No Collateral Challenge Of Patent Application Revival

In Exela Pharma Sciences, LLC v. Lee, the Federal Circuit held that the USPTO's decision to revive a patent application "is not subject to third party collateral challenge" under the Administrative Procedures Act (APA). In so doing, it affirmed the district court's dismissal of Exela's action challenging the revival of Cadence's patent application, but on different grounds.

The Patent at Issue

The patent at issue was U.S. 6,992,218, which is listed in the Orange Book for Cadence's Ofirmev® injectable acetaminophen product. Exela filed an Abbreviated New Drug Application seeking approval of a generic version of Cadence's product, which triggered patent litigation under the Hatch-Waxman Act. While that litigation was pending, Exela filed a petition in the USPTO collaterally challenging the USPTO's decision to revive the application.

The Missed Deadline and Revival

The '218 patent stems from a U.S. national stage application of a PCT application that claimed priority to a French application. According to the Federal Circuit decision, the applicant originally failed to file the U.S. national stage application within the 30 month window of 35 USC § 371. Less than one month after the missed deadline, the applicant filed a petition to revive the application, asserting that the delay in satisfying the filing requirements was "unintentional". The USPTO granted the petition, the application was examined, and the patent was granted in due course.

The Revival Challenge

Exela challenged this patent application revival, asserting that the USPTO did not have authority to revive the application after "unintentional" delay, because the governing statute only permitted revival after "unavoidable" delay. Indeed, 35 USC § 371(d) provided:

The requirements ... shall be complied with by the date of the commencement of the national stage or by such later time as may be fixed by the Director. .... Failure to comply with these requirements shall be regarded as abandonment of the application by the parties thereof, unless it be shown to the satisfaction of the Director that such failure to comply was unavoidable.

On the other hand, the USPTO permitted application revival under either an "unintentional" standard or an "unavoidable" standard. See 37 CFR § 1.137(a), (b).

The USPTO dismissed Exela's petition seeking review of the revival, "stating that no statute or regulation authorizes third party challenge to a PTO ruling concerning revival of a patent application."...