Apotex Inc. v. Amgen Inc.
Petition for certiorari denied on December 12, 2016
Issue: (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.
| Date | Proceedings and Orders (key to color coding) |
|---|
| Sep 9 2016 | Petition for a writ of certiorari filed. (Response due October 14, 2016) |
| Sep 27 2016 | Order extending time to file response to petition to and including November 8, 2016. |
| Oct 3 2016 | Consent to the filing of amicus curiae briefs, in support of either party or of neither party, received from counsel for the petitioners, |
| Oct 14 2016 | Brief amicus curiae of The Biosimilars Council filed. |
| Oct 14 2016 | Brief amicus curiae of Mylan Pharmaceuticals Inc. filed. |
| Nov 8 2016 | Brief of respondents Amgen Inc., et al. in opposition filed. |
| Nov 17 2016 | Letter of November 17, 2016, from counsel for petitioners received waiving the 14-day waiting period for the distribution of the petition pursuant to Rule 15.5. |
| Nov 21 2016 | DISTRIBUTED for Conference of December 9, 2016. |
| Nov 21 2016 | Reply of petitioners Apotex Inc., et al. filed. (Distributed) |
| Dec 12 2016 | Petition DENIED. |
