Exela Pharma Sciences, LLC et al. v. Michele K. Lee (Cadence Pharma., Intervenors)

Docket No. 2013-1206

March 26, 2015

Brief Summary: PTO patent application revival rulings are not subject to third party collateral challenge under the APA.

Summary: Exela petitioned the PTO to “reconsider and withdraw” its revival of a national state application and cancel the resulting issue patent No. 6,992,218. The argument was brought under an ANDA paragraph IV challenge. The PTO refused to consider Exela’s petition on the grounds that no law or regulation authorizes non-party challenge to a PTO ruling to accept a late filing. The DC initially held Exela was entitled to challenge the revival but reconsidered in view of new Fourth Circuit precendent and then dismissed the complaint as time barred. Exela argued that “unintentional” delay was not an available ground for revival under the “PCT-implementing statute” then in effect and that §371(d) only applied to “unavoidable” abandonments (“…unless it be shown to the satisfaction of the Director that such failure to comply was unavoidable….”) The PTO, it argued, erroneously applied §1.137 (relating to both unavoidable and unintentional abandonments) since “a PTO regulation cannot override a statute”. The FC panel concluded PTO patent application revival rulings are not subject to third party collateral challenge under the APA (“not legislatively intended”) and therefore did not reach the time-bar issue. Judge Newman’s concurring opinion took issue with Judge Dyk’s concurring opinion arguing Aristocrat (FC 2008 (which “barred review of improper revival as a defense in infringement actions”)) was wrongly decided (based on conclusion that “improper revival was not literally among the catalog of defenses listed in 35 USC § 282).

This entry was posted in Generics / ANDA, Infringement, Patent Prosecution, Procedural Issues. Bookmark the permalink.

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