Novartis v. MSN & Alembic: Entresto ANDA Non-Infringement Ruling After 991 Days
Novartis AG brought a Hatch-Waxman patent infringement action against MSN Laboratories, Alembic, Mylan, and related entities over US11096918B2, a patent covering valsartan/sacubitril combination tablets marketed as Entresto. The Delaware District Court entered final judgment in MSN’s favour on non-infringement of claim 1, a significant blow to Novartis’s effort to block generic entry after nearly three years of litigation.
Novartis Loses Entresto ANDA Battle in Delaware on Non-Infringement
Novartis AG filed this Hatch-Waxman action on 24 October 2022 in the District of Delaware before Judge Richard G. Andrews, asserting US11096918B2 against MSN Laboratories Private Limited, MSN Pharmaceuticals Inc., MSN Life Sciences Private Limited, Alembic and its global affiliates, Mylan Pharmaceuticals Inc., Mylan Laboratories Limited, Viatris Inc., Crystal Pharmaceutical (Suzhou), and Nanjing Noratech Pharmaceutical. The sole patent in suit covers formulations of the angiotensin receptor-neprilysin inhibitor (ARNI) combination valsartan/sacubitril — the active ingredients in Entresto, Novartis’s blockbuster heart-failure therapy. The defendants had filed ANDA No. 213748 and related applications seeking approval to market generic versions before patent expiry.
The case closed on 11 July 2025 after 991 days. The court entered judgment on the merits in MSN’s favour, finding that MSN’s filing of ANDA No. 213748 — including any amendments or supplements — does not infringe claim 1 of the ‘918 Patent under 35 U.S.C. § 271(e)(2), and that any future use, sale, offer for sale, manufacture, or importation of MSN’s ANDA products during the patent term would likewise not infringe. MSN’s invalidity counterclaim was dismissed with prejudice, meaning the ‘918 Patent’s validity was not adjudicated and the patent formally survives — but MSN is cleared to seek FDA approval without Novartis’s consent.
A 991-day duration is consistent with the typical ANDA litigation schedule in Delaware, which often runs through expert discovery and trial preparation before settlement or merits decision. The non-infringement finding on claim 1 alone — without a validity ruling — suggests the court may have determined that MSN’s ANDA product simply fell outside the claim scope, making it unnecessary to reach invalidity. What the public record does not reveal is whether other defendants (Alembic, Mylan, Crystal Pharmaceutical, Nanjing Noratech) reached separate consent judgments or remain subject to distinct proceedings, nor whether Novartis plans to appeal the non-infringement finding to the Federal Circuit.
Filing to Judgment on the merits for Defendant in 991 days
991 days litigated — lengthy for an ANDA Hatch-Waxman first-instance proceeding
Judgment for MSN: what the non-infringement ruling means for both parties
Non-infringement on the merits under § 271(e)(2)
Under 35 U.S.C. § 271(e)(2), the act of filing an ANDA for a patented drug is itself a technical act of infringement enabling the patent holder to sue pre-launch. A judgment on the merits that the ANDA filing does not infringe means the court conducted a full claim-construction and infringement analysis and found MSN’s proposed product falls outside claim 1 of the ‘918 Patent — clearing the path for FDA approval without patent consent.
Merits adjudication — non-infringementNovartis loses exclusivity shield — generic entry risk elevated
The non-infringement judgment means Novartis cannot block MSN’s ANDA on the basis of claim 1 of the ‘918 Patent. Critically, the invalidity counterclaim was dismissed with prejudice, so the ‘918 Patent formally remains valid — but that validity is commercially irrelevant if no claim covers MSN’s ANDA product. Novartis may appeal to the Federal Circuit, but until any stay is obtained, MSN can pursue FDA approval and launch upon receiving it.
Generic entry pathway now open for MSNMSN cleared on non-infringement — invalidity argument extinguished
MSN achieved its primary objective: a finding that its ANDA product does not infringe the asserted claim. The trade-off is significant — MSN’s invalidity counterclaim was dismissed with prejudice, meaning MSN cannot re-litigate validity in another forum or use this case to invalidate the ‘918 Patent. If Novartis asserts the same patent against other ANDAs, those defendants cannot rely on a prior invalidity ruling from this case.
No invalidity precedent createdEntresto generic market opens — but only for MSN’s specific formulation
Entresto generated over $6 billion in annual sales for Novartis before this ruling. The non-infringement finding is product-specific: it reflects that MSN’s ANDA formulation falls outside claim 1 as construed, not that any generic valsartan/sacubitril formulation is free to launch. Other ANDA filers — Alembic, Mylan, Crystal Pharmaceutical, and Nanjing Noratech — may remain subject to separate proceedings or consent judgments, creating a fragmented competitive landscape for generic entry.
Fragmented generic entry; Novartis appeal likelyFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Novartis, AG | Company | Global pharma innovator — holder of US11096918B2 covering valsartan/sacubitril tabletsSearch in Eureka ↗ |
| Defendant | Alembic | Individual | MSN Laboratories and Alembic group: generic pharmaceutical manufacturers seeking ANDA approval for valsartan/sacubitril tabletsSearch in Eureka ↗ |
| Co-Defendant | Mylan Laboratories Limited | Individual | Search in Eureka ↗ |
| Co-Defendant | Alembic Global Holding SA | Company | Search in Eureka ↗ |
| Co-Defendant | Alembic Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Mylan Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | MSN Laboratories Private Limited | Individual | Search in Eureka ↗ |
| Co-Defendant | MSN Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Msn Life Sciences Private Limited | Individual | Search in Eureka ↗ |
| Co-Defendant | Crystal Pharmaceutical (Suzhou) Co., Ltd. | Company | Search in Eureka ↗ |
| Co-Defendant | Nanjing Noratech Pharmaceutical Co., Limited | Company | Search in Eureka ↗ |
| Co-Defendant | Viatris, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Alexandra M. Joyce | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Carrie S. Park | 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 A. O’Brien | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Daniel M. Silver | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Erin Belfield | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Gregory J. Manas | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Jared L. Stringham | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Maliheh Zare | 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 law firm | McCarter & English, LLP | Law Firm | Representing Novartis, AGSearch in Eureka ↗ |
| Plaintiff law firm | Venable LLP | Law Firm | Representing Novartis, AGSearch in Eureka ↗ |
| Defendant counsel | Daniel Taylor | Attorney | Counsel for AlembicSearch in Eureka ↗ |
| Defendant counsel | Eve H. Ormerod | Attorney | Counsel for AlembicSearch in Eureka ↗ |
| Defendant counsel | Neal C. Belgam | Attorney | Counsel for AlembicSearch in Eureka ↗ |
| Defendant law firm | Smith, Katzenstein & Jenkins LLP | Law Firm | Representing AlembicSearch in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The judgment is precise in its scope: it addresses only claim 1 of the ‘918 Patent and only MSN’s ANDA No. 213748 product. The dual finding — that both the ANDA filing and any future commercialisation would not infringe — tracks standard Hatch-Waxman relief structure, removing both the § 271(e)(2) paper infringement and any future enforcement risk for MSN’s specific formulation. The dismissal with prejudice of MSN’s invalidity counterclaim is notable: it suggests the parties or court determined that invalidity need not be reached once non-infringement was established, but it forecloses MSN from relitigating validity. The public record does not indicate whether other named defendants (Alembic, Mylan, Crystal, Nanjing Noratech) are subject to separate orders.
US11096918B2 — Valsartan/Sacubitril ARNI Combination Tablet Formulation
US11096918B2, filed under application number US16/579581, protects formulations of valsartan and sacubitril — the two active moieties in Novartis’s Entresto (sacubitril/valsartan), an angiotensin receptor-neprilysin inhibitor approved for heart failure with reduced ejection fraction. The patent covers the solid oral dosage form and likely the specific crystalline or compositional arrangement enabling co-formulation of the two mechanistically distinct compounds. As a later-filed member of Novartis’s Entresto patent family, it represents a formulation-layer protection strategy layered on top of earlier compound patents.
Strategically, the ‘918 Patent was part of Novartis’s multi-layer exclusivity approach for a product generating multi-billion-dollar annual revenues. The formulation-specific nature of claim 1 — as evidenced by MSN’s successful non-infringement defence — suggests the claim is narrow enough that alternative ANDA formulations may design around it. For competitors in the ARNI cardiovascular space, this ruling signals that Novartis’s formulation patents may offer weaker blockade than its earlier compound-level protection, particularly as courts apply rigorous claim construction to ANDA-specific formulation differences.
Should you run an FTO analysis against US11096918B2?
Any company developing or marketing a generic or follow-on valsartan/sacubitril combination product — whether an ANDA filer, a contract manufacturer, or an API supplier — should conduct a freedom-to-operate analysis against US11096918B2. Despite the non-infringement finding in MSN’s favour, the ‘918 Patent remains formally valid and in force. The non-infringement ruling is specific to MSN’s ANDA No. 213748 formulation and claim 1 as construed in this litigation. A different formulation or a different claim construction record could yield a different outcome.
PatSnap Eureka’s FTO Search Agent can map your specific valsartan/sacubitril formulation against claim 1 of US11096918B2, identify related family members across Novartis’s ARNI portfolio, and flag post-grant proceedings — including any IPR petitions — that may affect the patent’s enforceability. For regulatory and R&D teams preparing ANDA submissions, Eureka’s claim-by-claim analysis helps document design-around rationale that can be critical in Hatch-Waxman litigation.
Run a freedom-to-operate analysis on US11096918B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman ANDA Patent Cases in Delaware: ARNI & Cardiovascular Drugs
Explore comparable ANDA infringement actions involving cardiovascular formulation patents litigated in the District of Delaware before Judge Andrews and related Hatch-Waxman proceedings.
What this case signals for the ARNI and branded pharma IP landscape
A merits-based non-infringement ruling in a flagship Hatch-Waxman case has ripple effects well beyond the two primary parties.
Non-infringement without invalidity creates a narrow but exploitable gap
When a court finds non-infringement but dismisses the invalidity counterclaim with prejudice, the patent survives formally intact. This means Novartis can continue asserting the ‘918 Patent against other ANDA filers whose formulations differ from MSN’s. Generic manufacturers should not assume this ruling grants a sector-wide licence — each ANDA’s formulation must be independently evaluated against claim 1 as construed by this court.
Hatch-Waxman claim-construction outcomes are increasingly formulation-specific
The outcome here is consistent with a broader Delaware trend: patent holders draft broad claims, but courts apply rigorous claim construction at trial that may exclude specific generic formulations without invalidating the patent. R&D and regulatory teams designing around branded ARNI patents should document formulation design-around rationale contemporaneously — it can be outcome-determinative at the § 271(e)(2) infringement stage.
Novartis v Alembic — key questions answered
The Delaware District Court entered judgment in MSN’s favour, finding that MSN’s ANDA No. 213748 for generic valsartan/sacubitril tablets does not infringe claim 1 of US11096918B2 under 35 U.S.C. § 271(e)(2). The court also held that future commercialisation of MSN’s ANDA product would not infringe. MSN’s invalidity counterclaim was dismissed with prejudice.
US11096918B2 is a Novartis patent filed under application US16/579581 covering formulations of valsartan and sacubitril — the active ingredients in Entresto, an angiotensin receptor-neprilysin inhibitor (ARNI) approved for heart failure with reduced ejection fraction. The patent protects the solid oral dosage form and specific compositional arrangements of the co-formulated compounds.
The public record does not specify the precise procedural reason. Typically in Hatch-Waxman cases, once a court finds non-infringement, the invalidity counterclaim becomes moot and may be dismissed. Dismissal with prejudice means MSN cannot re-litigate validity of the ‘918 Patent in a new proceeding, though other parties may still challenge validity via inter partes review at the USPTO.
No. The judgment is explicitly limited to MSN’s ANDA No. 213748 and MSN’s specific ANDA product formulation. Other defendants — Alembic, Mylan Pharmaceuticals, Mylan Laboratories, Viatris, Crystal Pharmaceutical, and Nanjing Noratech — are not covered by this ruling unless separate orders were entered in their favour. Each must have its own formulation evaluated against claim 1 as construed.
Yes. As a final judgment on the merits in a district court action, Novartis has the right to appeal to the United States Court of Appeals for the Federal Circuit. If Novartis appeals, it must file within 30 days of the final judgment (subject to any post-trial motions). An appeal would not automatically stay FDA approval of MSN’s ANDA unless Novartis obtains a separate injunction pending appeal.
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