Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: FDA Litigation
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Mylan Pharms. v. FDA and Ranbaxy Labs., No. 11-566-JEB (D.D.C. 2011) In an Opinion released earlier today, the U.S. District Court for the District of Columbia dismissed Mylan's lawsuit that sought to force FDA to act on Ranbaxy's ANDA for generic Lipitor (atorvastatin) and determine whether Ranbaxy forfeited its 180-day exclusivity for the product. The…
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Mylan Pharms. and Matrix Labs. v. FDA, No. 11-566 (D.D.C.) Last month, Mylan filed suit against the FDA in the U.S. District Court for the District of Columbia, seeking a declaration that there is no applicable period of 180-day exclusivity for generic Lipitor (atorvastatin) that would block approval of Mylan's atorvastatin ANDA; and an injunction…
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Sanofi-Aventis, et al. v. Food and Drug Administration, et al., No. 09-1495 (D.D.C. 2010) The question in this case is "whether a vacatur entered by an appellate court overrides the terminating effect that the entry of district court judgment has on the thirty-month stay under the FDCA." The answer is "no" — the thirty-month stay…
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Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch. FDA confirmed the final approval in a press release. Risperdal is a schizophrenia drug marketed by…
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Last Thursday, FDA Law Blog reported on the Lupin v. Abbott case scheduled for oral argument at the Federal Circuit on Wednesday. The case concerns a very unusual situation, where Abbott obtained two patent term extensions under 35 U.S.C. § 156 for a single drug product. In what is being reported as a setback for…
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In November 2001, Apotex became the first company to file an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification. In March 2002, Sanofi-Synthelabo and Bristol-Myers Squibb sued Apotex for infringing the Orange Book-listed patent, U.S. Patent No. 4,847,265, thereby initiating an automatic 30-month stay of FDA approval of Apotex’s…
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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…
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Fosamax, Merck’s blockbuster osteoporosis drug, went generic on Wednesday. The In Vivo Blog posted an interesting report on the unusual steps Merck took to promote Fosamax in the last month, before its patents expired. The WSJ Health Blog posted an interesting story this week on contributions from the pharmaceutical industry to the presidential candidates. Apparently…
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Last week, the U.S. District Court for the District of Columbia denied Mylan’s emergency motion for a temporary restraining order that would have forced FDA to relist Pfizer’s Norvasc patent in the Orange Book. Until June 22, when FDA delisted Pfizer’s patent, Mylan and Apotex had the only approved ANDAs for generic Norvasc. Bloomberg reported…
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Mylan Laboratories announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007. Mylan launched its generic Norvasc last week and, with the exception of Pfizer’s authorized generic, currently has the only generic…
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