Novartis v. Mylan: Entresto® Patent Appeal Dismissed at Federal Circuit in Landmark Pharma Case
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📋 Case Summary
| Case Name | Novartis AG v. Mylan NV |
| Case Number | 2023-2260 (Fed. Cir.) |
| Court | Federal Circuit, Appeal from District of Columbia |
| Duration | Aug 2023 – Mar 2024 210 days |
| Outcome | Appeal Dismissed — No Merits Ruling |
| Patents at Issue | |
| Accused Products | Sacubitril/Valsartan Tablets (24/26 mg, 49/51 mg, 97/103 mg) |
Case Overview
The Parties
⚖️ Plaintiff
Swiss multinational pharmaceutical innovator, markets Entresto® — a blockbuster heart failure medication. Focuses on robust patent enforcement.
🛡️ Defendant
One of the world’s largest generic drug manufacturers, challenging Entresto® patents via ANDA litigation.
Patents at Issue
This dispute involved four U.S. patents protecting Entresto® (sacubitril/valsartan), a commercially significant cardiovascular drug. These patents collectively cover the chemical compositions, crystalline forms, and pharmaceutical formulations underlying Entresto®’s active ingredients, registered with the U.S. Patent and Trademark Office (USPTO).
- • US8,101,659 B2 — Chemical compositions and crystalline forms
- • US8,796,331 B2 — Pharmaceutical formulations
- • US9,388,134 B2 — Crystalline forms and pharmaceutical compositions
- • US8,877,938 B2 — Combination drug composition and uses
Developing a Generic Drug?
Check if your sacubitril/valsartan formulation might infringe these or related patents before launch.
The Dismissal & Legal Analysis
Outcome
On March 6, 2024, the Federal Circuit issued an order granting a joint stipulation to dismiss Appeal No. 23-2260, with each side bearing its own costs. No damages were awarded, and no merits ruling was issued. Importantly, the court simultaneously deconsolidated this case from four companion appeals (Nos. 2023-2218, 2023-2219, 2023-2220, and 2023-2221) and lifted the stay on those remaining appeals.
Key Legal Issues
Because this appeal was dismissed by stipulation, the legal reasoning underlying the original infringement allegations was not adjudicated at the appellate level. The most legally consequential element is the deconsolidation and lifting of the stay on the companion appeals. These four cases now proceed independently before the Federal Circuit’s merits panel, where substantive legal questions—likely involving claim construction, obviousness under 35 U.S.C. § 103, and potentially enablement under 35 U.S.C. § 112—remain live and potentially precedent-setting for pharmaceutical formulation and combination drug patents.
Freedom to Operate (FTO) Analysis for Pharma
This case highlights critical IP risks in pharmaceutical development. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications from this pharmaceutical litigation.
- View all related patents in the sacubitril/valsartan space
- See which companies are most active in cardiovascular patents
- Understand claim construction patterns for pharma formulations
🔍 Check My Generic Product’s Risk
Run a comprehensive FTO analysis for your sacubitril/valsartan or similar generic product.
- Input your product’s chemical compositions or formulations
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High Risk Area
Sacubitril/Valsartan formulations
4 Active Appeals
Affecting generic market entry
Design-Around Options
For specific formulations
✅ Key Takeaways
Joint stipulation dismissals under FRAP Rule 42(b)(1) can be powerful tactical tools in multi-case consolidated patent litigation.
Search related case law →Deconsolidation orders have procedural consequences — lifting stays on companion cases requires immediate strategic re-evaluation.
Explore precedents →Monitor Federal Circuit Appeal Nos. 2023-2218 through 2023-2221 for substantive rulings on sacubitril/valsartan patent validity and infringement.
Track these cases →Frequently Asked Questions
Four U.S. patents: US8,101,659 B2; US8,796,331 B2; US9,388,134 B2; and US8,877,938 B2, covering compositions and formulations of Entresto® (sacubitril/valsartan).
The parties filed a joint stipulation of dismissal under FRAP Rule 42(b)(1), with each side bearing its own costs. No merits ruling was issued.
Four companion appeals (Nos. 2023-2218 through 2023-2221) were deconsolidated and their stay lifted — those cases now proceed before the Federal Circuit’s merits panel and will determine key substantive patent questions.
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References
- United States Court of Appeals for the Federal Circuit — Case 2023-2260
- U.S. Patent and Trademark Office — Patent Database
- Cornell Legal Information Institute — 35 U.S.C. § 103
- Cornell Legal Information Institute — 35 U.S.C. § 112
- Google Patents — US8,877,938 B2
- PatSnap — IP Intelligence Solutions for Pharmaceutical Industry
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.