Pfizer, Inc. v. Lee

Addressing patent term adjustment issues, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. Patent and Trademark Office’s (USPTO) decision not to adjust the term of a patent, where the 197-day delay resulted from an examiner’s issuance of a corrected restriction requirement. Pfizer, Inc. v. Lee, Case No. 15-1265 (Fed. Cir., Jan. 22, 2016) (O’Malley, J.) (Newman, J., dissenting).

The Patent Term Guarantee Act (35 U.S.C. § 154(b)) provides for the restoration of patent term under certain circumstances, including so-called “A-Delay” arising from the USPTO’s failure to act on a pending application by certain examination guidelines. Prosecution of Pfizer’s application (covering pharmaceutical methods for cancer treatment) incurred an initial delay when the examiner waited 404 days beyond the deadline for his first office action to mail a restriction requirement. Thereafter, during the course of a telephone interview, Pfizer persuaded the examiner that the restriction requirement omitted six dependent claims from its categorization of the various pending claims. The examiner then issued a corrected restriction requirement 601 days after the original deadline.

USPTO credited only the initial 404-day delay in its patent term adjustment when Pfizer’s application issued as a patent but not the additional 197 days until the corrected restriction requirement issued. Pfizer sued the USPTO in district court to recoup the 197-day period. After the district court affirmed USPTO’s calculation on an undisputed summary judgment record, Pfizer appealed.

On appeal the Federal Circuit agreed with the USPTO. Citing Chester v. Miller, the Court observed that § 154(b) stops A-Delays from accruing when an examiner makes an office action that informs the applicant “of the broad statutory basis for the rejection of his claims, so that he may determine what the issues are on which he can or should produce evidence.” A contrary rule would reach beyond § 154(b)’s purpose of compensating applicants for undue prosecution delays and instead guarantee the correctness of every USPTO decision.

Because the original restriction requirement put Pfizer on notice of the steps it needed to take (and in fact did take) to circumvent that rejection, the Court held that Pfizer was not entitled to the longer adjustment. The Court found support for its decision in MPEP § 814 guidance that a restriction requirement does not automatically fail because it omits a particular claim. The Court did, however, posit that a future case turning on the omission of independent claims from a restriction requirement (as opposed to the dependent claims, as in this case) may reach a different result.

In dissent, Judge Newman reasoned that the examiner’s mis-categorization of claims warranted an award of the full adjustment sought by Pfizer. In her view, Congress intended § 154(b) to compensate for delays caused by erroneous office actions made through no fault of the applicant.