However, with the Federal Circuit’s reversal, Novartis regains a critical legal tool to defend its market position.
Patent Challenges: A Mixed Outcome
While the Federal Circuit restored the patent’s validity regarding its written description, it upheld the district court’s earlier findings that the patent was not invalid due to obviousness, lack of enablement, or indefiniteness. These findings further solidified the patent’s strength moving forward.
Broader Implications
Entresto brought in $6 billion in 2023, underscoring its importance to Novartis’ portfolio. This ruling could delay the introduction of generics, preserving Novartis’ exclusivity and market dominance for the drug.
For generic manufacturers like MSN Pharmaceuticals, the decision highlights the challenges of navigating patent litigation in the pharmaceutical industry, particularly in high-stakes cases involving blockbuster drugs.
