Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc.

Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc. The Federal Circuit held that "a pH of 13 or higher" in the epoprostenol bulk-solution claims means a pH measured at standard temperature (25±2°C), so Mylan's ANDA product does not literally infringe. It also held the doctrine of equivalents is barred by both prosecution history estoppel and the disclosure-dedication rule, and affirmed the judgment of noninfringement. Where a claim recites pH (or another temperature-dependent property) without stating measurement conditions, an established industry default such as the USP can fix the meaning, and a narrowing amendment tied to unexpected results plus disclosed-but-unclaimed alternative ranges can foreclose equivalents. Affirmed. Actelion's '802 and '227 patents claim lyophilized epoprostenol compositions formed from a bulk solution with a pH of 13 or higher. Mylan's ANDA bulk solution is refrigerated and measures well below 12.98 at 25±2°C, but Actelion argued it exceeds 13 at the cold operating temperature. On remand from an earlier appeal, the district court construed the term as pH 12.98 or higher, and that construction was unchallenged. Claim construction: the claim language does not specify measurement conditions. The specification favored standard-temperature measurement because it defines an alkaline environment as pH>7 (accurate only at standard temperature) and reports uniform comparative results. The examiner's reasons for allowance and the invention's stated purpose were consistent with that reading. Extrinsic evidence reinforced the intrinsic record: the USP, which both sides' experts agreed is influential, defaults to 25±2°C 'unless otherwise specified', and textbooks and expert testimony agreed. The court found no clear error and rejected Actelion's contrary evidence as merely showing instances where a temperature was specified. With that construction, noninfringement was undisputed. Prosecution history estoppel: Actelion narrowed the claim from 'greater than 12' to '13 or higher' after an obviousness rejection, with the examiner treating pH 13 as the threshold for unexpected results. The tangentiality exception failed because that threshold was the discernible objective reason for the amendment. Disclosure-dedication independently barred equivalents: the specification disclosed pH ranges such as 12.5-13, 12-13, and greater than 12 as alternatives to the claimed range. The court held these ranges were sufficiently specific and rejected the argument that the disclosed alternatives must be mutually exclusive, saying overlapping alternatives can be partially unclaimed. claim construction infringement Hatch-Waxman / ANDA precedential