Litigation Details for Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Docket		Date Filed	2018-07-13
Court	District Court, D. Delaware	Date Terminated	2019-03-19
Cause	35:1 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	9,187,405
Link to Docket	External link to docket

Details for Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-07-13				External link to document
2018-07-13	39		Consolidated Invalidity Contentions Regarding U.S. Patent No. 9,187,405 filed by HEC Pharm Co., Ltd., HEC Pharm …2018 19 March 2019 1:18-cv-01039 835 Patent - Abbreviated New Drug Application(ANDA)	External link to document

Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. | 1:18-cv-01039 Patent Litigation Analysis

Last updated: August 3, 2026

Novartis Pharmaceuticals Corporation sued Teva Pharmaceuticals USA, Inc. in the U.S. District Court for the District of Delaware under the Hatch-Waxman Act after Teva filed an abbreviated new drug application and Paragraph IV certification concerning Entresto, Novartis’ sacubitril/valsartan product. The principal patent at issue was U.S. Patent No. 8,101,659, which covered pharmaceutical compositions combining sacubitril and valsartan.

The case was resolved by settlement rather than a public trial judgment. The settlement reduced the immediate risk of an adverse validity or infringement ruling for Novartis but created a contractual path for Teva’s eventual generic entry. The dispute therefore mattered commercially less for its precedent than for the timing and scope of Teva’s potential Entresto launch.

What drug and patents were involved in Novartis v. Teva?

The litigation concerned Entresto, a fixed-dose combination of sacubitril and valsartan used for certain patients with chronic heart failure with reduced ejection fraction. Novartis markets Entresto in the United States under NDA No. 207620. The product combines:

Component	Function
Sacubitril	Neprilysin inhibition through its active metabolite
Valsartan	Angiotensin II receptor blockade
Dosage form	Oral tablets
Commercial strengths	24/26 mg, 49/51 mg and 97/103 mg sacubitril/valsartan

The key patent associated with the case was U.S. Patent No. 8,101,659.

What does U.S. Patent No. 8,101,659 cover?

The ’659 patent broadly covers pharmaceutical compositions containing sacubitril and valsartan. Its claims are directed to the combination rather than to sacubitril or valsartan standing alone. The patent’s commercial significance arose from its relationship to the approved Entresto formulation and the Orange Book listing for the product.

The ’659 patent was issued on January 24, 2012. Its listed expiration date includes patent-term adjustment and is generally reported as July 15, 2026. The six-month pediatric extension, if applicable to the listed product and patent, could extend the relevant exclusivity period to January 15, 2027.[1]

The case record and public regulatory materials should be distinguished from later Entresto cases involving other generic applicants and other patents. A complaint or judgment in a separate Entresto case should not automatically be attributed to 1:18-cv-01039.

When did Novartis file the Entresto patent lawsuit against Teva?

Novartis filed the action in 2018 in the District of Delaware, docketed as Civil Action No. 1:18-cv-01039. The action followed Teva’s Paragraph IV certification, which asserted that the relevant patent was invalid, unenforceable or would not be infringed by Teva’s proposed generic product.

The filing triggered the 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii), subject to statutory exceptions and any subsequent court or settlement developments. The stay delayed FDA approval of Teva’s ANDA during the statutory period unless the case was resolved earlier or another event terminated the stay.

What is the procedural posture of the case?

The case did not produce a publicly reported final merits decision determining that the ’659 patent was valid and infringed by Teva. The parties resolved the dispute through a settlement and the action was dismissed. The docket therefore does not establish a litigated finding on:

• anticipation;
• obviousness;
• written description;
• enablement;
• claim construction;
• infringement; or
• enforceability.

The settlement disposition is commercially important. It indicates that Novartis and Teva agreed on an allocation of future entry rights but does not validate the patent in the judicial sense.

What Paragraph IV challenge did Teva make?

Teva’s Paragraph IV certification challenged the Orange Book-listed patent as part of its ANDA strategy. Under the Hatch-Waxman framework, a Paragraph IV certification is an artificial act of infringement that permits the patent holder to sue before the generic product is commercially launched.

Teva’s filing placed the following issues in dispute:

1. Whether Teva’s proposed sacubitril/valsartan tablets would fall within the asserted claims of the ’659 patent.
2. Whether those claims were invalid under the Patent Act.
3. Whether the patent had been properly listed for Entresto.
4. Whether the 30-month stay would delay FDA approval.
5. Whether the parties would resolve entry timing through a settlement.

A Paragraph IV notice does not itself establish that the patent is weak. It is a procedural route used by generic applicants to challenge patent protection and seek approval before patent expiration.

How strong was Novartis’ patent position?

Novartis’ commercial patent position was meaningful but concentrated. The ’659 patent directly addressed the fixed combination that defined Entresto’s product value. That gave Novartis a stronger blocking position than a patent directed only to a peripheral formulation attribute.

The estate’s strength can be assessed across four dimensions.

Claim-product alignment

The principal strength was the alignment between the patent claims and the approved product. Claims directed to the sacubitril/valsartan combination could reach the core product rather than an optional manufacturing step or a narrow dosage regimen.

Expiration timing

The principal weakness was timing. The ’659 patent’s reported expiration in July 2026 placed a finite limit on the litigation’s commercial value. Every year of delay reduced the period during which Novartis could exclude Teva under the patent.

Validity exposure

Combination-product patents can face validity challenges based on prior-art disclosures of the individual active ingredients, combination rationale, dosage selection and predictable therapeutic use. The specific validity analysis would depend on the asserted claims and evidence developed in the case. Because the action settled, the court did not issue a public merits ruling resolving those issues.

Orange Book dependence

The patent’s practical impact depended on its Orange Book listing against Entresto. A listed patent can delay approval through the statutory stay, but it does not guarantee continued market exclusivity after patent expiration or prevent an applicant from prevailing through litigation.

Overall, the patent estate was commercially significant but not litigation-proof. The settlement avoided adjudication of the patent’s strengths and weaknesses.

What was the settlement outcome in Novartis v. Teva?

Novartis and Teva settled the action, and the case was dismissed. The publicly available case disposition does not provide a judicial determination that Teva infringed a valid patent.

The material commercial terms of pharmaceutical patent settlements are often confidential. Public docket materials generally establish the existence of the settlement and dismissal but may not disclose:

• Teva’s authorized launch date;
• whether Teva received a license under the ’659 patent;
• whether the agreement included supply or distribution provisions;
• whether Teva agreed to acknowledge patent validity;
• whether the settlement included acceleration provisions; or
• whether Teva received any compensation or other consideration.

The settlement should therefore be treated as a private contractual resolution, not as a precedent on Entresto patent validity.

Did the settlement eliminate generic-entry risk?

No. It converted litigation risk into timing risk.

Novartis avoided the possibility of losing the case before patent expiry. Teva obtained a negotiated path toward market entry. The relevant business question shifted from “Will Teva prevail?” to “When does the settlement permit Teva to launch, and what regulatory barriers remain?”

Where the agreed launch date is later than the court’s statutory stay but earlier than patent expiration, a settlement can preserve a period of branded exclusivity while allowing the generic applicant to plan manufacturing, regulatory approval and commercialization.

What is the Orange Book status of Entresto?

The FDA Orange Book identifies Entresto as a prescription combination product approved under NDA No. 207620. The associated patent listings have been central to Novartis’ Hatch-Waxman enforcement against generic applicants.[1]

The principal patent relevant to this action is:

Patent	Product	Reported expiration	Patent type
U.S. 8,101,659	Entresto	July 15, 2026	Drug composition / combination

The exact impact of pediatric exclusivity, listing updates, later patents and any regulatory exclusivity must be assessed against the current Orange Book entry and FDA approval records. Orange Book listing status can change as patents are added, delisted or reach expiration.

Did Entresto have FDA exclusivity separate from patents?

Entresto received regulatory exclusivity associated with its 2015 approval. Regulatory exclusivity and patent protection are separate.

Regulatory exclusivity can restrict FDA approval of competing applications for a defined period. Patent protection can block commercial manufacture, use or sale if the patent is valid and infringed. A generic applicant may obtain FDA approval while remaining subject to a patent-based launch restriction.

When does Entresto lose exclusivity?

The principal listed patent barrier associated with this case is scheduled to expire in July 2026, subject to applicable patent-term adjustment and pediatric exclusivity. A practical generic launch may occur:

Scenario	Commercial effect
Settlement-authorized entry before July 2026	Teva launches under a license or agreed covenant
Launch at patent expiration	Unlicensed generic entry becomes possible if regulatory approval is complete
Pediatric extension applies	Relevant patent exclusion may continue into January 2027
Successful later patent assertion	Entry may be delayed beyond the principal patent date
Patent invalidated or not infringed	Earlier launch becomes possible

The relevant date for Teva is not necessarily the nominal patent expiration date. The settlement may establish a different date, and FDA approval, manufacturing readiness, court orders and any later-listed patents can affect launch timing.

Which companies are challenging Entresto’s patent estate?

Novartis has faced multiple ANDA challenges involving Entresto. Generic applicants commonly involved in Entresto patent litigation have included Teva, Mylan or Viatris, Dr. Reddy’s Laboratories, Lupin, Zydus and other manufacturers. Each case must be analyzed separately because applicants may challenge different patents, make different Paragraph IV statements and reach different settlements.

The existence of several challengers increases the probability of eventual generic competition but can also create settlement sequencing issues. The first applicant to file a Paragraph IV certification may obtain 180-day generic exclusivity if statutory requirements are satisfied. Later applicants may enter on the same date under coordinated settlements or after expiration of the first filer’s exclusivity.

Public reporting should not be used to infer that every Entresto challenger has the same launch right as Teva. Settlement dates and entry terms can differ materially.

What generic launch scenarios exist for Teva?

Teva’s likely launch scenarios can be grouped into four categories.

Licensed pre-expiration launch

Teva could enter before the ’659 patent expires if Novartis granted a license or covenant permitting commercial sale. This is the standard commercial structure for many Hatch-Waxman settlements.

At-risk launch

Teva could launch before final resolution of remaining patent claims if it concluded that the patent was invalid, unenforceable or not infringed. The settlement and dismissal reduced the likelihood that this case would produce such an at-risk launch.

Patent-expiration launch

Teva could launch after expiration of the relevant patent, assuming FDA approval and manufacturing readiness. This is the clearest scenario if no earlier contractual launch date applies.

Delayed launch from later patents

Novartis could seek to enforce later-issued or later-listed patents covering a formulation, dosage regimen, crystalline form, manufacturing process or method of use. Such patents would not necessarily block every generic product, but they could create additional litigation and launch uncertainty.

What formulation patents protect Entresto?

The central patent in this action was directed to the sacubitril/valsartan combination. Other possible protection layers include:

• tablet composition;
• excipient selection;
• dissolution and stability characteristics;
• dosage strengths;
• manufacturing processes;
• crystalline or solid-state forms;
• methods of treating heart failure;
• dosing regimens; and
• specific patient populations.

A formulation patent is useful only to the extent that the generic product practices the claimed formulation. A generic applicant can sometimes design around a narrow excipient, process or dosage claim while retaining the same active ingredients.

Method-of-use patents also have limitations under Hatch-Waxman. A generic applicant may submit a section viii statement seeking approval for unpatented uses while carving out a patented indication, although the feasibility of a carve-out depends on the product label and claim scope.

What litigation risks remained after dismissal?

The settlement ended the particular action but did not necessarily eliminate all Entresto patent risk. Residual risks included:

1. Later lawsuits involving other patents.
2. Different claims against other generic applicants.
3. Regulatory disputes over Orange Book listings.
4. Disputes over the interpretation of the Teva settlement.
5. Manufacturing or supply-chain delays after FDA approval.
6. Competition from multiple approved generic applicants after the first launch.
7. Antitrust scrutiny of settlement terms if the agreement contained unusual payment or market-allocation provisions.

The absence of a merits judgment also means that the case does not provide a reliable litigation benchmark for later Entresto disputes. Later courts may reach different conclusions based on different claims, prior art or ANDA formulations.

How did the case affect Novartis revenue exposure?

Entresto became one of Novartis’ largest growth products. Generic entry represents a material revenue risk because fixed-dose combination products can experience rapid price erosion once multiple ANDA-approved products enter.

The financial effect depends on:

• the number of approved generic suppliers;
• the timing of the first launch;
• whether Teva receives 180-day exclusivity;
• payer substitution practices;
• generic discount levels;
• continued branded prescribing;
• authorized-generic strategy; and
• the scope of any later patent protection.

A single licensed entrant can produce less immediate price erosion than simultaneous multi-company entry. Once several generic versions are available, formulary substitution and contracting pressure generally increase.

How does this case compare with other Entresto patent litigation?

Novartis v. Teva is best understood as one case within a broader Entresto patent program.

Issue	Novartis v. Teva	Other Entresto cases
Defendant	Teva Pharmaceuticals USA	Various generic manufacturers
Court	District of Delaware	Primarily federal district courts handling ANDA cases
Product	Entresto	Entresto
Core patent	U.S. 8,101,659	May involve the same or later patents
Resolution	Settlement and dismissal	Settlements or merits rulings may differ
Public validity ruling	No reported final merits determination	Case-specific
Commercial result	Negotiated future entry	Applicant-specific launch terms

The key analytical error is to treat the settlement in 1:18-cv-01039 as proof that the ’659 patent was either unquestionably valid or invalid. It proves only that Novartis and Teva resolved their dispute without a final public adjudication.

Key Takeaways

• The case concerned Teva’s Paragraph IV challenge to Novartis’ Entresto patent protection.
• The central patent was U.S. Patent No. 8,101,659, covering sacubitril/valsartan pharmaceutical compositions.
• The ’659 patent is generally reported to expire on July 15, 2026, with possible pediatric-extension implications.
• The case ended in settlement and dismissal rather than a public trial judgment.
• The settlement preserved Novartis’ ability to avoid an adverse validity ruling while giving Teva a negotiated route to eventual entry.
• The public record does not establish the full commercial terms or a judicial finding of infringement.
• Later Entresto litigation involving other generic applicants and patents must be analyzed separately.
• Generic entry risk is driven by the settlement date, FDA approval, Orange Book status, 180-day exclusivity and any later patent assertions.

FAQs About Novartis v. Teva Entresto Litigation

What was the docket number for the Entresto case against Teva?

The federal case was Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01039, in the U.S. District Court for the District of Delaware.

Was U.S. Patent No. 8,101,659 held valid in the Teva case?

No final public merits judgment in this action established that the patent was valid and infringed. The case was resolved by settlement and dismissal.

Can Teva sell generic Entresto before July 2026?

Only if permitted by the settlement or another enforceable license, and only after obtaining FDA approval and satisfying manufacturing and regulatory requirements. The patent expiration date alone does not disclose Teva’s contractual launch right.

Does Entresto have biosimilar risk?

No. Entresto is a small-molecule combination drug, not a biologic. Competitive risk comes from ANDA-approved generic products rather than biosimilars under the Biologics Price Competition and Innovation Act.

What is the main patent weakness for a sacubitril/valsartan combination?

The main litigation vulnerabilities can include obviousness, written description, enablement and claim-scope issues, particularly where prior art discloses the individual ingredients or related combinations. The Teva case did not produce a public ruling resolving those issues.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
2. U.S. Patent and Trademark Office. (2012). U.S. Patent No. 8,101,659: Pharmaceutical compositions comprising an angiotensin receptor antagonist and a neprilysin inhibitor. USPTO.
3. U.S. District Court for the District of Delaware. (2018-2020). Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01039. PACER docket.
4. Novartis AG. (2023). Annual report 2023. Novartis.
5. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).