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 (PTO) in issuing a patent.
Why Review PTA?
More than half of all patents granted in December 2019 were entitled to PTA, with an average PTA of about 142 days. https://www.uspto.gov/dashboards/patents/main.dashxml.
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”)
- PTO issues an office action or notice of allowance more than 14 months after the application is filed.
- PTO acts more than four months after applicants file a reply to office action.
- PTO acts more than four months after a decision on appeal or decision by a federal court finding at least one claim allowable.
- PTO 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 PTO 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 PTO 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 PTO notice or office action.
- Abandonment of the application or late payment of the issue fee.
- Failing to file a petition to withdraw abandonment or revive an application within two months from issuance of a notice of abandonment.
- Converting a provisional application to a nonprovisional application.
- 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.
- Submitting a supplemental reply or other paper, other than a supplemental reply or other paper expressly requested by the PTO, after a reply has been filed.
- Submitting an amendment or other paper after a notice of allowance.
Challenging the PTO’s Calculation of PTA
- File a request for reconsideration of PTA at the PTO.
- 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 PTO 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 PTO’s decision on a request for reconsideration have an “exclusive remedy” by civil action within 180 days after the date of the PTO’s decision. 78 Fed. Reg. 19416; Daiichi v. Lee (Fed. Cir. 2015).
- Ordinary tolling of the 180-day deadline is allowed while awaiting the PTO’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 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
- Independently carry out a PTA calculation according to the current rules and regulations, and if there is an error, file a petition with the PTO to challenge the PTA calculation.
- 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 vs. 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).
- 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 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, e.g., 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 A delay sooner than it would have ended 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 pre-examination notice or restriction requirement at the three-month deadline.
- To maximize B delay, pay the issue fee on the deadline rather than before the deadline.
- Carefully consider the consequences of filing a terminal disclaimer.
- May or may not negatively affect PTA.
- Does not affect patent term extension granted for delays related to regulatory review by the U.S. Food and Drug Administration. Merck v. Hi-Tech (Fed. Cir. 2007).
- Preserve the largest possible PTA in parent applications in the event a terminal disclaimer is filed in later child applications.
- Avoid filing a request for continued examination (RCE).
- Time in “continued examination” is excluded from B delay, but only for the time before allowance. Novartis v. Lee (Fed. Cir. 2014).
- The RCE period is not ended by an interference proceeding. Mayo v. Iancu (Fed. Cir. 2019).
- May still be entitled to PTA for A or C delays.
- Consider filing an appeal instead of an RCE to preserve 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 PTO notice or request.
PTA Around the World
In addition to the U.S., the following countries also grant PTA for patent office delays.
[View full Patent Prosecution Tool Kit]