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

253 Fed. Appx. 26 (2007)

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Nature of the Case

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Facts

The '318 and '320 patents relate to stable flocculated suspensions of megestrol acetate and methods for making such suspensions. Bristol-Myers Squibb (BMS) developed and patented a liquid pharmaceutical composition of megestrol acetate. Patent '732 teaches that stable suspensions of megestrol acetate can be created but that the type and concentration of the surfactant in solution is critical to creating a stable flocculated suspension. The '732 patent discloses only one stable flocculated suspension composition, combining megestrol acetate with polyethylene glycol as a wetting agent and polysorbate 80 as a surfactant. P sought to design around the '732 patent claims by utilizing other surfactants and wetting agents. P discovered that flocculated suspensions of megestrol acetate could be formed using a much wider range of ingredients and concentrations than taught in the '732 patent, including other surfactants and wetting agents. P received a series of patents on its flocculated suspensions, including the '318 and '320 patents. P sued D claiming D infringes certain claims in the '318 and '320 patents. D asserts that the claims of the '318 and '320 patents are invalid and unenforceable. D moved for summary judgment of invalidity, arguing that the asserted claims are invalid for lack of enablement. The district court granted d's motion for summary judgment, concluding that 'as a matter of law P is not entitled to the broad claims it asserts in this action.' P appealed.