Orange Book Blog

At the intersection of Patent and FDA Law

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Category: Paragraph IV Cases

  • Ranbaxy Appeals Lipitor Case to Supreme Court

    Lipitor (atorvastatin calcium), indicated for the reduction of cholesterol, is the world’s best-selling pharmaceutical.  Ranbaxy has applied to market a generic version of Lipitor and has challenged Pfizer’s patents on Lipitor in many countries around the world–usually without success.  For instance, in August 2006 the Federal Circuit upheld the validity of Pfizer’s U.S. Patent No.…

  • Caraco Wins Appeal Over Ortho-McNeil in Generic Ultracet Case

    Ortho-McNeil Pharma. v. Caraco Pharma. Labs., No. 06-1102 (Fed. Cir. 2007) Last Friday the Federal Circuit affirmed a district court ruling that Caraco Pharmaceutical Laboratories' ANDA for a generic version of Ortho-McNeil's Ultracet does not infringe Ortho's U.S. Patent No. 5,336,691.  Ultracet, an analgesic combining tramadol and acetaminophen, generated sales of approximately $350 million last…

  • FTC Commissioner Blasts “Reverse Payment” Agreements in Senate Testimony

    In testimony yesterday before the Senate Committee on the Judiciary, Federal Trade Commission Commissioner Jon Leibowitz voiced support for legislation to prohibit litigation settlement agreements between generic and pharmaceutical brand manufacturers that include both payments to the generic manufacturer and a delay in generic drug market entry ("reverse payment" agreements).  Leibowitz argued that such reverse…

  • Celgene’s Day in Court With Barr Over Generic Thalidomide Coming Soon

    In the '50s and '60s thousands of pregnant women all over the world took thalidomide to prevent morning sickness.  However, the drug was banned after many of these women gave birth to babies with severe birth defects.  Now that researchers have discovered new uses for thalidomide, it has become so widely prescribed that generic drug…

  • Senate Judiciary Committee Plans Hearing on Reverse Payment Settlements of Hatch-Waxman Cases

    This Wednesday, January 17, at 10 am, the Senate Judiciary Committee will hold a hearing entitled "Paying Off Generics to Prevent Competition with Brand Name Drugs: Should it Be Prohibited?"  The hearing is intended to examine the effects of "reverse payment" settlements of Hatch-Waxman litigation, in which an innovator drug company makes a cash payment…

  • Ethyol Case Between MedImmune and Sun Pharma Heats Up

    MedImmune Oncology v. Sun Pharm. Indus., No. 04-2612 (D. Md. 2007) MedImmune earns about $100 million annually from sales of Ethyol (amifostine), an injectable drug approved for the relief of certain side effects of chemotherapy and radiation therapy.  Sun Pharmaceutical Industries filed an ANDA to market a generic version of Ethyol.  In what appears to…

  • Biovail Continues to Fight FDA, Anchen, Impax, and Teva to Protect Wellbutrin XL

    Last August, the U.S. District Court for the Central District of California granted summary judgment of noninfringment to Anchen Pharmaceuticals in its case against Biovail over generic Wellbutrin XL.  Biovail has appealed to the Federal Circuit, but in the meantime, on December 15, 2006, the FDA granted final approval to Anchen's ANDA for Wellbutrin XL…

  • Federal Circuit Sides With Abbott in Biaxin XL Case Against Andrx

    Abbott Labs. v. Andrx Pharms. et al., No. 06-1101 (Fed. Cir. 2006) Abbott Labs is fending off multiple generic challenges to Biaxin XL (clarithromycin extended-release tablets), an antibiotic with annual sales of over $300 million in the United States.  Companies that have filed ANDAs for generic versions of Biaxin XL include Ranbaxy, Teva, Andrx, Roxane,…

  • Savient Loses Motion for Preliminary Injunction in Oxandrin Case, Launches Authorized Generic, and Halts Promotion of Branded Oxandrin

    Savient Pharms. v. Sandoz, No. 07-1081 (Fed. Cir.) On December 28, 2006, the Federal Circuit Court of Appeals denied Savient Pharmaceuticals’ motion for a preliminary injunction, pending appeal, to prevent Sandoz and Upsher-Smith from marketing their generic Oxandrin (Oxandrolone) products.  Oxandrin, with annual sales of $60 million, is indicated for the promotion of weight gain…

  • Lilly Prevails Over IVAX, Teva, and Dr. Reddy’s in Zyprexa Appeal

    Eli Lilly & Co. et al. v. Zenith Goldline Pharms. et al., Nos. 05-1396, -1429, and -1430 (Fed. Cir. 2006) Yesterday the Federal Circuit affirmed Eli Lilly’s April 2005 district court victory in its dispute with ANDA filers Zenith Goldline (now IVAX), Teva, and Dr. Reddy’s over generic Zyprexa.  The patent-in-suit, U.S. Patent No. 5,229,382,…