IP News

On Feb. 20 2014, a unanimous Federal Circuit Panel of Judges Prost, Plager, and Chen, issued an opinion, authored by Judge Prost, in Takada Pharm. v. Zydus Pharm. USA, Case No. 2013-1406. In it, the panel reversed the district court's claim construction and infringement rulings, but affirmed the lower court's validity findings.

The patent at issue, U.S. Patent No. 6,328,994 (the '994 patent) covers tablets including granules of lansoparazole, a proton pump inhibitor used to treat acid reflux. A patient allows the tablet to disintegrate in his or her mouth, and then swallows the granules, which release the drug in the patient's stomach. The stated objective of the '994 patent is for a formulation containing granules small enough that they do not feel rough in the patient's mouth. To that end, the claims require, inter alia, 'fine granules having an average particle diameter of 400 'm or less,' '994 patent, col. 37 ll. 44'45. During claim construction, the district court agreed with Takada, that the term '400 'm or less' should be construed to include a deviation of '10%, because a 10% error rate was 'universally accepted' for particle size measurement. Takeda Pharm. Co. v. Zydus Pharms. USA Inc., No. 10-1723, 2011 WL 4736306, at *3'4 (D.N.J. 2011). The district court also agreed with Takeda that, when the granules were measured, aggregates of granules (those stuck together) should be virtually dissected, such that the diameter of each granule within the aggregate is separately measured. Takeda, No. 10-1723, slip op. at 12'13. Based on these holdings, the district court found that Zydus' product infringed; the court further found that Zydus had failed to prove that the '994 patent was invalid. Id. at 25'42. Zydus appealed.