Last month, in Pfizer, Inc. v. Lee, the Federal Circuit determined that the District Court for the Eastern District of Virginia did not err in granting summary judgment in favor of the U.S. Patent and Trademark Office on the issue of whether the USPTO properly calculated the Patent Term Adjustment for U.S. Patent No. 8,153,768, and affirmed the judgment of the District Court.

The '768 patent, which is directed to compositions comprising a drug conjugate that comprises calicheamicin derivatives and an antibody, is assigned to Wyeth Holdings Corp., which was acquired by Pfizer in 2009.  The '768 patent issued from U.S. Application No. 10/428,894, which was filed on May 2, 2003.  On August 10, 2005, the USPTO issued a restriction requirement in the case.  During a telephonic interview with the Examiner on February 6, 2006, Wyeth noted that the restriction requirement had omitted claims 75, 76, and 103-106 from its categorization of the claims presented in the application.  The Examiner acknowledged the omission during the interview and agreed to withdraw the restriction requirement and issue a corrected restriction requirement, which the Examiner did on February 23, 2006.  Wyeth filed a response to the corrected restriction requirement on May 22, 2006.

When the '894 application issued as the '768 patent nearly six years later, the patent was awarded 1,291 days of PTA, of which 684 days were attributed to A Delay (or USPTO delay).  The A Delay consisted of 404 days for issuing the first restriction requirement on August 10, 2005 more than a year past the fourteen-month deadline of July 2, 2004 for the USPTO to issue an action under 35 U.S.C. § 132, and 280 days for another USPTO delay that was not at issue in the case.  The USPTO did not, however, award the 197 days that elapsed between the issuance of the first restriction requirement on August 10, 2005 and the issuance of the corrected restriction requirement on February 23, 2006.

In response to the USPTO's PTA determination, Wyeth brought an action against the Office in the Eastern District of Virginia, seeking a corrected PTA determination including the 197 days between the issuance of the first restriction requirement and the issuance of the corrected restriction requirement.  Wyeth and the USPTO cross-moved for summary judgment on the issue, and the District Court issued a decision granting the USPTO's motion for summary judgment and denying Wyeth's motion.

On appeal, Wyeth argued that the USPTO's original restriction requirement failed to satisfy the notice requirement of § 132.  In particular, Wyeth argued that the original restriction requirement failed to satisfy the notice requirement because it failed to classify six dependent claims into the Examiner's defined invention groups, and thus failed to place Wyeth on notice of the restriction requirement as to those dependent claims.  Wyeth also argued that the first restriction requirement was not valid because the Examiner treated that action as though it had been withdrawn.

Noting that Title 35 "provides that A Delay will stop accruing when the PTO 'provide[s] at least one of the notifications under Section 132,'" the majority indicated that "under the statute's plain meaning, the issue of whether the PTO provided a notification under Section 132 is dispositive of this case."  The majority cited Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990), for the proposition that "[s]ection 132 is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection."

Siding with the USPTO, and affirming the judgment of the District Court, the majority determined that in the instant case:

[T]he examiner's initial restriction requirement satisfied the statutory notice requirement because it informed the applicant of “the broad statutory basis for [the rejection of] his claims."  Chester, 906 F.2d at 1578.  Here, 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.  Indeed, the applicants never challenged the content of the invention groups defined by the examiner.  And, significantly, the examiner's defined invention groups remained identical between the two restriction requirements.  . . .  Viewed as a whole, the restriction requirement provided adequate grounds on which the applicants could "recogniz[e] and seek[] to counter the grounds for rejection."  Chester, 906 F.2d at 1578.

The majority noted that "[a]s for the six claims whose classifications were omitted from the initial restriction requirement, Wyeth could have taken direction for their classification from the fact that their respective independent claims were each included in the initial restriction requirement."

The majority also noted (as did the District Court) that the instant case was similar to Univ. of Mass. v. Kappos, 903 F. Supp. 2d 77 (D.D.C. 2012) ("UMass").  In UMass, a first restriction requirement was replaced with a second restriction requirement after the applicant pointed out a defect in the first restriction requirement and convinced the examiner to issue the second restriction requirement.  The District Court in UMass similarly declined to award additional time for A Delay for the period between the first and second restriction requirements, indicating that while the process of patent prosecution often involves changes in both the applicant's and examiner's positions, an examiner's reissuance of an Office action in response to an applicant's suggestion does not automatically mean that an application has been "delayed" for purposes of Patent Term Adjustment.

The majority contrasted the UMass decision with two decisions cited by Wyeth, noting that "Janssen and Oncolytics are distinguishable from the present scenario because in both cases the examiner sua sponte rescinded and replaced the issued restriction requirements without explanation and without prompting from the applicants."  The majority therefore concluded that the District Court did not err in granting summary judgment in favor of the USPTO on the issue of whether the USPTO properly calculated the length of PTA for the '768 patent, and affirmed the judgment of the District Court.

Writing in dissent, Judge Newman explained that:

The panel majority reasons that Wyeth could have or should have filed a speculative response to the flawed restriction requirement, on the premise that Wyeth should have guessed as to which of the 21 groups the examiner would have chosen for each of the six claims that the examiner erroneously omitted from the requirement for restriction.  On the premise that Wyeth might have guessed correctly and that the examiner might have proceeded with the prosecution without correcting his error, my colleagues refuse to include the period of actual delay in the adjustment of the patent term.

In reviewing the timeline, Judge Newman notes that:

The Wyeth patent application was completed and filed on December 8, 2003.  The 14-month deadline for PTO issuance of the first official action was not met, and the incomplete initial restriction requirement was issued by the PTO on August 10, 2005, with response due on February 10, 2006.  Wyeth phoned the examiner on February 6, 2006, pointing out the error.  The examiner withdrew the flawed restriction requirement, and issued a corrected restriction requirement on February 23, 2006.  The patent issued on April 10, 2012.

The PTO issued a Patent Term Adjustment of 1201 days.  Pfizer seeks to increase the adjustment by 197 days, measured as the period from the examiner's incomplete restriction requirement on August 10, 2005 to the issuance of the corrected restriction requirement on February 23, 2006.  It is not disputed that the pendency period was lengthened by this amount.

With respect to the majority's distinguishing of UMass, Janssen, and Oncolytics, Judge Newman countered that "[t]he panel majority erroneously holds that term adjustment is not available because the applicant, not the PTO, spotted the PTO's error," stating that "[w]hether the examiner's actions 'were outside the normal 'give-and-take process' of patent prosecution,' should not turn on who recognized the error" (citation omitted).  With regard to the majority's characterization of UMass, Judge Newman contended that "UMass does not support the proposition that a facially incomplete Office action does not count for patent term adjustment."

Pfizer, Inc. v. Lee (Fed. Cir. 2016)
Panel: Circuit Judges Newman, Dyk, and O'Malley
Opinion by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Newman