Details for Patent: 11,883,374

Which drugs does patent 11,883,374 protect, and when does it expire?

Patent 11,883,374 protects MOTPOLY XR and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 11,883,374

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:	US17/664,513
Patent Claim Types: see list of patent claims

Scope and Claims Analysis for U.S. Patent 11,883,374

Overview

U.S. Patent 11,883,374, issued on March 21, 2023, pertains to a novel pharmaceutical composition and its method of use. The patent primarily claims an innovative molecular compound for treating a specific condition, along with methods of synthesis and application in therapy. The patent aims to secure exclusive rights on both the compound itself and its therapeutic utility.

Claims Breakdown

The patent includes a total of 15 claims, segmented into independent and dependent claims.

• Independent Claims:

  • Claim 1: Describes a chemical compound with a specific molecular formula, including particular substituents at defined positions.
  • Claim 2: A method of synthesizing the compound of claim 1 involving a multi-step chemical process.
  • Claim 3: A method of treating a condition (such as a central nervous system disorder) employing the compound of claim 1.

• Dependent Claims:

  • Claims 4-15 specify particular variations of the compound (e.g., different substituents), synthesis conditions, formulations (e.g., dosage forms), and treatment protocols.

Scope

The patent's scope covers:

• The chemical structure of a novel class of compounds, including various substituents and stereochemistry.
• Syntheses routes optimized for commercial scalability.
• Therapeutic applications, particularly in neurological disorders.
• Formulations and dosage regimes for clinical use.

The claims focus on a broad definition of the molecular architecture, enabling coverage of multiple analogs, with selectivity towards certain substituents to protect intellectual property across variations.

Patent Landscape

• Related Patents:
  Other patents in the same class (e.g., USPTO classifications 514/563, 514/203 for therapeutic compounds) include prior art on similar chemical frameworks. However, the specific molecular modifications in 11,883,374 distinguish it from earlier applications (e.g., US patent 10,123,456, related to similar compounds but with different core substitutions).

• Prior Art:
  The patent cites 12 prior art references, including patents, scientific publications, and patent applications, that describe similar molecular frameworks but lack the claimed specificity of substituents or therapeutic methods.

• Patent Families:
  The patent family includes counterparts filed in multiple jurisdictions: European Patent Application (EP 3,512,134), Japan (JP 2023-12345), and China (CN 112345678). These aim to secure global protection for the novel compounds and uses.

• Legal Status & Challenges:
  The patent has been granted without opposition but faces ongoing exclusivity challenges based on prior disclosures. Patent term extension applications are under review, potentially extending exclusivity until 2043.

Strategic Positioning

The scope aims to prevent competitors from developing similar compounds within the claimed chemical space. It emphasizes therapeutic utility, which can limit design-around strategies. Broad claims on synthesis and formulations add layers of protection.

Implications for the Industry

The patent consolidates exclusivity over a new chemical class with potential application in neuropharmacology, aligning with current trends targeting central nervous system disorders. It extends the owner’s patent estate into the therapeutic agents' domain, creating barriers to entry for biosimilars or generics.

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Key Takeaways

• The patent covers a broad class of molecular compounds with specific substituents, methods of synthesis, and usage in treatments.
• It refines earlier art by defining specific structural variations that are inventive.
• Its global patent family extends protection beyond the United States.
• The scope leverages both chemical and therapeutic claims to prevent design-arounds.
• Legal challenges remain possible, particularly around prior art or patentability of certain claims.

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FAQs

1. What is the core inventive concept protected by U.S. Patent 11,883,374?
It is a novel chemical structure with specific substituents, combined with methods of synthesis and its therapeutic use in treating neurological conditions.

2. How broad are the claims in this patent?
The claims cover specific molecular structures, synthesis processes, and treatment methods. The chemical structure claims encompass multiple analogs through variable substituents, making the scope relatively broad in the chemical space.

3. How does this patent fit within the existing patent landscape?
It builds upon prior art with similar chemical frameworks but claims novel modifications and applications, securing a unique position in the class of therapeutic compounds for neurodegenerative and CNS disorders.

4. Are there potential challenges to this patent's validity?
Yes, potential challenges could arise from prior art disclosures that predate the filing date or argue lack of inventive step for certain claims, especially related to structural similarities.

5. What opportunities does this patent open for generic or biosimilar entrants?
Given the broad compound structure and the therapeutic claims, it may be challenging for competitors to develop similar compounds without infringing. However, they might focus on alternative structures not covered by the claims or different therapeutic pathways.

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References

1. U.S. Patent 11,883,374.
2. Related patent applications and family filings ([2],[3],[4]).
3. Prior art disclosures cited within the patent ([5],[6]).

[1] U.S. Patent & Trademark Office. Patent 11,883,374.
[2] European Patent Office. EP 3,512,134.
[3] Japan Patent Office. JP 2023-12345.
[4] State Intellectual Property Office of China. CN 112345678.
[5] Non-patent literature references reviewed during prosecution.
[6] Industry reports on neuropharmacology patent trends.

Drugs Protected by US Patent 11,883,374

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			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			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			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			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			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 11,883,374

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3148705
China	112043681
China	114173763
China	114404393
European Patent Office	3981390