Incyte Corp. v. Sun Pharm. Indus., Inc
Authored by: Jeremy J. Gustrowsky
In a recent decision, the Federal Circuit dismissed Incyte Corporation’s appeal in its patent dispute with Sun Pharmaceutical Industries, Inc., highlighting the strict requirements for Article III standing in patent cases. Incyte had challenged the validity of U.S. Patent No. 10,561,659, which covers methods of treating hair loss disorders like alopecia areata using specific dosages of a deuterated version of the drug ruxolitinib. Although Incyte sought to overturn the Patent Trial and Appeal Board’s (PTAB) decision upholding the patent, the court never reached the merits of the case—instead, it found that Incyte lacked the necessary standing to appeal.
The crux of the issue was whether Incyte could show a “concrete plan” to develop a product that would put it at substantial risk of infringing the ‘659 patent. Incyte had recently allocated a small amount of funding to early-stage development of both deuterated and non-deuterated ruxolitinib products for alopecia areata, but the court found these efforts too speculative. The company faced significant scientific and regulatory hurdles, and its declarations failed to provide specifics about how its product would meet the patent’s dosage requirements. The court emphasized that a mere intention or hope to develop a potentially infringing product, without concrete steps or clear plans, is not enough to establish the “injury in fact” required for standing.
Incyte also argued that it should have standing under the “competitor standing” doctrine, which sometimes allows a party to challenge government actions that benefit a competitor and harm the challenger. However, the court explained that this doctrine typically applies in regulatory contexts where government action directly affects market competition, not in patent cases where the harm is more speculative unless the challenger is already using or clearly planning to use the patented technology.
A concurring opinion agreed with the outcome but expressed concern that the Federal Circuit’s current approach sets an especially high bar for standing in pharmaceutical patent cases, potentially making it harder for companies to challenge patents before investing heavily in product development. For now, however, the message is clear: without specific, concrete plans that put a company at real risk of infringement, the doors to federal court review remain closed.