Novartis v. Torrent Pharma: Entresto Patent Appeal Voluntarily Dismissed
Novartis Pharmaceuticals Corporation appealed against Torrent Pharma Inc and Torrent Pharmaceuticals Ltd. over four patents protecting Entresto (sacubitril/valsartan), a blockbuster heart failure drug. The Federal Circuit appeal was voluntarily dismissed by joint stipulation after 400 days, with each side bearing its own costs — leaving the public record silent on merits.
Entresto appeal exits Federal Circuit without a merits ruling
Novartis Pharmaceuticals Corporation filed this appeal at the Court of Appeals for the Federal Circuit on 31 July 2023, asserting infringement of four patents — US8101659B2, US9388134B2, US8796331B2, and US8877938B2 — covering Entresto (sacubitril/valsartan) tablets in 24/26 mg, 49/51 mg, and 97/103 mg doses. The defendants, Torrent Pharma Inc and its parent Torrent Pharmaceuticals Ltd., are generic pharmaceutical companies whose ANDA filing for a sacubitril/valsartan product triggered the original infringement claim.
On 3 September 2024, the Federal Circuit entered an order voluntarily dismissing the appeal pursuant to Federal Rule of Appellate Procedure 42(b)(1), acting on a joint stipulation filed by both parties as ECF No. 18. The dismissal carried no merits adjudication and directed each side to bear its own costs. Because the parties filed jointly, neither can be characterised unambiguously as the initiating party in the withdrawal, and the public record does not specify whether the dismissal was with or without prejudice at the appellate level.
A 400-day duration before voluntary dismissal is consistent with meaningful settlement or licensing negotiations occurring in parallel with appellate briefing — a pattern frequently observed in Hatch-Waxman appeals involving high-value branded drugs. What drove the resolution, whether a licence, a consent judgment at district court level, or another commercial arrangement, is not disclosed in the Federal Circuit docket. The underlying district court proceedings and any related ANDA status remain outside the scope of this appellate record.
Filing to Voluntary dismissal in 400 days
400-day appeal — above median for voluntarily dismissed Federal Circuit ANDA cases
Joint voluntary dismissal: what the FRAP 42(b)(1) order means for both parties
FRAP 42(b)(1): voluntary dismissal on joint stipulation
Federal Rule of Appellate Procedure 42(b)(1) allows parties to dismiss an appeal by filing a signed dismissal agreement. Unlike a unilateral withdrawal, a joint stipulation requires consent from all parties, which typically signals a negotiated resolution. The Federal Circuit enters the order ministerially — it does not evaluate the merits, make any patentability or infringement finding, or determine which party prevailed. The underlying district court record, if any, is unaffected by this order alone.
No merits adjudicationWith or without prejudice? The record is silent
A voluntary dismissal can be with prejudice — permanently barring re-litigation of the same claims — or without prejudice, preserving the right to refile. The Federal Circuit’s order in this case does not specify either. Under FRAP 42(b), the default in appellate practice is generally that the appeal is terminated, but the effect on the underlying district court judgment or any right to further review depends on terms the parties may have agreed privately. Patent professionals should treat this outcome as indeterminate on the prejudice question absent additional docket information.
Prejudice status undisclosedEach side bears its own costs — no prevailing party
The order expressly directs that each side shall bear its own costs. In Federal Circuit patent appeals, cost-shifting to a prevailing party is the default under FRAP 39 when one side wins on the merits. A mutual ‘own costs’ allocation in a joint dismissal is consistent with a negotiated settlement where neither party concedes liability, and where the parties have agreed not to seek cost recovery as part of the resolution package. It provides no signal about the relative strength of the underlying patent claims.
No cost-shifting; neutral allocationEntresto exclusivity picture remains commercially sensitive
Entresto (sacubitril/valsartan) is among the highest-revenue cardiovascular drugs globally. A voluntary dismissal without a merits ruling leaves the four asserted patents in a legally ambiguous position vis-à-vis Torrent specifically: no court has found them valid, invalid, infringed, or not infringed. Other ANDA filers facing these same patents may draw limited inference from this outcome. Branded exclusivity and any agreed launch dates or consent judgments remain undisclosed, making Entresto’s generic entry timeline difficult to model from the public record alone.
Generic entry timeline uncertainFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Novartis Pharmaceuticals Corporation | Company | Innovative pharmaceutical company — holder of US8101659B2 and three further Entresto patentsSearch in Eureka ↗ |
| Defendant | TORRENT PHARMA INC | Company | Generic pharmaceutical manufacturer seeking ANDA approval for sacubitril/valsartan tabletsSearch in Eureka ↗ |
| Co-Defendant | Torrent Pharmaceuticals, Ltd. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Christina A. L. Schwarz | Attorney | Counsel for Novartis Pharmaceuticals CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Deanne Maynard | Attorney | Counsel for Novartis Pharmaceuticals CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Nicholas Nick Kallas | Attorney | Counsel for Novartis Pharmaceuticals CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Seth W. Lloyd | Attorney | Counsel for Novartis Pharmaceuticals CorporationSearch in Eureka ↗ |
| Plaintiff law firm | Morrison & Foerster LLP | Law Firm | Representing Novartis Pharmaceuticals CorporationSearch in Eureka ↗ |
| Plaintiff law firm | Venable LLP | Law Firm | Representing Novartis Pharmaceuticals CorporationSearch in Eureka ↗ |
| Defendant counsel | Dmitry Shelhoff | Attorney | Counsel for TORRENT PHARMA INCSearch in Eureka ↗ |
| Defendant counsel | Edward D. Pergament | Attorney | Counsel for TORRENT PHARMA INCSearch in Eureka ↗ |
| Defendant counsel | Julia S. Kim | Attorney | Counsel for TORRENT PHARMA INCSearch in Eureka ↗ |
| Defendant counsel | Kenneth Canfield | Attorney | Counsel for TORRENT PHARMA INCSearch in Eureka ↗ |
| Defendant law firm | Pergament & Cepeda LLP | Law Firm | Representing TORRENT PHARMA INCSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The Federal Circuit’s order is purely procedural: it records the parties’ joint agreement to end the appeal and allocates costs neutrally. No patentability finding, no infringement determination, and no validity ruling attaches to any of the four Entresto patents. Because the dismissal is joint and made under FRAP 42(b)(1), the appellate court applies no standard of review to the merits — it simply closes the docket. The substantive IP rights of both parties remain as they stood before the appeal was filed, subject only to whatever private terms the parties may have agreed.
US8101659B2 and three further patents — Entresto sacubitril/valsartan formulations
The four patents at issue — US8101659B2, US9388134B2, US8796331B2, and US8877938B2 — collectively protect the chemistry, formulation, and potentially the manufacturing processes underlying Entresto (sacubitril/valsartan), approved by the FDA for heart failure with reduced ejection fraction. Application dates span filings from the mid-2000s through to 2014, reflecting Novartis’s strategy of building a multi-layered patent estate around both the active molecular entities and the finished dosage forms across the three commercially available strengths.
Entresto generated multi-billion-dollar annual revenues for Novartis, making this patent portfolio among the most commercially significant in cardiovascular medicine. A four-patent assertion in a single Hatch-Waxman action signals that Novartis anticipated compound-claim vulnerability and sought redundancy through formulation and process patents. For competitors and IP analysts, the unadjudicated status of these patents post-dismissal means each remains a potential enforcement tool against other ANDA filers, and their claim scope warrants independent FTO evaluation.
Should your team run an FTO against US8101659B2 and the Entresto patent family?
Any pharmaceutical company developing or commercialising a sacubitril/valsartan combination product — or a closely related neprilysin inhibitor/ARB combination — should treat the four Novartis Entresto patents as live enforcement risks. The voluntary dismissal of the Torrent appeal provides no safe harbour: the patents remain in force and unadjudicated on the merits. R&D teams formulating heart failure combination therapies, and business development teams evaluating ANDA or 505(b)(2) strategies, face meaningful infringement exposure that a current FTO analysis should address.
PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to map claim scope across all four Entresto patents simultaneously, identify prior art that may support design-around strategies, and monitor for continuation filings or related applications that could extend exclusivity. Eureka’s litigation overlay also flags where these patents appear in other active ANDA disputes, giving strategic context that goes beyond the single dismissed appeal visible in this Federal Circuit docket.
Run a freedom-to-operate analysis on US8101659B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit Hatch-Waxman patent appeals in cardiovascular pharma
Cases involving sacubitril/valsartan formulation patents and Hatch-Waxman ANDA challenges before the Federal Circuit, with comparable voluntary dismissal or settlement patterns.
What this case signals for the cardiovascular pharmaceutical IP landscape
Voluntary Federal Circuit dismissals in Hatch-Waxman cases often mask commercially significant private agreements. Four key implications follow.
Joint dismissals in ANDA appeals typically reflect negotiated resolution
When both an innovator and a generic agree to dismiss a Federal Circuit appeal jointly, it is consistent with a settlement, licence, or agreed launch date reached outside the court. Patent teams monitoring Entresto generic entry should treat this outcome as a signal to investigate ANDA status and any consent judgments filed in the originating district court rather than relying solely on the appellate docket.
Four-patent assertion across formulation and compound claims signals layered exclusivity strategy
Novartis asserted patents spanning compound, formulation, and potentially method-of-use claims across four US patents for Entresto. This layered approach is a standard Hatch-Waxman enforcement strategy designed to maximise the cost and complexity of generic challenge. Competitors and freedom-to-operate analysts should evaluate each patent independently — a voluntary dismissal of the appeal does not constitute a waiver or invalidation of any individual patent.
Novartis v TORRENT — key questions answered
The voluntary dismissal under FRAP 42(b)(1) means the Federal Circuit made no ruling on the validity or infringement of any of the four Entresto patents. All four — US8101659B2, US9388134B2, US8796331B2, and US8877938B2 — remain in force and unadjudicated on the merits. The dismissal does not invalidate, limit, or narrow any patent claim.
The Federal Circuit order (ECF No. 18) does not specify whether the dismissal is with or without prejudice. The public record is silent on this point. Under FRAP 42(b)(1), the appeal is terminated, but the effect on any underlying district court judgment or right to refile depends on terms agreed privately between the parties.
Novartis asserted four US patents: US8101659B2 (application US12/147570), US9388134B2 (application US14/311788), US8796331B2 (application US13/687659), and US8877938B2 (application US11/722360). All four relate to Entresto (sacubitril/valsartan) tablets in 24/26 mg, 49/51 mg, and 97/103 mg strengths.
The 400-day duration before joint dismissal is consistent with appellate briefing timelines at the Federal Circuit proceeding in parallel with private settlement or licensing negotiations. It suggests the parties reached a commercially negotiated resolution rather than an early procedural exit. The specific terms driving the timing are not disclosed in the public docket.
No. The dismissal is binding only as between Novartis and the Torrent entities in this appellate proceeding. Other ANDA filers challenging the same four Entresto patents face independent litigation tracks. Novartis retains full rights to assert US8101659B2 and the other three patents against any other generic applicant, and this outcome provides those challengers with no estoppel or precedential benefit.
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