TAKEAWAY: For purposes of calculating patent term adjustment (PTA), a declaration of an interference is not tantamount to allowance, and the time period from termination of the interference to mailing of a Notice of Allowance is not included in PTA if a Request for Continued Examination (RCE) was previously filed.

In Mayo Foundation for Medical Education and Research v. Iancu, decided on September 16, 2019, the U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling on the U.S. Patent and Trademark Office’s (USPTO’s) calculation of patent term adjustment (PTA). Specifically, the Federal Circuit held that the time period between termination of an interference and the date of mailing of a Notice of Allowance, where a Request for Continued Examination (RCE) has previously been filed, is not eligible for PTA.

The patent term statute entitles an applicant to PTA for each day the application is pending beyond three years from the effective filing date, referred to as “B Delay” (35 U.S.C. § 154(b)(1)(B)). However, B Delay is subject to several exclusions, including “any time consumed by continued examination of the application” requested by the applicant, i.e., by filing an RCE. Following the Federal Circuit’s 2014 ruling in Novartis AG v. Lee, the USPTO clarified that the RCE time excluded from PTA calculations extends from the RCE filing date to the Notice of Allowance mailing date, and that the time period between allowance and issuance may add PTA. This serves as the backdrop to Mayo v. Iancu.

In 2009, Mayo Foundation for Medical Education and Research filed a patent application covering antibodies useful for treating conditions characterized by immunosuppression. In the course of prosecution, Mayo filed an RCE in September 2011 along with remarks suggesting an interference with a patent. An interference was declared in February 2012 and a decision to award priority to Mayo’s application became final in April 2014. The application was then returned to the examiner, who conducted a further prior art search and issued an Office Action rejecting the claims under double patenting. The examiner eventually withdrew the rejection and issued a Notice of Allowance in November 2014. The patent issued in March 2015 with 621 days of PTA, which did not include any added term for B delay.

Mayo argued that the time period after termination of the interference should have been included as B delay in the PTA calculation. Mayo argued that, because the USPTO’s regulations require an application “otherwise be in condition for allowance” before an interference is declared, the declaration of interference was tantamount to a Notice of Allowance. Based on this rationale, Mayo contended that the time after the interference declaration should be eligible for PTA. The USPTO responded that a declaration of an interference does not close prosecution, as the USPTO’s operating procedures allow examination to continue after termination of an interference.

The district court and the Federal Circuit both agreed with the USPTO. The Federal Circuit reasoned that the USPTO’s regulations as a whole do not hold that a declaration of an interference amounts to allowance, because the regulations explicitly allow the Patent Trial and Appeal Board (PTAB) to recommend further action by the examiner after remand. The Federal Circuit also sided with the USPTO’s position that Mayo’s proposed rule, which would have required a determination of when the USPTO deems the claims allowable, could lead to “an unduly burdensome, fact-intensive inquiry.” Based on the foregoing, the Court held that the RCE time did not end until the USPTO mailed a Notice of Allowance.

This case reaffirms the Court’s decision in Novartis that the “time consumed by continued examination” ends when a Notice of Allowance is mailed. The case also serves as a reminder that, in a procedural dispute, an appellant’s position that requires “an unduly burdensome, fact-intensive inquiry” might be disfavored by the Court.