Context:
- Actelion Pharmaceuticals1 owns patents on medical compositions containing epoprostenol, which is the active ingredient in Veletri, its branded hypertension drug.
- Mylan Pharmaceuticals2 submitted an abbreviated new drug application (ANDA) to the United States Food and Drug Adminstration (FDA) in February 2020, seeking approval to market a generic epoprostenol drug prior to the expiration of Actelion’s patents.
- In June 2020, Actelion sued Mylan in the U.S. District Court for the Northern District of West Virginia, alleging that Mylan’s generic infringed two of its patents, literally and under the doctrine of equivalents (DOE).
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Court and counsel
Panel: Circuit Judge Richard G. Taranto, Circuit Judge Jimmie V. Reyna, and Circuit Judge Kara F. Stoll.
Actelion was represented by Irell & Manella’s Lisa Glasser, Jason Sheasby, and Philip Warrick.
Mylan was represented by Katten Muchin Rosenman’s Eric T. Werlinger, Timothy H. Gray, Jitendra Malik, Deepro R. Mukerjee, Lance A. Soderstrom, and Jillian M. Schurr-Hendrix.