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:
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
35 U.S.C. §112 requires that a patent contain a description
that enables one skilled in the art to make and use the
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
The amount of direction of
The presences or absence of
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