Your patent may be entitled to a later expiration date if the U.S. Patent and Trademark Office (USPTO) characterized time periods during which you could not engage in reasonable efforts to conclude prosecution as “applicant delay” when calculating your patent term adjustment (PTA).
The U.S. Court of Appeals for the Federal Circuit recently curtailed the USPTO’s ability to reduce PTA 1 because of so-called “applicant delay” in its January 23, 2019 decision in Supernus v. Iancu.
In light of these developments, applicants should consider whether any of their patents may be entitled to additional PTA, and therefore later expiration dates. Reconsideration of the PTA accorded a patent can be requested in an appropriate petition but the time to file such petitions is of the essence, as they must be made within two months of patent issuance, with extensions of up to five months. See 37 C.F.R. 1.705.
At this time, we do not expect the USPTO to adopt ad hoc procedures for those who want to request reconsideration of PTA for patents that issued more than seven months ago.
Background on the Supernus Decision
Supernus, a pharmaceutical company, filed a Request for Continued Examination (RCE) of a patent application after receiving a final rejection. While Supernus awaited a response from the USPTO, 546 days after the RCE was filed, a Notice of Opposition (NO) with related prior art was filed against Supernus’s European counterpart of the patent-at-issue.
One hundred days after the NO was filed, while still awaiting USPTO correspondence, Supernus filed an Information Disclosure Statement (IDS) notifying the USPTO of the NO and the related prior art. 2 The following graphic illustrates these events:
After Supernus’s U.S. patent issued, the USPTO held that the entire period from the RCE filing to the NO IDS filing (646 days) constituted applicant delay, which it deducted from over 2,000 days of USPTO delay that occurred during prosecution.
Supernus filed a Request for Reconsideration of PTA and argued that 546 days of the 646-day period were improperly deducted from the PTA total. The USPTO rejected Supernus’s argument under 37 C.F.R. 1.704. Supernus then appealed to the U.S. District Court for the Eastern District of Virginia, which affirmed the USPTO’s decision.
Supernus appealed again to the Federal Circuit, which reversed the District Court and held that because the NO did not exist during the first 546 days of the 646 day period, Supernus could not have taken “reasonable efforts to conclude examination” during those 546 days, and thus “[t]he USPTO’s additional 546-day assessment as applicant delay [under 37 C.F.R. 1.704] is contrary to the plain meaning of [35 U.S.C. § 154(b)(2)(C)(i)] because the 646-day total reduction is not equal to a period of time during which Supernus failed to engage in reasonable efforts to conclude prosecution.”
How the Supernus Decision Could Change Things
Unlike the Federal Circuit’s 2014 decision in Novartis AG v. Lee, which merely held the time between a patent application’s allowance and issuance may not be reduced from the PTA total, Supernus potentially implicates a myriad of circumstances where the USPTO improperly reduced PTA because it determined an applicant “fail[ed] to engage in reasonable efforts to conclude prosecution.”
Such circumstances may include but are not limited the USPTO assessing applicant delay when an applicant files papers notifying the USPTO of newly discovered prior art and/or new concurrent proceedings.
What Could Come Next
In the aftermath of Novartis, the USPTO solicited comments from the public regarding proposed amendments to its PTA rules and eventually promulgated a final rule amending the PTA rules to reflect the decision. That process took roughly one year and the USPTO did not provide patentees with a mechanism to retroactively seek PTA outside of the timing guidelines set forth in 37 C.F.R. 1.705.
Accordingly, if the USPTO takes the same approach with Supernus, there may not be any mechanism other than the typical petition process to address any improper PTA determinations by the USPTO. However, as noted above, the petition process is time-barred if a patent issued more than seven months ago.
- The USPTO adjusts—i.e., extends—a patent’s nominal expiration date when USPTO delays during prosecution (e.g., waiting too long to issue an Office Action) exceed the applicant’s delays (e.g., waiting too long to respond to an Office Action).
- Supernus had a duty to disclose any information potentially relevant to the patentability of its patent application to the USPTO.