Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc.
253 Fed.Appx. 26 (Fed. Cir. 2007)

  • Bristol-Myers Squib patented a liquid form of a drug called megestrol acetate. Their patent specified a single chemical that could be used as the 'wetting agent and a single chemical for use as the 'surfactant'.
    • The surfactant and the wetting agent were the chemicals that made the drug a liquid.
  • PRI was a generic drug company that found that a bunch of different chemicals could be used as wetting agents and surfactants. They got a number of patents on different combinations of wetting agents and surfactants that could be used.
    • The claim in PRI's patents went something like this:
      • "An oral pharmaceutical composition in the form of a stable flocculated suspension in water comprising: (a) megestrol acetate; (b) at least two compounds selected from the group consisting of polyethylene glycol, glycol, glycerol, and sorbitol; and (c) a surfactant.
  • Roxane started making a liquid megestrol acetate. PRI sued for infringement.
    • Roxane argued that PRI's patents were invalid because they were too vague and overbroad. You'd still have to experiment with different combinations before you figured out which would work. You couldn't just follow the directions in PRI's patent.
      • 35 U.S.C. 112 requires that a patent contain a description that enables one skilled in the art to make and use the invention.
  • The Trial Court found for Roxane and invalidated the patent. PRI appealed.
  • The Appellate Court affirmed.
    • The Appellate Court found that there were eight factors relevant to enablement:
      • The quantity of experimentation necessary
      • The amount of direction of guidance presented
      • The presences or absence of working examples
      • The nature of the invention
      • The state of the prior art
      • The relative skill of those in the art
      • The predictability of unpredictability of the art
      • The breadth of the claims
      • See In re Wands (858 F.2d 731 (1988)).
    • The Court applied the factors and determined that PRI's disclosure of their invention was not detailed enough to meet the enablement requirement of 112.
      • The Court found that the art of making wetting agent was very unpredictable, and that PRI's claims were very broad because it claimed any surfactant in any concentration.