Pfizer, Inc. v. Lee
811 F.3d 466
Fed. Cir.2016Background
- Wyeth filed U.S. Patent Application No. 10/428,894 (later U.S. Patent No. 8,153,768) in May 2003; patent issued April 10, 2012.
- Patent Term Adjustment (PTA) under 35 U.S.C. § 154(b) awards A-, B-, and C-Delays to compensate PTO-caused prosecution delays; A-Delay stops when the PTO "provides at least one of the notifications under section 132."
- PTO issued a restriction requirement on August 10, 2005 (404 days past the 14‑month deadline). The restriction described 21 invention groups but omitted classification of six dependent claims.
- Wyeth contacted the examiner; the examiner withdrew the flawed restriction and issued a corrected restriction on February 23, 2006 (197 days later). PTO awarded PTA but excluded those 197 days from A-Delay.
- Wyeth/Pfizer sued under 35 U.S.C. § 154(b)(4), seeking inclusion of the 197 days as A-Delay; district court granted summary judgment to the PTO. The Federal Circuit affirmed (majority) with one dissent.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the PTO must count the 197‑day period between the initial, incomplete restriction requirement and the corrected restriction requirement as A‑Delay under § 154(b)(1)(A) | The initial restriction was defective under § 132 (omitted classifications), so it did not "provide" the required notification and A‑Delay continued until the corrected notice; PTO error caused the delay | The initial restriction satisfied § 132 because it identified the broad statutory basis and defined the 21 invention groups (unchanged in the correction), so the A‑Delay clock stopped when the initial restriction was mailed | Court held the initial restriction met § 132’s notice requirement; the 197 days were not PTO A‑Delay, so summary judgment for the PTO affirmed |
| Whether Appellants waived the § 132 notice argument by failing to raise it below | Appellants had sufficiently raised § 132 arguments in briefing and oral argument | PTO argued waiver | Court found no waiver; argument was preserved |
| Whether Chester v. Miller controls (i.e., whether an imprecise office action can still satisfy § 132) | Chester supports finding the initial restriction insufficient because it omitted claim classifications | PTO relied on Chester to show § 132 requires only that applicant be informed of the broad statutory basis and issues to respond to | Court applied Chester: initial restriction gave sufficient notice of the statutory basis and issues, so § 132 satisfied |
| Whether MPEP or § 121 safe‑harbor concerns change the result (consonance / patentability consequences) | Omission undermines the § 121 safe‑harbor and consonance; a complete restriction is required to preserve rights | Examiner’s grouping descriptions were unchanged and applicants could have replied and preserve rights; making the restriction final occurred after applicant response and examiner action | Court held § 121/safe‑harbor concerns did not make the initial restriction invalid for § 132 purposes |
Key Cases Cited
- Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010) (explaining PTA calculation and statutory framework)
- Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990) (Section 132 satisfied if rejection informs applicant of broad statutory basis so applicant can respond)
- White v. United States, 543 F.3d 1330 (Fed. Cir. 2008) (plain statutory language ends inquiry)
- Centech Group v. United States, 554 F.3d 1029 (Fed. Cir. 2009) (APA standard applies to PTO PTA determinations)
- In re Hughes, 345 F.2d 184 (C.C.P.A. 1965) (applicant must be informed of the broad statutory basis for rejection)