Amgen Inc. v. Sandoz Inc.
|Docket No.||Op. Below||Argument||Opinion||Vote||Author||Term|
|15-1195||Fed. Cir.||TBD||TBD||TBD||TBD||OT 2016|
Issues: (1) Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide;” and (2) whether, where an applicant fails to provide that required information, the sponsor's sole recourse is to commence a declaratory judgment under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii). CVSG: 12/07/2016.
|Date||Proceedings and Orders|
|Mar 21 2016||Petition for a writ of certiorari filed. (Response due April 22, 2016)|
|Apr 18 2016||Order extending time to file response to petition to and including May 17, 2016.|
|May 17 2016||Brief of respondent Sandoz Inc. in opposition filed.|
|May 27 2016||Reply of petitioners Amgen Inc., et al. filed.|
|May 31 2016||DISTRIBUTED for Conference of June 16, 2016.|
|Jun 20 2016||The Solicitor General is invited to file a brief in this case expressing the views of the United States.|
|Dec 7 2016||Brief amicus curiae of United States filed. VIDED.|
|Dec 20 2016||Supplemental brief of petitioners Amgen Inc., et al. filed. VIDED.|
|Dec 21 2016||DISTRIBUTED for Conference of January 6, 2017.|
|Jan 9 2017||DISTRIBUTED for Conference of January 13, 2017.|
|Jan 13 2017||Petition GRANTED The petition for a writ of certiorari in No. 15-1039 is granted. The cases are consolidated and a total of one hour is allotted for oral argument.|