Gaming of the Generic Drug Approval Process to be Disciplined by the Supreme Court?

摘要

The US Supreme Court is considering whether to grant certio-rari in a case that will significantly impact the generic drug industry. In this article, Jennifer Cozeolino of Baker Botts LLP sets forth the issues before the Court: whether listing a patent in the Food and Drug Administration's "Orange Book" creates a justiciable controversy under die Declaratory Judgment Act, and whether die reasonable apprehension standard enunciated by the Federal Circuit is the proper test to be applied pursuant to Article III of the US Constitution in these cases. According to the author, it remains to be seen whether this standard sets die threshold for a declaratory judgment action too high, thus debilitating a generic drug manufacturer's ability to market a drug that is the subject of an Orange Book listed patent.