In 1999, Congress created a system of patent term adjustment (PTA) that adds additional time to patent terms to remedy certain delays caused by the U.S. Patent and Trademark Office (USPTO) in issuing a patent.
Why Review PTA?
The USPTO continues to work on reducing application pendency and inventory of unexamined applications. However, the USPTO’s statistics from 2024 show that only 32% of applications received a first action within 14 months of filing, and 24% of applications had not issued within 36 months of filing. USPTO delays are still prevalent.
PTA: The Basics
- Available for utility or plant applications, not reissue or design applications.
- 35 U.S.C. § 154(b)(1)(A) – PTA granted if any of the following occur (“A delay”):
- USPTO issues an office action or notice of allowance more than 14 months after the application is filed.
- USPTO acts more than four months after applicants file a reply to office action.
- USPTO acts more than four months after a decision on appeal or decision by a federal court finding at least one claim allowable.
- USPTO issues a patent more than four months after payment of the issue fee.
- 35 U.S.C. § 154(b)(1)(B) – PTA granted if the application is pending for more than three years, excluding time consumed by the following (“B delay”):
- Continued examination
- Interference or derivation proceeding
- Imposition of a secrecy order
- Review by USPTO on appeal or by federal court
- Delays in processing requested by the applicant
- 35 U.S.C. § 154(b)(1)(C) – PTA granted if issuance was delayed due to interference or derivation proceeding, imposition of a secrecy order, or appellate review by USPTO or federal court that reversed an adverse determination of patentability (“C delay”).
- PTA is the sum of A, B, and C delays, excluding the following periods of time:
- Overlap between A, B, and C delays
- Patent term specified in a terminal or statutory disclaimer
- Applicant-caused delays such as:
- Taking longer than three months to reply to a USPTO notice or office action.
- Submitting an amendment or other paper after a notice of allowance.
- Submitting a supplemental reply or other paper, other than a supplemental reply or other paper expressly requested by the USPTO, after a reply has been filed.
- Submitting a preliminary amendment or other preliminary paper less than one month before issuance of an office action or notice of allowance that requires the issuance of a supplemental office action or notice of allowance.
- Submitting a reply having an omission.
- Failing to file a petition to withdraw abandonment or revive an application within two months from issuance of a notice of abandonment.
Challenging the USPTO’s Calculation of PTA
- File a request for reconsideration of PTA at the USPTO
- Due two months after patent issuance, with extensions of time available for up to five additional months.
- However, a request to reinstate PTA deducted for periods of time in excess of three months taken to reply to a USPTO notice or office action must be filed prior to issuance, with no extensions of time available.
- File a civil action within 180 days after issuance
- Applicants dissatisfied with the USPTO’s decision on a request for reconsideration have an “exclusive remedy” by civil action within 180 days after the date of the USPTO’s decision. 78 Fed. Reg. 19416; Daiichi v. Lee (Fed. Cir. 2015).
- Ordinary tolling of the 180-day deadline is allowed while awaiting the USPTO’s decision on a request for reconsideration of PTA. Novartis v. Lee (D.D.C. 2012); Bristol-Myers Squibb v. Kappos (D.D.C. 2012).
- But courts have not allowed equitable tolling of the 180-day deadline, e.g., when a significant new PTA (e.g., when a significant new PTA decision is issued). Novartis v. Lee (Fed. Cir. 2014); Actelion v. Kappos (D.D.C. 2013); Daiichi v. Rea (D.D.C. 2013).
Best Practices and Other Tips
- It has been reported that approximately 50% of patents granted in 2024 had applicant-caused delays. Avoiding these delays can preserve a PTA to which a patentee may otherwise be entitled.
- Independently carry out a PTA calculation according to the current rules and case law, and if there is an error, file a petition with the USPTO to challenge the PTA calculation.
- Avoid filing a paper containing only an information disclosure statement (IDS) after a reply has been filed.
- IDS filed after a reply to a restriction requirement and before examination is considered applicant delay. Gilead v. Lee (Fed. Cir. 2015).
- Review patent office communications from counterpart applications in other countries as soon as they are received, and instruct international associates to report such communications as quickly as possible.
- Paper containing only an IDS will not be considered applicant delay if, for example, the documents cited in the IDS were first cited in a communication that was not received more than 30 days prior to the filing of the IDS. 37 C.F.R. § 1.704(d).
- When multiple inventions are claimed, consider making an oral election of species to the examiner.
- Issuance of a written restriction requirement will likely end the period of an A delay sooner than it would end if the first PTO action is a substantive office action.
- To maximize A and/or B delay, consider taking a one-month extension of time and replying to a preexamination notice or restriction requirement at the three-month deadline.
- To maximize a delay, pay the issue fee on the deadline rather than before the deadline.
- Carefully consider the consequences of filing a terminal disclaimer.
- It may or may not negatively affect PTA.
- Preserve the largest-possible PTA in parent applications in the event a terminal disclaimer is filed in later child applications.
- A “first-filed, first-issued, later-expiring claim” cannot be invalidated for obviousness-type double patenting (ODP) by a “later-filed, later-issued, earlier-expiring reference claim” having the same priority date. Allergan v. MSN (Fed. Cir. 2024). This decision limited the scope of a prior decision holding that a patent having PTA can be invalidated for ODP over earlier-expiring patents in the same family. In re Cellect (Fed. Cir. 2023).
- Avoid filing a request for continued examination (RCE).
- Time in “continued examination” is excluded from a B delay, but only for the time before allowance. Novartis v. Lee (Fed. Cir. 2014).
- May still be entitled to PTA for an A or a C delay.
- Consider filing an appeal instead of an RCE to preserve a B delay.
- Avoid filing a supplemental amendment or an amendment after allowance.
- Considered applicant delay.
- If possible, correct problems in the next reply or with an examiner’s amendment.
- Challenge PTA detracted for such amendments when made in reply to a USPTO notice or request.
- Patentees can request reconsideration of PTA based on a deduction for “applicant delay” during a period of time when “there was no identifiable effort” the patentee could have taken to avoid the delay. Supernus v. Iancu (Fed. Cir. 2019).
- Ensure responses to a final office action are proper.
- Reply including “the same arguments that were previously found unpersuasive” for an obviousness rejection and claim amendments related to a different rejection was deemed a failure to engage in reasonable efforts to conclude processing or examination. Mayo v. Iancu (Fed. Cir. 2019).
PTA Around the World
In addition to the U.S., the following countries grant PTA for patent office delays:
This article appeared in the 2025 Life Sciences IP Tool Kit.
