ARGENTUM PHARM. LLC v. NOVARTIS PHARM. CORP.

Before Lourie, Moore, and Reyna. Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board.

Summary: A party lacks standing to appeal an adverse IPR decision if it cannot show an injury attributable to the decision.

Argentum joined an inter partes review (“IPR”) that had been instituted on a patent owned by Novartis. The Patent Trial and Appeal Board (“PTAB”) issued a final written decision holding that Argentum and the other petitioners failed to show the challenged claims were unpatentable, and petitioners appealed to the Federal Circuit. During the appeal, all petitioners other than Argentum settled with Novartis. Novartis moved to dismiss Argentum from the appeal for lack of Article III Standing.

The Federal Circuit granted the motion and dismissed Argentum’s appeal, finding Argentum failed to establish an injury sufficient to confer Article III standing. Argentum argued that it faced an imminent threat of litigation with Novartis due to its manufacturing partner’s forthcoming Abbreviated New Drug Application (“ANDA”) for a generic version of Novartis’s patented product. However, the court found no evidence beyond generic statements that Argentum would bear the risk of any such litigation. Next, Argentum argued that once its ANDA was approved, it would lose $10-50 million of profit per year due to the challenged patent. But the court found that Argentum failed to produce sufficient evidence to establish economic injury and that its claims to lost profits were conclusory and speculative. Finally, Argentum argued that an estoppel provision in the IPR statutes constituted injury as it would preclude Argentum from later challenging the Novartis patent. The court noted that estoppel, absent other cognizable harm, is not an injury sufficient for standing.

Editor: Paul Stewart