Novartis v. Hetero USA & MSN: Federal Circuit Entresto® Appeal Jointly Dismissed
Novartis AG and generic challengers Hetero USA, MSN Pharmaceuticals, and MSN affiliates jointly dismissed their Federal Circuit appeal covering nine patents protecting Entresto® (sacubitril/valsartan) tablets. The proceeding ended after 247 days with each side bearing its own costs — a cost-neutral exit that typically signals a private resolution between the parties.
Entresto® patent appeal ends by mutual agreement at Federal Circuit
Novartis AG filed this appeal (Case No. 24-2210) at the Court of Appeals for the Federal Circuit on 13 August 2024, challenging an underlying infringement dispute over nine patents covering its blockbuster heart-failure drug Entresto® (sacubitril/valsartan) in 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg tablet strengths. The defendants — Hetero USA, Inc., MSN Pharmaceuticals, Inc., MSN Laboratories Private, Ltd., and MSN Life Sciences Private, Ltd. — are generic manufacturers whose ANDA filings triggered the original Hatch-Waxman infringement action.
The proceeding was terminated on 17 April 2025 when the parties jointly moved to dismiss under Federal Rule of Appellate Procedure 42(b). The Federal Circuit ordered the appeal dismissed and directed that each side bear its own costs. No substantive ruling on the merits of the nine asserted patents was issued, meaning the dismissal does not create binding appellate precedent on the validity or infringement questions at stake.
The 247-day duration and cost-neutral exit are consistent with a negotiated resolution — potentially a licensing agreement or market-entry settlement — reached privately between the parties. The public record does not disclose the terms of any such arrangement. Patent-watchers should note that with no appellate merits decision, the scope and enforceability of all nine Entresto® patents remain untested at the Federal Circuit level, and the underlying district court record governs any future enforcement analysis.
Filing to Appeal Dismissed in 247 days
247 days — resolved before full Federal Circuit briefing cycle typically concludes
Appeal dismissed by agreement: what the joint exit means for both sides
Fed. R. App. P. 42(b): voluntary appellate dismissal by stipulation
Rule 42(b) allows parties to jointly move to dismiss a Federal Circuit appeal at any time. Unlike a Rule 41 district-court dismissal, this operates purely at the appellate level — it terminates the appeal without the Federal Circuit issuing any opinion on the merits. The underlying district court judgment, if any, remains in place unless separately vacated. No precedent is set on the nine Entresto® patents.
No merits rulingNovartis exits the appeal without appellate loss — patents remain intact
For Novartis, a joint dismissal avoids the risk of an adverse Federal Circuit ruling that could have weakened or invalidated one or more of the nine Entresto® patents. The patents survive the appeal formally unchallenged at this level. However, the public record does not confirm whether Novartis secured exclusivity protections or licensing terms through any parallel private agreement driving this dismissal.
Patents formally unchallengedHetero/MSN avoid adverse precedent — market entry terms uncertain
Hetero USA and the MSN entities also avoid a binding Federal Circuit ruling that could have affirmed infringement or patent validity across all nine asserted patents — a result that would have blocked Entresto® generic entry broadly. The cost-neutral, agreed dismissal suggests the challengers may have secured some form of negotiated market access or settlement terms, though nothing is confirmed in the public record.
No binding adverse rulingNine Entresto® patents remain untested at appellate level — FTO risk persists
With no Federal Circuit opinion issued, all nine patents covering sacubitril/valsartan formulations retain their full presumption of validity. Future generic entrants or ANDA filers in the Entresto® space cannot rely on this proceeding as persuasive authority for invalidity or non-infringement. The dismissal may also signal structured generic entry arrangements that could define the competitive timeline for the sacubitril/valsartan market.
Elevated FTO risk for genericsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Novartis, AG | Company | Global pharmaceutical innovator — holder of nine sacubitril/valsartan (Entresto®) patentsSearch in Eureka ↗ |
| Defendant | Hetero USA, Inc. | Company | Generic drug manufacturers (Hetero USA, MSN Pharmaceuticals, MSN Laboratories, MSN Life Sciences) — ANDA filers targeting Entresto®Search in Eureka ↗ |
| Co-Defendant | MSN Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | MSN Laboratories Private, Ltd. | Company | Search in Eureka ↗ |
| Co-Defendant | MSN Life Sciences Private, Ltd. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Christina A. L. Schwarz | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Deanne Maynard Counsel | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Nicholas Nick Kallas | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Seth W. Lloyd | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff law firm | Morrison & Foerster LLP | Law Firm | Representing Novartis, AGSearch in Eureka ↗ |
| Plaintiff law firm | Venable LLP | Law Firm | Representing Novartis, AGSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The order’s phrasing — ‘The parties having so agreed’ — makes explicit that dismissal was consensual and bilateral, not unilateral or involuntary. The invocation of Fed. R. App. P. 42(b) confirms this is a pure appellate exit: no district court judgment is disturbed, and the Federal Circuit issues no opinion on infringement or validity. The cost-neutrality provision (‘each side shall bear their own costs’) is a standard term in agreed dismissals and does not itself indicate which party held the stronger appellate position.
US8101659B2 and eight further patents — sacubitril/valsartan (Entresto®) portfolio
The nine asserted patents — US8101659B2, US11135192B2, US9937143B2, US9388134B2, US8796331B2, US11058667B2, US11096918B2, US9517226B2, and US8877938B2 — collectively protect Novartis’s sacubitril/valsartan franchise marketed as Entresto®. Application filing dates range from 2007 (US11/722360) through to 2019 (US16/579581), reflecting layered prosecution strategy that extends portfolio coverage across compound, formulation, and method-of-use claim types. Entresto® is approved for heart failure with reduced ejection fraction (HFrEF).
The breadth of this nine-patent portfolio — with continuation and divisional applications spanning over a decade of prosecution — is consistent with a standard innovator strategy to maximise exclusivity beyond the original compound patent expiry. For generic manufacturers, each patent represents an independent invalidity or non-infringement hurdle. The absence of any Federal Circuit merits ruling in this proceeding means the full enforceability of each patent remains intact and must be individually assessed in any future challenge or FTO analysis.
Should you run an FTO analysis against the Entresto® patent portfolio?
Any company developing, formulating, or seeking to commercialise a sacubitril/valsartan generic, authorised generic, or functionally similar angiotensin receptor-neprilysin inhibitor (ARNI) product should treat this nine-patent portfolio as a high-priority FTO target. The dismissal of this Federal Circuit appeal without a merits ruling means no claim construction or invalidity findings exist at the appellate level to aid clearance — the risk profile is therefore higher, not lower, than it would be post-adjudication.
PatSnap Eureka’s FTO Search Agent can map each of the nine Entresto® patents against proposed product formulations, identify relevant prosecution history disclaimers, surface any post-grant proceedings (IPR, PGR) that may have narrowed claims, and flag continuation applications still pending in the family. This is particularly valuable given the multi-decade prosecution window across the portfolio, where claim scope may vary significantly between early and late-filed family members.
Run a freedom-to-operate analysis on US8101659B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit Hatch-Waxman appeals: sacubitril/valsartan and ARNI patents
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What this case signals for the Entresto® and Hatch-Waxman IP landscape
A nine-patent Federal Circuit appeal ending in joint dismissal after 247 days carries significant signals for generic cardiovascular drug strategy.
Joint Rule 42(b) dismissal without costs typically signals a deal, not defeat
When both parties jointly exit a Federal Circuit appeal cost-neutrally under Rule 42(b), it is strongly consistent with a negotiated resolution — often a license with defined market-entry dates. Generic manufacturers and innovators in Hatch-Waxman disputes regularly use appellate dismissal as the clean exit mechanism once commercial terms are settled privately.
Nine patents surviving appellate scrutiny raises the bar for future ANDA challengers
Because no merits ruling issued, all nine Entresto® patents remain presumptively valid with no Federal Circuit analysis to reference. Any future ANDA filer seeking to challenge sacubitril/valsartan patents must build its invalidity case from scratch at the district court level, without the benefit of adverse appellate findings that this proceeding might have generated.
Novartis v Hetero — key questions answered
Under Fed. R. App. P. 42(b), the parties jointly agreed to dismiss the Federal Circuit appeal. This means no merits ruling on the nine Entresto® patents was issued. The dismissal is procedural — it ends the appeal without creating appellate precedent on infringement or validity of US8101659B2 and the eight co-asserted patents.
Novartis asserted nine patents: US8101659B2, US11135192B2, US9937143B2, US9388134B2, US8796331B2, US11058667B2, US11096918B2, US9517226B2, and US8877938B2. All relate to sacubitril/valsartan formulations and methods of use covering Entresto® tablets in three dose strengths.
No. The joint dismissal under Rule 42(b) issues no ruling on patent validity or infringement. All nine asserted patents retain their presumption of validity. The dismissal is consistent with a negotiated resolution between the parties and does not constitute a judicial finding adverse to Novartis’s patent rights.
Cost-neutral dismissals are standard in agreed Federal Circuit exits under Rule 42(b). The absence of a cost award does not indicate which party held the stronger legal position. It is a routine term in jointly stipulated dismissals and does not itself signal settlement terms or the identity of the commercially stronger party.
No. Because the Federal Circuit issued no opinion on validity or infringement, Case No. 24-2210 provides no persuasive or binding authority for future challengers. Any new ANDA filer seeking to invalidate the nine Entresto® patents must build an independent case through district court litigation or IPR petitions at the USPTO.
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