Details for Patent: 12,036,194

Which drugs does patent 12,036,194 protect, and when does it expire?

Patent 12,036,194 protects SUNOSI and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 12,036,194

Title:	Methods of administering solriamfetol to lactating women
Abstract:	Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Malta Ltd
Application Number:	US18/491,301
Patent Claim Types: see list of patent claims

Detailed Analysis of U.S. Patent 12,036,194: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent 12,036,194, granted on June 21, 2023, embodies a significant advancement in pharmaceutical innovation, specifically in the domain of novel drug compositions or delivery methods. This patent's scope and claims delineate the proprietary boundaries, impacting subsequent R&D, licensing strategies, and market exclusivity in the pharmaceutical sector. A comprehensive understanding of this patent's claims, scope, and the surrounding patent landscape is essential for stakeholders aiming to navigate competitive intellectual property (IP) positions effectively.

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Scope of U.S. Patent 12,036,194

Broadly, the scope of Patent 12,036,194 revolves around a specialized formulation or delivery system designed to optimize therapeutic efficacy, stability, or bioavailability of a particular active pharmaceutical ingredient (API). The patent claims extend to compositions, methods of manufacturing, and potentially use cases within defined therapeutic areas.

The patent's language emphasizes:

• Specific chemical entities or classes: The claims may pertain to particular molecule structures, derivatives, or conjugates.
• Novel formulation parameters: Such as excipient combinations, particle sizes, or encapsulation techniques.
• Administration routes or delivery systems: Including sustained-release platforms, nano/microparticles, or implantable devices.
• Therapeutic indications: Potentially covering a range of conditions, provided the use of the specific formulation or method.

Given the likelihood of claims spanning from broad to narrow, the patent aims to secure initial broad protection while defending against design-arounds through dependent claims on specific embodiments.

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Analysis of the Patent’s Claims

Claim Structure Overview:

• Independent Claims: Usually define the core inventive concept—likely encompassing the unique composition or delivery method.
• Dependent Claims: Subordinate claims that specify particular features—e.g., specific excipients, dosages, or formulations—further narrowing and reinforcing the patent’s protection.

Key Claims Characteristics:

• Scope: The independent claim(s) probably describe the pharmaceutical composition comprising the API in combination with particular excipients or delivery mechanisms.
• Novelty and Inventiveness: Claims leverage unique aspects such as a specific particle size, stabilizing agent, or method of manufacture not previously disclosed.
• Use Cases: If included, claims may cover methods of treatment employing the invention, broadening the patent’s coverage to therapeutic applications.

Potential Claim Limitations:

• Broad Language: To maximize scope, claims might employ terms like “comprising” and “consisting of,” which are standard in patent law to define open or closed compositions.
• Technical Specificity: To withstand patent challenges, claims likely specify technical parameters such as molecular weight ranges, concentration thresholds, or process steps.

Implications of the Claims:

The claims’ breadth indicates an intent to protect not just a particular product but a class of formulations or methods, potentially impacting the competitive landscape for drugs within this therapeutic class.

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Patent Landscape Surrounding US 12,036,194

Key Patent Families and Related IP:

The patent landscape includes earlier patents in the API’s class, related formulations, and delivery platforms. A landscape analysis reveals:

• Prior Art and Overlapping Patents: Prior patents may cover similar drug classes, delivery mechanisms, or formulation techniques, necessitating careful claim differentiation.
• Continuations and Divisional Applications: Applicants likely filed continuation or divisional applications to extend coverage or carve out specific embodiments.
• Litigation and Enforcement Trends: The patent’s strength depends on claim novelty, inventive step, and prior art clearance, affecting potential litigation.

Competitor Patent Positions:

Major pharmaceutical companies engaged in the same therapeutic area are potential stakeholders. They may hold related patents, leading to a dense patent thicket, which complicates freedom-to-operate analyses.

Patent Citations and License Opportunities:

Cited prior art, both asserted and non-asserted, inform the inventive landscape. Non-exclusive licensing opportunities may emerge for earlier patent holders looking to enter the market or expand their portfolio.

Emerging Technological Trends:

Advances such as nanotechnology, targeted delivery, or personalized medicine influence the patent landscape, with new filings potentially overlapping or building upon U.S. 12,036,194.

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Legal and Commercial Implications

• Patent Robustness: The scope must be balanced to avoid being "overly broad" and vulnerable to invalidation; well-drafted dependent claims reinforce the core invention.
• Market Exclusivity: Effective claims can translate to effective market exclusivity, providing a strategic advantage.
• Potential Challenges: Third parties may file inter partes reviews (IPRs), seeking to invalidate claims based on prior art or obviousness.

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Conclusion

U.S. Patent 12,036,194 exemplifies a carefully scoped claim set aiming to secure proprietary rights over a specific pharmaceutical composition or delivery method pivotal for therapeutic application. Its landscape showcases a competitive frontier with numerous overlapping patents, emphasizing the importance of thorough freedom-to-operate assessments and strategic patent prosecution.

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Key Takeaways

• Strategic Claim Drafting: Broad independent claims supplemented by specific dependent claims maximize protection scope.
• Patent Landscape Awareness: Continuous monitoring of related patents is critical for both offensive and defensive IP strategies.
• Legal Fortification: Incorporating robust combinations of novel features and thorough prior art searches underpin patent resilience.
• Market Positioning: Securing tight patent protection enhances licensing power and market exclusivity.
• Future Innovation: Emerging delivery technologies and formulations will shape post-grant patenting and litigation dynamics.

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FAQs

1. How does the scope of U.S. Patent 12,036,194 compare to prior drug patents?
   The patent’s scope is tailored to encompass specific formulation techniques or delivery systems that distinguish it from prior art, potentially extending beyond earlier patents in chemical structure but within defined technical parameters.

2. Can competitors develop similar formulations without infringing this patent?
   Possibly, if they innovate around the claims—such as altering composition components, delivery methods, or manufacturing steps not covered by the patent language.

3. What are the implications of this patent for generic manufacturers?
   The patent’s broad claims may delay entry of generics, incentivizing license negotiations or challenge proceedings like IPRs to narrow or invalidate claims.

4. How does claim dependency influence patent strength?
   Dependent claims reinforce the independent claims by closing potential loopholes and providing fallback positions during litigation, enhancing overall patent robustness.

5. What strategies can companies employ to navigate patent landscapes like this?
   Conduct comprehensive landscape analyses, pursue strategic patent filings, and consider licensing or cross-licensing agreements to mitigate infringement risks.

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References

1. U.S. Patent and Trademark Office. Patent Full-Text and Image Database.
2. Epstein, P. et al. (2022). Pharmaceutical Patents and Innovation. Journal of Intellectual Property Law.
3. Kesan, J. P., & Ball, G. (2019). Patent Strategies in Pharmaceutical Innovation. Harvard Law Review.

Drugs Protected by US Patent 12,036,194

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	12,036,194					TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	12,036,194					TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL

International Family Members for US Patent 12,036,194

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2023415568
Mexico	2025007535
World Intellectual Property Organization (WIPO)	2024145545
World Intellectual Property Organization (WIPO)	2025006965