Regeneron v. Amgen: Federal Circuit Dismisses Biologic Patent Appeal in Record Time
What would you like to do next?
Choose your path based on your current needs:
📋 Case Summary
| Case Name | Regeneron Pharmaceuticals, Inc. v. Amgen, Inc. |
| Case Number | 2024-1402 (Fed. Cir.) |
| Court | Federal Circuit |
| Duration | Jan 30 – Apr 12, 2024 73 days |
| Outcome | Dismissed for Lack of Jurisdiction |
| Patents at Issue | (and 22 other patents across various technologies) |
| Accused Products | Amgen’s Biosimilar Aflibercept Candidate |
Case Overview
The Parties
⚖️ Plaintiff
A leading biopharmaceutical company and originator of Eylea (aflibercept), holding an extensive patent portfolio protecting both the drug product and manufacturing processes.
🛡️ Defendant
A global biopharmaceutical leader and biosimilar developer, frequently involved in Hatch-Waxman-adjacent biosimilar patent litigation under the BPCIA.
The Patents at Issue
This litigation involved 25 U.S. patents, spanning several distinct technology categories crucial for biologic drug development and manufacturing. These patents reflect a layered IP strategy, protecting both the therapeutic molecule and the complex processes required for its commercial production.
- • US11174283B2 — Anti-VEGF therapeutic compositions and methods
- • US9222106B2 — CHO cell integration sites and expression systems
- • US10130681B2 — Aflibercept manufacturing and cell culture media
- • US10406226B2 — Protein formulations for intravitreal administration
- (and 21 other patents across these categories)
Developing a new biologic?
Check if your biosimilar or novel therapy might infringe these or related biopharma patents before launch.
The Verdict & Legal Analysis
Outcome
Both Appeal No. 2024-1402 and cross-appeal No. 2024-1405 were dismissed for lack of jurisdiction. Each party was ordered to bear its own costs. No damages were assessed, and no injunctive relief was granted at the appellate level. The merits of infringement or invalidity were not reached.
Key Legal Issues
The Federal Circuit’s dismissal turned on 28 U.S.C. § 1295 and the well-established principle that the court’s appellate jurisdiction requires a final judgment disposing of all claims between all parties. The underlying district court ruling of December 27, 2023 resolved only a portion of the contested patent claims — leaving the remainder unresolved. This procedural issue implicated Rule 54(b) of the Federal Rules of Civil Procedure, which requires a specific certification for partial judgments to be appealable.
Freedom to Operate (FTO) Analysis in Biologics
This case highlights critical IP risks in biopharma development. Choose your next step:
📋 Understand Biopharma IP Landscape
Learn about the specific IP risks and implications from this litigation.
- View all 25 patents in this technology space
- See which companies are most active in biologic patents
- Understand process patent claim strategies
🔍 Check My Biologic’s Risk
Run a comprehensive FTO analysis for your own technology or product.
- Input your biologic description or manufacturing process
- AI identifies potentially blocking patents (incl. process patents)
- Get actionable risk assessment report for biopharma IP
High Risk Area
VEGF Antagonist & Manufacturing Patents
25 Patents
Covering molecule, process, formulation
Early FTO Critical
Avoid costly litigation delays
✅ Key Takeaways
Jurisdictional finality under 28 U.S.C. § 1295 requires full resolution of all claims; partial district court rulings are not automatically appealable.
Search BPCIA case law →Rule 54(b) certification is an essential tool — and an easy miss — in complex multi-patent BPCIA litigations.
Explore appellate finality doctrine →Frequently Asked Questions
The case involved 25 U.S. patents covering anti-VEGF therapeutic compositions, CHO cell manufacturing platforms, aflibercept formulations, cell culture media, and biological contaminant detection methods. Key patent numbers include US11174283B2, US9222106B2, US10130681B2, and US10406226B2, among others.
The Federal Circuit dismissed the appeal because the underlying district court decision of December 27, 2023 resolved fewer than all patent claims at issue, failing to constitute a final appealable judgment under 28 U.S.C. § 1295. Both parties agreed to dismissal following the court’s February 22, 2024 show cause order.
The dismissal was procedural, not substantive. The underlying patent infringement claims remain pending at the district court level, and the merits of validity and infringement were not decided on appeal.
Ready to Strengthen Your Biopharma Patent Strategy?
Join 18,000+ IP professionals using PatSnap Eureka to conduct prior art searches, draft patents, and analyse competitive landscapes with AI-powered precision for biologics.
References
- United States Court of Appeals for the Federal Circuit — Case 2024-1402
- U.S. Patent and Trademark Office — Patent Center
- Cornell Legal Information Institute — 28 U.S.C. § 1295 (Appellate Jurisdiction)
- Cornell Legal Information Institute — Federal Rules of Civil Procedure Rule 54(b)
- PACER: Public Access to Court Electronic Records
- Google Scholar — Federal Circuit Decisions
- PatSnap — IP Intelligence Solutions for Biopharma
This article is for informational purposes only and does not constitute legal advice. All case information is drawn from publicly available court records. For platform capabilities, visit PatSnap.