"Actelion owns U.S. Patent Nos. 8,318,802 and 8,598,227 for "certain pharmaceutical compositions involving epoprostenol." Each independent claim of the patents recites a bulk solution pH of "13 or higher" or "greater than 13." After Mylan submitted its Abbreviated New Drug Application (ANDA) to the FDA, Actelion sued Mylan for infringement of the patents. Mylan argued that its generic drug was "manufactured from a bulk solution with a pH outside the patents' claims.""
"Initially, the district court construed the claims to mean a pH of 12.5 or higher due to rounding rules, but the CAFC in 2023 remanded that ruling, explaining that "the proper claim construction cannot be reached without the aid of extrinsic evidence." On remand, the district court determined that the pH of 13 or higher should be construed to mean a pH of 12.98 or higher. It was undisputed that Mylan's bulk solution has a pH of well below 12.98, but Actelion argued that, when refrigerated, as the ANDA indicates the solution is when manufactured, "if measured at that cold temperature, has a pH of above 13.""
"Actelion further argued that the generic drug is an equivalent to its patented product because "Mylan's manufacturing process performs the same function (improved manufacturing stability) to a""
Actelion owns patents covering pharmaceutical compositions involving epoprostenol, with independent claims requiring a bulk solution pH of 13 or higher (or greater than 13). After Mylan filed an ANDA, Actelion sued for infringement. The district court initially construed the pH limitation using rounding rules, but the CAFC remanded, requiring extrinsic evidence to reach proper claim construction. On remand, the district court construed the limitation as pH 12.98 or higher. The parties agreed Mylan’s bulk solution pH is well below 12.98. Actelion argued that refrigeration could raise measured pH above 13 and also asserted infringement by equivalence based on improved manufacturing stability, but the court found Actelion did not prove equivalence and was barred from asserting it.
#patent-infringement #claim-construction #pharmaceutical-compositions #ph-limitation #doctrine-of-equivalents
Read at IPWatchdog.com | Patents & Intellectual Property Law
Unable to calculate read time
Collection
[
|
...
]