Litigation Details for Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. (Fed. Cir. 2023)

Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. (Fed. Cir. 2023)

Docket	23-2218	Date Filed	2023-07-31
Court	Court of Appeals for the Federal Circuit	Date Terminated	2025-01-10
Cause		Assigned To
Jury Demand		Referred To
Patents	10,188,632; 11,007,179; 11,090,291; 11,160,792; 11,311,516; 7,741,356; 7,786,158; 8,101,659; 8,344,011; 8,609,709; 8,877,938; 9,388,134; 9,675,587
Link to Docket	External link to docket

Details for Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. (Fed. Cir. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-07-31				External link to document

Novartis v. Torrent Pharma, 23-2218: Entresto Patent Litigation Summary and Analysis

Last updated: September 28, 2026

Novartis Pharmaceuticals Corporation prevailed against Torrent Pharma Inc. in Federal Circuit appeal No. 23-2218 concerning generic sacubitril/valsartan, marketed as Entresto. The dispute centered on U.S. Patent No. 8,877,938, which covers pharmaceutical compositions combining sacubitril and valsartan. The Federal Circuit affirmed the district court’s judgment sustaining the patent and finding infringement based on Torrent’s abbreviated new drug application, or ANDA. The decision delayed Torrent’s ability to market a generic version before the relevant patent exclusivity period ended. (U.S. Court of Appeals for the Federal Circuit, 2024).

What is Novartis v. Torrent Pharma, 23-2218?

Novartis v. Torrent Pharma, No. 23-2218, was a Federal Circuit appeal arising from ANDA patent litigation in the U.S. District Court for the District of Delaware.

Item	Detail
Federal Circuit case	Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc.
Appeal number	23-2218
Plaintiff-appellee	Novartis Pharmaceuticals Corporation
Defendant-appellant	Torrent Pharma Inc.
Product	Generic sacubitril/valsartan tablets
Reference product	Entresto
Primary patent	U.S. Patent No. 8,877,938
Technology	Combination pharmaceutical composition
Lower court	U.S. District Court for the District of Delaware
Statutory framework	Hatch-Waxman Act
Federal Circuit outcome	Judgment for Novartis affirmed

Entresto combines sacubitril, a neprilysin inhibitor, with valsartan, an angiotensin II receptor blocker. The FDA approved Entresto in 2015 for heart failure with reduced ejection fraction and later expanded its labeling to additional heart-failure populations. (U.S. Food and Drug Administration, 2015, 2021).

What patent protected Entresto in the Torrent litigation?

The principal patent was U.S. Patent No. 8,877,938, assigned to Novartis AG and licensed or enforced in the United States by Novartis Pharmaceuticals Corporation.

The patent claims pharmaceutical compositions containing sacubitril and valsartan, including combinations in which the two active ingredients are administered together. The patent is directed to the active-ingredient combination rather than only to a manufacturing process or a particular tablet coating.

U.S. Patent No. 8,877,938

Field	Detail
Patent number	8,877,938
Patent title	Pharmaceutical compositions comprising an angiotensin receptor antagonist and a neprilysin inhibitor
Patent owner or assignee	Novartis-related entities
Core compounds	Sacubitril and valsartan
Product association	Entresto
Legal role	Composition patent asserted against Torrent’s ANDA
Patent term	Extended beyond the ordinary 20-year term through patent-term adjustment
Litigation status	Found valid and infringed in the underlying litigation; judgment affirmed on appeal

The Federal Circuit decision addressed the patent claims asserted against Torrent’s proposed product. The court did not authorize generic entry and did not invalidate the patent.

What did the Federal Circuit decide in case No. 23-2218?

The Federal Circuit affirmed the district court’s judgment in Novartis’s favor. The decision preserved the finding that Torrent’s ANDA product would infringe asserted claims of the ’938 patent and rejected Torrent’s invalidity arguments.

The appeal focused primarily on obviousness and the district court’s assessment of the prior art and technical evidence. The Federal Circuit applied the conventional framework under 35 U.S.C. § 103:

1. Identify the scope and content of the prior art.
2. Determine the differences between the prior art and the challenged claims.
3. Assess the level of ordinary skill in the art.
4. Evaluate objective indicia, including unexpected results and commercial success where supported by the record.

The Federal Circuit gave substantial weight to the district court’s factual findings, including findings concerning motivation to combine, reasonable expectation of success, and objective indicia of nonobviousness. The decision left the ’938 patent enforceable against Torrent’s ANDA product.

Was the Entresto patent found invalid for obviousness?

No. The Federal Circuit did not invalidate the asserted Entresto patent. The judgment sustaining the patent survived appellate review.

Torrent argued that the claimed sacubitril/valsartan combination would have been obvious based on prior disclosures of neprilysin inhibition, angiotensin receptor blockade, and related cardiovascular treatment strategies. Novartis disputed that the prior art supplied a sufficient motivation to select the claimed compounds and combine them with a reasonable expectation of achieving the claimed therapeutic result.

The court’s outcome preserved the distinction between:

• A general suggestion to investigate a therapeutic class;
• A disclosure of individual compounds; and
• A legally sufficient teaching or motivation to select the specific sacubitril/valsartan combination.

That distinction is material for combination-drug patents. A challenger may identify a broad field of potentially useful compounds without proving that a skilled artisan would have selected the precise combination claimed by the patent.

How did Torrent’s ANDA create infringement liability?

Torrent filed an ANDA seeking FDA approval to market generic sacubitril/valsartan tablets. The ANDA included a Paragraph IV certification asserting that the relevant Novartis patent was invalid, unenforceable, or would not be infringed.

Under the Hatch-Waxman Act, a Paragraph IV certification is an act of patent infringement under 35 U.S.C. § 271(e)(2)(A). Novartis responded by filing suit within the statutory period. The litigation triggered the FDA’s 30-month stay of final approval for Torrent’s ANDA, subject to court orders and statutory exceptions.

The infringement analysis focused on the product described in Torrent’s ANDA, including its active ingredients, dosage strengths, and proposed labeling. A generic applicant cannot avoid infringement merely by declining to reproduce the brand’s trade dress. The relevant question is whether the ANDA product falls within the asserted patent claims.

What was the Orange Book status of Entresto?

Entresto was listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book. The listed patents provided Novartis with a basis to assert patent rights against ANDA applicants.

The key Orange Book considerations were:

Issue	Analysis
Listed drug	Entresto tablets
Active ingredients	Sacubitril and valsartan
ANDA pathway	Section 505(j) of the Federal Food, Drug, and Cosmetic Act
Certification at issue	Paragraph IV
Patent consequence	ANDA filing created statutory infringement exposure
Regulatory effect	Litigation supported a 30-month stay of final approval
Product category	Small-molecule combination drug, not a biologic

Orange Book listings can include composition, method-of-use, and other patents that meet FDA listing requirements. The existence of a listing does not itself establish validity or infringement. Those issues are resolved in patent litigation.

When does Entresto lose patent exclusivity?

The principal commercial patent barrier associated with the ’938 patent extends into 2026 after patent-term adjustment. Entresto also benefited from FDA regulatory exclusivity and pediatric exclusivity considerations that affected the timing of final generic approval.

The practical exclusivity timeline is:

Milestone	Date or period
Entresto FDA approval	July 7, 2015
ANDA litigation period	Primarily 2021 onward
Federal Circuit appeal	23-2218
Core patent expiry	2026, subject to the applicable patent-term adjustment and any pediatric extension
Generic approval risk	Concentrated around the end of patent and regulatory exclusivity

Patent expiration does not automatically mean immediate generic sales. FDA approval timing, litigation settlements, manufacturing readiness, state substitution rules, and any additional enforceable patents can affect the launch date.

What formulation patents protect Entresto?

The Torrent appeal primarily concerned the active-ingredient combination patent rather than a narrow formulation patent directed only to tablet coating, excipient selection, or release profile.

Entresto is supplied as immediate-release tablets containing sacubitril and valsartan in fixed-dose combinations. The product’s commercial formulation includes the active ingredients in a specific pharmaceutical dosage form and uses excipients that support tablet manufacture, stability, dissolution, and administration.

Formulation-related patent risk can arise from:

• Fixed-dose tablet composition;
• Salt or stereochemical form;
• Particle size and solid-state properties;
• Stability-enhancing excipients;
• Dissolution characteristics;
• Manufacturing processes;
• Dosage strengths and administration methods.

A generic applicant can design around some formulation claims while still infringing a broader composition claim. The ’938 litigation illustrates the commercial value of a composition patent because it reaches the active combination itself rather than only a particular excipient system.

Are there method-of-use patents for sacubitril/valsartan?

Yes. Entresto has been associated with method-of-use patent protection covering treatment of cardiovascular disease, including heart failure and related conditions. Method-of-use patents can remain relevant after a composition patent expires if the generic applicant’s label includes the patented indication.

The FDA’s “skinny label” mechanism allows an ANDA applicant to omit patented indications in certain circumstances. That strategy does not eliminate infringement risk where the proposed label, marketing conduct, prescribing information, or product design still encourages use for the patented method.

For Entresto, method-of-use analysis must be separated from the composition claims at issue in Novartis v. Torrent. The Federal Circuit decision did not convert all Entresto-related patents into a single enforceable right. Each patent requires separate analysis of claim scope, listing status, expiration, and the generic label.

Which companies challenged Entresto patents?

Novartis has faced ANDA challenges from multiple generic pharmaceutical companies seeking to market sacubitril/valsartan. Publicly reported participants in Entresto patent disputes have included Torrent and other generic manufacturers that filed ANDAs or pursued related litigation.

The competitive field includes:

• Torrent Pharma;
• Teva Pharmaceuticals;
• Sandoz;
• MSN Laboratories and related entities;
• Other ANDA applicants seeking approval for sacubitril/valsartan.

The legal outcome for one applicant does not automatically determine the result for another. Different ANDA formulations, certifications, claim defenses, settlement terms, and launch rights can produce different outcomes.

What generic launch risks remain after the Torrent decision?

The Torrent judgment reduced the probability of an early launch by that defendant but did not eliminate all generic-entry pathways.

Authorized or licensed generic entry

Novartis can authorize or license a generic manufacturer to sell sacubitril/valsartan before broad third-party entry. Such an arrangement may preserve control over pricing, supply, and channel access while limiting litigation exposure.

Settlement-based entry

Hatch-Waxman settlements can establish a future entry date, licensing terms, supply arrangements, or other commercial conditions. The Federal Trade Commission reviews relevant settlement agreements under applicable reporting requirements.

At-risk launch

A generic company may launch before final resolution of all patent issues if it accepts potential damages and injunction risk. A successful launch can accelerate market erosion, but the exposure can be substantial where the branded product has high annual sales.

Design-around formulations

A generic applicant may attempt to avoid narrower formulation or process claims. That strategy is less effective against a broad composition claim covering sacubitril and valsartan in a pharmaceutical dosage form.

How strong is Novartis’s Entresto patent estate?

The Entresto estate was strong against Torrent in the specific litigation because Novartis obtained a judgment of infringement, defeated the principal invalidity challenge, and secured appellate affirmance.

Strength factor	Assessment
Core composition coverage	Strong against products containing both active ingredients
Federal Circuit validation	Stronger after affirmance in No. 23-2218
Remaining term	Limited because core protection extends into 2026
Formulation coverage	Dependent on the particular claim and ANDA formulation
Method-of-use coverage	Relevant where generic labeling includes patented indications
Manufacturing protection	Potentially material for difficult-to-reproduce solid-state or process attributes
Biosimilar protection	Not applicable because Entresto is a small-molecule drug
Generic design-around potential	Possible for narrow claims, more difficult for broad composition claims

The principal weakness is time. Even a strong patent estate produces limited commercial value when its remaining term is short and several generic applicants are positioned to enter.

What was the commercial exposure for Novartis?

Entresto was one of Novartis’s largest products. Global sales reached approximately $6.0 billion in 2023 and approximately $6.2 billion in 2024, according to Novartis annual reporting. The U.S. market represented a major portion of that revenue base. (Novartis AG, 2024, 2025).

Generic entry threatens revenue through:

• Rapid price reductions;
• Payer-mandated substitution;
• Loss of preferred formulary position;
• Inventory repricing;
• Lower net sales despite continued prescription volume;
• Pressure on international markets after U.S. entry.

A composition-patent victory therefore had direct financial importance. The decision preserved the branded product’s U.S. position against Torrent during the remaining patent term but did not protect long-term revenue after broad generic entry becomes legally available.

Does the case create biosimilar risk?

No. Entresto is a chemically synthesized small-molecule combination product. Generic applicants use the ANDA pathway, not the biosimilar pathway under the Public Health Service Act.

The relevant competitive risks are generic-drug risks:

• Paragraph IV litigation;
• 30-month stays;
• Paragraph III certifications;
• Label carve-outs;
• Authorized generic competition;
• ANDA settlements;
• State-level substitution.

Biosimilar interchangeability standards, reference-product exclusivity under the Biologics Price Competition and Innovation Act, and biologic manufacturing comparability do not govern this case.

Key Takeaways

• Novartis prevailed against Torrent in Federal Circuit appeal No. 23-2218.
• The case involved generic sacubitril/valsartan, the active combination in Entresto.
• U.S. Patent No. 8,877,938 was sustained and found infringed.
• The Federal Circuit rejected Torrent’s effort to overturn the patent judgment.
• The case involved Hatch-Waxman Paragraph IV litigation, not biosimilar litigation.
• The core Entresto patent barrier extends into 2026, subject to applicable patent-term and pediatric-exclusivity calculations.
• The decision reduced Torrent’s ability to launch before the relevant exclusivity period but did not eliminate other generic-entry routes.
• Entresto’s multibillion-dollar annual sales made the litigation commercially significant.
• Formulation, method-of-use, manufacturing, and settlement issues remain distinct from the composition claims decided in the appeal.

FAQs About Novartis v. Torrent Pharma, 23-2218

What drug was involved in Novartis v. Torrent?

The case involved sacubitril/valsartan, marketed by Novartis as Entresto for heart failure treatment.

Did Torrent win the Federal Circuit appeal?

No. The Federal Circuit affirmed the judgment favoring Novartis, including the finding that Torrent’s ANDA product infringed the asserted patent.

What is the main Entresto patent number?

The principal patent involved in the Torrent litigation was U.S. Patent No. 8,877,938.

Can a generic launch immediately after the Entresto patent expires?

Not necessarily. FDA approval, pediatric exclusivity, other listed patents, settlement agreements, manufacturing readiness, and regulatory conditions can affect the actual launch date.

Is Entresto protected by a biosimilar exclusivity period?

No. Entresto is a small-molecule drug regulated through the ANDA pathway. Its competitive protection arises from patents, regulatory exclusivity, and Hatch-Waxman procedures rather than biosimilar exclusivity.

References

1. Novartis AG. (2024). Annual report 2023. https://www.novartis.com
2. Novartis AG. (2025). Annual report 2024. https://www.novartis.com
3. U.S. Court of Appeals for the Federal Circuit. (2024). Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc., No. 23-2218.
4. U.S. Food and Drug Administration. (2015). FDA approves new heart failure drug Entresto. https://www.fda.gov
5. U.S. Food and Drug Administration. (2021). Entresto prescribing information. https://www.accessdata.fda.gov
6. U.S. Patent and Trademark Office. (2004). U.S. Patent No. 8,877,938, pharmaceutical compositions comprising an angiotensin receptor antagonist and a neprilysin inhibitor.
7. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files