IP Update

Time for Orange Book Audit: Declaratory Judgment Decision will Boost Generic Drug Challenges

October 1, 2007

In January, the Supreme Court overruled the decades-old test used by the U.S. Court of Appeals for the Federal Circuit to determine whether a case or controversy exists for purposes of declaratory judgment jurisdiction. In March, a Federal Circuit decision demonstrated that the high court had indeed changed the landscape of declaratory judgment jurisdiction in pharmaceutical cases by relaxing the case-or-controversy standard for patent challengers.

Taken together, the Supreme Court's decision in MedImmune Inc. v. Genentech Inc. and the Federal Circuit's response in Teva Pharmaceuticals USA v. Novartis Pharmaceuticals Corp. provide new declaratory judgment opportunities for generic drug companies, the practical effects of which are multifaceted and suggest a need for heightened due diligence of Orange Book-listed patents.

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