Court rules Mylan's generic hypertension drug does not infringe Actelion's patents
The U.S. Court of Appeals for the Federal Circuit (CAFC) has upheld a district court ruling in favour of Mylan Pharmaceuticals. The decision confirms that Mylan’s generic hypertension drug does not infringe Actelion Pharmaceuticals’ patents for Veletri®. The case centred on whether Mylan’s product fell within the scope of Actelion’s patent claims or their equivalents. Actelion holds two patents, U.S. Patent Nos. 8,318,802 and 8,598,227, covering pharmaceutical compositions involving epoprostenol. These patents specify that the drug must be formed from a bulk solution with a pH of '13 or higher' or 'greater than 13'. When Mylan filed an Abbreviated New Drug Application (ANDA) for its generic version, Actelion sued for infringement.
The district court ruled that Mylan’s product did not literally infringe because its bulk solution had a pH well below 12.98. The CAFC agreed with this interpretation, affirming that the claim phrase 'formed from a bulk solution having a pH of 13 or higher' should be read as 'a pH of 12.98 or higher'. Mylan had argued that its manufacturing process used a pH outside the patents’ claimed range, which the courts accepted. Actelion also attempted to argue infringement under the doctrine of equivalents. However, the CAFC blocked this claim, citing the 'disclosure-dedication rule'. The rule prevents a patent holder from recapturing subject matter disclosed but not claimed during prosecution. The court further noted that Actelion’s amendments to narrow its claims during prosecution estopped it from later asserting that the excluded material was merely an equivalent.
The CAFC’s decision reinforces the limits of patent claims and the doctrine of equivalents. Actelion cannot pursue infringement claims against Mylan for its generic hypertension drug. The ruling also clarifies how courts interpret pH-related patent language in pharmaceutical disputes.
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