Phigenix, Inc. v. Immunogen, Inc.
845 F.3d 1168
| Fed. Cir. | 2017Background
- Phigenix petitioned for inter partes review (IPR) of U.S. Patent No. 8,337,856, challenging claims 1–8 as obvious; the PTAB found those claims nonobvious.
- ImmunoGen is the patent assignee; Genentech holds an exclusive license and commercializes Kadcyla® under that license.
- Phigenix is a biotech company that owns U.S. Patent No. 8,080,534 and seeks to monetize its portfolio through licensing; it claims competition with ImmunoGen/Genentech and alleges economic harm from the ’856 patent.
- After the PTAB decision, Phigenix appealed to the Federal Circuit; ImmunoGen moved to dismiss for lack of Article III standing, arguing Phigenix failed to show an injury in fact.
- Phigenix submitted declarations and a lawyer’s letter asserting licensing-encumbrance and lost revenue theories, but did not allege infringement risk, actual licenses to the same licensees, or imminent harm.
- The Federal Circuit held Phigenix failed to meet the summary-judgment-level burden to prove a concrete, particularized injury and dismissed the appeal for lack of standing.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Phigenix has Article III standing to appeal the PTAB decision | The existence of ImmunoGen’s ’856 patent has encumbered Phigenix’s licensing efforts and caused economic injury; invalidation would increase Phigenix’s licensing revenue | Phigenix has not alleged infringement risk, prospective licensees, or other concrete and particularized injury; its declarations are conclusory and unsupported | No standing; Phigenix failed to show a concrete, particularized injury in fact |
| Whether statutory right to appeal (35 U.S.C. §141(c)) suffices for Article III standing | Statutory appeal right and Spokeo’s recognition of procedural-right injuries support standing | A statutory right to appeal does not satisfy Article III’s injury requirement by itself | Rejected; statutory appeal right does not replace Article III injury requirement |
| Whether PTAB estoppel (35 U.S.C. §315(e)) creates an Article III injury | Estoppel could impair Phigenix’s ability to provide contractual warranties, causing injury | Phigenix is not engaged in activities that would give rise to infringement suits; estoppel alone does not create injury | Rejected; estoppel does not create injury on these facts |
| Standard and timing for proving standing in appeals from final agency action | Phigenix relied on declarations produced after PTAB and in briefing | ImmunoGen argued that summary-judgment-level evidence must be presented early and meet Rule 56 standards | Court applied summary-judgment burden: appellant must show standing with record or supplemental evidence at earliest appropriate time; Phigenix failed to meet it |
Key Cases Cited
- DaimlerChrysler Corp. v. Cuno, 547 U.S. 332 (2006) (federal courts must assure litigants’ Article III standing)
- Massachusetts v. EPA, 549 U.S. 497 (2007) (party appealing agency action must show actual or imminent injury)
- Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016) (injury-in-fact must be concrete and particularized)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (three-part standing test; burden of proof principles)
- Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016) (not every IPR appellant has constitutional standing to sue)
- Sierra Club v. EPA, 292 F.3d 895 (D.C. Cir. 2002) (summary-judgment-style burden applies to standing in agency-review appeals)
- Consumer Watchdog v. Wis. Alumni Research Found., 753 F.3d 1258 (Fed. Cir. 2014) (appellant must show injury in fact when seeking judicial review of agency action)