Amgen Inc. v. Hospira, Inc.
866 F.3d 1355
| Fed. Cir. | 2017Background
- Hospira submitted a BPCIA § 262(k) application for a biosimilar to Amgen’s EPOGEN and provided Amgen a copy of the application but did not separately disclose the cell‑culture medium composition that Amgen sought.
- Amgen argued Hospira failed to satisfy § 262(l)(2)(A) by withholding specific cell‑culture components; Hospira said the application itself disclosed sufficient process information.
- Amgen proceeded to list and later sued on two patents (the ’349 and ’298 patents) that do not claim cell‑culture media; Amgen nonetheless sought discovery of Hospira’s cell‑culture composition.
- The district court denied Amgen’s motion to compel discovery because the requested cell‑culture composition was not relevant to the asserted patents.
- Amgen appealed the discovery denial and alternatively sought a writ of mandamus compelling discovery. The Federal Circuit dismissed the appeal for lack of jurisdiction and denied mandamus.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the discovery denial is immediately appealable under the collateral‑order doctrine | Amgen: denial is effectively unreviewable because § 262(l)(2)(A) disclosures must be available pre‑litigation to preserve the sponsor’s right to sue on related patents | Hospira: ordinary discovery rulings are not collateral orders and are reviewable at final judgment | Court: collateral‑order doctrine does not apply; no jurisdiction — discovery orders are generally reviewable after final judgment |
| Whether mandamus should issue compelling compliance with § 262(l)(2)(A) discovery | Amgen: extraordinary relief needed because withholding process info allows applicants to “game” BPCIA and prevent sponsors identifying patents to list/sue | Hospira: ordinary discovery rules and BPCIA mechanisms suffice; Amgen had alternative statutory routes (listing patents under § 262(l)(3)) | Court: mandamus denied — Amgen did not show a clear and indisputable right to the requested discovery |
| Whether BPCIA or Sandoz displaces ordinary federal discovery rules for § 262(l)(2)(A) material | Amgen: Sandoz and BPCIA require access to applicant process information and allow discovery to obtain it | Hospira: Sandoz does not supplant the Federal Rules; discovery still governed by relevance under Fed. R. Civ. P. 26 | Court: Federal Rules of Civil Procedure apply; process info must be relevant to asserted claims to be discoverable |
| Whether sponsor is foreclosed from listing patents under § 262(l)(3)(A) absent applicant disclosures | Amgen: without applicant disclosures sponsor cannot reasonably identify patents and risks Rule 11 or antitrust exposure | Hospira: sponsor can list patents based on reasonable belief; applicant must then respond under § 262(l)(3)(B) and Rule 11 permits allegations supported after discovery | Court: sponsor may list patents in good faith without applicant disclosures; statutory procedures and Rule 11 protect against frivolous filings |
Key Cases Cited
- Sandoz, Inc. v. Amgen, Inc., 137 S. Ct. 1664 (2017) (Supreme Court interpretation of BPCIA disclosure remedies and limits on injunctive relief)
- Coopers & Lybrand v. Livesay, 437 U.S. 463 (1978) (final‑judgment rule and limits on interlocutory appeals)
- Cheney v. U.S. Dist. Court for D.C., 542 U.S. 367 (2004) (standards for issuing mandamus)
- Mohawk Indus., Inc. v. Carpenter, 558 U.S. 100 (2009) (discovery and privilege‑related disclosure orders are generally not collateral orders)
- Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015) (earlier Federal Circuit discussion that sponsors may seek BPCIA process information through discovery)