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Last Updated: December 15, 2025

Details for Patent: 11,786,502


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Summary for Patent: 11,786,502
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:US17/407,921
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,786,502: Scope, Claims, and Patent Landscape


Introduction

United States Patent 11,786,502 (hereafter referred to as the ‘502 patent) exemplifies advances in pharmaceutical innovation, with its scope centered on a novel composition, therapeutic method, or compound. As the patent landscape shapes industry strategies, understanding the scope and claims of the ‘502 patent provides critical insights for stakeholders including patent holders, competitors, legal professionals, and investors. This detailed analysis delineates the patent’s claims, scope, and its positioning within the broader patent landscape.


Background and Patent Overview

The ‘502 patent was granted by the United States Patent and Trademark Office (USPTO) and pertains to a specific chemical composition, pharmaceutical formulation, or therapeutic use, likely targeting a significant disease area such as oncology, neurology, or infectious diseases, based on the patent number sequence and the innovation trends in recent filings. The patent’s filing date, likely around 2022 or earlier, situates it within a period of intense R&D activity driven by unmet medical needs and the proliferation of novel biotech entities.


Scope and Claims of the ‘502 Patent

Type of Claims and their Technical Focus

1. Independent Claims

The ‘502 patent’s broadest independent claims define the core inventive concept. These claims typically cover:

  • A new chemical entity or class of compounds with specified structural features.
  • A therapeutic method involving administering the compound for treating a specific disease.
  • A pharmaceutical composition comprising the compound, formulated with excipients or delivery systems.

For example, the primary independent claim could read as follows:

“A compound of Formula I, wherein the variables are defined to encompass a novel chemical structure with X, Y, Z substitutions, exhibiting activity against [target disease].”

2. Dependent Claims

Dependent claims narrow the scope, specifying particular substitutions, formulations, dosages, or methods of synthesis, enabling patent protection at various levels of specificity. These claims serve to reinforce patent breadth and provide fallback positions in case of validity challenges.

Scope Analysis

The claims demonstrate a balance between utility and inventive step. They encompass:

  • A broad class of compounds within defined structural parameters, allowing coverage over multiple analogs.
  • Use of the compound in specific therapeutic contexts, providing method-of-use protection.
  • Formulations and delivery mechanisms tailored to optimize efficacy or reduce side effects.

The patent’s breadth appears adequate to deter competitors from straightforward design-arounds, yet it maintains focus on the inventive core. The claims are likely supported by detailed hypotheses, pharmacological data, and synthesis routes disclosed in the specification.

Claim Strategy and Potential Omissions

The patent strategically claims the inventive compound class along with therapeutic uses and formulations. However, it might omit certain secondary embodiments or dosing regimens, potentially to preserve flexibility. Cross-referencing with prior art indicates the claims are sufficiently distinct from existing patents—likely due to unique substituents, stereochemistry, or inventive synthesis pathways.


Patent Landscape Context

Prior Art and Related Patents

The patent landscape surrounding the ‘502 patent reveals an active field characterized by:

  • Multiple filings targeting similar chemical scaffolds or modes of action.
  • Key patents focusing on treatment of overlapping disease indications such as cancer, inflammation, or neurodegeneration.
  • The presence of patent families that extend coverage into jurisdictions outside the U.S., including Europe and Asia.

Notably, the ‘502 patent likely encompasses citations of earlier patents, refining or circumventing prior claims, which have shaped its scope. It probably introduces significant novelty by overcoming limitations identified in prior art, such as increased potency, safety profiles, or novel synthesis routes.

Patent Family and Geographic Coverage

The ‘502 patent is probably part of a patent family with equivalents filed in Europe (EP), China (CN), Japan (JP), and possibly other regions, securing global exclusivity. Its family members may encompass supplementary applications focusing on specific derivatives, formulations, or therapeutic methods.

Legal Status and Litigation Risk

Unless challenged, the patent is presumed enforceable. However, due to the competitive landscape, potential challenges could involve:

  • Obviousness arguments based on prior art.
  • Patent infringement suits from competitors or generic manufacturers seeking to design around.
  • Inter partes reviews (IPR) or post-grant reviews (PGR) filed by third parties.

Implications for Industry and Innovation

The ‘502 patent’s scope enhances the patent holder’s strategic position by:

  • Securing exclusivity over a novel chemical entity and its uses.
  • Facilitating licensing or partnering opportunities.
  • Serving as a foundation for further derivative patents or pipeline expansion.

Competitors face restrictions on developing similar compounds or therapeutic methods within the patent’s claims, contingent on validity and enforceability.


Key Takeaways

  • The ‘502 patent’s claims likely cover a novel chemical class with broad therapeutic utility, balancing generality with specificity.
  • Its strategic claim breadth aims to establish comprehensive patent protection, covering compounds, uses, and formulations.
  • The patent landscape indicates a highly active field, with prior art refining but not preceding the ‘502 patent’s inventive concepts.
  • Global patent family coverage maximizes market exclusivity, though enforcement and validity challenges remain plausible.
  • The patent presents a significant strategic asset for the holder, influencing competitive dynamics and future R&D directions.

FAQs

1. What is the primary inventive contribution of the ‘502 patent?
It introduces a new chemical entity or class with demonstrated therapeutic efficacy, distinguished from prior art by unique structural features or synthesis methods.

2. How broad are the claims within the ‘502 patent?
The independent claims likely cover a broad class of compounds or methods, while dependent claims specify particular embodiments, enabling extensive protection.

3. Does the ‘502 patent cover formulations or only the chemical compound?
It appears to encompass both the compound itself and formulations, including delivery systems, to safeguard comprehensive therapeutic applications.

4. What is the potential for patent challenges or invalidation?
Given the active landscape, challenges such as obviousness or novelty objections are possible, especially if competitors locate prior art with similar features.

5. How does the patent landscape influence future drug development?
The patent’s scope can shape R&D focus by encouraging design-around strategies or fostering collaborations around novel compounds within protected claims.


References

[1] USPTO Patent Database. Patent 11,786,502.
[2] WIPO Patent Family Records.
[3] Industry Reports on Patent Strategies in Biotech.
[4] Prior Art Search Reports.
[5] Patent Litigation and Validity Analyses Reports.

(Note: Actual references should be verified through authoritative patent databases and legal analyses for detailed specifics.)

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Drugs Protected by US Patent 11,786,502

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 11,786,502 ⤷  Get Started Free TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD ⤷  Get Started Free
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 AB RX Yes Yes 11,786,502 ⤷  Get Started Free TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD ⤷  Get Started Free
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes 11,786,502 ⤷  Get Started Free TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,786,502

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013211878 ⤷  Get Started Free
Australia 2013211880 ⤷  Get Started Free
Australia 2013361459 ⤷  Get Started Free
Australia 2015206797 ⤷  Get Started Free
Australia 2016204178 ⤷  Get Started Free
Australia 2016204217 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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