915 F.3d 764
Fed. Cir.2019Background
- BMS owns U.S. Patent No. 8,476,239 covering stable formulations of CTLA4Ig (abatacept/Orencia®). Momenta petitioned for inter partes review (IPR) seeking to invalidate the patent while developing a biosimilar to Orencia®.
- PTAB instituted review, held trial, and sustained the patent claims. Momenta appealed to the Federal Circuit under 35 U.S.C. § 319.
- After filing the appeal, Momenta signaled it was winding down its Orencia® biosimilar program and in October–November 2018 informed partners it would exit development; later filings showed Momenta delivered formal partial termination notice to Mylan.
- BMS moved to dismiss the appeal for lack of Article III standing and mootness; Momenta argued it retained an injury from PTAB estoppel and a continued economic stake (possible future royalties) and relied on the relaxed standing standard for statutorily authorized appeals.
- The court found Momenta ceased any potentially infringing activity, eliminating any concrete, particularized injury; speculative future royalties or third‑party development were insufficient to sustain Article III jurisdiction.
- The Federal Circuit dismissed the appeal for lack of standing and as moot.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III standing to appeal PTAB decision | Momenta: statutory right to appeal and estoppel under 35 U.S.C. § 315(e) create a concrete interest; continued economic stake (possible royalties) | BMS: Momenta abandoned the biosimilar program; no certainly impending injury; speculative royalties insufficient | No standing — Momenta lacks a concrete, particularized injury after abandoning development |
| Mootness of the appeal | Momenta: remains economically tied to development with Mylan; decision still affects cost/risk choices | BMS: Momenta formally terminated participation; events removed any live controversy | Moot — cessation of potentially infringing activity moots the case |
| Whether estoppel alone supplies injury‑in‑fact | Momenta: estoppel creates legal injury affecting future choices | BMS: estoppel cannot injure a party not engaged in infringing activity; hypothetical future harm is too speculative | Estoppel cannot supply Article III injury where petitioner abandoned activity that could give rise to infringement |
| Effect of statutory right to appeal on Article III floor | Momenta: AIA’s grant of review relaxes standing requirements | BMS: statutory appeal does not eliminate the constitutional injury‑in‑fact requirement | Statute does not displace Article III’s injury‑in‑fact floor; petitioners must still show concrete interest |
Key Cases Cited
- DaimlerChrysler Corp. v. Cuno, 547 U.S. 332 (federal courts limited to actual cases or controversies)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (statutory rights may relax redressability but plaintiff must have concrete, particularized interest)
- Clapper v. Amnesty Int’l USA, 568 U.S. 398 (speculative future injuries from independent actors insufficient for Article III standing)
- Summers v. Earth Island Institute, 555 U.S. 488 (injury‑in‑fact is a hard floor that cannot be removed by statute)
- Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (Article III requires a concrete injury even for statutory violations)
- Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (PTAB parties need not have constitutional standing to initiate IPR, but judicial review remains subject to Article III)
- Consumer Watchdog v. Wisconsin Alumni Research Found., 753 F.3d 1258 (general/public interest without particularized injury does not confer standing to appeal PTAB decisions)
- JTEKT Corp. v. GKN Automotive Ltd., 898 F.3d 1217 (standing may exist for petitioners with concrete plans creating substantial risk of future infringement)
- E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996 (standing where petitioners were commercial competitors with concrete plans and substantial risk of infringement)