Federal Circuit Affirms Ruling Against Biosimilar Makers in Regeneron VEGF Patent Battle
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📋 Case Summary
| Case Name | Regeneron Pharmaceuticals, Inc. v. Mylan NV et al. |
| Case Number | 24-2009 (Fed. Cir.) |
| Court | Federal Circuit, D.C. |
| Duration | June 26, 2024 – January 29, 2025 217 days |
| Outcome | Plaintiff Win – Affirmed / Appeal Dismissed |
| Patents at Issue | |
| Accused Products | Biosimilar versions of aflibercept (Eylea) |
Case Overview
The Parties
⚖️ Defendant/Appellee
Originator and patent holder of aflibercept (Eylea), a VEGF antagonist fusion protein approved for treatment of neovascular age-related macular degeneration and other angiogenic eye disorders. Eylea represents one of the highest-grossing ophthalmic drugs globally.
🛡️ Plaintiffs/Appellants
Coalition of major biosimilar manufacturers: Mylan NV, Amgen Inc., Biocon Biologics Inc., Samsung Bioepis Co. Ltd., Celltrion Inc., and FORMYCON AG.
Patents at Issue
This landmark case involved thirteen U.S. patents spanning a sophisticated, layered IP portfolio:
- • US9222106B2 — Anti-VEGF protein compositions and production methods
- • US11084865B2 — CHO cell integration sites and uses
- • US9816110B2 — Detection of biological contaminants
- • US11253572B2 — Methods for producing aflibercept with reduced variants
- • US10415055B2 — Enhanced expression and stability
- • US10669594B2 — Enhanced expression and stability
- • US10888601B2 — Enhanced expression and stability
- • US10130681B2 — Manufacturing and formulation methods
- • US10464992B2 — Manufacturing and formulation methods
- • US11066458B2 — Manufacturing and formulation methods
- • US9254338B2 — VEGF antagonist formulations for intravitreal administration
- • US11306135B2 — VEGF antagonist formulations for intravitreal administration
- • US11104715B2 — VEGF antagonist formulations for intravitreal administration
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The Verdict & Legal Analysis
Outcome
The Federal Circuit issued a clean affirmance: “THIS CAUSE having been considered, it is ORDERED AND ADJUDGED: AFFIRMED.” The appeal was dismissed, and the infringement action verdict from the trial court stands in full.
Key Legal Issues
The Federal Circuit’s affirmance signals agreement with the trial court’s interpretations on several key legal dimensions, including claim construction, the rejection of biosimilar challenges on obviousness and enablement grounds, and the enforceability of manufacturing method patents (process patent protection).
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⚠️ Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in biologics development. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications from this biologics litigation.
- View all 13 patents at issue in this biologics space
- See which companies are most active in anti-VEGF patents
- Understand claim construction patterns for biologics
🔍 Check My Product’s Risk
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- AI identifies potentially blocking patents
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High Risk Area
Aflibercept and anti-VEGF protein production methods
13 Patents Affirmed
Across manufacturing, formulation, cell biology
Biologics IP Strategy
Layered patent portfolios are robust
✅ Key Takeaways
For Patent Attorneys & Litigators
Federal Circuit affirmed 13-patent portfolio protecting aflibercept manufacturing, formulation, and use — validating layered biologics IP strategy.
Search related case law →Process and manufacturing patents proved as enforceable as composition-of-matter claims in biologics.
Explore precedents →For R&D Teams
Document process evolution thoroughly and conduct FTO analysis before finalizing biosimilar manufacturing platforms.
Start FTO analysis for my product →Consider filing patents covering upstream manufacturing (cell lines, media) and downstream formulation early in the product development cycle.
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