IP Law Daily, PATENT—Fed. Cir.: PTAB decision upholding Sun Pharma’s hair loss treatment patent affirmed on appeal, (May 8, 2025)

By Saurabh Kashyap, B.A., LL.B., LL.M.

The appellant did not have Article III standing as it failed to establish injury in fact based on potential infringement or competitive harm.

The U.S. Court of Appeals for the Federal Circuit dismissed Incyte Corporation’s appeal from a Patent Trial and Appeal Board decision upholding Sun Pharmaceutical Industries, Inc.’s hair loss treatment patent. The appellate court held that Incyte lacked Article III standing to seek judicial review because it failed to demonstrate a concrete injury in fact. The court rejected Incyte’s reliance on potential infringement liability and the competitor standing doctrine, finding its product development plans too speculative and its evidence of competitive harm insufficient (Incyte Corp. v. Sun Pharmaceutical Industries, Ltd., No. 23-1300 (Fed. Cir. May 7, 2025)).

Background. The appellant, Incyte Corporation, is a biopharmaceutical company engaged in developing treatments for autoimmune and inflammatory diseases. The appellee, Sun Pharmaceutical Industries, Inc., is a multinational pharmaceutical company that acquired the asserted patent from Concert Pharmaceuticals.

The patent at issue, U.S. Patent No. 10,561,659 (the '659 patent), is owned by Sun and discloses a method of treating hair loss disorders, including alopecia areata, using a deuterium-modified version of ruxolitinib. The method claims precise daily dosages—16 mg/day or 24 mg/day—of a compound referred to as Compound (I), in which designated hydrogen positions are replaced with deuterium to enhance metabolic stability. Claims 1–3 cover oral administration of the compound for alopecia areata, while dependent claims 4–21 specify variations. Sun disclaimed claim 8 during post-grant review.

In 2020, Incyte filed a petition for post-grant review (PGR) of all claims of the ’659 patent, asserting that they were unpatentable for obviousness. In May 2022, the Patent Trial and Appeal Board (PTAB) upheld claims 1–7 and 9–21, finding Incyte failed to demonstrate unpatentability. Incyte’s request for rehearing was denied in October 2022. In December 2022, Incyte appealed the Board’s decision to the Federal Circuit under 28 U.S.C. § 1295(a)(4)(A).

Standing requirement. The Federal Circuit began by reaffirming that although standing is not required to initiate a PGR, it is a constitutional prerequisite for appealing a Board decision. A party seeking judicial review must demonstrate an injury in fact that is concrete, particularized, and actual or imminent. The court cited Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016), and Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992), as the governing precedents.

Potential infringement liability. To establish injury in fact based on potential infringement, the court required Incyte to demonstrate concrete plans for future conduct that would create a substantial risk of infringing the ’659 patent. Incyte relied on declarations from its executives, Dr. Jim Lee (head of Inflammation and Autoimmunity), and Dr. Keith Mikkelson (head of Business Development). Both described the company's early-stage efforts to develop a topical deuterated ruxolitinib formulation for alopecia areata.

The appellate court found these plans too speculative. Although Incyte had earmarked a modest amount of funding shortly before filing its appeal, the record showed that the company faced numerous hurdles, including formulation, manufacturing, testing, and regulatory approval, before bringing a product to market. Importantly, Incyte’s declarations failed to explain how the topical formulation would meet the patent’s oral dosage claims of 16 or 24 mg/day. The testimony also lacked evidence of specific concentrations, dosing conversions, or marketing plans. The appellate court concluded that Incyte’s development efforts reflected a “wish to enter the market” rather than a concrete plan with imminent risk of infringement.

The court drew on its precedents in JTEKT Corp. v. GKN Automotive LTD., 898 F.3d 1217 (Fed. Cir. 2018), and Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, 85 F.4th 1377 (Fed. Cir. 2023), which emphasized that general intent or early development activity is insufficient to create standing. The appellate court also distinguished E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996 (Fed. Cir. 2018), where the appellant had concrete manufacturing operations that could infringe the challenged patent.

Supplemental declaration. Incyte attempted to bolster its standing argument by submitting a supplemental declaration from Dr. Lee with its reply brief. The court declined to consider the late-filed evidence, finding no reasonable cause for its delayed submission. It emphasized that standing evidence must be provided at the first appropriate stage, citing Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168 (Fed. Cir. 2017).

Competitor standing doctrine. The court next rejected Incyte’s reliance on the competitor standing doctrine, which can confer standing when government action, such as a regulatory decision, increases competition in a way that predictably harms the challenger. The appellate court explained that patent decisions differ because they confer exclusivity over specific features, not marketwide advantages. Quoting AVX Corp. v. Presidio Components, Inc., 923 F.3d 1357 (Fed. Cir. 2019), the court clarified that a competitor cannot establish injury in fact merely by operating in the same market as a patentee; it must show that the challenged patent harms its own concrete interests.

Incyte failed to show such harm. Although it claimed that Sun’s acquisition of the ’659 patent from predecessor Concert Pharmaceuticals positioned Sun as a future competitor, Incyte had no evidence of current infringing activity or non-speculative development plans covered by the claims.

Concurring opinion. Circuit Judge Todd Hughes filed a separate concurrence agreeing with the result but criticizing the court’s standing jurisprudence as overly rigid, particularly in pharmaceutical patent appeals. He argued that requiring a challenger to be on the brink of commercial launch before standing is recognized discourages early and efficient invalidity challenges. He also noted that Incyte had invested significantly in ruxolitinib development since 2004 and that deuteration is a minimal modification, making the risk of infringement in this context more realistic than speculative.

Conclusion. Thus, the Federal Circuit dismissed Incyte’s appeal for lack of Article III standing, holding that Incyte failed to show a concrete injury sufficient to invoke federal jurisdiction. The ruling leaves in place the PTAB’s decision upholding Sun’s hair loss treatment patent.

The Case is No. 23-1300.

Judge: Moore, K.

Attorneys: Mark J. Feldstein (Garrett & Dunner, LLP) for Incyte Corp. William M. Jay (Goodwin Procter LLP) for Sun Pharmaceutical Industries, Inc.

Companies: Incyte Corp.; Sun Pharmaceutical Industries, Inc.

Cases: Patent FedCirNews USPTO