SUBJECT-MATTER JURISDICTION UNDER THE HATCH-WAXMAN ACT DOES NOT REQUIRE (I) A PARAGRAPH IV CERTIFICATION BY THE ANDA HOLDER; OR (II) THE PATENTS-IN-SUIT TO BE LISTED IN THE ORANGE BOOK.

Case Name: Celgene Corp. v. Sun Pharma Global FZE, No. 19-10099 (SDW) (LDW), 2020 WL 1921700 (D.N.J. Apr. 6, 2020) (Wigenton, J.)

Drug Product and Patent(s)-in-Suit: Revlimid® (lenalidomide); U.S. Patents Nos. 7,977,357 (“the ’357 patent”), 8,193,219 (“the ’219 patent”), and 8,431,598 (“the ’598 patent”)

Nature of the Case and Issue(s) Presented: On May 30, 2018, Sun notified Celgene that it had filed an ANDA containing Paragraph IV certifications against three Celgene patents listed in the Orange Book covering Revlimid. Celgene sued Sun on July 13, 2018. That suit remained pending. On April 16, 2019, Celgene filed the instant suit against Sun, claiming that Sun’s proposed ANDA product would infringe three additional patents, the patents-in-suit, that were not listed in the Orange Book for Revlimid. The patents-in-suit claimed different crystal forms of lenalidomide. Sun responded by filing its motion to dismiss, arguing that Celgene’s claims lacked subject-matter jurisdiction under the Hatch-Waxman Act because the patents-in-suit were not listed in the Orange Book and were not subject to any Paragraph IV certifications from Sun. The court denied defendants’ motion.

Why Celgene Prevailed: The Hatch-Waxman Act stated, “It shall be an act of infringement to submit an [ANDA] ... for a drug claimed in a patent or the use of which is claimed in a patent, ... if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug ... which is claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.” Therefore the plain text of the statute did not require (i) a Paragraph IV certification to commit the technical act of infringement; or (ii) the patents-in-suit to be listed in the Orange Book. Sun argued that the statute did not authorize a patent-infringement suit against an ANDA product unless the plaintiff were to allege both (i) that the asserted patents were listed in the Orange Book in connection with the plaintiff’s drug products and (ii) that the defendants had submitted Paragraph IV certifications that the asserted patents were invalid or not infringed. But Celgene alleged neither. Instead, the court relied on Federal Circuit precedent, which held that a Paragraph IV certification was not necessary to confer subject-matter jurisdiction under § 271(e)(2). Relying on that precedent, courts in the District of New Jersey had reached the same outcome.