Amgen vs. Samsung Biologics: Denosumab Biosimilar Patent Settlement
What would you like to do next?
Choose your path based on your current needs:
📋 Case Summary
| Case Name | Amgen Inc. v. Samsung Bioepis Co., Ltd. et al. |
| Case Number | 1:24-cv-08417 (D.N.J.) |
| Court | U.S. District Court for the District of New Jersey |
| Duration | Aug 2024 – Jan 2026 1 year 5 months |
| Outcome | Plaintiff Win – Consent Judgment (21 Patents Valid & Infringed) |
| Patents at Issue | |
| Accused Products | Samsung Bioepis’s Denosumab-dssb Biosimilar Products (referencing Prolia® & XGEVA®) |
Case Overview
The Parties
⚖️ Plaintiff
Global biopharmaceutical pioneer and originator of denosumab — a multi-billion-dollar antibody product (Prolia® & XGEVA®).
🛡️ Defendant
South Korean biosimilar developer, subsidiary of Samsung Biologics, with a growing U.S. biosimilar pipeline, targeting denosumab-dssb.
Patents at Issue
This landmark case involved an extraordinary 34 U.S. patents in total, with 21 specifically asserted and adjudicated in the consent judgment. These patents span:
- • US7364736B2 — Denosumab antibody composition
- • US8058418B2 — Pharmaceutical formulations
- • US10106829B2 — Manufacturing and cell culture methods
- • US11098079B2 — Downstream processing and purification
- • And 17 other related patents.
Developing a new biologic?
Assess the IP landscape. Check if your antibody program might encounter these or related patents.
The Verdict & Legal Analysis
Outcome
On January 22, 2026, the District of New Jersey entered a Consent Order and Judgment by stipulation of both parties. The operative findings are unambiguous: for purposes of this action, the asserted claims of all 21 enumerated patents are deemed valid, enforceable, and infringed by Samsung’s making, using, selling, offering to sell, or importing denosumab biosimilar products in the United States and its territories.
Key Legal Issues
This was a BPCIA patent infringement action — specifically triggered by Samsung Bioepis’s BLA filing, which under the Biologics Price Competition and Innovation Act constitutes a technical act of infringement sufficient to confer standing under 35 U.S.C. § 271(e)(2)(C). The consent judgment was entered solely to effectuate settlement, with Samsung neither admitting infringement nor invalidity beyond the scope of this action and its enforcement. The parties waived findings of fact and conclusions of law under Rule 65 of the Federal Rules of Civil Procedure.
Drafting biologics patents?
Learn from Amgen’s strategy. Use AI to draft layered claims that secure your innovation.
Power Your Patent Strategy with PatSnap Eureka IP
From novelty searches to patent drafting, PatSnap Eureka’s AI-powered tools help you navigate the patent landscape with confidence.
⚠️ Freedom to Operate (FTO) Analysis for Biologics
This case highlights critical IP risks in the biologics space. Choose your next step:
📋 Understand Biologics IP Landscape
Gain insights from this dense patent portfolio and competitive activity.
- View all 34 patents related to this technology space
- See which companies are active in RANKL antibody patents
- Understand claim scope for composition, formulation, manufacturing
🔍 Check My Biosimilar Product’s Risk
Run a comprehensive FTO analysis for your proposed biosimilar or biologic product.
- Input your product sequence or manufacturing process
- AI identifies potentially blocking biologics patents
- Get actionable risk assessment report
High Risk Area
RANKL antibody composition & formulation
34 Related Patents
In denosumab/RANKL space
Lifecycle Management
Amgen’s layered patent strategy
✅ Key Takeaways
For Patent Attorneys & Litigators
Consent judgments with deemed-infringement findings provide enforceable IP protection beyond private settlement contracts.
Search related BPCIA case law →BPCIA MDL consolidation amplifies enforcement leverage across multiple biosimilar applicants simultaneously.
Explore BPCIA precedents →Waiver of Rule 65 findings preserves confidentiality while achieving judicial enforceability.
Understand Rule 65 implications →For IP Professionals & R&D Teams
Amgen’s 34-patent denosumab portfolio exemplifies lifecycle IP management for biologics.
Monitor USPTO prosecution →Manufacturing method patents (not just composition claims) pose independent FTO risks for biosimilar developers.
Start FTO analysis for my product →RANKL-targeting antibody programs face a dense Amgen patent landscape through at least the early 2030s based on current patent terms.
Try AI patent drafting →Ready to Strengthen Your Patent Strategy?
Join thousands of IP professionals using PatSnap Eureka to conduct prior art searches, draft patents, and analyze competitive landscapes.