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: Orange Book Blog: At the Intersection of Patent Law and FDA Law

Pharma News Briefs

By Aaron Barkoff

• Last Monday, the Federal Circuit affirmed a district court decision in McNeil-PPC v. Perrigo, concerning a generic version of Pepcid Complete.  The decision was affirmed without an opinion, under Rule 36.
• On Tuesday, AstraZeneca and Ranbaxy announced a settlement of their patent litigation over generic Nexium (esomeprazole), with Astra granting Ranbaxy exclusive rights to sell a generic version of Nexium in 2014, six months before the first patent expires.  Teva and Dr. Reddy's plan to continue challenging Astra's patents.  For more: Astra press release; Ranbaxy press release; AP story ; Bloomberg; WSJ Health Blog.
• In a very surprising decision, a district court in the District of Columbia recently ruled in favor of Teva in a case in which Teva alleged that the FDA wrongfully delisted a patent on Risperdal (risperidone) from the Orange Book, depriving Teva of 180-day exclusivity.  FDA Law Blog has a full report.
• Pharmalot had an interesting post earlier this month speculating, based on a report about the Food and Drug Law Institute's annual meeting, that biosimilars legislation may actually be passed this year.
• FDA Law Blog recently updated their coverage of the generic Depakote (divalproex sodium) litigation between Nu-Pharm (a former subsidiary of Apotex) and FDA, in which Nu-Pharm is seeking an injunction requiring FDA to grant final approval to its divalproex ANDA.

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on April 18, 2008 (boomark / email).