PIV Certifications Do Not Preclude IPR Challenges

PIV certifications do not preclude ANDA filers from seeking inter partes review of Orange Book patents, according to the court in Senju Pharmaceutical Co. v. Metrics, Inc., 14-CV-3962 (D. N.J. Mar. 31, 2015). Plaintiffs Senju and Bausch & Lomb own three patents covering formulations of bromfenac, the active ingredient in Prolensa®. They sued Metrics for infringement under section 271(e) after receiving a notice letter from Metrics informing them that it had filed PIV certifications for two of plaintiffs’ patents. Six days after the complaint was filed, Metrics filed IPR petitions with the PTAB for the asserted patents.

Plaintiffs moved to enjoin Metrics from pursuing inter partes review, arguing that, by filing a PIV certification, Metrics had “filed a civil action” challenging the validity of the patent, thus barring it from pursuing an IPR on the same patents under 35 U.S.C. § 315(a). The court denied the motion, holding that PIV certifications do not trigger the bar of § 315(a). The court explained that a PIV certification is “merely an administrative application to the FDA certifying that the patent in question is invalid or is not infringed by the generic product.”

The court likewise rejected Plaintiffs’ alternative argument that the IPRs were barred under the “first-filed rule” because Plaintiffs filed their district court case first. The court reasoned that the rule’s purpose of preventing duplicative judicial effort is not implicated where the burdens of proof for patent challengers are different between district courts (clear and convincing evidence) and the PTAB (preponderance of evidence). In conclusion, the court noted that Plaintiffs’ motion in reality sought an injunction “against the IPR process itself.” Because PTAB decisions to institute review are final under 35 U.S.C. § 314(d), the court opined that the injunction sought by Plaintiffs would undermine the PTAB’s authority by preventing it from reviewing the patents after it had decided to institute review.