Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al.

Allowing certification for appeal of patent with severable invention from remaining patents in suit.

July 21, 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al., Civil Action Nos. 14-3168 (JBS/KMW), 2016 U.S. Dist. LEXIS 48689 (D.N.J. Apr. 12, 2016) (Simandle, C.J.)

Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); U.S. Patents Nos. 5,006,528 (“the ’528 patent”), 7,053,092 (“the ’092 patent”), 8,017,615 (“the ’615 patent”), 8,580,796 (“the ’796 patent”), 8,462,600 (“the ’600 patent”), 8,642,760 (“the ’760 patent”), and 8,739,350 (“the ’350 patent”)

Nature of the Case and Issue(s) Presented: The court construed the claims of the asserted patents, including the ’350 patent. The ’350 patent used the terms “a/the pharmaceutical composition” and “in combination with,” which the court construed as “a single dosage form, or ‘pharmaceutical composition’ containing at least two active ingredients: aripiprazole and at least one of citalopram, escitalopram and salt thereof.” In light of the construction, the parties stipulated to non-infringement of the ’350 patent. Otsuka sought certification of the stipulated judgments under Fed. R. Civ. P. 54(b) on the grounds that the now-resolved ’350 patent infringement claims presented issues severable from and not intertwined with the remaining infringement claims and counterclaims raised in related actions. The court granted certification.

Why Otsuka Prevailed: Certification for appeal requires: (i) a final judgment on the merits; and (ii) no just reason for delay. Here, there was no dispute that a final judgment existed—the parties stipulated to non-infringement such that no litigable issues remained regarding the ’350 patent. Although the court was initially skeptical due to Otsuka’s delay in seeking certification, it found that no reason for delay. The specification of the ’350 patent was different from the specifications of the other asserted patents, and the claims related to a method of use, not a specific polymorphic formulation. Thus, the ’350 patent implicated an analysis different from that of the other patents-in-suit. Accordingly, the Court permitted certification of the ’350 patent infringement claims.

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