Background
Patent term adjustment (PTA) is a statutory mechanism that extends a patent’s term when the USPTO takes an unusually long time to issue it. Under 35 U.S.C. § 154(b), a patent owner is entitled to extra term for delays caused by the USPTO — but the statute also allows the USPTO to reduce PTA for periods when the applicant failed to engage in “reasonable efforts to conclude prosecution.”
Supernus Pharmaceuticals filed a U.S. patent application and a corresponding European application in 2006. In February 2011, Supernus filed a Request for Continued Examination (RCE) to keep its U.S. application alive. In August 2012 — nearly 18 months later — the European Patent Office notified Supernus’s European counsel that a third party had filed an opposition to the European patent. About 100 days after that notification, Supernus filed a supplemental Information Disclosure Statement (IDS) with the USPTO to disclose the EPO opposition.
The USPTO reduced Supernus’s PTA by 546 days, counting both the time between the RCE and the EPO notification (when Supernus had no idea the opposition existed) and the 100-day period between notification and the IDS filing. Supernus argued that only the 100-day period after notification could properly be counted as applicant delay — it could not have disclosed information it did not yet have.
The Court’s Holding
The Federal Circuit agreed with Supernus. The court held that a PTA reduction for applicant delay must be “equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution.” Critically, the court held that the USPTO cannot reduce PTA by a period during which “there is no identifiable effort in which the applicant could have engaged to conclude prosecution.”
The 18-month period between the RCE filing and the EPO notification was entirely outside Supernus’s control — the company had no knowledge of the opposition and no way to disclose it. The court found that the USPTO’s rule mechanically counting all time from the RCE filing as applicant delay was an unreasonable interpretation of the statute. Only the 100-day period between Supernus’s receipt of the EPO notification and its IDS filing could properly be considered applicant delay subject to PTA reduction.
Key Takeaways
- PTA reductions for applicant delay are limited to periods during which the applicant actually had the ability to take action to advance prosecution — delay cannot be charged for periods in which no action was possible.
- Filing a supplemental IDS after an RCE does not automatically trigger a PTA reduction for the entire period from the RCE filing to the IDS; the delay clock only starts when the applicant gains knowledge of the information that needs to be disclosed.
- Patent applicants who have been charged PTA reductions for periods before they received notice of foreign-office actions or third-party events should review those calculations for potential errors.
- The USPTO subsequently issued new rules and procedures to implement the Supernus decision, revising how PTA is calculated across the examination system.
Why It Matters
Patent term adjustment can be worth substantial money, particularly for pharmaceutical and biotechnology patents where a few additional months of exclusivity can mean hundreds of millions of dollars in sales. The Supernus decision corrected a systematic practice by the USPTO that unfairly penalized applicants for delays that were entirely outside their control.
After the decision, the USPTO updated its rules in 2020 to conform PTA calculations to the Federal Circuit’s reasoning. This regulatory change affected thousands of pending and recently issued patents, giving many patent holders the opportunity to seek recalculation of their PTA. For practitioners, the case underscores the importance of monitoring PTA calculations during prosecution and challenging reductions that appear to count periods of unavoidable delay against the applicant.