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Pfizer v. Lee: A Patent Term Adjustment Double Standard?

In Pfizer v. Lee (No. 2015-1265, January 22, 2016), the Federal Circuit upheld the U.S. Patent and Trademark Office’s (USPTO) determination that the toll period for A-type patent term Business_Timeadjustment (PTA) delay stops upon the mailing of a deficient USPTO paper.  Conversely, by statute, an applicant’s submission of a deficient paper to the USPTO does not stop the toll period for applicant delay that is subtracted from PTA accrued due to USPTO delay.  Before further considering the Pfizer decision and its contrast with applicant delay, let’s start with a reminder of PTA rules.

PTA Overview

35 U.S.C. § 154 provides for three types of USPTO delay in prosecution that entitle a patent to an extension of term beyond the standard term of the patent:

  • A-Delay: accrued when the USPTO does not mail a response to the applicant within time periods provided in 35 U.S.C. 154(b)(1)(A).
  • B-Delay: accrued, per 35 U.S.C. § 154(b)(1)(B), when a patent does not issue within three years of the filing date, subject to reductions upon certain occurrences including the filing of a Request for Continued Examination (RCE), appeal, and applicant-requested delay.
  • C-Delay: derivation proceedings, secrecy orders, and appeals trigger PTA, per 35 U.S.C. § 154(b)(1)(C).

Any accrued A, B, and C type delay is reduced, per 35 U.S.C. § 154(b)(2)(C), by delay caused by the applicant’s failure “to engage in reasonable efforts to conclude prosecution of the application.”  35 CFR § 1.704 elaborates on actions that constitute applicant failure, including identification of fourteen circumstances that trigger applicant delay.  One of these circumstances is identified in 37 CFR § 1.704(c)(7) as an applicant’s “[s]ubmission of a reply having an omission (§ 1.135(c)), in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed.”

Pfizer v. Lee Decision

In Pfizer, the relevant PTA delay at issue was A-Delay when the USPTO does not mail a first action within 14 months of the application’s filing date.  The USPTO mailed a restriction requirement to the applicant, Wyeth Holdings Company (now Pfizer), 404 days after the time period expired for the USPTO to mail an action without accrual of A-Delay.  The patent examiner and applicant agreed by telephone interview that this action was deficient by omitting certain claims from the restriction.  The examiner withdrew the action and mailed a corrected restriction requirement seventeen days after the telephone interview and over six months after the mailing of the original restriction requirement.

Pfizer argued that A-Delay should have accrued until the corrected restriction requirement was mailed because the original action failed to satisfy the notice requirement of 35 U.S.C. § 132.  The USPTO argued that A-Delay should have accrued only until the first restriction requirement was mailed.  The Federal Circuit agreed with the USPTO.  Quoting Chester v. Miller, the Federal Circuit stated that “[s]ection 132 merely requires that an applicant ‘at least be informed of the broad statutory basis for [the rejection of] his claims, so that he may determine what the issues are on which he can or should produce evidence.’”

A Double Standard?

37 CFR § 1.704 provides that an applicant submitting a deficient paper to the USPTO reduces available PTA until the deficiency is corrected.  Conversely, the court decided in Pfizer that the USPTO mailing a deficient paper to the applicant does not accrue PTA (as long as the paper satisfies the § 132 notice requirement).  The court did not acknowledge this discrepancy between deficient applicant action that accrues delay versus deficient USPTO action that does not accrue delay.

For now, in order to help maximize PTA, applicants may be wise to double check filing papers for any omissions before their submission to the USPTO and to double check in a timely fashion USPTO actions for any deficiencies in order to bring them to the USPTO’s attention for correction as soon as possible.

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Christina Sperry is a Mintz patent attorney who drafts and prosecutes patents for clients in the electrical, mechanical, and electro-mechanical fields. She represents companies and academic institutions in the medical technology field and helps protect patent innovations for medical and surgical devices.