This week, in Idorsia Pharmaceuticals, Ltd. v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting summary judgment in favor of the U.S. Patent and Trademark Office, finding that the District Court had correctly concluded that the Office properly calculated the Patent Term Adjustment for U.S. Patent No. 8,518,912.  In particular, the District Court had determined that the Examiner's issuance of the first of three restriction requirements during prosecution of the application that issued as the '912 patent satisfied the notice requirement of 35 U.S.C. § 132, and thus ended any further accumulation of "A Delay" for the '912 patent.

Actelion Pharmaceuticals, Ltd. -- Plaintiff-Appellant Idorsia Pharmaceuticals' predecessor in interest in the '912 patent -- filed U.S. Patent Application No. 12/745,358.  On March 14, 2012, the Examiner issued a restriction requirement, identifying six invention groups.  Actelion notified the Examiner by telephone that the invention groups omitted subject matter from the scope of the claims (but without electing any of the invention groups).  The Examiner agreed, indicated that a new restriction requirement would be issued, and then issued a new restriction requirement on April 18, 2012 (35 days after the first restriction requirement).  In the second restriction requirement, which superseded and replaced the first restriction requirement, the Examiner identified eight invention groups.  Acetelion again notified the Examiner by telephone that the invention groups omitted subject matter from the scope of the claims (but without electing any of the invention groups).  The Examiner again agreed, indicated that a new restriction requirement would be issued, and issued a new restriction requirement on June 21, 2012 (64 days after the second restriction requirement).

The '358 application eventually issued as the '912 patent, and the Office determined that the PTA was 314 days, which included 229 days of A delay.  Actelion requested reconsideration of that PTA determination, and the Office issued a final decision determining that the PTA for the '912 patent was 346 days, including 261 days of A Delay, with the Office determining that the Examiner's second restriction requirement stopped the accrual of A delay.  Actelion filed suit in the Eastern District of Virginia, challenging the Office's PTA determination, and the District Court remanded the case to the USPTO to reconsider its PTA determination in light of Pfizer, Inc. v. Lee.  On remand, the Office determined that Actelion was entitled to 311 days of PTA, including 226 days of A Delay, with the Office determining that the Examiner's first restriction requirement stopped the accrual of A delay.

In Pfizer, Inc. v. Lee, the Federal Circuit affirmed the finding by the District Court for the Eastern District of Virginia that the USPTO properly calculated the PTA for Pfizer's U.S. Patent No. 8,153,768 (see "Pfizer, Inc. v. Lee (Fed. Cir. 2016)").  In calculating the PTA, the USPTO denied Pfizer 197 days between the time the Examiner issued a first restriction requirement and then, after the applicant noted that the Examiner had omitted claims 75, 76, and 103-106, issued a corrected restriction requirement.  Noting that the applicant "could have taken direction for the[] classification [of the six omitted claims] from the fact that their respective independent claims were each included in the initial restriction requirement," the panel majority sided with the District Court and USPTO.

In the instant case, Idorsia challenged the Office's decision on remand, arguing that A Delay continued to accrue for 99 days until the third restriction requirement was issued because the first and second restriction requirements did not meet the notice requirement of 35 U.S.C. § 132.  Idorsia and the Office each moved for summary judgment, with the District Court granting summary judgment in favor of the USPTO, finding that the first restriction requirement complied with the notice requirement of § 132 based on the standard set forth in Pfizer.  Idorsia appealed.

On appeal, the Federal Circuit determined that under Pfizer, the Examiner's first restriction requirement stopped the accrual of A delay because the first restriction requirement met the notice requirement of § 132.  Citing 35 U.S.C. § 154(b)(1)(A)(i), the Court noted that "A Delay stops accruing when the PTO 'provide[s] at least one of the notifications under section 132,'" and citing Pfizer, the Court noted that "[a] written restriction requirement qualifies as a 'notification[] under section 132.'"  The Court explained, again citing Pfizer, that "§ 132 'is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.'"  According to the opinion, "the parties' dispute focuses on whether the first restriction requirement was 'sufficiently informative to allow [Actelion] to counter the grounds for rejection.'"  The Federal Circuit "agree[d] with the district court and the PTO that under Pfizer, the examiner's first restriction requirement for the '912 patent satisfied the notice requirement of § 132."  In particular, the Court stated that "[t]he examiner's first restriction requirement asserted that all pending claims of the '358 application were subject to the restriction requirement," noting that "Actelion was able to respond to the first restriction requirement and successfully oppose the examiner's description of the multiple invention groups, which demonstrates that Actelion was able to understand the examiner's proposed invention groups and prepare responsive arguments."

Idorsia argued that the first and second restriction requirements violated § 132 because "Actelion plainly lacked the necessary information to determine how to proceed," and attempted to distinguish Pfizer on the ground that the restriction requirement at issue in Pfizer omitted dependent claims and not subject matter from independent claims.  The Federal Circuit, however, rejected Idorsia's "overly narrow reading of Pfizer," stating that "[a] restriction requirement need not be correct to satisfy the statutory notice requirement," and adding that "Actelion's and the examiner's 'exchanges concerning the challenged restriction requirement were part of the typical 'back and forth' process of patent prosecution,'" citing Pfizer.  The Court also stated that "[a]lthough this process '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,'" again citing Pfizer.  Agreeing with the USPTO and District Court that "Idorsia's alleged delay is 'not the type of error for which the Act was intended to compensate'" (again citing Pfizer), the Federal Circuit determined that the USPTO properly calculated the PTA for the '912 patent, and concluded that the District Court did not err in granting summary judgment in favor of the USPTO.

Idorsia Pharmaceuticals, Ltd. v. Iancu (Fed. Cir. 2020)
Nonprecedential disposition
Panel: Circuit Judges Chen, Hughes, and Stoll
Opinion by Circuit Judge Stoll