827 F.3d 1052
Fed. Cir.2016Background
- Amgen owns FDA-licensed Neulasta (pegfilgrastim). Apotex filed a §262(k) biosimilar application referencing Neulasta; FDA accepted review and Apotex provided the §262(l)(2)(A) application/manufacturing info to Amgen.
- The parties exchanged patent lists and responses under §262(l)(3)–(6); Amgen sued under the first-stage (paragraph 6) process on one patent. Apotex previously sent a pre-licensure April 2015 notice that it characterized as an (8)(A) notice but lacked an FDA license.
- Amgen moved for a preliminary injunction to require Apotex, if and when licensed, to give a post-licensure §262(l)(8)(A) notice and to delay commercial marketing for 180 days after that notice.
- The district court granted the injunction; Apotex appealed the legal question whether (8)(A) is mandatory and enforceable by injunction when the applicant has complied with (2)(A).
- The Federal Circuit affirmed, holding (8)(A) is mandatory and enforceable by injunction regardless of whether the applicant engaged the §262(l) information-exchange process by providing (2)(A) notice.
Issues
| Issue | Amgen's Argument | Apotex's Argument | Held |
|---|---|---|---|
| Whether §262(l)(8)(A)’s 180‑day post‑licensure notice is mandatory | "Shall" is categorical; (8)(A) is a standalone mandatory requirement enforceable by injunction | (8)(A) is not enforceable by injunction for applicants that complied with (2)(A); (9) makes declaratory judgment the exclusive remedy | Court: (8)(A) is mandatory and injunctively enforceable regardless of (2)(A) compliance |
| Whether (9) implies exclusivity of declaratory‑judgment remedies for (8)(A) violations | (9) does not preclude equitable/injunctive relief; no text limits remedies to declaratory relief | (9)(B) makes declaratory judgment the sole remedy for (8)(A) failures | Court: (9) does not create an exclusive remedy; equitable relief remains available |
| Whether enforcing (8)(A) adds impermissible delay to §262(k)(7) exclusivity | 180 days is consistent with §262(k)(7) (12‑year earliest effectiveness); Congress fixed the 180‑day window purposefully | Requiring post‑licensure notice effectively extends exclusivity beyond 12 years | Court: No contradiction; §262(k)(7) sets earliest effective date and (8)(A) fits that scheme |
| Whether Amgen likely to suffer irreparable harm warranting a preliminary injunction | Stipulated irreparable harm, balance of hardships and public interest favor Amgen; legal question dispositive | Disputed remedy scope; appealed legal ruling | Court: Because (8)(A) is mandatory and parties stipulated the other PI factors, injunction affirmed |
Key Cases Cited
- Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015) (held (8)(A) notice must be post‑licensure and interpreted (8)(A) as mandatory)
- Sanofi‑Synthelabo v. Apotex, Inc., 470 F.3d 1368 (Fed. Cir. 2006) (statutory interpretation reviewed de novo)
- Endo Pharm. Inc. v. Actavis, Inc., 746 F.3d 1371 (Fed. Cir. 2014) (standard of review for preliminary injunction abuse of discretion)
- Nat’l Ass’n of Home Builders v. Defs. of Wildlife, 551 U.S. 644 (2007) (interpretation of "shall" as generally mandatory)
- Lopez v. Davis, 531 U.S. 230 (2001) (use of mandatory language in statutory interpretation)
- Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998) (interpretation of statutory commands)
- Porter v. Warner Holding Co., 328 U.S. 395 (1946) (equitable jurisdiction not denied absent clear legislative command)
- Mitchell v. Robert DeMario Jewelry, Inc., 361 U.S. 288 (1960) (limitations on equitable relief require clear statutory language)
- United States v. Oakland Cannabis Buyers’ Coop., 532 U.S. 483 (2001) (same principle regarding judicial equity)
- eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006) (preliminary injunction factors and equitable relief standards)