept. 14

    Via the Antitrust Review, three ABA committees will be presenting a lunch seminar entitled "Who’s Drug is it Anyway?  Authorized Generics, Their Role in the Pharmaceutical Marketplace, and the FTC Study" on Thursday, September 14 from noon to 1:30 pm EST.  You may attend the seminar in person at Drinker Biddle & Reath’s Washington D.C.…

  • Lipitor Worldwide Patent Infrinement Litigation Update

    Ranbaxy announced in a press release yesterday that it won a court decision in Norway that Ranbaxy does not infringe two of Pfizer’s Norwegian patents on Lipitor.  Pfizer responded with its own press release, announcing that the ruling "has no practical effect on Pfizer’s ability to protect Lipitor" from generic competition in Norway because a…

  • Purdue and Endo Settle Oxycontin Patent Case

    Endo Pharmaceuticals announced today that it has reached an agreement with The Purdue Frederick Company settling a long-standing patent infringement case concerning Endo's generic equivalent to Oxycontin, sold by Purdue. The case was on remand to the district court after the Federal Circuit ruled in February that further fact finding was required to balance the…

  • Biovail Sues FDA to Force Decision on Wellbutrin XL Citizen Petition

    Biovail Corporation (Canada) filed suit yesterday in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration.  Biovail's complaint and motion for a temporary restraining order and preliminary injunction request the court to compel FDA action on Biovail's citizen petition submitted in December 2005 relating to the criteria used…

  • Pfizer Victorious in Norvasc Case Against Synthon IP

    Pfizer announced in a recent press release that a jury in the Eastern District of Virginia has found that Pfizer does not infringe Synthon IP’s patent on a process for making amlodipine, the active ingredient in Norvasc.  The jury also found Synthon’s patent invalid.  Norvasc, a treatment for hypertension, is Pfizer’s second largest selling product…

  • New Paper on Authorized Generics by Prof. Jay Thomas

    Prof. Jay Thomas recently wrote a new paper entitled "Authorized Generic Pharmaceuticals: Effects on Innovation".  The paper was publised by Congressional Research Service, of the Library of Congress. Prof. Thomas’s new paper provides a very nice, concise summary of the authorized generics issue.  After going through the basics of Hatch Waxman and how the practice…

  • Strategic Planning for Growth in the Competitive Generics Marketplace: September 27-29, 2006: Washington, DC

    The Institute for International Research (IIR) has announced that its 7th Annual Generic Drugs Summit will be taking place September 27-29 in Washington, D.C.  Orange Book Blog is a media partner of this conference. According to IIR, the generics industry is currently faced with several unfavorable trends hindering the marketplace and margins are under pressure…

  • Maximizing Pharmaceutical Patent Life Cycles Conference October 23-25 in New York City

    American Conference Institute has announced that its seventh annual conference on Maximizing Pharmaceutical Patent Life Cycles will be taking place October 23-25, 2006, in New York. According to ACI, the conference is designed specifically for pharmaceutical patent attorneys, and allows patent practitioners for brand name and generic drug makers to benchmark their companies’ current patent…

  • Apotex Launches Generic Plavix At Risk

    Apotex announced today that it has launched its generic version of Plavix.  Earlier this morning, MarketWatch reported that Bristol-Myers Squibb expected Apotex to launch its generic Plavix shortly.  Plavix, a blood thinner, is the second best selling pharmaceutical in the world, with $5.9 billion in annual sales. Apotex is currently in patent litigation with Bristol-Myers…

  • Abbott and Teva Settle Patent Litigation Over Biaxin XL

    Abbott Laboratories and Teva Pharmaceuticals have settled their Biaxin XL patent infringement litigation in the U.S. District Court for the Northern District of Illinois.  Biaxin XL is an extended release formulation of clarithromycin used to treat bacterial respiratory infections, with over $1 billion in annual sales. The parties filed a stipulation of dismissal with the…