Sanofi owns U.S. Patent Nos. 8,318,800 and 8,410,167, which describe and claim compositions and uses of the cardiovascular (specifically, antiarrhythmic) drug dronedarone. The ’800 patent, which expires in 2019, claims pharmaceutical compositions containing dronedarone. The ’167 patent, which expires in 2029, claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. Sanofi’s subsidiary, Sanofi-Aventis U.S., LLC, received approval in mid-2009 for New Drug Application No. 022425 for 400 mg tablets of dronedarone, sold as Multaq®.
Both the ’800 and the ’167 patents are listed in the Food and Drug Administration’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) as patents claiming either Multaq® or a method of using Multaq®. Watson Laboratories Inc. and Sandoz Inc., hoping to market generic versions of Multaq®, filed abbreviated new drug applications with the Food and Drug Administration. Both firms certified, under 21 U.S.C§ 355(j)(2)(A)(vii)(IV), their beliefs that the ’167 and ’800 patents were invalid and/or that the manufacture, use, and sale of the proposed generic drugs would not infringe either patent. Upon receiving notice of the paragraph IV certifications, the two Sanofi firms, which we will simply call “Sanofi,” sued Watson and Sandoz for infringement of the two patents under 35 U.S.C. § 271(e)(2)(A).
After a three-day bench trial, the district court ruled in crucial respects for Sanofi. Sanofi v. Glenmark Pharm. Inc., USA, 204 F. Supp. 3d 665, 704–705 (D. Del. 2016). As to the ’167 patent, the court made the following rulings of relevance here: Sanofi proved that Watson’s and Sandoz’s sale of their proposed generic drugs, with their proposed labels, would induce physicians to infringe all but one of the asserted claims, id. at 673–84; and Watson and Sandoz did not prove that any of the asserted claims were invalid for obviousness, id. at 685–96. As to the ’800 patent, the district court, rejecting the non-infringement argument made by Watson and Sandoz, concluded that the asserted claims do not exclude compositions containing polysorbate surfactants. Id. at 699–704. The district court then entered a final judgment rejecting the obviousness challenge to claims 1–6, 8–13, and 16 of the ’167 patent; finding inducement of infringement, by both defendants, of all of those claims except claim 5; and finding infringement by both defendants of claims 1–3, 5- 9, and 12–15 of the ’800 patent and by Watson of claims 10 and 11 as well.
Watson and Sandoz appeal. We have jurisdiction under 28 U.S.C. § 1295(a)(1). We affirm.
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