In January, the Federal Circuit determined in Supernus Pharmaceuticals, Inc. v. Iancu that the U.S. Patent and Trademark Office had erred in calculating the Patent Term Adjustment for Supernus' U.S. Patent No. 8,747,897. In particular, the Court found that because there were "no identifiable efforts" that Supernus could have undertaken in the time period between the filing of an RCE during prosecution of the application that issued as the '897 patent and the mailing of an EPO notification of opposition for a European counterpart patent (which resulted in Supernus filing a supplemental Information Disclosure Statement during prosecution of the '897 patent), Supernus had not failed to engage in reasonable efforts to conclude prosecution during that time period.
In response to the Federal Circuit's decision in Supernus, the USPTO issued a Federal Register notice (84 Fed. Reg. 20343) earlier this month notifying stakeholders of the impact of the decision on its PTA determinations. In the notice, entitled "Patent Term Adjustment Procedures in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu," the Office indicates that it is "modifying its patent term adjustment procedures in view of the decision." However, the notice states that "the USPTO will continue to make the patent term adjustment determinations indicated in patents under the existing regulations using information recorded in its PALM [Patent Application Locating and Monitoring] system," and that a patentee who believes there were no identifiable efforts it could have undertaken to conclude prosecution of an application (as Supernus argued with respect to the '897 patent) "may raise the issue in a timely request for reconsideration of the patent term adjustment, providing any relevant information that is not recorded in the USPTO's PALM system."
The Office did note -- in support of essentially maintaining the status quo on PTA determinations and challenges to those determinations -- that "[t]he event from which the Federal Circuit measured the beginning of the patent term adjustment reduction in Supernus (the EPO's notice to Supernus of the opposition on August 21, 2012) is an event external to the USPTO and is thus not an event that is recorded in the USPTO's PALM system." Therefore, until the Office is better able to track actions in foreign counterpart applications and patents (using, for example, the Citation List of its Global Dossier Initiative; see "USPTO News Briefs," October 25, 2017), it is hard to see what additional modifications the Office could make to its PTA procedures.
The notice also points out that "the USPTO expects that the situation in Supernus should arise infrequently," explaining that:
An extended delay between the filing of a request for continued examination and the subsequent Office action (932 days in Supernus) should be a rare occurrence now, as the average time between the filing of a request for continued examination and the subsequent Office action is currently only 79 days.
In addition, the Office reminds stakeholders in a footnote that:
The patent term adjustment reduction at issue in Supernus can be avoided by the prompt submission of the information disclosure statement. Specifically, 37 CFR 1.704(d) provides a "safe harbor" in that a paper containing only an information disclosure statement in compliance with 37 CFR 1.97 and 1.98 will not be considered [a] failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10) if the information disclosure statement is accompanied by one of the statements set forth in 37 CFR 1.704(d)(1)(i) or (d)(1)(ii).
Noting that the Office has "adopted ad hoc procedures for seeking reconsideration of the patent term adjustment determination in the past when there have been changes to the interpretation of the provisions of 35 U.S.C. 154(b) as a result of court decisions," the notice indicates that such ad hoc procedures were necessary because former provisions of 35 U.S.C. § 154(b)(4) "provided a time period for seeking judicial review that was not related to the filing of a request for reconsideration of the USPTO's patent term adjustment determination or the date of the USPTO's decision on any request for reconsideration of the USPTO’s patent term adjustment determination." The Office therefore determined that no such ad hoc procedures were required in response to the Supernus decision because 37 C.F.R. § 1.705 allows patentees to file a request for reconsideration up to seven months after a patent is issued and to wait until after the Office reaches a final PTA determination before seeking judicial review of that determination.
