Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc.
United States Court of Appeals for the Federal Circuit
253 Fed. Appx. 26 (2007)
After designing around a Bristol-Myers Squibb patent using different surfactants and wetting agents, Pharmaceutical Resources and Par Pharmaceuticals (plaintiffs) obtained patents covering broadly worded formulations of stable megestrol acetate suspensions, then sued Roxane Laboratories (defendant) for infringement. Roxane argued the patents were invalid for lack of enablement, since the claims covered any surfactant in any concentration (with one exception) despite the specification disclosing only three working examples and the inventor himself succeeding with only seven of many possible surfactants; the district court granted Roxane summary judgment of invalidity.
Whether the written description of the claims made in a patent must not be overly broad and must contain a clear and concise written description of the invention, as well as the exact method or process, to enable a person skilled in the relevant art to make and use it.