In In Re: AndroGel Antitrust Litigation (No. II), Northern District of Georgia judge Thomas W. Thrash granted defendants summary judgment on antitrust claims alleging that Solvay Pharmaceuticals Inc. filed sham patent infringement litigation to delay the entry of generic Androgel. The court had previously dismissed a claim challenging a reverse payment agreement between Solvay and generic manufacturers.
Under Eleventh Circuit law, pay-for-delay settlements of infringement claims against generic drug manufacturers are legal as long as they do not exceed the scope of the patent. But a drug patent holder may violate the antitrust laws if plaintiffs can prove that the settlements were based on objectively baseless, sham litigation.
Proving sham litigation requires plaintiffs to bear what the court described as a “heavy burden.” It must be objectively obvious that the litigation would fail and the patent holder must have filed it, knowing it would fail, solely for illegitimate purposes. Here, that standard could not be met. As Judge Thrash explained, “a reasonable litigant could have expected some chance that the patent was not invalid based on prior public use.”
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