Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court explained that a novel product with unexpected advantageous properties is not obvious just because the process by which it was made might have been.

The Velcade® Patent At Issue

The patent at issue was Millennium's U.S. Patent No. 6,713,446, which is listed in the Orange Book for Velcade®, which is used to treat multiple myeloma and mantle cell lymphoma. The patent is directed to stable esters of boronic acid compounds, including the D-mannitol ester of bortezomib, which turned out to have surprising stability and overcame the problem of lack of stability of other bortezomib compounds and formulations.