Patent Term Adjustment

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.

This article appeared in the 2020 Patent Prosecution Tool Kit.