Apotex Inc. v. Amgen Inc.

(1) Whether the U.S. Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the Biologics Price Competition and Innovation Act for the resolution of patent disputes (viz. 42 U.S.C. § 262(l)(2)(A)) must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A); and (2) whether the Federal Circuit improperly extended the statutory 12-year exclusivity period to 12 1/2 years by holding that a biosimilar applicant cannot give effective notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) for its biosimilar product until it receives a Food and Drug Administration license and therefore may not commercially market its biosimilar product for 180 days after receiving its license.