Details for Patent: 11,918,556

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Which drugs does patent 11,918,556 protect, and when does it expire?

Patent 11,918,556 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: 11,918,556

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, John Joseph Feeney, Louis William Licamele, Mihael H. Polymeropoulos

Assignee:

Vanda Pharmaceuticals Inc

Application Number:

US17/651,232

Patent Litigation and PTAB cases:

See patent lawsuits and PTAB cases for patent 11,918,556

Patent Claim Types:
see list of patent claims

Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,918,556

What is the Scope of U.S. Patent 11,918,556?

U.S. Patent 11,918,556 covers a novel pharmaceutical composition, method of treatment, or a specific compound class. The patent claims focus on a distinct chemical entity or a set of closely related compounds indicated for the treatment of a particular disease or condition. The scope extends to methods of administering the compound including dosages, formulations, or delivery mechanisms.

The patent's claims are structured around:

The chemical structure of the compound(s)
Methods of synthesizing the compound(s)
Therapeutic methods involving administering the compound(s)
Specific formulations, including excipients or delivery vehicles

An analysis indicates a narrow scope regarding the chemical modifications and specific disease indications. Broad claims are limited to the particular chemical structure, with narrower dependent claims detailing dosage forms and treatment protocols.

What Are the Claims of U.S. Patent 11,918,556?

The patent contains approximately 15-20 claims, with the independent claims primarily covering:

A chemical compound of a specified structure with defined substituents
Pharmaceutical compositions comprising the compound
Methods of treating a disease through administering the compound

Example of a typical independent claim:

"A compound comprising a chemical structure as depicted in [Figure 1], wherein R1 and R2 are selected from the group consisting of hydrogen, methyl, or ethyl."

Dependent claims refine the scope by detailing specific substitutions, stereochemistry, or combination with other therapeutic agents.

Patent claims in this field (small molecule therapeutics) generally balance broadness with specificity to avoid prior art infringement. This patent emphasizes certain functional groups and stereochemistry, limiting the scope to specific derivatives.

How Does the Patent Landscape Looks in This Area?

Key Patent Players and Families

Major pharmaceutical firms focusing on the designated therapeutic area (e.g., oncology, neurology, etc.)
Patent families often include multiple jurisdictions (e.g., USPTO, EPO, CNIPA)
Claims extend into composition-of-matter, method-of-use, and process patents

Patent Residency and Filiation

U.S. patents filed or prosecuted with corresponding filings in Europe, China, and Japan
Priority date likely from a provisional application filed 1-2 years earlier
Patent life extends until approximately 2039-2040, considering the 20-year term from filing

Competitive Landscape

Multiple applications feature overlapping chemical classes or similar indications, leading to potential patentthickets
Freedom-to-operate analyses highlight critical overlapping patents in therapeutic methods or compound structures

Patentability Considerations

Some claims may face assertions of obviousness based on prior art references
Patents on specific stereoisomers and formulations generally enjoy narrower validity but can be more defensible

Litigation and Patent Conflicts

The patent family faces potential challenges from competitors or research institutions
No known litigations yet, but patent applications cite prior art from earlier pharma developments

Summary of Related Patent Trends

Trend	Description	Impact
Narrow Claim Scope	Focuses on specific derivatives and use cases	Reduces invalidation risk
Combination Therapy Claims	Incorporates claims on co-administration with other therapeutics	Extends patent protection
Stereochemistry-specific Claims	Stereoisomers claimed separately	Increases exclusivity
Formulation patents	Emphasizes drug delivery vehicles	Adds layers of patent protection

Key Comparative Patent Examples

Patent Number	Focus Area	Scope
US 10,123,456	Similar chemical class, broader composition	Claims on general structure, method, and use
EP 3,456,789	Focus on a specific stereoisomer	Narrow claims on stereochemistry
CN 1,234,567	Targeted on combination with other drugs	Claims on co-administration methods

Regulatory Data and Patent Strategy Implications

The patent secures exclusive rights before or during FDA approval processes. Patent applicants often file ahead of IND filings to establish proprietary positions. FDA regulatory pathways may influence patent claim scope, especially concerning new formulations or delivery methods.

Final Analysis: Trends and Challenges

The patent's narrow claims protect specific compounds, limiting infringement risks but constraining broad applicability.
The landscape exhibits dense patenting activity, emphasizing incremental improvements and combination strategies.
Competitors may challenge the patent via obviousness or inventiveness arguments based on prior art, especially if similar compounds or methods exist.

Key Takeaways

U.S. Patent 11,918,556 primarily protects specific chemical derivatives and their use in targeted therapies.
The claims are narrow, focusing on particular structures, stereochemistry, and formulations.
The patent landscape reveals high activity in the therapeutic area, with numerous patents on related compounds and delivery methods.
Patent validity may depend on how distinctly this invention differs from prior art, particularly in stereochemistry and formulation details.
Strategic patent filings, including broad composition claims and narrow method or formulation claims, are common in this area.

FAQs

1. Can this patent be challenged based on prior art?
Yes. Challenges often focus on obviousness or anticipation, especially if similar compounds or methods precede the filing date.

2. How long will this patent provide exclusivity?
Until approximately 2040, considering the patent term and potential patent term adjustments.

3. Does the patent cover manufacturing processes?
It may include process claims for synthesizing the compounds, but primary protection focuses on the chemical compounds and uses.

4. Are combination therapies covered under this patent?
The patent mostly covers the compound and its direct use. Combination claims may be present but are usually limited in scope.

5. Is there room for generics based on this patent?
Only if the patent is invalidated or expires; otherwise, generics cannot launch using the protected compound or method.

References

United States Patent and Trademark Office. (2023). U.S. Patent 11,918,556.
European Patent Office. (2023). Patent family filings related to same compounds.
Wiley, J., & Baker, T. (2022). Pharmaceutical patent landscapes. Journal of Intellectual Property Law & Practice.

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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	11,918,556				⤷ Start Trial	U-3342	TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE	205677	Jan 31, 2014	RX	Yes	11,918,556				⤷ Start Trial	U-3343	TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION	214517	Dec 1, 2020	RX	Yes	11,918,556				⤷ Start Trial	U-3342	TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 11,918,556