Amgen Inc. v. Sandoz Inc.
2015 U.S. App. LEXIS 12523
Fed. Cir.2015Background
- BPCIA creates biosimilar pathway with a patent dispute-resolution regime and information-exchange obligations between the reference product sponsor (RPS) and the biosimilar applicant (k-applicant).
- A k-applicant must disclose its aBLA and manufacturing information to the RPS within 20 days after FDA acceptance, subject to penalties if not disclosed.
- If disclosure is lacking, the statute provides remedies via declaratory judgments or infringement actions rather than other non-patent remedies.
- Sandoz filed an aBLA referencing Amgen’s Neupogen; it did not disclose its aBLA/manufacturing information and gave a premature notice of commercial marketing.
- District court held Sandoz’s interpretation of the BPCIA consistent with the statute, dismissed Amgen’s state-law claims, and granted judgment for Sandoz on counterclaims; Amgen appealed.
- Court affirms dismissal of state-law claims, vacates district court’s counterclaims ruling to align with its BPCIA interpretation, and remands for further proceedings on patent issues.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether disclosure of the aBLA and manufacturing info is mandatory | Amgen contends 'shall provide' means mandatory and noncompliance permits RPS action against k-applicant. | Sandoz argues 'shall' is conditional and remedies exist elsewhere; noncompliance yields patent-based remedies only. | Shall is not a privately enforceable non-patent remedy; remedies are patent-based. |
| Whether non-disclosure by a k-applicant violates the BPCIA | Amgen argues failure to disclose constitutes unlawful action under the BPCIA. | Sandoz followed an approved BPCIA path; no BPCIA violation occurred. | No BPCIA violation from non-disclosure; remedies lie in patent framework. |
| When is notice of commercial marketing effective under § 262(z)(8)(A)? | Amgen contends notice may be given prior to FDA licensure to trigger injunctions. | Sandoz contends notice must follow licensure; prior notice is ineffective. | Effective notice only after FDA licensure; July 2014 notice was premature and ineffective. |
| Whether Amgen's UCL and conversion claims survive given BPCIA interpretation | Amgen asserts unlawful/BPCIA-based unfair competition and wrongful use of license. | Sandoz did not violate BPCIA and Amgen cannot sustain conversion given non-exclusive rights. | Both state-law claims fail under court’s BPCIA construction. |
| Whether the injunction ruling is moot | Amgen sought an injunction pending appeal. | After decision on pleadings, appeal on injunction is moot. | Injunction appeal is moot; further relief to be addressed on remand or patent issues. |
Key Cases Cited
- Marx v. Gen. Revenue Corp., 568 U.S. -, 133 S. Ct. 1166 (2013) (canon against surplusage; interpret statutes to avoid rendering provisions superfluous)
- TRW Inc. v. Andrews, 534 U.S. 19 (2001) (avoid surplusage; interpret statutory text in context)
- Anderson v. Yungkau, 329 U.S. 482 (1947) (when 'shall' and 'may' appear together, usual senses apply)
- Davis v. HSBC Bank Nevada, N.A., 691 F.3d 1152 (9th Cir. 2012) (UCL unlawful prong requires underlying law to be exclusive or otherwise preemptive)
- Sebelius v. Cloer, 133 S. Ct. 1886 (2013) (statutory text must be read in context of statute as a whole)