Novartis v. Hetero USA: ENTRESTO® Patent Dispute Settled via Consent Judgment
Novartis AG filed suit against Hetero USA and Hetero Labs in the District of Delaware, asserting two patents covering its blockbuster heart failure drug ENTRESTO® (sacubitril/valsartan). After 918 days of litigation, the parties resolved the dispute through a confidential settlement and consent judgment, with Hetero enjoined from commercialising its ANDA No. 213668 products until a negotiated Generic Entry Date.
Hatch-Waxman Battle Over ENTRESTO® Ends in Negotiated License
Novartis AG initiated this Hatch-Waxman infringement action on December 16, 2021, in the District of Delaware before Judge Richard G. Andrews, asserting US Patent Nos. 11,096,918 and 11,058,667 against Hetero USA Inc., Hetero Labs Limited, and Hetero Labs Limited Unit III. The patents cover ENTRESTO® tablets — a sacubitril/valsartan combination therapy available in three dose strengths (24/26 mg, 49/51 mg, and 97/103 mg) — which Novartis markets for the treatment of chronic heart failure with reduced ejection fraction.
The case resolved on June 21, 2024, through a Consent Judgment and Order of Injunction entered by the court, underpinned by a confidential Settlement and License Agreement. The consent judgment records that Novartis granted Hetero a license covering the ANDA No. 213668 products, extinguishing the cause of action on the ‘918 and ‘667 Patents with respect to those products. Hetero is enjoined from commercially distributing those products in the United States until a ‘Generic Entry Date’ defined in the confidential settlement — a standard ANDA settlement mechanism that gives Novartis revenue runway while providing Hetero a guaranteed market entry pathway.
At 918 days, the litigation ran a typical Hatch-Waxman course before settling ahead of any trial date, which is consistent with the majority of ANDA disputes in Delaware that resolve before a merits decision. The parties expressly waived rights to appeal the consent judgment, suggesting confidence in the negotiated terms. The specific Generic Entry Date and any royalty terms remain confidential, meaning the precise commercial value of the settlement to either party cannot be determined from the public record alone.
Filing to Consent Judgment in 918 days
918 days — approximately 2.5 years, consistent with ANDA Hatch-Waxman timelines in Delaware
Consent judgment entered: what the settlement means for both parties
Consent judgment with injunction — not a merits ruling
A consent judgment is a court-approved agreement, not a finding of patent validity or infringement. Here, the court entered both a judgment and an order of injunction on the parties’ stipulation. No claim or defence was adjudicated on the merits. Hetero expressly waived appeal rights, making the order immediately final. The court retained jurisdiction to resolve any disputes arising from the Settlement Agreement.
Hatch-Waxman consent judgmentNovartis secures injunction and deferred generic entry
Novartis obtained a court-backed injunction preventing Hetero from supplying ANDA No. 213668 products in the US until the confidential Generic Entry Date. By licensing rather than litigating to judgment, Novartis preserved the formal validity of the ‘918 and ‘667 Patents — no invalidity finding was made. ENTRESTO® revenues are protected through the negotiated entry window, consistent with Novartis’s broader strategy of managed genericisation.
Patents intact; generic entry deferredHetero secures a licensed market entry pathway
While Hetero accepted an injunction, it secured a licence and a defined Generic Entry Date — avoiding the risk of an adverse merits ruling that could have blocked entry indefinitely or exposed it to damages. All counterclaims and defences were dismissed without prejudice, preserving some optionality. The settlement is commercially rational for a generic filer seeking near-certain market access over uncertain litigation outcomes.
Licensed entry; no merits finding againstENTRESTO® competitive timeline now partly visible to the market
The existence of a Generic Entry Date signals that at least one generic competitor will eventually enter the sacubitril/valsartan market with Novartis’s consent. Other ANDA filers should monitor whether their own entry dates align with or follow Hetero’s. For payers and healthcare systems, this settlement reinforces that ENTRESTO® exclusivity has a negotiated horizon — though the precise date remains confidential and cannot be inferred from the public record.
Managed genericisation underwayFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Novartis, AG | Company | Global pharmaceutical innovator — holder of US11058667B2 and US11096918 covering ENTRESTO®Search in Eureka ↗ |
| Defendant | Hetero USA, Inc. | Company | Generic pharmaceutical manufacturer and its Indian parent, filing ANDA No. 213668 for sacubitril/valsartanSearch in Eureka ↗ |
| Co-Defendant | Hetero Labs Limited | Individual | Search in Eureka ↗ |
| Co-Defendant | Hetero Labs Limited | Individual | Search in Eureka ↗ |
| Plaintiff counsel | Alexandra M. Joyce | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Christina Schwarz | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Christopher E. Loh | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Daniel M. Silver | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Jared L. Stringham | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Laura K. Fishwick | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Melinda R. Roberts | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Nicholas N. Kallas | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Shannon K. Clark | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff law firm | McCarter & English LLP | Law Firm | Representing Novartis, AGSearch in Eureka ↗ |
| Defendant counsel | Daniel Taylor | Attorney | Counsel for Hetero USA, Inc.Search in Eureka ↗ |
| Defendant counsel | Dmitry V. Shelhoff | Attorney | Counsel for Hetero USA, Inc.Search in Eureka ↗ |
| Defendant counsel | Edward D. Pergament | Attorney | Counsel for Hetero USA, Inc.Search in Eureka ↗ |
| Defendant counsel | Eve H. Ormerod | Attorney | Counsel for Hetero USA, Inc.Search in Eureka ↗ |
| Defendant counsel | Julia S. Kim | Attorney | Counsel for Hetero USA, Inc.Search in Eureka ↗ |
| Defendant counsel | Kenneth S. Canfield | Attorney | Counsel for Hetero USA, Inc.Search in Eureka ↗ |
| Defendant counsel | Neal C. Belgam | Attorney | Counsel for Hetero USA, Inc.Search in Eureka ↗ |
| Defendant law firm | Smith, Katzenstein & Jenkins LLP | Law Firm | Representing Hetero USA, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The Consent Judgment and Order of Injunction reflects a fully negotiated resolution, not a judicial finding on the merits of infringement or validity. Notably, the order’s operative paragraphs are substantially redacted in the public docket — a common feature of Hatch-Waxman settlements where Generic Entry Dates are commercially sensitive. The judgment’s structure — licence extinguishing the cause of action, court-retained jurisdiction, and express appeal waiver — is consistent with a settlement in which both parties regarded the agreed terms as commercially superior to continued litigation risk.
US11058667B2 — Sacubitril/valsartan combination therapy for heart failure
US11058667B2 (application no. US15/572399) covers pharmaceutical formulations central to ENTRESTO® — Novartis’s sacubitril/valsartan combination indicated for heart failure with reduced ejection fraction. Co-asserted with US11096918, the patents protect the composition and/or use of the sacubitril/valsartan supramolecular complex in the specific tablet dosage forms marketed by Novartis. ENTRESTO® launched in 2015 following clinical data showing significant mortality benefit, and rapidly became one of the world’s highest-grossing cardiovascular drugs.
The strategic importance of the ‘667 and ‘918 Patents lies in their role as late-stage lifecycle management assets for ENTRESTO®, which generated multi-billion dollar annual revenues for Novartis. Generic challengers filing ANDAs under Paragraph IV must overcome these patents before lawful US commercialisation, making them high-value litigation targets. The settlement here — granting Hetero a licence rather than litigating validity — suggests Novartis judged the commercial risk of an adverse invalidity finding as material, consistent with the significant revenue at stake.
Should you run an FTO against US11058667B2 and US11096918?
Any company developing, formulating, or seeking to commercialise sacubitril/valsartan combination products in the United States — whether as a generic, branded follow-on, or novel heart failure therapy — should conduct a freedom-to-operate analysis against the ‘667 and ‘918 Patent family and any related Novartis continuation applications. The consent judgment confirms these patents remain valid and enforceable; no invalidity finding was made. Teams working on ARNi-class cardiovascular products, fixed-dose combination formulations, or HFrEF indications are particularly exposed.
PatSnap Eureka’s FTO Search Agent can map the full Novartis sacubitril/valsartan patent family, identify granted claims, and flag prosecution history estoppel that may limit or expand claim scope. Eureka’s landscape view surfaces related continuation, divisional, and international counterpart filings that often extend exclusivity beyond the patents asserted in any single litigation. R&D and regulatory teams should run this analysis before ANDA filing or IND submission to identify design-around opportunities or invalidity positions early.
Run a freedom-to-operate analysis on US11058667B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA Patent Cases: Cardiovascular Drug Formulations in Delaware
Explore comparable Hatch-Waxman infringement actions over cardiovascular pharmaceutical patents litigated in the District of Delaware.
What this case signals for the cardiovascular pharmaceutical IP landscape
This settlement is a textbook ANDA resolution — but the terms and injunction structure carry broader signals for generic entrants and brand defenders alike.
Consent judgments with defined entry dates are the preferred ANDA endgame
Rather than litigating to a validity or infringement finding, Novartis and Hetero followed the established Hatch-Waxman playbook: confidential settlement, licensed entry date, and court-backed injunction. Patent holders in the cardiovascular space should structure litigation strategy around this model — preserving patent validity while controlling the generic timeline.
Waiver of appeal rights signals high settlement confidence — and finality
Both parties expressly waived appeal rights in the consent judgment, an unusually explicit finality provision. This suggests the negotiated Generic Entry Date was sufficiently certain that neither side anticipated needing to revisit the order. For litigants, this is a signal that well-structured consent judgments can achieve commercial certainty faster than a trial verdict.
Novartis v Hetero — key questions answered
The case settled via a Consent Judgment and Order of Injunction entered on June 12, 2024, and the case was closed on June 21, 2024. Novartis granted Hetero a licence covering ANDA No. 213668 products, and Hetero was enjoined from US commercialisation until a confidential Generic Entry Date. No merits finding on patent validity or infringement was made.
Novartis asserted US Patent Nos. 11,096,918 and 11,058,667, both covering aspects of ENTRESTO® (sacubitril/valsartan) tablets. The ‘667 patent corresponds to application number US15/572399. Both patents remained valid and enforceable at settlement — no invalidity or non-infringement finding was entered.
Under paragraph 7 of the Consent Judgment, Hetero and each of its affiliates are enjoined from directly or indirectly passing title or delivering ANDA No. 213668 products to customers in the United States prior to the Generic Entry Date as defined in the confidential Settlement Agreement, subject to exceptions also set out in that agreement.
The Generic Entry Date is defined in the confidential Settlement and License Agreement, which is not part of the public court record. Its precise date cannot be determined from publicly available documents. This is a standard feature of Hatch-Waxman ANDA settlements, where the entry date is commercially sensitive to both the innovator and the generic filer.
Per paragraph 5 of the Consent Judgment, all Novartis claims and all Hetero defences, demands, and counterclaims in Civil Action Nos. 21-1330-RGA and 21-1760-RGA were dismissed without prejudice. This means neither party is formally barred from relitigating those specific claims in future proceedings, though the appeal waiver in paragraph 11 limits the ability to challenge the consent judgment itself.
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