Cephalon, Inc. v. Watson Pharma., Inc. (Fed. Cir.)

Case Name: Cephalon, Inc. v. Watson Pharma., Inc., 707 F.3d 1330 (Fed. Cir. Feb. 14, 2013) (Circuit Judges Reyna, Bryson, and Wallach presiding; Opinion by Wallach) (Appeal from D. Del., Robinson, J.)

Drug Product and Patent(s)-in-Suit: Fentora® (fentanyl); U.S. Patent Nos. 6,200,604 (“the ’604 patent”) and 6,974,590 (“the ’590 patent”)

Nature of the Case and Issue(s) Presented: The district court held: (i) Watson’s ANDA products did not infringe the asserted claims of the patents-in-suit because Cephalon failed to demonstrate that the those products were “saliva activated” and the tests Cephalon conducted to prove infringement were only done in water; and (ii) that the patents-in-suit were invalid as not enabled because undue experimentation would be necessary to create an embodiment where the effervescent agent and active component were co-administered.

Why Watson Prevailed: The Federal Circuit affirmed the finding of non-infringement. The Federal Circuit stated that the district court was free, as the trier of fact, to find Watson’s expert more credible, including his opinion that tests done in water were not the same or similar to performing the tests in artificial saliva. Thus, there was no clear error in the factual findings of the district court’s non-infringement determination.

With respect to the lower court’s holding that the asserted claims were not enabled, the Federal Circuit reversed that determination. First, the Federal Circuit found that the district court improperly implemented a burden shifting onto Cephalon once Watson had made a prima facia case on enablement. The Federal Circuit reasoned that the burden is always on the patent challenger as patents are presumed valid and enabled. Second, with respect to the merits of the claimed defense, Watson failed to provide clear and convincing evidence that the patent was not enabled. Watson’s expert testified that determining the combination of the effervescent and active components being co-administered would be “complicated” and “difficult.” The Federal Circuit held that this was insufficient to sustain a finding of invalidity. The fact that some experimentation would be needed does not render a patent not enabled. Rather, Watson was required to present evidence regarding the amount of experimentation that would be needed. Because no such evidence was in the record, the Federal Circuit reversed the district court’s determination of invalidity.