November 7, 2014

Paragraph IV Certification Does Not Constitute “Civil Action” That Bars IPR

By Matthew L. Cutler, Principal

Momentum is growing in the filing of inter partes petitions by drug companies seeking to invalidated Orange Book patents. We will be keeping a close eye on some of the issues that are unique to these pharmaceutical IPR proceedings, including Noven Pharm., Inc. v. Novartis AG and LTS Lohmann Therapie-Systeme AG, IPR2014-00550, involving US Pat. No. 6,335,031. In this case, the PTAB considered whether the filing of a Paragraph IV certification constitutes a “civil action” for inter partes review purposes, barring the filing of an IPR petition.

In its preliminary response, Patent Owner argued that the petition-at-issue was barred pursuant to 35 U.S.C. § 315(a) because Petitioner filed a Paragraph IV certification with the FDA prior to filing the IPR petition. § 315(a) states that an IPR shall not be instituted if petitioner filed a “civil action,” challenging validity of the patent, prior to filing the IPR petition. Petitioner argued that, because of the Paragraph IV certification stated that the ‘031 patent was invalid, Patent Owner was forced to bring a civil action to defend the ‘031 patent. Decision at 6. Thus, even though it was Patent Owner that actually filed the civil action, Petitioner’s action in filing the Paragraph IV certification should be considered the filing of a civil action.  Id. at 7.

The Board disagreed, determining that, when § 315(a) refers to a “civil action,” it means the filing a complaint with a court. Though Petitioner’s filing of a Paragraph IV certification with the FDA was a form of challenge to the ‘031 validity, it was not a filing of complaint with a court. Therefore, the Petition is not barred.  Id. at 7.