MSN Laboratories Pvt. Ltd. suffered a significant setback in its efforts to launch a generic version of Novartis AG's blockbuster heart-disease drug Entresto, as federal courts at both the district and appellate levels rejected the company's attempts to circumvent patent protections and expedite market entry.
District Court Dismisses Patent Delisting Challenge
Judge Richard G. Andrews of the US District Court for the District of Delaware granted Novartis' motion to dismiss MSN's delisting counterclaim during a hearing on Tuesday. The judge refused to remove a key patent for Entresto from the FDA's Orange Book, effectively maintaining the regulatory barrier that prevents MSN from launching its generic version until mid-July 2025.
The court also denied MSN's attempt to vacate or amend the final judgment from earlier Hatch-Waxman litigation. Judge Andrews noted that MSN had not raised the delisting argument throughout five years of litigation, undermining the company's current legal strategy.
Federal Circuit Upholds Injunction
The US Court of Appeals for the Federal Circuit delivered another blow to MSN's market entry plans by denying the company's motion for a stay and request to expedite its appeal. Circuit Judge Timothy B. Dyk wrote that MSN failed to demonstrate it was "likely to succeed in demonstrating that the district court abused its discretion in declining to allow amendment of the complaint to state a delisting counterclaim."
This decision ensures that Novartis' injunction blocking MSN's generic Entresto launch remains in effect, preventing market entry before July 16, 2025. The appeals court's ruling also rejected MSN's attempt to fast-track the appeal process, which would have potentially shortened the timeline for resolution.
Pediatric Exclusivity Protection
The legal dispute centers around Novartis' enforcement of pediatric exclusivity protections for Entresto. The January 2025 lawsuit filed by Novartis successfully secured an injunction that prevents MSN from launching its generic version until the exclusivity period expires in mid-July.
MSN's failed delisting counterclaim represented an attempt to challenge the validity of Novartis' patent listing in the FDA's Orange Book, a regulatory database that identifies patents covering approved drug products. The dismissal of this counterclaim leaves Novartis' patent protections intact and enforceable.
Market Impact
The court decisions preserve Novartis' market exclusivity for Entresto, described as a blockbuster heart-disease drug, for several additional months. MSN's inability to launch its generic version until July 2025 maintains Novartis' pricing power and market position during this critical period.
The rulings demonstrate the effectiveness of pharmaceutical patent litigation strategies in protecting branded drug revenues, particularly when combined with pediatric exclusivity provisions that extend market protection beyond standard patent terms.
