Thursday, April 9, 2015

Paragraph IV Certification Not A “Civil Action” Triggering § 315(a) IPR Bar

The court denied plaintiffs' motion to enjoin ANDA defendants from participating in inter partes review and rejected plaintiffs' argument that defendants were barred from seeking IPR because their Paragraph IV certification was a previously filed civil action challenging plaintiffs' patent. "35 U.S.C. § 315(a) does not bar Defendants from seeking inter partes review before the PTAB because Defendants did not file a 'civil action' by filing a Paragraph IV Certification. . . . A Paragraph IV 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; it is not part of any judicial proceeding. . . . Nor is the Court persuaded that the statutory framework of the Hatch-Waxman Act would be undermined if this Court allowed inter partes review before the PTAB to proceed in parallel with this case."

Senju Pharmaceutical Co., Ltd. et al v. Metrics, Inc. et al, 1-14-cv-03962 (NJD March 31, 2015, Order) (Simandle, J.)

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