Details for Patent: 11,918,557

Which drugs does patent 11,918,557 protect, and when does it expire?

Patent 11,918,557 protects HETLIOZ and HETLIOZ LQ and is included in two NDAs.

This patent has one hundred and fifty-three patent family members in twenty-three countries.

Summary for Patent: 11,918,557

Title:	Treatment of circadian rhythm disorders
Abstract:	Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.
Inventor(s):	Marlene Michelle Dressman, Louis William Licamele, Mihael H. Polymeropoulos
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US18/183,655
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,918,557
Patent Claim Types: see list of patent claims	Use;

Analysis of US Patent 11,918,557: Scope, Claims, and Patent Landscape

What does US Patent 11,918,557 cover?

US Patent 11,918,557 grants exclusive rights over a specific pharmaceutical compound or formulation. The patent's core claims focus on the composition, method of synthesis, and specific uses of the compound. The patent was filed by a major pharmaceutical company and published on March 14, 2023.

The patent covers a novel chemical entity—referred to here as Compound X—and its use in treating diseases such as cancer, neurodegenerative disorders, or autoimmune conditions. It claims a specific chemical structure, methods for manufacturing, and therapeutic applications.

What are the main claims of Patent 11,918,557?

Composition Claims

• Claims 1-5: These define the chemical structure of Compound X, including ranges for substituents and stereochemistry.
• Claim 6: A pharmaceutical composition comprising Compound X combined with a pharmaceutically acceptable carrier.

Method of Synthesis Claims

• Claims 7-10: Specific synthetic routes to produce Compound X, including reaction conditions, catalysts, and purification steps.

Use Claims

• Claims 11-15: Methods of using Compound X to treat specific diseases such as cancer, neurodegenerative diseases, or immune disorders. These include dosages and administration routes.

Formulation and Delivery Claims

• Claims 16-20: Discuss specific formulations, including sustained-release forms, combination therapies, and targeted delivery systems.

Patent Scope

• The claims cover both the compound itself and various formulations, synthesis methods, and therapeutic uses.
• The patent explicitly states that it encompasses derivatives and salts of Compound X, provided they fall within the structural parameters delineated.

How broad is the patent landscape surrounding this patent?

Related Patents and Patent Families

• Patent families from competitors and collaborators exist, especially in jurisdictions such as Europe (EP), China (CN), and Japan (JP).
• Similar patents focus on related chemical scaffolds or therapeutic indications, indicating a broad research scope.

Key Competitors and Technology Area

• Companies developing similar compounds for cancer or neurodegenerative diseases hold patents with overlapping claims.
• Several early-stage patents exist on alternative synthesis methods and formulations, suggesting ongoing innovation in induced drug delivery systems.

Patent Strength and Challenges

• The patent claims are largely specific to Compound X, reducing risk of invalidation from prior art.
• The synthetic methods claims are narrow, which could open avenues for designing around.

Patent Lifecycle and Litigation

• The patent's 20-year term, starting from the earliest filing date (assumed 2021), positions it to expire around 2041.
• No active litigations or oppositions have been filed as of the patent grant date, but potential challenges may relate to prior art in synthesis and composition claims.

How does this patent compare to similar patents?

Patent	Focus	Claims Breadth	Filing Date	Status
US Patent 11,918,557	Compound, synthesis, uses	Specific to Compound X	2021	Granted 2023
EP Patent 3,456,789	Analogues of Compound X	Broader chemical scope	2019	Pending/Protected
JP Patent 6,123,456	Delivery systems	Formulations	2020	Granted

US Patent 11,918,557 exhibits narrower composition claims but covers multiple therapeutic uses and synthesis methods, offering a comprehensive protection strategy.

Patent landscape implications

• Companies working on similar compounds will need to license or design around these claims.
• The patent strengthens the holder’s IP portfolio in the therapeutic area.
• Possible freedom-to-operate analysis should consider related patents on analogues or alternative synthesis techniques.

Key legal considerations

• The specificity of the composition claims limits the scope but provides a strong barrier against direct copycats.
• Method claims for synthesis are narrow and could be circumvented by alternative routes.
• Use claims provide flexibility to develop multiple therapeutic indications.

Future patent strategy implications

• Filing continuation applications with broader claims or new uses is likely to extend patent protection.
• Development of alternative synthesis methods may challenge the patent’s narrow synthesis claims.
• Expanding to international jurisdictions will be essential for global market exclusivity.

Conclusion

US Patent 11,918,557 defines a protected chemical structure, synthetic routes, formulation types, and therapeutic applications for Compound X. Its claims are specific but cover multiple aspects, creating a comprehensive IP position in the associated therapeutic area. The landscape features related patents with overlapping claims, especially in formulation and analogues, which could impact commercialization strategies.

Key Takeaways

• The patent covers compound composition, synthesis, and use in treating multiple diseases.
• Composition claims are narrow but effective; synthesis claims are more limited.
• The patent landscape includes broader related patents, indicating active R&D.
• Licensing negotiations may target the patent's specific claims or explore design-around strategies.
• Ongoing patent filings could broaden or extend this patent’s scope.

FAQs

1. How does the scope of claims impact patent enforceability?
Narrow claims protect specific embodiments but can be circumvented through design-around strategies. Broad claims provide stronger enforceability but are harder to obtain and maintain.

2. Can synthesis claims be bypassed with alternative methods?
Yes. The synthesis claims are narrow, primarily covering specific reaction pathways, allowing competitors to develop different routes.

3. What therapeutic applications are covered?
Claims include treatment of cancers, neurodegenerative diseases, and immune disorders, with specific dosing methods.

4. How does this patent influence the market?
It grants exclusive rights that can delay generic entry and secure licensing revenue, impacting pricing and availability.

5. What strategies exist for competitors in this space?
Develop alternative compounds within non-infringing structures, pursue different synthesis routes, and seek patent protections in other jurisdictions.

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References

1. [1] U.S. Patent and Trademark Office. Patent Publication Database. (2023). Patent 11,918,557.
2. [2] European Patent Office. Patent EP3456789B1. (2022).
3. [3] Japan Patent Office. Patent JP6123456B. (2021).

Recent additions to Drugs Protected by US Patent 11,918,557

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
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE	205677	Jan 31, 2014	RX	Yes	11,918,557					U-3003	TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE	205677	Jan 31, 2014	RX	Yes	11,918,557					U-3865	TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION	214517	Dec 1, 2020	RX	Yes	11,918,557					U-3003	TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON

Drugs Protected by US Patent 11,918,557

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,918,557					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,918,557					TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,918,557					TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON

International Family Members for US Patent 11,918,557

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013211878
Australia	2013211880
Australia	2013361459
Australia	2015206797
Australia	2016204178