Bristol-Myers Squibb Company v. Doll
891 F. Supp. 2d 135
D.D.C.2012Background
- Plaintiffs Bristol-Myers Squibb and Kosan sue to review PTO patent term adjustments (PTA) challenged as based on Wyeth v. Kappos interpretation.
- Court previously remanded thirteen patents to PTO for recalculation per Wyeth; eight counts remained as of Jan. 27, 2012.
- Plaintiffs argued PTO misinterpreted §154(b), tolling until reconsideration; statute of limitations tolled by reconsideration request.
- Court granted summary judgment for plaintiffs on timeliness of appeals; PTO moved for reconsideration; briefing and argument followed.
- Tolling follows Locomotive Engineers and similar caselaw: reconsideration keeps agency action non-final for review; if final, statute runs.
- B-delay is not final until patent grant; A-delay may be reconsidered before grant; final PTA embeds in the issued patent
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether tolling applies to appeals of PTA determinations after reconsideration requests | Wyeth tolls unless statute expressly contravenes | Timeliness begins at grant regardless of reconsideration | Tolling applies; reconsideration does not defeat timely review |
| Whether the 180-day limit runs from grant or other trigger given reconsideration | Limit begins at grant, tolling applies to reconsideration | Limit fixed from grant date, not affected by reconsideration | 180-day period runs from grant; tolling applies to reconsideration timing |
| Whether Congress intended to depart from tolling rule in patent terms cases | Statutory structure shows tolling should apply | Plain language shows limit not tolled by reconsideration | Congress intended tolling to apply; compatibility with 5 U.S.C. §704 discussed |
| Policy implications of tolling PTA reconsiderations | Reconsideration + review avoids duplicative litigation | Could delay patent grant or create inefficiencies | Tolling promotes judicial efficiency; prevents duplicative review |
Key Cases Cited
- United Transp. Union v. Interstate Commerce Comm’n, 871 F.2d 1114 (D.C. Cir. 1989) (tolling and reconsideration interplay in agency review)
- Locomotive Engineers, 482 U.S. 270 (Supreme Court 1987) (tolling rule central to finality and reviewability of agency actions)
- Stone v. INS, 514 U.S. 386 (Supreme Court 1995) (tolling not applied to deportation review; contrasts patent context)
- Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010) (binding interpretation of §154(b) external to tolling)
- Columbia Falls Aluminum Co. v. EPA, 139 F.3d 914 (D.C. Cir. 1998) (tolling from promulgation/denial of regulation)
- Los Angeles SMSA Ltd. P’ship v. FCC, 70 F.3d 1358 (D.C. Cir. 1995) (notice-based tolling considerations)