In reversing a district court decision as to whether a validity issue remained justiciable after the challenged claims were disclaimed, the US Court of Appeals for the Federal Circuit explained that the patent owner’s statutory disclaimer of certain patent claims mooted any controversy over those claims. Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., et al., Case Nos. 18-1804, -1808, -1809 (Fed. Cir. Aug. 14, 2019) (Lourie, J).

Sanofi owns the patent at issue covering methods of using a compound, cabazitaxel, for treating certain drug-resistant prostate cancers. Defendants filed an abbreviated new drug application to market generic versions of cabazitaxel, and Sanofi sued for patent infringement. While the district court case was pending, the Patent Trial and Appeal Board (PTAB) instituted inter partes review of certain claims of the patent-in-suit. Soon after the district court trial began, the PTAB found the patent claims obvious. The PTAB also denied Sanofi’s motion to amend the claims. Thereafter, Sanofi filed a statutory disclaimer of those claims. The district court, however, concluded that a case or controversy existed as to those disclaimed claims and invalidated them as obvious. Sanofi appealed, arguing that after it disclaimed the claims, there was no case or controversy as to those claims, and the district court lacked authority to invalidate the claims.

The Federal Circuit agreed, stating that Sanofi’s disclaimers mooted any controversy over the disclaimed claims and left the patent-in-suit “as though the disclaimed claims had never existed.”

Defendants argued that they were entitled to preserve the district court’s invalidity judgment to provide themselves with patent certainty and a potential claim preclusion defense in the event Sanofi were to succeed in amending the claims and again assert them against defendants. The Federal Circuit rejected the argument, explaining that under certain circumstances, jurisdiction may exist even when there is no risk of infringement. However, the party seeking such judicial relief must demonstrate some other concrete and realistic threat traceable to the claims that existed at the time the district court rendered its judgment, which defendants had not done in this case. As the Court explained, loss of a potential issue preclusion defense did not provide the requisite case or controversy for at least two reasons. First, the defense was “speculative,” as it was premised on hypothetical appellate reversal or remand of the PTAB’s inter partes review decision, given that the PTAB had declined to allow Sanofi to amend its claims. Second, the disclaimed claims were not material to a possible future suit.

The Federal Circuit concluded: “[w]e cannot issue an advisory opinion on such a theoretical dispute and we decline to do so here. Defendants will have ample opportunity to raise a claim preclusion defense at the district court should Sanofi sue them again.”