Intendis GMBH v. Glenmark Pharma., Inc., No. 15-1902 (Fed. Cir. 2016)
Annotate this CaseFinacea® Gel contains azelaic acid as the therapeutically active ingredient in a concentration of 15% by weight and is indicated for the topical treatment of rosacea. Finacea® is manufactured as a “hydrogel,” which the court construed to mean “a semisolid dosage form that contains water and a gelling agent to form a gel, which may contain dispersed particles and/or insoluble liquids.” The FDA Orange Book lists the 070 patent as covering Finacea® Gel. The 070 patent, entitled “Composition with Azelaic Acid,” issued in 2003 and claims priority to a 1998 provisional application. Glenmark submitted an Abbreviated New Drug Application to the FDA seeking to market a generic version of Finacea®, including a paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)) that the patent was invalid and not infringed. Unlike Finacea®, the proposed generic product substituted isopropyl myristate for the claimed triglyceride and lecithin. The court held that certain claims were infringed under the doctrine of equivalents and not invalid. The court concluded that the isopropyl myristate in Glenmark’s generic product met the claim elements triglyceride and lecithin under the doctrine of equivalents, relying on the function-way-result test. The court rejected arguments that infringement under the doctrine of equivalents would encompass the prior art and was barred by prosecution history estoppel. The Federal Circuit affirmed, agreeing that the asserted claims would not have been obvious.
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