Federal Circuit Ruling Portends Changes to Generic Drug Patent Infringement Litigation and Walker Process Antitrust Claims

摘要

In response to the Supreme Court's Medimmune decision, different panels of the Court of Appeals for the Federal Circuit have issued decisions sustaining the justiciability of declaratory judgment actions by generics manufacturers attacking patents listed in the Orange Book against which plaintiffs have filed Paragraph IV certifications under the Hatch-Waxman Act. These cases make clear that the circuit no longer follows the former reasonable-apprehension-of-suit standard criticized by the Supreme Court in Medimmune. But the decisions leave unclear what precisely the new standard may be. In this article, James B. Kobak, Jr., and Robert P. Reznick of Hughes Hubbard & Reed LLP investigate the implications of this recent case law for Walker Process and other antitrust claims that arernoften asserted in connection with claims that listed patents are invalid or not infringed.