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.