By Cheryl Beise, J.D.
The USPTO’s inadvertent exclusion of six dependent claims in an initial restriction requirement during prosecution of a pharmacological method patent application did not warrant adjustment of the term of the issued patent, the U.S. Court of Appeals for the Federal Circuit has decided. Although there was a delay of 197 days between the examiner’s issuance of the original restriction requirement and the corrected restriction requirement, the original restriction sufficed to put the applicant on notice of the appropriate classification of the missing dependent claims (Pfizer, Inc. v. Lee, January 22, 2016, O’Malley, K.). Circuit Judge Pauline Newman filed a dissenting opinion.
Prosecution timeline. On May 2, 2003, Wyeth Holdings Corporation filed Patent Application No. 10/428,894 (the’894 application) entitled “Calicheamicin Derivative-Carrier Conjugates,” which generally claimed a pharmacological method utilized in the treatment of cancer. Prosecution of the ’894 application continued until October 11, 2011, when the PTO issued a Notice of Allowance. On April 10, 2012, the ’894 application issued as U.S. Patent No. 8,153,768 (the ’768 patent).
The PTO awarded Patent Term Adjustment (PTA) of 1291 days, of which 684 days were attributed to “A Delay.” A Delays are those caused by the USPTO’s failure to act by certain examination deadlines. Pfizer, Inc. acquired Wyeth in 2009.
Pfizer and Wyeth (collectively, “Wyeth”) brought an action in the federal district court in Alexandria, Virginia, seeking a judgment correcting the PTO’s A Delay award. Wyeth argued that the PTO should have awarded 197 additional days as A Delay to account for the period from August 10, 2005, the date on which the PTO mailed a first restriction requirement, and February 23, 2006, the date on which the PTO mailed a corrected restriction requirement. The district court awarded summary judgment to the PTO. Wyeth and Pfizer appealed.
PTA standard. With respect to A Delay, the Patent Term Guarantee Act (“the Act”), 35 U.S.C. §154(b), provides for restoration of patent term “if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to provide at least one of the notifications under section 132 or a notice of allowance under section 151” within the times specified in the statute.
Section 132, in turn, provides that if a patent examiner finds that a patent application does not comply with the standards of patentability, the examiner will issue an office action with respect to the application, “stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application.” Thus, the Act provides that A Delay will stop accruing when the USPTO “provide[s] at least one of the notifications under section 132,” the Federal Circuit observed.
Thus, the dispositive issue in his case was whether the USPTO provided a notification under Section 132 when it mailed the first restriction requirement.
Original restriction requirement. Wyeth argued that the USPTO’s original restriction requirement failed to satisfy the notice requirement of Section 132 because it failed to classify six dependent claims—claims 75-76, which depended from independent claim 73, and claims 103-106, which depended from independent claim 98—into the examiner’s defined invention groups, and thus failed to place the applicants on notice of the restriction requirement as to those dependent claims.
The Federal Circuit disagreed that the original restriction requirement failed to put Wyeth on notice. “The examiner’s detailed descriptions of the 21 distinct invention groups outlined in the examiner’s initial restriction requirement were clear, providing sufficient information to which the applicants could have responded,” the court said. Wyeth never challenged the content of the invention groups and the defined invention groups remained identical in the two restriction requirements. Although the examiner did not classify the omitted six dependent claims into one of the 21 groups, the examiner made clear on the face of the initial restriction requirement that he intended to account for all pending claims. Moreover, Wyeth could have recognized that the inadvertently omitted dependent claims would naturally be classified in a subset of the invention groups that included the claims from which they depended.
The Manual of Patent Examining Procedure (MPEP) also supported the position that the original restriction requirement satisfied Section 132, according to the court. The MPEP’s restriction form letter instructs USPTO examiners to “look for omitted claims” in issuing a restriction requirement, and provides that a restriction requirement is not automatically invalid simply because it fails to account for a particular claim, the court noted.
The Federal Circuit concluded that the initial restriction requirement was sufficiently informative to satisfy the notice requirements of Section 132. The judgment of the district court was affirmed.
Dissent. Circuit Judge Pauline Newman filed a dissenting opinion. “The panel majority erroneously holds that term adjustment is not available because the applicant, not the PTO, spotted the PTO’s error,” Judge Newman said. She opined that the statutory purpose is clear that when patent issuance is delayed because of proceedings that are not the fault of the applicant, the patent term is extended to compensate for the delay. “My colleagues’ statutory interpretation and application are contrary to the letter and purpose of the law,” Judge Newman said.
The case is No. 2015-1265.
Attorneys: Simeon G. Papacostas (Kirkland & Ellis LLP) for Pfizer, Inc. and Wyeth Holdings Corporation. Dennis C. Barghaan, Jr., Office of the United States Attorney, Eastern District of Virginia, for Michelle K. Lee.
Companies: Pfizer, Inc.; Wyeth Holdings Corporation
MainStory: TopStory Patent FedCirNews
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