CAFC Affirms Calculation of Patent Term Adjustment

Last week, the United States Court of Appeals for the Federal Circuit issued an opinion in Mayo Foundation for Medical Education and Research v. Iancu, No. 2018-2031 (September 16, 2019). The Court held the PTO’s interpretation of 35 U.S.C. § 154(b)(1)(B)(i) regarding the calculation of “RCE time” for patent term adjustment (PTA) was correct.

Under 35 U.S.C. § 154(b), a patent owner is entitled to an adjustment of the patent term based on three types of statutory delays: (1) when the PTO does not meet certain deadlines in the processing of patent applications; (2) when the application is pending beyond three years; and (3) when the application is pending in an interference proceeding, a secrecy order, or a successful appeal to the PTAB or a federal court. The adjustment, however, is reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution, including periods during the prosecution of an RCE.

Mayo Foundation for Medical Education and Research (“Mayo”) owns United States Patent No. 8,981,063 (“the ’063 patent”). The timeline of the ’063 patent’s prosecution history is as follows:

PTO Calculation.png

Upon issuance of the ’063 patent, the Patent Office calculated 621 days of PTA. Mayo argued it was due 685 days because the examiner’s reopening of prosecution after the interference (bracket 3) should not be counted as RCE time. Mayo appealed the PTA calculation to the Eastern District of Virginia, which granted summary judgment in favor of the PTO.

The Federal Circuit affirmed. The Court rejected Mayo’s argument that the reopening of prosecution after the interference was attributable to the PTO because Mayo never “requested” further examination. Citing Novartis AG v. Lee, Mayo argued RCE time ends when the claims are “deemed allowable.” Mayo contended its RCE time terminated with the declaration of interference because the interference could not have been initiated but for the claims otherwise being in condition for allowance. The PTO’s interference regulations, however, are not so exacting. The regulations contemplate further action by the examiner, including issuance of a rejection, following an interference proceeding. The Court thus held RCE time includes the time from the conclusion of the interference to the mailing of the notice of allowance. Any other procedure, explained the Court, would require an unduly burdensome, fact-intensive inquiry into when the PTO conceded allowability of the claims.

CAFC Partially Reverses PTAB on Primary References

CAFC Holds Design Patents Are Limited to Specific Products