Salvaging Patent Term Adjustment Under Supernus

21 April 2020 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

One of the most confusing—and frustrating—aspects of the USPTO’s Patent Term Adjustment (PTA) rules is the mismatch between the PTA rules and the Information Disclosure Statement (IDS) rules. In Gilead Sciences, Inc. v. Lee, the Federal Circuit upheld one such mismatched PTA rule, but the court’s opinion did not address the inconsistency with the applicable IDS rule. Stakeholders caught in the gaps between the PTA rules and the IDS rules may be able to salvage some PTA under Supernus.

PTA-IDS Mismatches

In Supernus v. Iancu, the Federal Circuit held that the USPTO cannot charge a PTA deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.” Although the ruling is not limited to IDS-based PTA deductions, the deduction at issue stemmed from an IDS that was timely under the IDS rules but nonetheless incurred a PTA deduction under the PTA rules. 

The USPTO tweaked some of its PTA rules in view of Supernus, but did not change the rule at issue in Supernus (37 CFR § 1.704(c)(8)) or the 30-day IDS-PTA rule of 37 CFR § 1.704(d). The latter is the source of two types of PTA-IDS mismatches, one based on timing and the other based on subject matter. 

On its face, PTA rule 704(d) looks similar to IDS rule 97(e), but the PTA rule has a 30-day time period for filing an IDS without incurring a PTA deduction while the IDS rule has a three-month period for filing a timely IDS. 

On its face, the certification required to invoke PTA rule 704(d) looks similar to the certification of IDS rule 97(e), but the PTA rule applies in much more limited circumstances. To avoid an otherwise applicable PTA deduction, the IDS must only cite items that are, or were first cited in, a “communication from a patent office in a counterpart foreign or international application or from the [USPTO].” On the other hand, the IDS certification encompasses any items not previously known to an individual covered by the duty of disclosure rule, 37 CFR § 1.56(c), regardless of how they were identified. Thus, even a promptly filed IDS can lead to a PTA deduction if the item cited came to the Applicant’s attention under circumstances not covered by the limited scope of 37 CFR § 1.704(d).

Salvaging Patent Term Adjustment Under Supernus

While some IDS-based PTA deductions cannot be avoided, it may be possible to salvage some PTA deductions under Supernus. As explained in this article, an Applicant can request reconsideration of a deduction for “applicant delay” that embraces a period when the applicant could not have done anything to advance prosecution. For example, if an IDS was filed shortly after an individual covered by the duty of disclosure rule first became aware of the cited items but incurred a PTA deduction, the deduction might be reduced to exclude the time period during which “there was no identifiable effort” that could have been taken, i.e., the time period running from the start of the charged delay period until the individual first became aware of the item(s) at issue. Under current USPTO practice such a request for reconsideration requires a fee, and a PTA deduction still will be charged for the time period running from when the individual first became aware of the item(s) until the IDS was filed, but at least some PTA might be recouped.

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