In a significant Hatch-Waxman decision, a Delaware District Court recently denied the defendants’ motion to dismiss under Federal Rule of Civil Procedure 12(b)(1), rejecting the argument that the conversion of the defendants’ Paragraph IV certifications to Paragraph III certifications deprived the court of subject matter jurisdiction, but granted the defendants’ motion for partial judgment on the pleadings under Federal Rule of Civil Procedure 12(c).
In H. Lundbeck A/S v. Apotex Inc., the defendants converted their Paragraph IV certifications for certain patents at issue to Paragraph III certifications. Under 21 U.S.C. § 355(j)(2)(A)(viii), an ANDA filer must make any one of four (I-IV) certifications for each Orange Book listed patent. A Paragraph IV certification is an ANDA filer’s statement that it intends to market its bioequivalent pharmaceutical product before the expiration of a patent listed as covering that product because the ANDA filer believes such patent is either not infringed or invalid. A Paragraph III certification is an ANDA filer’s statement that it will not market its bioequivalent product until after the expiration of a patent listed as covering that product. The Court reasoned that in a Hatch-Waxman action, subject matter jurisdiction exists when a patent owner alleges that the filing of an ANDA infringes its patent under 35 U.S.C. § 271(e)(2) and conversion from a Paragraph III to a Paragraph IV certification did not deprive the court of subject matter jurisdiction. The court also reasoned that a Paragraph VI to Paragraph III conversion would not moot a case unless the defendant met the “formidable burden” to show that its wrongful conduct would not occur and the defendants had not met that burden because they had expressly refused to stipulate that they would not reconvert back to a Paragraph IV certification. Thus, the court denied the defendants’ motion to dismiss for lack of subject matter jurisdiction.
The court however, granted the defendants’ motion for partial judgment on the pleadings, finding that because the plaintiff could no longer obtain relief on their claim for infringement pursuant to 35 U.S.C. § 271(e)(2). Specifically, because the defendants had converted to Paragraph III certifications, the FDA would not approve the defendants’ ANDA product until after the expiration of the plaintiffs’ patents, there was no additional relief the court could provide.
Gibbons P.C. will continue to monitor and report developments in Hatch-Waxman litigation.