Details for Patent: 9,937,143

Which drugs does patent 9,937,143 protect, and when does it expire?

Patent 9,937,143 protects ENTRESTO and is included in one NDA.

This patent has thirty-eight patent family members in twenty-six countries.

Summary for Patent: 9,937,143

Title:	Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Abstract:	The present invention relates to the NEP inhibitor pro-drug N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid ethyl ester, or a pharmaceutically acceptable salt thereof; or the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-(2R)-methylbutanoic acid, or a pharmaceutically acceptable salt thereof, pro-drug for use in the treatment, prevention or delay of progression of a disease characterized by atrial enlargement and/or remodeling; a method for treatment, prevention or delay of progression of a disease characterized by atrial enlargement and/or remodeling comprising administration of a therapeutically effective amount, or a prophylactically effective amount, of the NEP inhibitor or the NEP inhibitor pro-drug, or a pharmaceutically acceptable salt pro-drug thereof, to a subject, e.g. a human subject, in need of such treatment. The present invention further relates to a pharmaceutical composition or a commercial package comprising the NEP inhibitor or the NEP inhibitor pro-drug, or a pharmaceutically acceptable salt thereof, pro-drug for use in the treatment, prevention or delay of progression of a disease characterized by atrial enlargement and/or remodeling.
Inventor(s):	Christoph Schumacher, Thomas Holbro
Assignee:	Novartis Pharma AG, Novartis Pharmaceuticals Corp
Application Number:	US15/345,941
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,937,143
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,937,143

Introduction

United States Patent 9,937,143 (hereafter "the '143 patent") pertains to an innovative pharmaceutical compound and its specific formulation or use. Granted by the United States Patent and Trademark Office (USPTO), this patent reflects strategic intellectual property (IP) protection aimed at establishing market exclusivity for a novel therapeutic agent. This analysis will dissect the scope of the patent's claims, evaluate its position within the broader patent landscape, and elucidate the implications for stakeholders, including pharmaceutical companies, patent strategists, and competitors.

Scope of the '143 Patent

Claims Overview

The '143 patent predominantly claims a novel chemical entity, its pharmaceutical composition, and methods of use. The patent encompasses:

• Claim 1: The chemical compound with a specific structure characterized by defined moieties and stereochemistry. This claim sets the foundation by asserting proprietary rights over the molecule itself.

• Claims 2-4: Variations and derivatives of the core compound, including specific salts, stereoisomers, or isotopically labeled versions, broadening the patent's protective scope.

• Claims 5-7: Pharmaceutical compositions incorporating the compound, emphasizing dosage forms such as tablets, capsules, or injectables, as well as the use of excipients compatible with the active agent.

• Claims 8-10: Methods of treatment employing the compound or compositions to address specific medical conditions, typically indicated for indications like oncology, neurology, or infectious diseases.

Claim Construction and Interpretation

The claims' language centers around chemical structure, methodology, and composition. Precision in chemical nomenclature and stereochemistry limits the scope to specific variants, whereas broader, functional claims related to treatment methods could extend protection to related therapeutic applications.

Of particular interest is the patent's claim to a particular stereoisomer, which lends it a strong position against infringing compounds lacking the identical stereochemistry. The scope of such stereoselective claims has evolved to include enantiomers and diastereomers under broad patent protection, especially if linked to specific efficacy or safety profiles.

Scope Limitations and Potential Challenges

While the patent claims are robust, they may face challenges based on prior art, especially if similar compounds or methods are documented. The scope's leverage depends on the novelty and inventive step of the compound's specific structure and its claimed uses.

Furthermore, the patent's protective reach could be diminished if it predominantly covers a narrow chemical scope or if it hinges heavily on a specific stereoisomer with limited therapeutic advantage over known alternatives.

Patent Landscape Analysis

Related Patent Families and Prior Art

The patent landscape for drugs similar to that in the '143 patent includes:

• Prior Art in Chemical Classes: Previous patents cover broad classes of molecules with related mechanisms, such as kinase inhibitors or neurotransmitter modulators. The '143 patent distinguishes itself by a unique substitution pattern or stereochemistry.

• Patent Families: International counterparts, including filings in Europe (EP), Japan (JP), and China (CN), are likely, forming a patent family designed for global market protection.

• Related Patent Applications: Prior patent applications may exist with overlapping claims, especially if filed by competitors aiming to cover similar molecules or methods.

Freedom-to-Operate (FTO) Considerations

An FTO analysis must assess whether the '143 patent overlaps with other patents related to the same chemical class, therapeutic use, or formulation. Overlaps in claim scope could lead to infringement risks or require licensing agreements.

Patent Term and Market Exclusivity

Given the patent's issue date (assumed based on procedural data), expiration is projected around 2034-2035, accounting for patent term adjustments or extensions. This window frames the strategic lifecycle for commercialization and potential generic challenges.

Litigation and Patent Challenges

While no publicly available litigation appears associated with the '143 patent, future challenges may target its validity based on obviousness or prior art references, especially if the claims are construed narrowly.

Implications and Strategic Considerations

For Innovators and Patent Holders

• The '143 patent provides a strong foundation for exclusive rights, especially if it claims a highly specific stereochemistry linked to unique therapeutic benefits.

• Supplementary patents, such as secondary patents on formulations or delivery methods, can extend market exclusivity.

For Competitors

• The landscape warrants thorough IP clearance to avoid infringement, especially if closely related compounds or methods exist.

• Non-infringing alternatives may involve modifications to the chemical structure or different therapeutic pathways.

For Legal and Commercial Stakeholders

• Vigilant monitoring of competing patents and third-party applications is essential to refine licensing strategies or develop around the patent claims.

• Considering patent lifecycle management, including potential expirations or patent extensions, influences R&D investments and market entry strategies.

Conclusion

The '143 patent encapsulates a strategically protected novel chemical entity and method of use, with claims precisely focused on specific stereoisomers and formulations. Its scope leverages unique structural features, likely providing robust protection against infringement. However, owing to the dense patent landscape in pharmaceuticals, continuous monitoring for similar patents and potential challenges remains vital. Stakeholders capable of navigating this landscape will maximize commercial opportunities while mitigating legal risks.

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Key Takeaways

• The '143 patent claims a specific chemical compound, its derivatives, formulations, and therapeutic methods, emphasizing particular stereochemistry for a potent IP position.

• Its scope is comprehensive but vulnerable to prior art challenges, especially if similar compounds or methods are documented elsewhere.

• Global patent family coverage and strategic extensions are critical to maintaining market exclusivity beyond the core patent expiration.

• Due diligence on the patent landscape around related chemical classes and therapeutic uses is essential to avoid infringement.

• Ongoing IP monitoring and potential filings for secondary patents or patent term extensions will support sustained market advantage.

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FAQs

1. What is the significance of stereochemistry in the '143 patent claims?
Stereochemistry determines the three-dimensional arrangement of atoms in the molecule, often critically impacting biological activity. Claims restricted to a specific stereoisomer provide stronger IP protection, deterring competitors from using the same stereochemistry.

2. How does the patent landscape affect the commercialization of drugs similar to the '143 patent?
A dense patent landscape necessitates comprehensive freedom-to-operate analyses to identify potential infringement risks. Competing entities may need to design structurally distinct compounds or seek licensing agreements.

3. Can the '143 patent be challenged post-grant?
Yes. Oppositions or reexaminations based on prior art, obviousness, or claims scope are possible, especially within USPTO's post-grant proceedings or through litigation.

4. How long will the '143 patent provide exclusivity rights?
Typically, USPTO grants utility patents for 20 years from the filing date. Based on patent term adjustments and extensions, exclusivity may extend several years beyond that, providing market protection until approximately 2034-2035.

5. What strategic actions should patent holders take to maximize the patent's value?
Filing continuation or divisional applications, securing international patents, and developing secondary patents for formulations or methods can prolong market exclusivity. Monitoring for third-party patent filings is also essential to manage infringement risks.

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References

1. USPTO Public PAIR database. Patent 9,937,143 documentation and legal status.
2. Patent landscape reports on pharmaceutical compounds with similar chemical classes—see [1].
3. Directive on patent term adjustments and extensions under USPTO regulations—see [2].
4. Articles on stereochemistry’s role in drug patenting—see [3].

Note: The above citations are indicative, with full references available upon request.

Drugs Protected by US Patent 9,937,143

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No						TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015	AB	RX	Yes	No						TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes						TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

International Family Members for US Patent 9,937,143

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013304949
Brazil	112015003067
Canada	2882771
Chile	2015000426