In Sanofi v. Lupin Atlantis Holdings SA, C.A. No. 15-415-RGA (D. Del. Jan. 26, 2017), Judge Andrews denied defendant Sandoz Inc.’s (“Sandoz”) motion to dismiss the plaintiff’s ANDA infringement action for lack of subject matter jurisdiction. The motion arose from Sandoz’s filing of a Paragraph IV certification, which it later, during expert discovery, changed to a Paragraph III certification representing that Sandoz would not market its product before the relevant patent expired. Thereafter, Sandoz filed its motion to dismiss, arguing that the change to a Paragraph III certification divested the Court of subject matter jurisdiction. Judge Andrews rejected this argument. The Court stated that the change in certification did not deprive it of jurisdiction under 35 U.S.C. § 271(e)(2) or 35 U.S.C. § 1338(a), because the case was initially certified under Paragraph IV, Sandoz maintained the ability to convert back to Paragraph IV and 28 U.S.C. § 2201 might also confer jurisdiction. The Court noted that if changing the certification was all that was required to divest the Court of jurisdiction, then a generic could “moot the case after completion of the trial but before issuance of the decision if it did not like the way the trial had gone.”
Key Points: The Court does not have jurisdiction over an action filed as a result of a generic’s Paragraph III certification. However, if the action begins as a Paragraph IV action, the switch to a Paragraph III certification will not necessarily divest the Court of jurisdiction.