GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed Cir)

Appeal from D. Del., Andrews, J.) (District court’s finding that the written description requirement is met is affirmed because “solvates” of dutasteride are not distinguished by a particular performance property.

Spring 2014

GENERICally Speaking

Case Name: GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., Nos. 2013-1593, -1594, -1595, -1598, 2014 U.S. App. LEXIS 3356 (Fed. Cir. Feb. 24, 2014) (Circuit Judges Taranto, O’Malley, and Wallach presiding; Opinion by Taranto, J.) (Appeal from D. Del., Andrews, J.)

Drug Product and Patent(s)-in-Suit: Avodart® and Jalyn® (dutasteride); U.S. Patent No. 5,565,467 (“’the ’467 patent”)

Nature of the Case and Issue(s) Presented: GSK sued defendants alleging that drug products containing the molecule dutasteride that defendants propose to market fell within claims of the ’467 patent, which covers dutasteride and its pharmaceutically acceptable solvates. All defendants stipulated to infringement, but alleged that the asserted claims were invalid for anticipation, lack of utility, lack of enablement, and inadequacy of the written description. After a three-day bench trial, the district court issued an opinion concluding that defendants did not prove the asserted claims invalid. Defendants appeal the rejection of their written-description challenge. Their appeal presents only one contention: that “solvate” is not adequately described, whether as construed by defendants or the district court. The Federal Circuit affirmed. 

Why GSK Prevailed: Banner asserted that the proper construction of “solvate” was limited to the crystalline form, and that the specification did not demonstrate that the inventors were in possession of that claimed invention. GSK argued that the district court’s construction of “solvate” was proper because the disclosure was not limited to just the crystalline structure. Moreover, GSK argued that the specification demonstrated the inventors were in possession of the claimed invention because it disclosed the formation of a “solvate.” The Federal Circuit’s holding was not dependent on either of the two posited claim-construction arguments. Thus, the Federal Circuit did not specifically adopt a construction.

As to the issue of adequate description for “solvate,” the Federal Circuit agreed with the district court that the specification disclosed one method of making the claimed solvate, which matched the scope of the claims. The Federal Circuit emphasized that the asserted claims did not include functional language, so the specification did not need to disclose sufficient description for a solvate created by the method functioning as claimed. Rather, the specification merely needed to disclose a solvate that had the chemical makeup claimed in the asserted claims, and which was created one of three possible ways. Because the specification included this disclosure, the asserted claims were not invalid.

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