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.

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.

Table 1

This article appeared in the 2020 Patent Prosecution Tool Kit.

© 2020 Sterne, Kessler, Goldstein & Fox P.L.L.C.