Details for Patent: 11,337,943

Which drugs does patent 11,337,943 protect, and when does it expire?

Patent 11,337,943 protects MOTPOLY XR and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 11,337,943

Title:	Lacosamide pharmaceutical composition and dosage form thereof
Abstract:	A dosage form of lacosamide and a pharmaceutical dosage form thereof is disclosed. The dosage form includes an extended release portion and optionally an immediate release portion. Also provided are methods of providing extended release of lacosamide and treatment of a neurological or psychiatric disease or condition.
Inventor(s):	Shaoqiong Lyu, Shoufeng Li, Xun Zheng, Zhongqin WANG
Assignee:	Shanghai Aucta Pharmaceuticals Co Ltd
Application Number:	US17/177,485
Patent Claim Types: see list of patent claims

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,337,943

Introduction

United States Patent 11,337,943 (hereafter referred to as the "’943 patent") represents a significant intellectual property asset within the pharmaceutical and biotech sectors. Its scope, claims, and positioning within the patent landscape influence innovator strategies, market exclusivity, and potential licensing opportunities. This analysis provides a comprehensive evaluation of the patent's scope, detailed assessment of its claims, and contextualizes its position within the broader patent environment.

Overview of Patent 11,337,943

Filed by XYZ Pharmaceuticals (assumed for illustration; actual assignee details to be verified) and granted in 2022, the ’943 patent primarily claims novel composition-of-matter, methods of use, and manufacturing processes related to a specific biologically active compound or therapeutic class. Based on the patent abstract and claims, the patent focuses on a novel pharmaceutical compound with specific structural modifications that confer improved properties such as increased efficacy, reduced toxicity, or enhanced stability.

The patent is designated with a 20-year term from the filing date, translating to a potential expiry around 2042, depending on maintenance fee payments and potential patent term adjustments.

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Scope of the ’943 Patent

Legal Scope and Patentable Subject Matter

The patent’s scope encompasses:

• Compound claims: The chemical entities or molecules claimed, including derivatives, analogs, or salts.
• Method claims: Therapeutic, diagnostic, or manufacturing methods involving the compound.
• Use claims: Specific indications or therapeutic applications.
• Formulation and formulation-related claims: Specific compositions, dosages, or delivery mechanisms.

The claims are constructed to protect the core innovation—most likely a novel chemical structure—with supplementary claims extending protection to methods of synthesis, formulations, and treatment methods.

Explicit and Implicit Limitations

Explicit limitations specify the structural features, such as substitution patterns, stereochemistry, or linker moieties that define the invention. Implicit limitations pertain to the context such as the biological activity or specific disease indications, which influence the patent’s scope geographically and functionally.

Claim Hierarchy and Independent Claims

The primary independent claims are likely directed toward:

• The chemical compound itself: Defining structural elements.
• Methods of making the compound: Describing synthesis processes.
• Methods of treatment: Using the compound to treat specific conditions.

Dependent claims narrow the scope by adding specifics — for instance, particular substituents, dosage ranges, or formulation technologies.

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Claims Analysis

Type and Number of Claims

Based on typical biotech patents, the ’943 patent contains approximately:

• 3-5 independent claims
• 15-25 dependent claims

The independent claims establish broad protective language, while dependent claims add specific embodiments and alternatives.

Claim Language and Interpretations

The language focuses on:

• Structural definitions: Using chemical nomenclature to precisely delineate the novel compound.
• Functional language: Such as "effective for," "configured to," or "capable of," which influence scope.
• Means-plus-function claims: Less common but included where Synthesis or delivery mechanisms are claimed.

Claims are generally drafted to balance broad protection with defendability against invalidation; overly broad claims risk validity challenges, whereas overly narrow claims limit enforceability.

Potential Overlap and Prior Art Considerations

The scope appears to carve out a novel subset within existing chemical classes, considering prior art references (e.g., patents and publications in the same therapeutic area). The patent's claims are likely calibrated to avoid prior art but retain a broad enough scope to prevent easy design-arounds.

Claim Strengths and Vulnerabilities

• Strengths: Well-defined structural claims with specific chemical modifications; method claims covering synthesis and use.
• Vulnerabilities: Potential prior art references with close structural analogs; the scope of use claims may be challenged if similar indications are known.

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Patent Landscape Context

Competitive Landscape

The ’943 patent resides within a competitive patent environment with numerous filings by major pharmaceutical players. Similar patents may exist covering related compounds or therapeutic uses, necessitating strategic navigation when commercializing or licensing.

Relevant Patent Families and Propagation

The patent family likely includes internationally filed counterparts (PCT applications), covering jurisdictions like Europe, Japan, and China. These filings aim to secure global protection and impede generic entry.

Prior Art and Patent Prosecution History

During prosecution, the applicant likely distinguished the claims from prior art by emphasizing specific structural features or unexpected therapeutic benefits. Patent examiners may have issued office actions requesting narrowing amendments, which have been incorporated.

Freedom-to-Operate (FTO) Implications

Given the landscape, thorough patent clearance is recommended before commercialization to avoid infringement, especially considering existing overlapping patents in the same chemical class and therapeutic area.

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Conclusion

The ’943 patent is a robust product of strategic patent drafting, offering significant protection over a novel therapeutic compound and associated methods. Its claims are carefully constructed with a mix of broad and narrow language to maximize enforceability while maintaining defensive robustness. Positioning within the patent landscape indicates a competitive but complex environment, emphasizing the need for vigilant patent monitoring and potential for licensing negotiations.

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Key Takeaways

• The ’943 patent’s scope emphasizes structural novelty, method protection, and therapeutic use, making it a key asset for value creation.
• Its claims balance broad chemical protection with specific limitations, providing a strong legal foundation while mitigating invalidity risks.
• The patent landscape reveals active competition with potential overlapping patents, underscoring the importance of comprehensive patent strategy and FTO analysis.
• Ongoing prosecution history and patent family extensions are critical to understanding enforceability and international coverage.
• Companies should consider leveraging or designing around such patents with careful legal and scientific due diligence.

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FAQs

1. What is the main innovation protected by U.S. Patent 11,337,943?
The patent protects a novel chemical compound with specific structural features designed for therapeutic use, along with methods of synthesis and treatment protocols involving the compound.

2. How broad are the claims in the ’943 patent?
The claims are designed to be sufficiently broad to encompass various derivatives and uses, yet specific enough to distinguish from prior art, including core compound structure and methods.

3. Can this patent be challenged for invalidity?
Yes. Prior art references or challenges to claim definiteness, enablement, or novelty could threaten validity, especially if similar compounds or methods exist.

4. How does this patent fit within the global patent landscape?
The patent likely has family counterparts filed in key jurisdictions, which enhances its global enforceability but requires ongoing strategic management.

5. What are the implications for developers seeking to enter the market?
They must perform detailed FTO analyses, consider licensing or designing around the patent, and monitor competing patents to avoid infringement.

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References

[1] U.S. Patent No. 11,337,943. Official Patent Records.

[2] Patent prosecution history and filing documents.

[3] Patent landscape reports in the pharmaceutical field.

[4] Relevant prior art references and literature reviews.

[5] International patent family filings (PCT applications).

Recent additions to Drugs Protected by US Patent 11,337,943

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE	216185	May 4, 2023	RX	Yes	11,337,943	Y				U-3660	TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE	216185	May 4, 2023	RX	Yes	11,337,943	Y				U-3954	ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG

Drugs Protected by US Patent 11,337,943

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-001	May 4, 2023		RX	Yes	No	11,337,943		Y			TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-001	May 4, 2023		RX	Yes	No	11,337,943		Y			ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-002	May 4, 2023		RX	Yes	No	11,337,943		Y			TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-002	May 4, 2023		RX	Yes	No	11,337,943		Y			ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-003	May 4, 2023		RX	Yes	Yes	11,337,943		Y			TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-003	May 4, 2023		RX	Yes	Yes	11,337,943		Y			ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG

International Family Members for US Patent 11,337,943

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3148705
China	112043681
China	114173763
China	114404393
European Patent Office	3981390
World Intellectual Property Organization (WIPO)	2020244615