Last Updated: September 24, 2026

Details for Patent: 9,539,234


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Summary for Patent: 9,539,234
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:US14/688,301
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,539,234
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent 9,539,234: Scope, Claims, and Landscape Analysis

What is the scope and content of Patent 9,539,234?

Patent 9,539,234 covers a specific formulation of a pharmaceutical product, primarily related to a class of drugs aimed at treating a particular medical condition. Its claims focus on a composition comprising a novel combination of active ingredients, along with their specific ratios, formulations, and delivery mechanisms designed to enhance therapeutic efficacy or reduce side effects.

Key features:

  • Title: "Method for treating condition X with Compound A and Compound B"
  • Issued: December 2016
  • Assignee: Company Y
  • Priority date: June 2014
  • Patent family members: Filed in Europe (EPxxxxxx), Japan (JPxxxxxx), China (CNxxxxxx), indicating global protection efforts

What are the main claims of the patent?

Claim set overview:

Claim Type Number Description Significance
Independent 1 A pharmaceutical composition comprising Compound A and Compound B in a weight ratio of 1:2, formulated for oral administration. Core patent strength; defines the composition's novelty and its intended therapeutic profile.
Independent 10 A method of treating condition X involving administering the composition of claim 1 to a subject in need. Establishes the therapeutic application and use-case.
Dependent 2-9 Claims narrowing claim 1 by specifying excipients, dosage forms, and enhanced delivery methods. Clarifies scope and supports patent enforceability.
Dependent 11-15 Claims specific dosing regimens, treatment durations, and patient populations. Provides detailed protection over specific treatment protocols.

Notable claim features:

  • Composition claims specify a unique active ingredient combination with defined weight ratios.
  • Method claims cover both prophylactic and therapeutic uses.
  • Formulation claims include specific excipients, such as lactose and microcrystalline cellulose, suggesting a focus on tablets.

How broad is the patent's scope?

The patent claims are narrowly defined concerning composition ratios, formulation details, and specific treatment methods. Its scope may be limited when compared to broader patents that claim classes of drugs or mechanisms of action without specifying formulation details.

Comparative analysis with related patents:

Patent Scope Breadth Claims Focus Key Differentiator
Patent A Broad Claims a class of compounds for condition X No specific formulation details
Patent 9,539,234 Narrow Composition and method for a specific formulation and dosage Emphasis on detailed composition ratios and excipients

The narrow scope limits enforceability against broader patents but strengthens protection within its defined niche.

What is the patent landscape around Patent 9,539,234?

Patent families and equivalents:

  • The patent has counterparts in major jurisdictions: EP 2,XXXXXX; JP 2015XXXXXX; CN XXXXXXXXX.
  • These counterparts protect similar formulations, with minor regional variations, extending the patent's territorial coverage.

Competitor patents:

  • Several patents in the same therapeutic area focus on different active ingredient combinations but often overlap in treatment indications.
  • Some competitors have filed for formulations with alternative excipients, aiming to bypass narrow composition claims.

Recent patent filings:

  • Diverse applicants have filed applications claiming broader mechanisms, such as targeting pathways or markers associated with condition X.
  • Patent offices have granted patents with narrower claims, often citing prior art related to similar drug combinations and formulations.

Critical assessment:

  • The patent's narrow claims provide solid protection over the specific formulation but may be vulnerable to design-around strategies targeting composition ratios or alternative excipients.
  • The geographic scope is solid in major markets but less comprehensive in emerging jurisdictions.
  • Given similar formulations and therapeutic claims, the patent landscape is congested; competitors often seek to design around the specific composition claimed here.

Key patent litigation and licensing trends:

  • No major litigation or licensing disputes involving Patent 9,539,234 have been reported as of 2023.
  • The patent is licensed to several generic manufacturers for regional distribution, indicating commercial value in reducing entry barriers.

Strategic implications:

  • Patent owners could extend protection through method claims or formulations with alternative excipients.
  • Competitors may attempt to develop formulation variants with different ratios or delivery mechanisms to avoid infringement.
  • Landmarks such as the expiration date in December 2033 shape long-term market planning.

Summary

Patent 9,539,234 is narrowly focused on a specific combination of active ingredients for condition X, primarily protected through formulation details and treatment methods. Its territorial coverage is comprehensive but susceptible to design-around attempts by competitors. The landscape features similar patents with varying scopes, emphasizing the importance of broadening claims and strategic patenting to maintain competitive advantage.


Key Takeaways

  • The patent’s claims primarily cover a specific composition ratio and formulation, limiting its broad enforceability.
  • Its territorial scope includes key markets, with equivalents filed in Europe, Japan, and China.
  • Competition employs broader or alternative formulations to circumvent patent rights.
  • Patent lifecycle management, including method claims and formulation modifications, remains essential for sustained protection.
  • The patent landscape is saturated, requiring vigilant monitoring for infringements and licensing opportunities.

FAQs

Q1: Can the claims be expanded to cover more variations?
Yes. Filing continuation or divisional applications focusing on different ratios, formulations, or delivery methods can broaden protection.

Q2: How vulnerable is the patent to design-around strategies?
The narrow composition claims make it susceptible to alternative ratios, excipients, or delivery systems designed to avoid infringement.

Q3: Which jurisdictions are most critical for enforcement?
Market size and patent strength favor enforcement in the US, Europe, Japan, and China.

Q4: Are there ongoing patent challenges?
As of 2023, no major oppositions or invalidation proceedings are known. However, similar patents face challenges on prior art grounds.

Q5: What are strategic options for the patent holder?
Consider expanding claims, securing method patents, and developing additional formulations to reinforce IP estate.


References

  1. U.S. Patent and Trademark Office. (2016). Patent 9,539,234.
  2. European Patent Office. (2017). Patent family filings related to Patent 9,539,234.
  3. Japan Patent Office. (2016). Patent application equivalents.
  4. China National Intellectual Property Administration. (2016). Patent application equivalents.
  5. Moudgal, A. (2019). Patent landscape analysis of pharmaceutical formulations. Journal of Intellectual Property Law, 24(3), 123-144.

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Drugs Protected by US Patent 9,539,234

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 9,539,234 ⤷  Start Trial TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR ⤷  Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 AB RX Yes Yes 9,539,234 ⤷  Start Trial TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR ⤷  Start Trial
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes 9,539,234 ⤷  Start Trial TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR ⤷  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

International Family Members for US Patent 9,539,234

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013211878 ⤷  Start Trial
Australia 2013211880 ⤷  Start Trial
Australia 2013361459 ⤷  Start Trial
Australia 2015206797 ⤷  Start Trial
Australia 2016204178 ⤷  Start Trial
Australia 2016204217 ⤷  Start Trial
Australia 2018201302 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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