Background
Actelion Pharmaceuticals owns patents covering pharmaceutical compositions of epoprostenol, the active ingredient in its hypertension drug Veletri. Mylan submitted an abbreviated new drug application to market a generic version. Actelion sued for infringement, alleging Mylan’s product met the patent’s claim requiring a bulk solution with a pH of thirteen or higher. The district court found no literal infringement because Mylan’s product did not meet the pH threshold at standard temperature, and no infringement by equivalence due to prosecution history estoppel and the disclosure-dedication rule.
The court’s reasoning
The court affirmed the district court’s claim construction, finding that intrinsic and extrinsic evidence supported the interpretation that pH values in the pharmaceutical art refer to standard temperature measurements unless specified otherwise. The court held that Actelion was estopped from asserting the doctrine of equivalents because it narrowed the claim during prosecution to pH thirteen or higher to demonstrate unexpected results. Additionally, the court applied the disclosure-dedication rule, noting that Actelion disclosed pH ranges below thirteen in the specification but declined to claim them, thereby dedicating those ranges to the public.
What it means going forward
Generic drug manufacturers must ensure their bulk solutions meet the specific pH threshold of thirteen or higher measured at standard temperature to avoid infringement of Actelion’s patents. Patent holders cannot rely on the doctrine of equivalents to capture subject matter they disclosed in the specification but failed to claim, or that they narrowed their claims to surrender during prosecution.
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