In re Bendamustine Consolidated Cases

Case Name: In re Bendamustine Consolidated Cases, Civ. No. 13-2046-GMS, 2015 U.S. Dist. LEXIS 55963 (D. Del. Apr. 29, 2015) (Sleet, J.) 

Drug Product and Patent(s)-in-Suit: Treanda^® (bendamustine HCl); U.S. Patents Nos. 8,436,190 ("the ’190 patent"), and 8,609,863 ("the '863 patent")

Nature of the Case and Issue(s) Presented: Cephalon filed a lawsuit against various defendants alleging patent infringement of at least one or more claims of the patents-in-suit. Defendants moved for a judgment on the pleadings with respect to Cephalon’s claims. The ’190 and ’863 patents claim compositions/preparations that include tertiary-butyl alcohol (“TBA”). Defendants’ ANDA products do not contain TBA.

Cephalon’s theory of infringement was premised on the doctrine of equivalents, rather than literal infringement. The only issue was whether Cephalon’s doctrine-of-equivalents argument was barred by the “disclosure-dedication rule.” The court found that it was.

Why Defendant Prevailed: The common specification for the patents-in-suit included a list of possible organic solvents, which included, “tertiary butanol, n-propanol, n-butanol, isopropanol, ethanol, methanol, acetone, ethyl acetate, dimethyl carbonate, acetonitrile, dichloromethane, methyl ethyl ketone, methyl isobutyl ketone, 1-pentanol, methyl acetate, carbon tetrachloride, dimethyl sulfoxide, hexafluoroacetone, chlorobutanol, dimethyl sulfone, acetic acid, and cyclohexane.” The specification identified TBA as the “more preferred organic solvent” of the list. But the ’190 and ’863 patents only claimed compositions or preparations containing TBA. Thus, defendants’ argument was premised on the application of the disclosure-dedicated doctrine because Cephalon provided a list of alternatives to TBA and not a broad genus in the specification and obtained only claims covering TBA.

In response, Cephalon argued that judgment on the pleadings was not proper because the Defendants sought to rely on documents outside of the pleadings. As such, the motion was a premature summary judgment motion that should be denied because factual issues existed. Cephalon also argued that simply listing alternatives was not a dedication to the public. Indeed, Cephalon had obtained another patent that included claims for such alternatives.

The court rejected Cephalon’s first argument. The patents-in-suit and the ANDA applications were properly considered by the court because those documents formed the basis of the allegations in the complaint, and thus could be considered for a motion for judgment on the pleadings without turning it into a summary judgment motion. And the court dismissed Cephalon’s second argument. The list of alternative solvents in the specification of the patents-in-suit made clear that the other compounds were alternatives to TBA. It did not include a description of a broad genus that included TBA and the other compounds. And the fact that Cephalon obtained a different patent that included the alternatives did not foreclose the application of the disclosure-dedication rule to the patents-in-suit.