Summary: CAFC rules on claim construction, infringement, and section 112 issues.

Case: Takeda Pharm. Co. v. Zydus Phram. USA, Inc., No. 2013-1406 (Fed. Cir. Feb. 20, 2014) (precedential). On appeal from D.N.J. Before Prost, Plager, and Chen.

Procedural Posture: In an ANDA litigation concerning a generic version of Prevacid®SoluTabTM, Defendant accused infringer Zydus appealed the district court’s claim construction and judgments that the asserted claim was literally infringed and not invalid. The CAFC reversed the claim construction and resulting finding of literal infringement, affirmed the judgment of no invalidity, and remanded for further proceedings.

  • Claim Construction: The asserted claim is directed to an orally disintegrable tablet comprising “fine granules having an average particle diameter of 400 µm or less.” The district court construed the term “400 µm or less” to include a deviation of + 10% because this deviation is “universally accepted” and the particles included agglomerated granules. The CAFC held that the district court erred in reading + 10% into the disputed claim term, and construed that term to mean “precisely 400 µm or less.” The CAFC reasoned that 1) the specification supported its construction; 2) the maximum particle size described as “practically 425 µm or less” excludes particles that are 10% larger than 400 µm; and 3) the prosecution history also confirmed its reading of the specification.
  • Infringement: The CAFC reversed the district court’s judgment of literal infringement because according to the CAFC’s claim construction, the accused product is outside the claimed range of “precisely 400 µm or lower.”
  • Section 112 Issues:
    • Indefiniteness: The CAFC rejected Defendant’s argument that the claim is indefinite because the patent does not specify the technique used to measure average particle diameter and that differences among available techniques could yield infringing or non-infringing measurements of the same sample. The CAFC reasoned that there was no evidence that any difference between the techniques was significant; to the contrary they were highly correlated.
    • Written Description: The CAFC rejected Defendant’s argument that the claimed particle sizes in the finished tablet lacked written support. Defendant argued that the patent claimed particle size in the finished tablet, but that the specification only described measuring particle size pre-formulation without any discussion on how to ensure that the particle size was not changed by that process. Plaintiff presented expert testing that there was no effect from compression forces on the product during the tableting process. The CAFC reasoned that it could not conclude that the district court clearly erred on the evidence before it.
    • Enablement: The CAFC rejected Defendant’s argument that the claim was not enabled because a skilled artisan would not be able to measure the average particle diameter using each disclosed method without undue experimentation. The CAFC agreed with the district court that the patent discloses a method that does not require undue experimentation, and that the enablement requirement is met if the patent discloses any method of making and using the invention.