Mandatory USPTO PIER Pilot Creates New Risks for PCT National Stage Filings

Key Takeaways

• The USPTO’s new PIER pilot program requires applicants with selected § 371 applications to affirmatively respond to a PIER Request for Information (RFI) by electing examination, delaying examination, or abandoning the application. Participation is mandatory for the selected applications, and failure to timely respond to the PIER RFI results in automatic abandonment of the application.
• Electing the program’s 12-month examination delay may significantly reduce patent term adjustment by stopping the USPTO’s first-action PTA clock and creating applicant-caused delay. These PTA reductions may carry substantial commercial consequences for high-value pharmaceutical and biotechnology assets.
• The PIER program effectively forces applicants to make prosecution and commercialization decisions much earlier in the national stage process. Applicants should evaluate in advance whether bypass continuations under § 111(a) or direct § 371 entry better align with their prosecution and patent term strategy.

The United States Patent and Trademark Office’s new PCT Informed Examination Request (PIER) pilot program creates several prosecution and patent term adjustment (PTA) issues for applicants entering the U.S. national stage under 35 U.S.C. § 371. The program requires selected applicants to affirmatively elect whether to proceed with examination, defer examination for up to 12 months or abandon the application altogether. As failing to respond results in abandonment — and electing the delay option may substantially reduce PTA — applicants should evaluate whether direct § 371 entry still makes sense for important cases before receiving a PIER RFI.

In this alert, we outline the program’s key procedural requirements, PTA implications and strategic considerations for applicants and patent prosecutors.

PIER Pilot Program Requirements for § 371 National Stage Applications When the USPTO issues a PIER Requirement for Information (RFI) for a selected application, the applicant must file Form PTO/SB/478 within a two-month window (extendable for up to an additional four months). Only the form is required for response, as the USPTO already has the PCT application, the International Search Report (ISR) and the Written Opinion.

On the form, respondents must select one of three choices: to continue forward with the U.S. national stage processing; request a delay for up to 12 months; or expressly abandon the application.

Applicant selection is at the sole discretion of the USPTO, and there is no mechanism for applicants to opt-out or petition for removal. The program specifically targets unexamined § 371 national stage patent applications that have completed pre-examination processing. It does not apply to plant, design or § 111(a) applications. The RFI acts as a formal Office action under 35 U.S.C. § 132, and failing to respond within the designated time frame results in automatic abandonment of the patent application.

Patent Term Adjustment Risks Under the PIER Pilot Program

The PIER program creates two distinct patent term adjustment consequences that applicants — especially pharmaceutical and biotechnology companies with high-value assets — should carefully evaluate before electing the 12-month delay option:

1. RFI mailing stops the USPTO’s first-action PTA clock. The RFI mailing will be treated as the date the USPTO satisfied its first-action obligation under 35 U.S.C. § 154(b)(1)(A)(i) and 37 CFR § 702(a)(1). This means the USPTO’s 14-month A-delay clock stops when the RFI is mailed, potentially reducing A-delay PTA that might otherwise have accrued if examination had proceeded directly to a substantive first Office action.
2. Electing the delay period creates applicant-caused PTA reduction. If the applicant elects the 12-month delay option, the USPTO will treat that period as a failure to engage in “reasonable efforts to conclude prosecution” under 35 U.S.C. § 154(b)(2)(C)(i), (iii) and 37 CFR § 1.704(c). As a result, the entire 12-month deferral is charged as applicant delay and will be deducted from any PTA earned on the application.

For high-value pharmaceutical and biotechnology assets, the PTA consequences associated with the PIER program may carry outsized commercial significance given the value often tied to patent life and exclusivity. Electing the 12-month delay without a clear business reason may carry financial consequences that dwarf the cost of simply proceeding with examination.

Key Action Items for Patent Prosecutors

Beyond the PTA implications, the PIER Pilot Program requires immediate attention to several prosecution management issues — particularly for pending § 371 national stage applications that may be selected for the program. If a PIER RFI is issued, applicants and counsel should be ready to respond quickly on several fronts:

• Docket monitoring: All pending § 371 national stage applications that have completed pre-examination processing should be flagged immediately as potential PIER targets. A missed RFI will result in abandonment with no revival under 37 CFR § 1.137 (deliberate abandonment cannot be considered unintentional).
• Power of attorney: Confirm that a power of attorney (POA) is on file for all § 371 national stage applications. Without a POA, counsel cannot timely respond to the RFI within the two-month response window. The POA is required because the PIER RFI involves making major, binding legal decisions. If necessary, the PIER RFI may also be signed directly by the applicant.
• Commercial readiness: The program forces applicants to make an early commercialization and prosecution decision before substantive U.S. examination begins. Applicants should decide in advance how they want to handle key national stage cases if a PIER RFI is issued. The ISR and Written Opinion usually provide a  reliable preview of rejections likely to arise during U.S. examination.
• Preliminary amendment opportunity: If proceeding with examination, consider whether a preliminary amendment to address ISR-cited prior art can put the application in better condition before the Examiner begins substantive examination.  However, a preliminary claim amendment is not required at the time of examination election.
• IDS timing: References cited in the PCT international phase will only be printed on a resulting patent if the applicant separately cites them on an IDS in compliance with 37 CFR §§ 1.97 and 1.98. File the initial IDS at least one month before the first action on the merits to avoid an additional applicant delay PTA charge.
• Abandonment signature requirement: When the express abandonment checkbox is selected on Form PTO/SB/478, the form must be signed by the applicant directly under 37 CFR § 1.33(b)(1) or (b)(3) — not by the registered practitioner acting in a representative capacity — unless the abandonment is made in connection with filing a continuing application. This procedural requirement can create timing complications and must be anticipated before the deadline arrives.
• Pre-publication abandonment: If the client’s goal is to avoid publication, a petition under 37 CFR § 1.138(c) must be recognized by the appropriate USPTO personnel more than four weeks prior to the projected publication date. This petition must be submitted as a separate request accompanying Form PTO/SB/478.

An Alternative Filing Path: Bypass Continuations Under § 111(a)

Applications filed under 35 U.S.C. § 111(a) are categorically excluded from the PIER Pilot Program. This exclusion makes bypass continuations — U.S. applications filed under § 111(a) that claim priority to a PCT application as a continuation, divisional, or continuation-in-part — an increasingly attractive alternative to direct § 371 national stage entry, particularly for high-value applications where PIER exposure or PTA erosion is a concern.

For more information or guidance regarding the PIER Pilot Program, PTA implications or national stage filing strategy considerations, contact Michelle McMullen, Rebecca Endsley or your preferred Polsinelli attorney.