United States Federal Circuit

In this patent infringement case, plaintiff sought a declaratory judgment that two patents licensed exclusively to defendant are invalid and unenforceable and will not be infringed if plaintiff uses, imports, or sells a biosimilar drug product. At the time of suit, plaintiff had not, and still has not, filed an application for approval of its contemplated product with the Food and Drug Administration (FDA) and had only just begun the testing required for its contemplated FDA filing. Dismissal on grounds that there is, as of yet, no Article III controversy between the parties, is affirmed, where plaintiff did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction.

Appellate Information

• Decided 12/05/2014
• Published 12/05/2014

Judges

• Taranto

Court

• United States Federal Circuit

Counsel