Category: Paragraph IV Cases

  • The Court of Appeals for the Federal Circuit recently affirmed a lower court’s determination that Alza’s patent on Ditropan XL, a controlled-release formulation of oxybutinin, is invalid due to obviousness.  Ditropan XL is a treatment for incontinence, with annual sales of $380 million. In the opinion, written by Judge Gajarsa, a unanimous panel of the…

  • The U.S. District Court for the Middle District of North Carolina recently found Pfizer’s patent on the active ingredient of Norvasc, amlodipine besylate, valid and infringed by Synthon’s generic equivalent.  Norvasc, a treatment for hypertension, has annual sales of nearly $5 billion. In the opinion, Judge James A. Beaty, Jr. concluded that Pfizer’s U.S. Patent…

  • 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…

  • 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…

  • 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…

  • 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 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…

  • The U.S. District Court for the District of Delaware released its opinion last Thursday in the Lexapro patent infringement case, finding in favor of Forest Labs.  Forest, the maker of Lexapro, sued IVAX, a division of Teva, for patent infringement based on IVAX’s ANDA to market generic versions of Lexapro.  Forest took in over $2…

  • In response to an emergency motion for preliminary injunction enforcement filed by Abbott Laboratories on June 26 in the U.S. District Court for the Northern District of Illinois, Teva Pharmaceuticals USA, Inc. announced on June 27 that it will cease sales of a generic version of Abbott's Biaxin XL (clarithromycin extended release), which Teva had…

  • In response to the Supreme Court's denial of certiorari in FTC v Schering earlier this week, four senators introduced Senate bill S3582 yesterday, which seeks to prohibit brand name drug companies from entering into "reverse payment" settlements with generic drug companies.  In FTC v. Schering, the FTC had petitioned the Court to decide whether a reverse…