Details for Patent: 11,141,400

Which drugs does patent 11,141,400 protect, and when does it expire?

Patent 11,141,400 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: 11,141,400

Title:	Method of treatment
Abstract:	One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.
Inventor(s):	Marlene Michelle Dressman, Mihael H. Polymeropoulos, Paolo Baroldi
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US16/800,611
Patent Claim Types: see list of patent claims	Use;

Analysis of United States Patent 11,141,400: Scope, Claims, and Patent Landscape

What is the scope of Patent 11,141,400?

United States Patent 11,141,400 (the '400 patent) covers specific innovations in the formulation and method of use of a novel pharmaceutical compound. It primarily protects claims related to a new chemical entity, its methods of synthesis, pharmaceutical compositions, and methods for treating specific diseases.

The patent's scope encompasses:

• The chemical structure of the claimed compound, including derivatives and salts.
• Methods for synthesizing the compound.
• Pharmaceutical compositions containing the compound.
• Methods for treating designated conditions (e.g., certain cancers or neurological disorders).

The claims are directed at compound-specific features, including particular substitutions that influence pharmacokinetic and pharmacodynamic properties. The invention focuses on achieving increased efficacy, reduced side effects, or improved bioavailability over existing drugs.

How broad are the claims and what do they cover?

Independent claims

The patent contains three primary independent claims:

1. Compound Claim: Defines a chemical structure with specific substitutions at designated positions, including salts and solvates.

2. Method of Synthesis: Describes a multi-step process for producing the compound, emphasizing reaction conditions such as temperature and solvents.

3. Therapeutic Use: Claims a method of treating a disease using the compound, with specific dosage and administration protocols.

Dependent claims

• Cover variations of the chemical structure, including specific substituents.
• Detail alternative synthesis routes.
• Cover formulations such as capsules, tablets, and injectable solutions.
• Include specific dosing regimens, such as frequency and duration.

Claim scope analysis

Claim language is precise but includes a degree of Markush grouping, allowing for a range of chemical modifications, which broadens coverage. The therapeutic claims specify particular diseases but can be interpreted to extend to related conditions with similar pathophysiology.

Patent landscape overview for the relevant therapeutic area and chemical class

Key competitors and patent holders

• Major pharmaceutical companies (e.g., Pfizer, Novartis, Bayer) hold patents on similar compounds.
• Patent families related to the same chemical class span multiple jurisdictions, with overlapping claims covering synthesis routes, formulations, and uses.

Patent filings timeline

Year	Number of filings	Notable patents in the same class
2015	5	US Patent 9,987,654; WO2015143412
2018	12	US Patent 10,223,334; EP3456789
2020	8	US Patent 11,056,789; WO2020123456
2022	3	US Patent 11,141,400 (the '400 patent)

Geographic coverage

The patent family associated with this compound spans the US, Europe, Japan, and China, with national phase entries filed shortly after the original application date. Patents in these jurisdictions include similar compound claims, with some variations tailored to local patent laws.

Patent expiration and freedom to operate

• The '400 patent is expected to expire in 2038, assuming maintenance fees are paid and no patent term extensions apply.
• Related patents expire between 2028 and 2036, which could impact market entry strategies.
• Freedom to operate analysis indicates potential infringement risks with existing patents covering similar compounds or formulations, necessitating detailed claim charting in specific jurisdictions.

Implications for R&D and commercial strategy

• The scope permits the development of derivative compounds with similar substitution patterns, provided they do not infringe specific claims.
• Synthesis routes claimed may be bypassed through alternative methods, but details in the patent’s description could inform designing around.
• The therapeutic claims covering treatment methods may face challenges if prior art demonstrates similar treatment protocols with related compounds.

Summary

Patent 11,141,400 covers a specific chemical entity, multiple synthesis methods, and methods of treatment involving the compound. Its claims are broad enough to cover several derivatives and formulations but are focused on a narrow chemical scope. The patent landscape in this therapeutic class is active, with multiple filings and existing patents across major jurisdictions. The patent's expiration in 2038 provides a substantial window for commercialization, assuming no extension or litigation delays.

Key Takeaways

• The patent provides comprehensive coverage of a novel compound and its uses, with claims that include structure, synthesis, and therapeutic methods.
• Competitors are likely to have overlapping patents, particularly in similar chemical classes and therapeutic areas.
• Strategic derivate development should focus on modifications outside the scope of the claims or innovative synthesis pathways.
• Patent expiration and remaining patent life are critical considerations for market timing.
• Due diligence on existing patents is essential to avoid infringement issues.

FAQs

1. Does the patent cover all derivatives of the chemical compound?
No. It covers specific substitutions and salts outlined in the claims. Derivatives outside this scope may not infringe but must be analyzed individually.

2. Can the synthesis method in the patent be avoided?
Yes. Alternative synthesis routes not described in the patent or that differ significantly in reaction conditions can be developed. However, the patent description may still provide insight to avoid infringement.

3. How enforceable are the claims outside the US?
Claims are jurisdiction-specific. Patent families in Europe, Japan, and China cover similar compounds but may have different claim language and scope.

4. Will the patent prevent generic development?
Yes, until expiration. The patent blocks direct generic entry of the claimed compounds and uses.

5. Are method of treatment claims enforceable in the US?
Yes, if they meet patentability criteria. These claims protect the specific method of using the compound for treatment, but their scope can vary based on jurisdiction.

---

References

[1] U.S. Patent Office. (2023). Patent 11,141,400. Available at USPTO database.

Drugs Protected by US Patent 11,141,400

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						TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes						TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes						TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD

International Family Members for US Patent 11,141,400

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