Digest of Ferring B.V. v. Watson Labs. Inc.(Fed. Cir. Aug. 22, 2014) (precedential). On appeal from D. Nev. Before Lourie, Dyk and Reyna.

Procedural Posture: Patent holder Ferring appealed a dismissal of its infringement claim as moot following ANDA applicant (Apotex)’s amendment to the ANDA to preclude the sale of an infringing product. CAFC affirmed.

  • Infringement: The infringement analysis turned on whether the ANDA product met the claimed dissolution rate. The originally filed ANDA did not specify whether the ANDA product would meet the claimed dissolution rate and therefore permitted infringement. However, bio-batch data provided by the ANDA applicant indicated that the product likely to be sold would not infringe. Further, the ANDA applicant amended the ANDA to preclude sale of an infringing product by specifying a dissolution rate that fell outside scope of claims. The district court properly mooted the claims of infringement because, even if the originally filed ANDA was infringing, the amended ANDA was properly considered for purposes of infringement. Therefore, the filing of the amended ANDA eradicated any infringing effects of Apotex’s originally-filed ANDA and any allegedly infringing conduct is unlikely to recur.