989 F.3d 1375
Fed. Cir.2021Background
- Janssen sued Mylan for infringement of U.S. Patent No. 9,439,906; within six months Mylan petitioned for inter partes review (IPR) raising four obviousness (§103) grounds.
- Janssen opposed institution, arguing substantial overlap with two co‑pending district‑court cases (one against Mylan, one against Teva) and that the district courts would likely reach final judgment before an IPR final written decision.
- The Patent Trial and Appeal Board applied the Fintiv factors and denied institution, relying in part on an imminent Teva trial date and concluding institution would be an inefficient use of resources.
- Mylan appealed the denial and sought mandamus, arguing the Board (1) adopted the Fintiv standard without notice‑and‑comment rulemaking (ultra vires), (2) effectively shortened the §315(b) filing period, and (3) violated due process by relying on co‑pending litigation to which Mylan was not a party.
- The Federal Circuit considered (a) whether it had jurisdiction to hear a direct appeal of a denial of institution, and (b) whether mandamus was available and warranted.
Issues
| Issue | Plaintiff's Argument (Mylan) | Defendant's Argument (Janssen/PTO) | Held |
|---|---|---|---|
| Jurisdiction over direct appeal of denial of institution | The denial is reviewable on appeal | §314(d) bars appeals of institution decisions; §1295(a)(4) does not override §314(d) | Appeal dismissed for lack of jurisdiction (§314(d) bars appeals from denials of institution) |
| Availability of mandamus to review denial of institution | Mandamus is available to vindicate rights and correct Board's adoption/application of Fintiv | Mandamus is extraordinary; jurisdiction for mandamus exists only in narrow circumstances | Court has mandamus jurisdiction to protect its prospective appellate jurisdiction, but availability is narrow |
| Merits: ultra vires rulemaking, §315(b) time‑bar, and due process challenge | Fintiv was adopted without notice‑and‑comment and shortens filing period; using Teva litigation violated Mylan's due process | Director has broad discretion to deny institution; no clear right to IPR; no deprivation of protected liberty/property interest | Mandamus denied: Mylan failed to show a clear and indisputable right; statutory and time‑bar claims fail; due process claims not colorable |
Key Cases Cited
- Insurance Corp. of Ireland v. Compagnie des Bauxites de Guinee, 456 U.S. 694 (statutory jurisdiction limits federal courts)
- St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014) (§314(d) bars appeals from denials of institution)
- Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016) (denials of institution are committed to agency discretion)
- SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018) (interpretation of IPR statutory scheme and petition’s centrality)
- Heckler v. Chaney, 470 U.S. 821 (1985) (agency’s decision not to initiate enforcement is presumptively unreviewable)
- Cheney v. United States Dist. Court for D.C., 542 U.S. 367 (2004) (standards for issuing mandamus)
- Telecommunications Research & Action Ctr. v. FCC, 750 F.2d 70 (D.C. Cir. 1984) (All Writs Act and protection of prospective jurisdiction)
- In re Tennant, 359 F.3d 523 (D.C. Cir. 2004) (limits on prospective jurisdiction and mandamus)
- Morales v. Trans World Airlines, Inc., 504 U.S. 374 (1992) (specific statutes govern over general ones)
- In re Power Integrations, Inc., 899 F.3d 1316 (Fed. Cir. 2018) (prior mandamus petitions challenging aspects of institution denied)