The Federal Circuit recently dismissed an appeal of an adverse IPR decision by a generic pharmaceutical company for lack of Article III standing, finding that the company—which had yet to file an ANDA—had not suffered an injury-in-fact.
The underlying IPR, originally filed by Apotex, involved U.S. Patent No. 9,187,405 (directed to methods of treating multiple sclerosis with the drug Gilenya®). After institution, the proceeding was joined by a handful of other generic developers including the appellant, Argentum. In its final written decision, the Board found that the petitioners had failed to demonstrate invalidity of the ’405 patent. Multiple petitioners appealed, but the patent holder settled with all except Argentum. The patent holder then filed a motion to dismiss Argentum’s appeal on the grounds that Argentum lacked standing.
The Federal Circuit’s decision hinged on whether Argentum had demonstrated a sufficiently concrete injury in fact. Argentum argued that, along with its manufacturing and marketing partner KVK-Tech, Inc. (“KVK”), Argentum faced a real and imminent threat of litigation, as the companies are in the process of filing an ANDA. While the Federal Circuit has previously held that a company intending to file an ANDA may have standing to appeal (discussed here), here, the ANDA would be filed by KVK, not Argentum, and thus Argentum is not at risk of being sued. Argentum presented evidence of the economic investment it had made in developing the drug, but the court rejected this evidence as “conclusory and speculative” at this stage in drug development. As no ANDA had yet been filed, and there was no evidence that Argentum would bear the risk of any infringement suit, the threat of litigation did not create an injury in fact.
Although standing to file dismiss an IPR petition is broad, standing for unsuccessful petitioners to appeal is narrower. See Consumer Watchdog v. Wis. Alumni Research Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014). Generic pharmaceutical developers collaborating to bring an ANDA product to market should be wary of the implications of this decision and should ensure that the same entity submitting the ANDA is named in the PTAB proceeding. Similarly situated companies would also be wise to collect specific evidence of economic investments and/or threats of litigation, and be ready to present that evidence before the Federal Circuit if an appeal arises.