956 F.3d 1374
Fed. Cir.2020Background
- Apotex filed an IPR petition challenging Novartis’s U.S. Patent No. 9,187,405; the PTAB instituted and joined multiple petitioners, including Argentum.
- The Board found Petitioners failed to prove unpatentability and denied Novartis’s contingent motion to amend as moot; Petitioners appealed.
- All appellants except Argentum settled, leaving Argentum as the sole appellant; Novartis moved to dismiss Argentum’s appeal for lack of Article III standing.
- Argentum submitted declarations claiming imminent litigation risk because it and partner KVK-Tech are developing a generic Gilenya® ANDA and investment-backed economic harm; it also argued potential estoppel under 35 U.S.C. § 315(e).
- The Federal Circuit required Argentum to prove injury in fact and held Argentum failed to show a concrete, particularized, and imminent injury; the court dismissed the appeal for lack of Article III standing.
Issues
| Issue | Argentum's Argument | Novartis's Argument | Held |
|---|---|---|---|
| Article III standing — threat of litigation from ANDA activity | Argentum: imminent risk of suit because it and KVK are jointly developing an ANDA; Novartis historically sues ANDA filers | Novartis: any ANDA will be filed by KVK, not Argentum; no concrete plan by Argentum to incur suit | Argentum failed to show imminent, personal risk of suit; threat speculative and insufficient for injury in fact |
| Article III standing — economic injury from investments | Argentum: will suffer substantial lost profits and has invested significant resources toward generic Gilenya® and ANDA | Novartis: alleged economic harm is speculative, not particularized to Argentum, and lacks documentary support | Court found investment and profit-loss assertions conclusory and speculative; no concrete economic injury shown |
| Article III standing — estoppel under 35 U.S.C. § 315(e) | Argentum: denial of review will subject it to estoppel in future infringement litigation | Novartis: estoppel threat depends on likelihood of suit, which is not established | Court held estoppel argument cannot supply injury where no underlying risk of suit; § 315(e) not a standalone injury in fact |
Key Cases Cited
- Amerigen Pharm. Ltd. v. UCB Pharma GmBH, 913 F.3d 1076 (Fed. Cir.) (Article III standing required to appeal PTAB decisions)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (U.S.) (framework for injury-in-fact requirement)
- Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (U.S.) (injury must be concrete and particularized)
- Phigenix, Inc. v. ImmunoGen, Inc., 845 F.3d 1168 (Fed. Cir.) (Article III standing is threshold when sole appellant remains)
- JTEKT Corp. v. GKN Automotive Ltd., 898 F.3d 1217 (Fed. Cir.) (appellant must supply proof of injury in fact to the appellate record)
- Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., 889 F.3d 1274 (Fed. Cir.) (standing can exist where the appellant itself faces imminent risk of suit)
- AVX Corp. v. Presidio Components, Inc., 923 F.3d 1357 (Fed. Cir.) (estoppel under § 315(e) insufficient without underlying risk of infringement activity)
- General Electric Co. v. United Techs. Corp., 928 F.3d 1349 (Fed. Cir.) (speculative economic harm fails to establish injury in fact)
- Consumer Watchdog v. Wis. Alumni Research Found., 753 F.3d 1258 (Fed. Cir.) (Article III standing required on appeal even if not required before the agency)