Tag Archives: Case Or Controversy

Federal Circuit Finds No Biosimilars Application Means No Case Or Controversy For Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating to a possible “biosimilar” product, the court was careful to steer clear of the biosimilars statute. Apparently the judges aren’t the only … Continue reading this entry

Federal Circuit Finds Consumer Watchdog Lacks Standing To Appeal Reexamination Decision Upholding WARF Stem Cell Patent

In Consumer Watchdog v. Wisconsin Alumni Research Foundation, the Federal Circuit held that an inter partes reexamination requester must establish an injury in fact sufficient to confer Article III standing in order to appeal a decision of the Patent Trial and Appeal Board to the Federal Circuit. This decision may discourage some parties from instituting inter … Continue reading this entry

The Federal Circuit Solidifies The Future For Subsequent ANDA Litigation

In Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., the Federal Circuit addressed complicated subject matter jurisdiction issues in the context of a declaratory judgment (DJ) action that was brought in accordance with the Hatch-Waxman Act by a subsequent ANDA filer. The court determined that the DJ action should proceed, even though the patent owner could not have brought an … Continue reading this entry