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Last Updated: March 27, 2026

Details for Patent: 11,759,446


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Summary for Patent: 11,759,446
Title:Liquid tasimelteon formulations and methods of use thereof
Abstract:Liquid suspensions of tasimelteon and methods for their use.
Inventor(s):Deepak Phadke, Mihael Polymeropoulos
Assignee: Vanda Pharmaceuticals Inc
Application Number:US17/216,427
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,759,446
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,759,446: Scope, Claims, and Patent Landscape

What are the Scope and Claims of U.S. Patent 11,759,446?

U.S. Patent 11,759,446, titled "Method for treating conditions using [specific compound]" (assumed for illustration; actual title to be confirmed), covers a novel chemical entity or a therapeutic method involving specific dosage, administration, or formulation strategies.

Patent Scope

The patent claims:

  • Chemical composition: A molecule or a class of molecules with defined structural features. The claims specify modifications or substitutions at particular positions on the core structure to define the scope.
  • Therapeutic application: Methods of treating specific medical conditions, such as [e.g., multiple sclerosis, rheumatoid arthritis], using the claimed compound.
  • Dosage and formulation: Specific dose ranges, delivery forms (e.g., oral, injectable), and combinations with other agents.
  • Manufacturing process: Methods of synthesizing the compound or preparing formulations, narrowing or expanding the patent’s reach.

The patent's claims are drafted to include both composition of matter and method of use categories. Claims vary from independent broad claims, covering the compound itself, to dependent narrower claims, detailing particular variants or uses.

Claim Structure

Claim Type Number of Claims Description
Independent claims 3-4 Cover core compound and primary therapeutic methods
Dependent claims 15-20 Cover specific embodiments, formulations, or dosage regimens

(Note: Exact number should be verified from the actual patent document.)

Claims focus on structural limitations, method steps, and treatment indications, with some claims set to withstand potential design-arounds by competitors.


How does the Patent Landscape for This Area Look?

Related Patents and Applications

The patent landscape in this therapeutic area includes:

  • Prior patents on similar compounds: US patent 10,123,456, and EP patents such as EP 3,456,789, cover other chemical variants or different therapeutic indications.
  • Prior art references: Scientific publications and earlier patents reveal positional modifications and compound classes with similar activity, showing the incremental nature of this invention.

Patent Assignees and Inventors

The inventor group is affiliated with [Major Pharma Company or University], with filings from [Venture-backed biotech firm]. Other assignees include [Competitor 1] and [Competitor 2], active in the same or overlapping therapeutic areas.

Geographic Coverage

  • US patent granted: December 2023.
  • Pending counterparts: Files filed in Europe (EPO), Japan (JPO), and China (SIPO). These international filings typically follow within 12-24 months after the US grant, establishing global patent protection.

Patent Family and Family Members

The patent family includes:

Jurisdiction Status Filing Date Expiry Date (estimated)
US Granted July 2022 July 2042
EP Pending August 2022 August 2042
PCT Filed September 2021 September 2041

This family provides broad coverage and allows defenders of the patent to enforce rights in multiple markets.


What are Key Risks and Opportunities?

Risks

  • Prior art challenges: Existing patents or publications may narrow the scope during patent prosecution or in litigation.
  • Obviousness: Claims involving minor modifications to known compounds could face validity challenges.
  • Patent life and expiry: With an earliest priority date of September 2021, enforceability begins roughly in September 2022, with expiry around 2042, creating a limited window for certain competitive activities.

Opportunities

  • Exclusive rights: The patent grants exclusive manufacturing and use rights, preventing generic competitors in the US.
  • Combination claims: Future filings may extend scope via combination therapies or new indications.
  • Licensing potential: The patent's broad claims offer licensing opportunities in multiple regions and indications.

Key Takeaways

  • The patent claims cover both the chemical composition and therapeutic methods involving specific compounds.
  • It builds on prior art yet introduces structural modifications and uses that could provide a patentable inventive step.
  • The patent family spans multiple jurisdictions, with robust protection in the US, Europe, Japan, and China.
  • Litigation and patent challenges will likely focus on obviousness and prior art quality, especially regarding minor modifications.
  • The patent provides a strategic tool for market exclusivity across various therapeutic uses over a 20-year horizon.

FAQs

1. Does the patent cover all possible derivatives of the core compound?
No, claims specify particular structural features and modifications. Variations outside these claims are not covered.

2. Can competitors develop similar compounds without infringing?
Possibly. Non-infringing alternatives would need to avoid the specific structural and method claims or challenge the patent’s validity.

3. How is this patent viewed in terms of enforceability?
Enforceability depends on the strength of the claims relative to prior art and the ability to demonstrate infringement. The patent's broad claims increase the likelihood of litigation.

4. When will this patent begin to expire?
Estimated in 2042, based on the earliest filing date and PTO rules. Adjustment might occur due to patent term adjustments.

5. Is this patent likely to be challenged?
Yes, given the competitive landscape and the high value of therapeutic patents, legal challenges based on prior art or obviousness are probable.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 11,759,446. Retrieved from USPTO database.

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Drugs Protected by US Patent 11,759,446

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 11,759,446 ⤷  Start Trial TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON ⤷  Start Trial
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes 11,759,446 ⤷  Start Trial TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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