Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc.

Bristol-Myers Squibb (“BMS”) was the first company to successfully develop a liquid composition of megestrol acetate using one stable suspension. BMS patented its process and named the only composition it used–polyethylene glycol–as a wetting agent and polysorbate 80 as a surfactant. After determining that flocculated stable suspensions of megestrol acetate could be formed using different surfactants and wetting agents, Pharmaceutical Resources, Inc. and Par Pharmaceuticals, Inc. (“Par” collectively) (plaintiff) designed around the BMS patent by utilizing different ingredients and concentrations to create stable flocculated suspensions of megestrol acetate. Par ultimately received several patents for its compositions as well as the processes for making the suspensions, including the ‘318 and ‘320 patents. In 2003, Par filed suit against Roxanne Laboratories, Inc. (“Roxanne”) (defendant) claiming infringement of the ‘318 and ‘320 patents. Roxanne denied infringement and argued that Par’s patents were invalid and unenforceable. After a Markman hearing, Roxanne moved for summary judgment of invalidity, arguing that Par’s claims in the ‘318 and ‘320 patents were invalid for lack of enablement. The district court granted Roxanne’s summary judgment motion, concluding that Par was not entitled to the broad claims it asserted in its ‘318 and ‘320 patents. Par appealed.