Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.,

Case Name:  Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., No. CV 20-5426 (SRC), 2022 WL 17352334 (D.N.J. Dec. 1, 2022) (Chesler, J.) 

Drug Products and Patent(s)-in-Suit: Duobrii® (halobetasol propionate/tazarotene) and Bryhali® (halobetasol propionate); U.S. Patents Nos. 10,251,895 (“the ’895 patent”), 10,426,787 (“the ’787 patent”), 8,809,307 (“the ’307 patent”), and 10,478,502 (“the ’502 patent”)

Nature of the Case and Issue(s) Presented: Padagis filed ANDAs to market generic versions of Duobrii and Bryhali. Bausch sued Padagis, asserting four OB-listed patents. The parties stipulated to infringement and proceeded to a bench trial on Padagis’s obviousness and indefiniteness defenses. After weighing the record evidence, the court determined that Padagis had not met its burden of proof.

Why Bausch Prevailed: Padagis’s obviousness defense began with the problem that the claimed inventions solved. Many psoriasis patients need topical treatment for longer than two weeks. But topical application of prior formulations of halobetasol propionate (the active ingredient in the drug products at issue) causes a significant side effect, preventing treatment for longer than two weeks. Padagis argued that the claimed inventions—including a lower concentration of the active—were obvious solutions to that known problem.

The court determined that Padagis did not cite any prior art reference to support its key proposition that lowering the concentration of the corticosteroid was a known solution to the known problem. Padagis offered witness testimony to support its proposition, but no prior art reference. And Bausch disputed Padagis’s proposition, adducing evidence that a skilled artisan would have been motivated to formulate a lower concentration only if it could maintain efficacy. Padagis did not adequately address the efficacy component, and it misconstrued one of its asserted prior art references, arguing that the reference addressed efficacy in low doses (it did not). In fact, the reference taught away from the claimed concentrations.

Regarding claim limitations reciting diethyl sebacate as a solvent, the court determined that “it is a big leap from the factual determination that the prior art knew about diethyl sebacate as a solvent for corticosteroids in topical preparations to the conclusion that a POSA would have been motivated to formulate a lower concentration HP composition with a liquid oil component comprising diethyl sebacate.” Padagis did not adduce evidence sufficient to show a motivation to combine its selected references, and indeed, Bausch adduced evidence suggesting that a skilled artisan would not have looked to a “dated” reference to select an oily solvent “from the whole universe of other solvents disclosed in the art.”

The third “major problem” with Padagis’s obviousness case was that it “seem[ed] to wander off the track of the problem to be solved.” Specifically, one of its asserted references taught using a particular solvent to increase delivery—but the problem to be solved necessarily implicated decreasing delivery to decrease side effects.

In sum, the court determined that Padagis had misread the prior art references or overlooked their full significance, had failed to demonstrate a motivation to combine those references, and had failed to demonstrate that a skilled artisan would have had a reasonable expectation of success.

Regarding indefiniteness, Padagis focused on the claim term “liquid oil component,” arguing that a table in the specification caused “a little bit of confusion” regarding the meaning of the term. But Padagis did not adduce evidence showing that a skilled artisan would have viable, alternative definitions for the term. Nor did Padagis’s arguments show indefiniteness regarding the scope of the claims.

Finally, two of the four asserted patents claimed certain “synergies” related to combining halobetasol propionate and tazarotene. Padagis argued that the synergies were expected. But Padagis’s own expert agreed on cross-examination that “synergy” had been used incorrectly in the literature, and that he had no way of knowing what the asserted references meant when they used “synergy.” Padagis’s obviousness arguments depended on its “synergy” arguments.