- 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.
- 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. Astra press release; Ranbaxy press release; AP; Bloomberg; Pharmalot; WSJ Health Blog.
- In a very surprising decision, a D.C. district court 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.
- Earlier this month, Depomed announced a settlement of patent litigation
against Teva over generic Glumetza (metformin HCl). Depomed
press release; AP story. - Pharmalot recently had two interesting posts about biosimilars: the first suggested, based on a report about the Food and Drug Law Institute’s annual meeting, that biosimilars legislation may actually be passed this year; the second reported on lobbying for a biosimilars bill.
- 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.
- Pharmalot posted a summary of a recent article in the Seattle Post-Intelligencer about a citizen petition that has stymied Nastech Pharmaceutical’s bid to market a generic version of Miacalcin (calcitonin), a treatment for postmenopausal osteoporosis.
- Takeda announced earlier this month that on March 31, the Supreme Court denied Alphapharm’s cert petition from the Federal Circuit’s decision last year in the Actos (pioglitazone) litigation.
Recent Posts
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- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Posted in 180-Day Exclusivity, Citizen Petitions, FDA Litigation, Orange Book Issues, Paragraph IV Cases
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