Defendants’ labels induce infringement in this dronedarone case

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Sanofi, et al. v. Glenmark Pharmaceuticals Inc., USA, et al., C.A. No. 14-264 – RGA, August 31, 2016.

Andrews, J. Court makes rulings following a three-day bench trial and post-trial briefing.

The disputed product in this ANDA case is 400 mg dronedarone tablets used as an antiarrhythmic drug. The court finds that defendants’ proposed product labels induce infringement of 12 claims of one patent but not another of the asserted claims. There are substantial non-infringing uses for this drug and there is no contributory infringement. All asserted claims of the patent-in-suit are valid.  The disclaimer of polysorbate surfactants in one patent does not carry over to that patent’s parent. The court’s claim construction of “nonionic hydrophilic” was disputed in in limine motions, and after post-trial briefing, the court revisits that construction.

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