Novartis v. Hetero USA & MSN: Federal Circuit Entresto Appeal Voluntarily Dismissed
Novartis AG voluntarily dismissed its Federal Circuit appeal against Hetero USA and three MSN entities over nine patents protecting Entresto (sacubitril/valsartan) tablets. The dismissal, agreed by all parties, concluded within 247 days with each side absorbing its own costs — a signal that a negotiated resolution likely preceded the withdrawal.
Nine-patent Entresto appeal ends by mutual agreement at Federal Circuit
Novartis AG filed Federal Circuit appeal No. 24-2209 on 13 August 2024, challenging an underlying district court outcome concerning nine US patents covering its blockbuster heart-failure drug Entresto (sacubitril/valsartan) tablets in 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg dosage strengths. The defendants — Hetero USA Inc., MSN Pharmaceuticals Inc., MSN Laboratories Private Ltd., and MSN Life Sciences Private Ltd. — are generic pharmaceutical companies whose ANDA filings triggered the infringement action.
The appeal closed on 17 April 2025 when the Federal Circuit issued an order dismissing the proceeding under Federal Rule of Appellate Procedure 42(b), the parties having agreed to the dismissal. The court directed that each side bear its own costs. No merits decision was issued; the appellate record therefore contains no ruling on the validity or infringement of any of the nine asserted patents.
A 247-day lifespan at the Federal Circuit — without full briefing reaching merits — is consistent with a negotiated settlement or licensing agreement reached in parallel. The mutual cost-bearing arrangement typically suggests neither party extracted a clear concession on costs, though the precise commercial terms, if any, are not reflected in the public record. The fate of the underlying district court judgment and any consent judgments or license terms remain undisclosed.
Filing to Voluntary dismissal in 247 days
247 days from filing to close — faster than most multi-patent Federal Circuit infringement appeals
Voluntarily dismissed: what the Federal Circuit order means for both parties
Fed. R. App. P. 42(b) — agreed appellate dismissal, no merits ruling
Rule 42(b) permits a Federal Circuit appeal to be dismissed upon the parties’ stipulation. Because the dismissal is procedural and not on the merits, the appellate court made no finding on patent validity, infringement, or claim construction. The underlying district court record — not this order — governs any precedential effect. This mechanism is commonly used when parties settle or enter licensing arrangements after an appeal is docketed.
Procedural dismissal — no merits adjudicationPublic record is silent on whether dismissal is with or without prejudice
The Basis of Termination is recorded as ‘Voluntary dismissal’ without further specification. A dismissal with prejudice bars re-filing the same claims; one without prejudice leaves that door open. The Federal Circuit’s order under Rule 42(b) does not expressly state either condition in the data available here. Practitioners should consult the full docket text to determine whether any consent judgment or stipulated terms govern re-filing rights before drawing enforcement conclusions.
Prejudice status undisclosedNovartis exits appeal without an appellate win — but retains nine patents intact
Novartis obtained no affirmance of the underlying decision and no appellate ruling strengthening its patent portfolio. However, because no invalidity or non-infringement ruling was issued at this level, all nine asserted patents remain uncancelled by this proceeding. Any commercial resolution negotiated privately — such as a licensed launch date for the generic — would not appear on the public record and may represent the operative outcome for Novartis.
Patents intact; no appellate rulingMSN and Hetero avoid an adverse Federal Circuit ruling — but gain no invalidity finding
The MSN entities and Hetero USA secured dismissal without suffering an appellate affirmance of any injunction or infringement holding. Equally, they obtained no Federal Circuit invalidity ruling they could use offensively against Novartis in other proceedings. The symmetric cost order and agreed dismissal suggest the commercial resolution, if any, was balanced. Their ANDA path to market for sacubitril/valsartan tablets depends on terms not visible in this docket.
No invalidity win; market path unclearFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Novartis, AG | Company | Pharmaceutical innovator — holder of US8101659B2 and 8 further Entresto patentsSearch in Eureka ↗ |
| Defendant | Hetero USA, Inc. | Company | Generic pharmaceutical group: Hetero USA Inc. and MSN Pharmaceuticals/Laboratories/Life SciencesSearch 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’ — confirms this was a stipulated dismissal, not a unilateral withdrawal. Dismissal under Fed. R. App. P. 42(b) terminates the appellate proceeding without the Federal Circuit reaching the merits of any patent claim. No claim construction, validity, or infringement ruling was issued. The equal cost allocation is procedurally neutral and does not signal which party held the stronger appellate position. The operative legal effect is that the Federal Circuit appeal is extinguished; any rights or obligations flowing from the underlying district court proceedings, or from any private agreement, govern the parties’ ongoing positions.
US8101659B2 and 8 further patents — sacubitril/valsartan (Entresto) formulation and use
The nine asserted patents — anchored by US8101659B2 (application No. 12/147570) and spanning applications through to US16/579581 — collectively protect the sacubitril/valsartan molecular entity, its pharmaceutical compositions, crystalline forms, dosage formulations at three specific strength combinations, and methods of treating heart failure. The portfolio represents a classic layered innovator strategy: compound patents at the core, surrounded by formulation, process, and method-of-use claims that collectively extend market exclusivity across different expiry dates.
Entresto generated over $6 billion in annual global sales for Novartis and is among the most commercially significant cardiovascular patents in litigation. The nine-patent cluster means generic entrants face a multi-front validity challenge: invalidating any single patent does not clear the path if others remain enforceable. This structural depth makes the portfolio strategically resilient and explains why generic filers such as MSN and Hetero typically pursue ANDA litigation in parallel with IPR petitions rather than relying on district court proceedings alone.
Should you run an FTO against US8101659B2 and the Entresto patent cluster?
Any pharmaceutical company developing, manufacturing, or seeking ANDA or 505(b)(2) approval for sacubitril/valsartan tablets at 24/26 mg, 49/51 mg, or 97/103 mg dosage strengths should treat this nine-patent portfolio as an active FTO risk. The voluntary dismissal in this appeal does not signal patent weakness — it signals a negotiated outcome that leaves all nine patents enforceable. Formulation scientists and regulatory teams should conduct independent claim mapping before initiating bioequivalence studies.
PatSnap Eureka’s FTO Search Agent can map each of the nine application numbers against your proposed composition, process, and method-of-use claims, flagging active claim scope, expiry timelines, and any post-grant proceedings. Eureka’s litigation overlay also surfaces parallel ANDA cases involving the same patent numbers, helping your team understand the full enforcement landscape before committing R&D resources to a sacubitril/valsartan generic program.
Run a freedom-to-operate analysis on US8101659B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit ANDA appeals involving cardiovascular combination drug patents
Federal Circuit appeals arising from sacubitril/valsartan and cardiovascular fixed-dose combination ANDA litigation — cases with overlapping patent numbers, parties, or dismissal mechanics.
What this case signals for the Entresto generic entry IP landscape
A nine-patent Federal Circuit appeal resolved in under nine months by mutual agreement — read the market signals carefully.
Agreed dismissals at the Federal Circuit often precede negotiated launch windows
When both sides absorb their own costs and stipulate to dismissal this early in Federal Circuit briefing, it typically signals a commercial resolution — frequently a consent judgment with a licensed entry date for the generic. Entresto’s exclusivity profile makes the timing of any such date commercially critical for both innovator and generic.
Nine patents still on the books — the Entresto fortress remains legally intact
No patent was invalidated or found unenforceable in this proceeding. Companies monitoring freedom-to-operate for sacubitril/valsartan combination therapies must independently assess all nine asserted patents, which span formulation, method-of-use, and compound claims across multiple application families.
Novartis v Hetero — key questions answered
The Federal Circuit dismissed the appeal voluntarily under Fed. R. App. P. 42(b) on 17 April 2025, by agreement of all parties. No merits ruling on any of the nine Entresto patents was issued. Each side was ordered to bear its own costs. The dismissal followed 247 days after the appeal was filed on 13 August 2024.
Novartis asserted nine US patents: US8101659B2, US11135192B2, US9937143B2, US9388134B2, US8796331B2, US11058667B2, US11096918B2, US9517226B2, and US8877938B2 — all covering aspects of sacubitril/valsartan (Entresto) including compositions, formulations, and methods of treating heart failure.
No. A dismissal under Fed. R. App. P. 42(b) is purely procedural and carries no merits ruling. None of the nine patents was invalidated or found unenforceable in this Federal Circuit proceeding. All nine remain on the register and retain their full legal presumption of validity absent a separate IPR, reexamination, or district court ruling to the contrary.
In Federal Circuit appeals, costs are typically awarded to the prevailing party under Fed. R. App. P. 39. An order that each side bears its own costs is a neutral allocation and does not indicate which party held the stronger legal position. It is a standard feature of agreed dismissals and does not constitute a finding on the merits or an exceptional-case fee award under 35 U.S.C. § 285.
The three MSN entities are related Indian generic pharmaceutical companies involved in developing and potentially supplying sacubitril/valsartan tablets for the US market via ANDA. MSN Pharmaceuticals Inc. is the US entity, while MSN Laboratories Private Ltd. and MSN Life Sciences Private Ltd. are Indian affiliates. All three were named defendants in the appeal alongside Hetero USA Inc., another India-origin generic pharmaceutical company with US operations.
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