SDNY Judge Liman Dismisses Entresto Orange Book Antitrust Suit With Prejudice
A district judge dismissed with prejudice an antitrust class action against Novartis over Entresto's Orange Book patent listing, a ruling pharma antitrust and Hatch-Waxman litigators will want to read.
Reported on Latham & Watkins' site, Judge Lewis J. Liman of the Southern District of New York dismissed with prejudice a putative antitrust class action concerning the heart failure drug Entresto, holding that the drug-product patent at issue was properly listed in the Orange Book. The suit had alleged that Novartis Pharmaceuticals Corporation improperly listed the patent in the FDA's Orange Book, with the practical effect of delaying generic entry; as described, the court concluded the listing was correct.
Why sophisticated counsel should care: Orange Book listing disputes sit at the intersection of antitrust and Hatch-Waxman law, and they recur across branded and generic portfolios, particularly where multiple listed formulations, patent-term extensions or Paragraph IV challenges are involved. A dismissal with prejudice ends the plaintiff's case entirely, but the pleading and factual theories that withstood scrutiny — and those that did not — will shape how similar complaints are drafted and defended. Pharma clients should assess whether pending Orange Book challenges warrant revisiting; generic filers now have a favorable district-court data point on listing defenses.
Caveats: the source excerpt does not set out the full reasoning, patent numbers, any settlement or payment arrangements alleged, or whether an appeal is contemplated. Watch for the opinion text, any appeal notice, and related Paragraph IV litigation before treating the ruling as settled precedent.