Exelixis, Inc. v. MSN Laboratories Private Ltd.

Exelixis, Inc. v. MSN Laboratories Private Ltd. The Federal Circuit affirmed the finding that the asserted claims of the '439, '440, and '015 patents had adequate written description under § 112(a). The court dismissed as moot MSN's appeal as to claim 3 of the '349 patent and vacated the district court's nonobviousness judgment for that claim. The decision reinforces that, for a structurally claimed crystalline salt genus, disclosure of chemical name, formula, crystalline structure, and making processes can support written description even without enumerating every polymorph, while also showing how mootness can lead to vacatur of an unreviewed validity ruling. Affirmed-in-part and dismissed-and-vacated-in-part; no costs. For the Malate Salt Patents, the asserted claims covered crystalline cabozantinib (L)-malate salts, formulations, and treatment methods; MSN conceded infringement but argued lack of written description. The Federal Circuit found no clear error in the district court's reliance on the specification's disclosure of cabozantinib (L)-malate's chemical name, formula, crystalline structure, and processes for making the invention. MSN's arguments about different properties among N-1, N-2, and other polymorphs did not show clear error because those properties were unclaimed and the district court did not rely on them to define the genus. The court distinguished broad genus cases such as AbbVie, ICU Medical, Tronzo, and Eli Lilly, emphasizing that the claims here were no broader than the disclosed crystalline cabozantinib (L)-malate salt. As to the '349 patent, Exelixis's dismissal of its noninfringement cross-appeal left no live controversy over MSN's invalidity appeal; the court dismissed that portion as moot and vacated the no-invalidity judgment. § 112(a) § 103 standing / jurisdiction Hatch-Waxman / ANDA precedential infringement § 112(a) § 103 standing / jurisdiction Hatch-Waxman / ANDA precedential infringement § 112(a) standing / jurisdiction § 103 Hatch-Waxman / ANDA