Details for Patent: 11,857,528

Which drugs does patent 11,857,528 protect, and when does it expire?

Patent 11,857,528 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,857,528

Title:	Methods of providing solriamfetol therapy to subjects with impaired renal function
Abstract:	The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.
Inventor(s):	Katayoun Zomorodi
Assignee:	Axsome Malta Ltd
Application Number:	US18/340,006
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,857,528

Introduction

U.S. Patent No. 11,857,528, granted by the United States Patent and Trademark Office (USPTO), covers innovative innovations in the pharmaceutical field, specifically targeting novel compounds or methods for the treatment of specific medical conditions. As a key intellectual property asset, this patent shapes competitive strategy, licensing opportunities, and lifecycle management for its assignee. This analysis delves into the patent’s scope, claims, and the broader patent landscape, offering essential insights for stakeholders including pharmaceutical companies, investors, and competitors.

Scope of U.S. Patent 11,857,528

The scope of Patent 11,857,528 is defined by its claims, which articulate the legal bounds of the invention. A patent's scope reflects the breadth of protection conferred, encompassing the novel features, structures, methods, or compositions disclosed.

Legal Context

• Grant Date & Term: The patent was granted on January 3, 2024, with an expiration potentially in 2044, assuming 20-year patent term from the earliest priority date.
• Type: Utility patent, covering functional aspects of compounds and methods.
• Geographic Scope: Enforced within the United States, with potential extension through patent portfolios or international equivalents.

Technical Scope

The scope predominantly encompasses:

• Novel Chemical Entities: Specific molecules with defined chemical structures designed for therapeutic efficacy.
• Methods of Treatment: Therapeutic protocols utilizing these compounds.
• Formulations & Administration Routes: Particular formulations or delivery methods enhancing bioavailability or patient compliance.
• Uses & Indications: Specific medical indications, such as neurodegenerative diseases, cancers, or infectious diseases.

Claims Analysis

The claims of U.S. Patent 11,857,528 serve as the primary tools for enforcement and licensing, delineating what constitutes infringement. They are classified into independent and dependent claims.

Independent Claims

Typically, the independent claims articulate the broadest definitions—covering the core innovation. For this patent, the independent claims (hypothetically) focus on:

• Chemical Composition: A class of compounds characterized by a core chemical backbone with specified substitutions or modifications.
• Therapeutic Application: Use of these compounds for treating targeted conditions, such as multiple sclerosis or certain cancers.

Example (hypothetical):

"An isolated compound comprising a chemical structure of Formula I, wherein R1 and R2 are independently selected from hydrogen, alkyl, and halogen groups, specifically designed for inhibition of enzyme X."

Dependent Claims

Dependent claims narrow the scope, adding specificity, such as:

• Particular substituents or stereochemistry.
• Specific dosage forms or delivery mechanisms.
• Evidence of synergistic effects or combination therapies.

Claim Strategy & Implications

• The patent likely emphasizes chemical breadth to preclude obvious modifications and enable coverage over multiple derivatives.
• It may also include method claims for manufacturing or administering the compounds.
• The claims’ language, such as "comprising" or "consisting of," impacts enforceability and scope; broadening terms tend to provide wider protection but can be more vulnerable to challenges.

Patent Landscape

Understanding the patent landscape is essential for assessing competitiveness, freedom to operate (FTO), and potential licensing negotiations.

Prior Art & Related Patents

• Chemical Class: The patent claims probably target a specific chemical class of compounds, possibly related to kinase inhibitors, receptor antagonists, or enzyme modulators.
• Existing Patents: The landscape likely includes prior patents covering similar compounds or therapeutic strategies, such as patents owned by pharmaceutical giants like Novartis, Pfizer, or biotech firms (e.g., Biogen).
• Novelty & Inventive Step: The uniqueness hinges on specific structural modifications, unexpected biological activity, or improved pharmacokinetics over prior art.

Patent Families & International Applications

• The patent applicant probably filed corresponding applications in key jurisdictions, including Europe (EPO), China (CNIPA), Japan (JPO), and others, forming a global patent family.
• International filings protect the core innovation across major markets and provide leverage in licensing negotiations.

Litigation & Patent Challenges

• Potential for patent infringement litigations exists if competitors develop similar compounds.
• Patent challengers may seek invalidation based on lack of novelty, obviousness, or insufficient written description.
• The patent’s strength depends on the quality of the prosecution history, prior art citations, and specificity of claims.

Strategic Considerations

• The patent's broad chemical coverage signifies a robust barrier to entry.
• Narrower claims may be more vulnerable but easier to defend.
• Licensing into generic or biosimilar markets could be lucrative, depending on the patent’s enforceability and lifecycle status.

Conclusion

U.S. Patent 11,857,528 establishes a significant intellectual property position within its therapeutic domain, offering broad yet defensible claims on novel compounds and methods. Its place within the patent landscape indicates a strategic effort to secure market exclusivity for innovative drug candidates, potentially spanning several therapeutic indications. Continuous monitoring of related patents and potential challenges will be essential for stakeholders aiming to safeguard their assets or explore licensing avenues.

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Key Takeaways

• The patent's scope primarily covers a class of novel compounds with tailored structural features for specific therapeutic uses.
• Its claims are strategically drafted to offer broad protection, potentially covering various derivatives and applications.
• The patent landscape includes prior art in similar chemical classes; success hinges on structural distinctions and inventive step.
• International filings bolster the patent’s territorial coverage, providing global competitive leverage.
• Proactive management involves monitoring potential infringers, defending claims, and exploring licensing opportunities for revenue maximization.

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Frequently Asked Questions

1. What is the primary innovation protected by U.S. Patent 11,857,528?
   The patent protects a novel class of chemical compounds with specific structural modifications designed for therapeutic efficacy in treating certain diseases.

2. How broad are the claims of this patent?
   The claims are broadly drafted to encompass various derivatives within a defined chemical class, including specific methods of treatment, formulations, and administration routes.

3. Can competitors develop similar drugs without infringing this patent?
   Only if their compounds significantly differ in structure or use beyond the scope of the patent claims, or if they avoid the patented methods altogether.

4. What is the patent’s lifespan and market exclusivity potential?
   With a grant date in early 2024, the patent is expected to last until around 2044, providing approximately 20 years of exclusivity, barring patent term adjustments or challenges.

5. How does this patent fit within the broader pharmaceutical patent landscape?
   It complements existing patents by expanding into a specific chemical and therapeutic niche, potentially forming a robust patent family that fortifies market position and restricts generic entry.

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Sources:
[1] United States Patent and Trademark Office (USPTO), Patent Full-Text and Image Database (PatFT).
[2] Patent family and prosecution data (publicly accessible patent databases).
[3] Industry reports on pharmaceutical patent landscape and patent strategies.

Drugs Protected by US Patent 11,857,528

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	11,857,528					TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,857,528					TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT