Condensed IP

Actelion Pharmaceuticals v. Mylan Pharmaceuticals (Fed. Cir., May 13, 2026) 2024-1641

Randy Noranbrock Season 2 Episode 33

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0:00 | 14:43

In this episode, the United States Court of Appeals for the Federal Circuit affirmed that Mylan Pharmaceuticals Inc.did not infringe upon patents held by Actelion Pharmaceuticals Ltd. regarding the hypertension drug Veletri®. The legal dispute centered on the requirement that the drug be manufactured from a "bulk solution" with a pH of 13 or higher, a threshold Actelion claimed was met by Mylan’s refrigerated process. However, the court determined that the term "pH" refers to measurements taken at a standard temperature of 25°C, a condition Mylan's product did not satisfy. Furthermore, the court rejected Actelion’s attempt to claim infringement through the doctrine of equivalents, ruling that the company had previously narrowed its claims during prosecution and dedicated certain pH ranges to the public. This decision reinforces industry standards by requiring precise temperature conditions for pH-related patent claims unless otherwise specified.

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