Exelixis Announces Update on Patent Litigation Trial Appeal with MSN Laboratories
Exelixis, Inc. (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) vs. MSN Laboratories Private Limited et al. (MSN), Civil Action No. 22-00228 (Consolidated), the U.S. Court of Appeals for the Federal Circuit (Appeal No. 25-1236) has affirmed a key portion of the 2024 judgment of the U.S. District Court for the District of Delaware in Exelixis’ favor. The appellate court upheld the District Court's decision that three patents covering the crystalline malate salt of cabozantinib (No. 11,091,439 [crystalline salt]; 11,091,440 [pharmaceutical compositions]; and 11,098,015 [methods of treatment]) are not invalid. Concurrently, the appellate court dismissed the appeal regarding the validity dispute over one of Exelixis’ patents covering low-impurity cabozantinib formulations (U.S. Patent No. 11,298,349), ruling the matter moot.
The Federal Circuit’s decision upholds the validity of the ’439, ’440 and ’015 crystalline salt patents, preserving market exclusivity of Exelixis’ cabozantinib (marketed under the brand name CABOMETYX®). While the appellate court issued a procedural ruling dismissing the ’349 formulation patent appeal as moot, this decision does not impact the broader strength or integrity of the cabozantinib patent estate.
