Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals USA, Inc.

Takeda Pharmaceutical Company and other related companies (collectively, Takeda) (plaintiffs) owned a patent (the ‘994 patent) directed to a formulation for the acid-reflux-treatment tablet sold under the trademark Prevacid SoluTab. Once placed in a patient’s mouth but before being swallowed, this tablet would disintegrate into small granules . The ‘994 patent sought to make the granules sufficiently small to optimize the patient’s comfort when swallowing the granules. Accordingly, claim 1 of the ‘994 patent began: “An orally disintegrable tablet which comprises (i) fine granules having an average particle diameter of 400 µm or less . . . .” Zydus Pharmaceuticals USA, Inc. and Cadila Healthcare Limited (collectively, Zydus) (defendants) sought to make a generic version of Prevacid. The average granule diameter of Zydus’s product was 412.28 µm. This prompted Takeda to sue Zydus in the United States District Court for the District of New Jersey for infringement of the ‘994 patent. The district court held a claim-construction hearing to interpret terms recited in claim 1, the sole claim of the ‘994 patent remaining at issue. Takeda argued that the court should interpret “400 µm or less” to mean 400 µm (± 10 percent) or less because a 10 percent standard of error for particle-size measurements was universally accepted. By contrast, Zydus argued that the court should interpret “400 µm or less” as precisely 400 µm or less. The district court agreed with Takeda’s interpretation and, applying that interpretation, entered a final judgment of infringement against Zydus, which then filed an appeal.