Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.

Case Name: Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., 2015-1588, 2016 U.S. App. LEXIS 4945 (Fed. Cir. March 18, 2016) (Circuit Judges Lourie, Dyk, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D.N.J., Chesler, J.)

Drug Product and Patent(s)-in-Suit: Atelvia® (risedronate); U.S. Patents Nos. 7,645,459 (“the ’459 patent”) and 7,645,460 (“the ’460 patent”)

Nature of the Case and Issue(s) Presented: The sole issue on appeal was whether one of skill in the art would be motivated to utilize a certain dosage that achieved similar absorption whether the patient was fed or fasting. Warner Chilcott argued that the term “pharmaceutically effective absorption” required that absorption in fed or fast state be similar, not that absorption be effective in either state.

Teva argued that the claims did not require that the absorption be the same in both states, but that, nevertheless, the prior art taught a formulation that would result in similar absorption rates in both states. Teva argued that one of skill would be motivated to obtain this result as providing logical benefits in administration of the drug to a patient. The district court agreed and the Federal Circuit affirmed.

Why Teva Prevailed: The Federal Circuit affirmed the district court’s finding of invalidity as to the asserted patents because the claims were not as narrow as proposed by Warner Chilcott. In particular, the Federal Circuit rejected the argument that the claims required the absorption rate to be the same or similar in both states, finding that the claim term required the composition to be such as to obtain “pharmaceutically effective absorption.”  Moreover, the Federal Circuit agreed with the district court’s finding that one of skill would have been motivated to obtain this goal of similar absorption, and would have a reasonable expectation of success based on the prior art references in the record.