Eagle Pharms. Inc. v. Slayback Pharma LLC

Case Name: Eagle Pharms. Inc. v. Slayback Pharma LLC, 958 F.3d 1171 (Fed. Cir. May 8, 2020) (Circuit Judges O’Malley, Reyna, and Chen presiding; Opinion by Reyna, J.) (Appeal from D. Del., Connolly, J.)

Drug Product and Patent(s)-in-Suit: Belrapzo® (bendamustine HCl); U.S. Patents Nos. 9,265,831 (“the ’831 patent”), 9,572,796 (“the ’796 patent”), 9,572,797 (“the ’797 patent”), and 10,010,533 (“the ’533 patent”).

Nature of the Case and Issue(s) Presented: Eagle sued Slayback for infringing the patents-in-suit. Slayback stipulated to literal infringement except for the claim limitation that recited a “pharmaceutically acceptable fluid,” which Eagle asserted that Slayback infringed under the doctrine of equivalents. Specifically, Eagle asserted that the ethanol in Slayback’s product was insubstantially different from the propylene glycol in the claimed composition. On Jan. 4, 2019, Slayback moved for a judgment of non-infringement on the pleadings. Slayback argued that the disclosure-dedication doctrine barred Eagle’s claim of infringement under the doctrine of equivalents because the asserted patents disclosed, but did not claim, ethanol as an alternative solvent to propylene glycol. The specification expressly and repeatedly identified “ethanol” as an alternative “pharmaceutically acceptable fluid” to propylene glycol. Eagle opposed Slayback’s motion, arguing that the asserted patents did not disclose ethanol as an alternative to propylene glycol for the claimed embodiment that contained an antioxidant. Eagle relied on the expert declaration of Dr. Mansoor Amiji who opined that a skilled artisan “would not view the specific ethanol-containing formulations including chloride salts as a disclosure that ethanol was specifically identified as an alternative to the claim limitation at issue in the asserted claims.” Slayback did not submit evidence to rebut Dr. Amiji’s testimony.

On May 9, 2019, the district court granted Slayback’s motion for judgment of non-infringement on the pleadings. The district court found that the written description of the asserted patents unambiguously and repeatedly identified ethanol as an alternative to propylene glycol. Eagle appealed and the Federal Circuit affirmed.

Why Slayback Prevailed: Eagle’s first argument was the one it had raised in the district court. The Federal Circuit disagreed here as well. The disclosure-dedication doctrine did not require the specification to disclose the allegedly dedicated subject matter in an embodiment that exactly matched the claimed embodiment. Here, the specification repeatedly identified―without qualification―ethanol as an alternative pharmaceutically acceptable fluid. Nothing in the specification suggested that the repeated disclosures of ethanol were limited to certain formulations, or that they did not extend to the claimed formulation.

Next, Eagle challenged the district court’s judgment on procedural grounds, asserting that at the time the district court entered judgment of non-infringement on the pleadings, a factual dispute existed; namely, whether a skilled artisan would understand the specification to disclose ethanol as an alternative to propylene glycol in the claimed invention. Eagle argued that the district court erred by resolving that factual dispute at the pleadings stage without drawing all reasonable inferences in Eagle’s favor, including by ignoring Dr. Amiji’s declaration.

The Federal Circuit concluded that the district court did not abuse its discretion when it set aside Dr. Amiji’s declaration. The Federal Circuit found that the district court reviewed Dr. Amiji’s declaration and determined that it was merely an “attempt to manufacture a factual dispute.” Moreover, Eagle conceded that the district court’s “reliance on expert testimony would be improper at this preliminary [pleadings] stage.” Thus, the Federal Circuit found no error in the district court’s decision to grant judgment of non-infringement on the pleadings. The application of the disclosure-dedication doctrine was a question of law and the district court properly concluded that the patents themselves provided sufficient context to decide the issue. Finally, the Federal Circuit noted that expert testimony was not always required for a district court to determine how a skilled artisan would understand a patent’s disclosure and claimed invention.