Case Caption: The Iron Workers Local 580 Insurance Fund v. Novartis Pharmaceuticals Corp.
Court: United States District Court for the Southern District of New York
Case Number: 1:25-cv-7230
Judge: Hon. Lewis J. Liman
Plaintiff: The Iron Workers Local 580 Insurance Fund
Defendant: Novartis Pharmaceuticals Corp.
Class Period: January 16, 2025 to July 16, 2025
This class action involves third-party payors (“TPPs”) that paid for Entresto, Novartis’s blockbuster heart failure drug. The case turns on a single issue: whether Novartis improperly listed its ‘659 patent in the FDA’s Orange Book as “claiming” Entresto.
Entresto is a “complex,” meaning that two other drugs are bound together into a single unit-dose-form through non-covalent bonds. The invention Novartis claimed by the ’659 patent, however, was a “combination,” which does not claim or reference the specific form of the Entresto complex. In a separate patent infringement litigation, the Federal Circuit held, as a matter of law, that the ‘659 patent could not have claimed Entresto because the complex that makes up the drug was not discovered until years after the ‘659 patent’s priority date. Put another way, a patent cannot claim or reference that which does not yet exist.
Based on this improper listing, which paved the way for a later-obtained pediatric indication, Novartis was able to secure an additional six months of exclusivity for Entresto. While generic manufacturers were blocked from entering the market, Novartis reaped an additional $2 billion in brand sales during this time.
Novartis moved to dismiss Plaintiff’s complaint, which is fully briefed. The Court has allowed limited discovery during the pendency of Novartis’s motion.