Intendis GMBH et al. v. Glenmark Pharms. Inc., USA

Affirming district court’s application of the doctrine of equivalents, in part, on the basis of Defendants’ representations to the FDA in their ANDA.

July 21, 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.)

Drug Product and Patent(s)-in-Suit: Finacea® (azelaic acid); U.S. Patent No. 6,534,070 (“the ’070 patent”)

Nature of the Case and Issue(s) Presented: Appellee Bayer Healthcare markets Finacea Gel as a topical treatment for inflammatory papules and pustules of mild to moderate rosacea. Finacea’s inactive ingredients, or excipients, include triglycerides and lecithin. The ’070 patent has a single independent claim, covering Finacea Gel, requiring at least one triacylgyceride in a concentration of 0.5 to 5% by weight and lecithin. The parties agreed that the term triacylglyceride meant “triglyceride.”

Defendants filed an ANDA seeking FDA approval to market generic Finacea. That ANDA listed isopropyl myristate in place of the triglyceride and lecithin. Plaintiffs argued that isopropyl myristate met the claim elements under the doctrine of equivalents. The district court found that it did, rejecting Defendants’ arguments that the doctrine of equivalents would encompass the prior art and was barred by prosecution-history estoppel. The Federal Circuit affirmed.

Why Plaintiffs Prevailed: Defendants appealed only the district court’s finding that isopropyl myristate performed substantially the same function as triglyceride and lecithin. The Federal Circuit determined that triglyceride and lecithin served as penetration enhancers for the compounds claimed in the ’070 patent, as did isopropyl myristate. Then, the Federal Circuit held that the patent was not required to explicitly spell out a claim element’s function, way, and result for the doctrine of equivalents to apply. Further, in their ANDA, Defendants stated that “[i]sopropyl myristate was selected as [a] penetration enhancer instead of lecithin and medium chain triglyceride.” In light of these clear representations to the FDA, the Federal Circuit found no clear error with the district court’s ruling.

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