Janssen Pharmaceutica, N v. v. Kappos
928 F. Supp. 2d 102
D.D.C.2013Background
- Janssen filed suit challenging USPTO's calculation of A-delay for the '356 patent and how term adjustment was determined.
- Suit was transferred to this court after initial filing in E.D. Va.; Defendants moved to dismiss as untimely.
- Court holds petitions for reconsideration toll the §154(b)(4)(A) 180‑day filing deadline.
- PTA process involves A-delay and B-delay; here only A-delay challenged.
- Patent issued June 22, 2010; final PTA determination and subsequent reconsideration petitions culminated in 2011 director decisions.
- Plaintiff filed suit in E.D. Va. September 9, 2011; district court transferred and then denied without prejudice on timeliness, leading to current decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether tolling applies to §154(b)(4)(A) timeliness | Plaintiff tolls via 1.181 petitions | Defendants reject tolling for §154(b)(4)(A) | General tolling rule applies |
| Whether §154(b)(4)(A) is jurisdictional or a claim‑processing rule | Tolling governs filing period | Statute should be treated as jurisdictional | Tolling applicable regardless; issue avoided |
| Whether 1.181 petitions toll the 180‑day deadline | 1.181 petitions toll the period | Petitions do not toll §154(b)(4)(A) deadline | 1.181 petitions toll the 180‑day period |
| Whether 1.181 and 1.705(d) tolling are distinguishable for tolling purposes | Both toll; serial petitions possible | Policy concerns merit distinction | No principled distinction; tolling treated the same |
| Timeliness of Janssen's suit given final Director decision | Filed within tolled period | Timeliness issue unresolved | Complaint timely filed |
Key Cases Cited
- Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375 (U.S. 1994) (subject-matter jurisdiction framework; presumption against jurisdictional bars)
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (plausibility standard for pleading; not mere conclusory allegations)
- Twombly v. Bell Atl. Corp., 550 U.S. 544 (U.S. 2007) (pleading requires plausibility, not just possible facts)
- Ward v. D.C. Dep’t of Youth Rehab. Servs., 768 F. Supp. 2d 117 (D.D.C. 2011) (proper pleading and evidentiary standards in agency actions)
- Wright v. Foreign Serv. Grievance Bd., 503 F. Supp. 2d 163 (D.D.C. 2007) (liberal construction of complaints at 12(b)(1) stage)