H. Lundbeck A/S v. Apotex Inc.

Case Name: H. Lundbeck A/S v. Apotex Inc., No. 18-88-LPS, 2020 WL 3507795 (D. Del. June 26, 2020) (Stark, J.) 

Drug Product and Patent(s)-in-Suit: Trintellix® (vortioxetine); U.S. Patents Nos. 8,722,684 (“the ’684 patent”), 8,969,355 (“the ’355 patent”), 9,227,946 (“the ’946 patent”), and 9,861,630 (“the ‘’630 patent”)

Nature of the Case and Issue(s) Presented: Lundbeck sued Sandoz, among others, alleging patent infringement based on the filing of Sandoz’s ANDA seeking marketing approval from the FDA to sell a generic version of Trintellix. When filed, Sandoz’s ANDA contained Paragraph IV certifications stating that Sandoz’s generic product would not infringe the patents-in-suit and/or that the patents-in-suit were invalid. After the suit was filed, Sandoz converted its Paragraph IV certifications into Paragraph III certifications, stating that it would not seek approval to market its generic product before the expiration of the patents-in-suit. Sandoz notified Lundbeck of the conversion and sought a stipulation of dismissal. Lundbeck requested that Sandoz also stipulate that it would not convert its Paragraph III certifications back into Paragraph IV certifications. Sandoz refused and Lundbeck declined to dismiss its infringement claims. Sandoz filed a motion to dismiss for lack of subject-matter jurisdiction and a motion for judgment on the pleadings.

Why Sandoz Prevailed: Sandoz first argued that once it converted its paragraph IV certifications to paragraph III certifications, the court lacked subject-matter jurisdiction under Fed. R. Civ. P. 12(b)(1) to hear the case. The court disagreed, holding that subject- matter jurisdiction is established once a patent owner alleges that the filing of an ANDA infringes its patent under § 271(e)(2). The court cannot thereafter lose subject matter- jurisdiction. Thus, the court denied Sandoz’s Rule 12(b)(1) motion to dismiss.

Sandoz next moved for judgment on the pleadings under Rule 12(c) arguing that Plaintiffs could no longer state a claim upon which relief could be granted. This time, the court agreed. First, the court explained that Lundbeck sought relief under § 271(e)(2), which deems it an act of infringement to submit an ANDA if the purpose of such submission is to gain FDA approval to market a drug claimed in a patent before the expiration of the patent. By converting to a Paragraph III certification, Sandoz could now gain FDA approval only after the expiration of the patents-in-suit. Because the relief Lundbeck requested was an injunction under § 271(e)(4) delaying FDA approval until the patents expired, the court held that there was no relief it could grant to Lundbeck under any set of facts that could be proven. Thus, the court granted Sandoz’s motion for judgment on the pleadings.