SANOFI-AVENTIS U.S., LLC v. FRESENIUS KABI USA, LLC

Before Lourie, Moore, and Taranto. Appeal from the United States District Court for the District of New Jersey.

Summary: District courts lack the authority to declare disclaimed patent claims invalid because no case or controversy exists with respect to such claims. Additionally, a case or controversy must exist at the time a court enters judgment, and not only at the time a complaint is filed.

Sanofi sued generic pharmaceutical companies (“Defendants”) for patent infringement related to applications to market generic versions of Jevtana®. While the district court case was pending, the Patent Trial and Appeal Board instituted inter partes review of one of the asserted patents. After trial began, the Board held the claims of the patent were obvious, and denied Sanofi’s motion to amend its claims. As a result of these proceedings, Sanofi filed a statutory disclaimer of several claims of the patent, and appealed the Board’s denial of its motion to amend. Despite the statutory disclaimer, the district court concluded that a case or controversy existed with respect to the disclaimed claims, and held that these disclaimed claims were invalid as obvious.

The Federal Circuit vacated the district court’s decision. The Federal Circuit explained that, to have standing, an injury to the Defendants must be “actual and imminent, not conjectural or hypothetical.” Further, the actual controversy must exist at all stages of review, not merely when the complaint is filed. Although the Defendants alleged that if the Court vacated the district court’s judgment of invalidity, Defendants would lose the possible benefit of an issue preclusion defense if Sanofi was able to amend the claims, the Federal Circuit held that the relevance of the disclaimed claims to a possible issue preclusion defense was merely speculative because at the time of the district court’s decision, the Board had denied Sanofi’s motion to amend. Any future assertion of amended claims was based on a hypothetical appellate reversal or vacatur and remand of the Board’s inter partes review decision. The Federal Circuit also concluded that Defendants failed to demonstrate any material impact that vacatur of the district court’s judgment regarding the disclaimed claims would have on its potential issue preclusion argument.

Editor: Paul Stewart

Written by: Ashley C. Morales & Andrea Cheek