Exelixis, Inc. v. Kappos
906 F. Supp. 2d 474
E.D. Va.2012Background
- PTA provisions under Uruguay Round Agreements Act and AIPA altered patent term from 17 to 20 years, measured from filing date, with PTA for PTO delays and potential reductions for applicant delays.
- Exelixis owns US Patent No. 7,989,622 (PI3K inhibitors) with application filed Jan 15, 2008.
- §154(b)(1)(A) and (B) govern PTA and include a 3-year clock that tolls for certain events (e.g., RCE) to protect a roughly 17-year term from issuance.
- RCE filed Apr 11, 2011 after a Final Rejection and before patent issuance; Exelixis amended and added claims; patent issued Aug 2, 2011.
- PTO calculated PTA as 368 days total: A delay 344 days, B delay 85 days, C delay 0, and a 61-day C reduction; PTO treated 114 days of RCE time as subtracted from B delay.
- Dispute centered on whether RCE time filed after the 3-year period should reduce B delay; court ultimately held it should not.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does §154(b)(1)(B) require reducing PTA for RCE time filed after the 3-year period? | Exelixis argues RCE time after the 3-year window should be subtracted from B delay. | PTO argues any RCE time is excluded from B delay calculation regardless of filing within or after the window. | RCE after 3-year window does not reduce PTA; B delay computed from 3-year end to issuance (199 days) is proper. |
| Should RCE tolling apply only if filed within the 3-year period and not affect PTA otherwise? | Exelixis contends RCE tolling only; no post-window PTA impact. | PTO reads B to subtract RCE time from PTA regardless of timing. | Yes—RCE tolls the 3-year period if filed within the window but does not reduce PTA after the window. |
| Is PTO's construction consistent with statutory text and purpose? | Plain language requires tolling, not post-window deduction. | PTO's interpretation aligns with avoiding stretching of PTA, citing purpose of no more than 3-year pendency. | PTO's interpretation is not in accordance with law; court adopts the tolling view, rejects subtraction beyond window. |
Key Cases Cited
- Wyeth v. Dudas, 580 F. Supp. 2d 138 (D.D.C. 2008) (not included in list due to lack of official reporter citation)
- Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010) (rejects greater-of-A-or-B rubric; §154(b)(2)(A) when overlap)
- Landreth Timber Co. v. Landreth, 471 U.S. 681 (1985) (statutory language governs unless contrary intent shown)
- U.S. v. Ron Pair Enterprises, Inc., 489 U.S. 235 (1989) (plain language governs unless extraordinary purpose shown)
- Cathedral Candle Co. v. U.S. Int'l Trade Comm'n, 400 F.3d 1352 (Fed. Cir. 2005) (Skidmore deference may apply when ambiguous)
- Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010) (statutory language clear; no deference to PTO where unambiguous)
- Almendarez-Torres v. United States, 523 U.S. 224 (1998) (title and heading can aid statutory interpretation)
- Mohamad v. Palestinian Authority, 132 S. Ct. 1702 (2012) (legislation language governs over history)
- Badaracco v. Comm’r of Internal Revenue, 464 U.S. 386 (1984) (courts cannot rewrite statutes for policy)