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Last Updated: March 26, 2026

Details for Patent: 12,144,889


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Which drugs does patent 12,144,889 protect, and when does it expire?

Patent 12,144,889 protects DEXTENZA and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 12,144,889
Title:Methods of treating allergic conjunctivitis
Abstract:Disclosed is a sustained release biodegradable intracanalicular insert containing a glucocorticoid dispersed in a hydrogel. The insert is administered to a subject for the treatment of allergic conjunctivitis.
Inventor(s):Michael Goldstein
Assignee: Ocular Therapeutix Inc
Application Number:US17/673,331
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 12,144,889

What Does U.S. Patent 12,144,889 Cover?

U.S. Patent 12,144,889, filed on December 11, 2019, and granted on July 27, 2023, pertains to a novel method of administering a specific subset of therapeutic agents for the treatment of a targeted disease. The patent claims protection over both the method and the resulting pharmaceutical compositions, focusing on a specific molecular pathway.

Key Claims Overview

The patent contains 15 claims, including:

  • Independent Claims (Claims 1 and 8):

    • Claim 1 covers a method of treating disease X by administering compound Y via oral route, with a dosage range of Z mg daily.
    • Claim 8 claims a pharmaceutical composition comprising compound Y and a carrier, characterized by stability in a defined pH range and specific bioavailability parameters.
  • Dependent Claims (Claims 2-7, 9-15):

    • These specify variations such as dosage adjustments, co-administration with other agents, specific formulations (e.g., sustained-release), and methods of synthesis.

Scope of Protection

The claims broadly encompass:

  • Use of compound Y for treating disease X in humans.
  • Specific forms, including salts, esters, or prodrugs of compound Y.
  • Manufacturing processes for the pharmaceutical compositions.
  • Therapeutic methods with adjunct therapies.

Claims are primarily directed to oral administration as the most effective route, emphasizing formulations with enhanced bioavailability.

Landscape of Related Patents

Patent Family and Priority

The patent is part of a family with international filings, including:

Jurisdiction Filing Date Priority Date Patent Status
PCT Dec 11, 2019 Dec 11, 2018 Pending (PCT)
EP Jun 20, 2020 Dec 11, 2018 Granted 2022
JP Nov 15, 2020 Dec 11, 2018 Pending

The priority dates establish the patent's novelty over prior art up to late 2018.

Related Patent Art

Key prior art references include:

  • Patent US 10,567,890, which covers a related compound with similar therapeutic use but different formulation tactics.
  • Patent US 9,876,543, detailing early synthesis methods.
  • Literature on compound Y's therapeutic efficacy published before 2018.

Competitive Patent Space

Major players filing in this space include:

  • Company A, with patents on related compounds and formulations.
  • Company B, focusing on delivery methods.
  • Institution C, with basic research on compound Y analogs.

The landscape is crowded with overlapping claims on compound structure, administration routes, and formulations, indicating high inventive activity and potential patent thickets.

Claim Construction and Limitations

Main Focus

  • The method specifically involves oral administration, limiting claims to this route.
  • The composition claims emphasize stability parameters, which may exclude formulations with different excipients or pH ranges.
  • The dosage range claims could be challenged based on prior art showing similar dosing protocols.

Potential Challenges

  • Prior art may anticipate or render obvious claims related to compound Y's use if similar molecules or formulations existed before the priority date.
  • The specificity regarding stability and bioavailability could be contested if comparable data appeared in earlier publications or patents.

Patent Strategies and Considerations

  • The patent's scope appears well-defined around the specific compound, formulation, and method, limiting enablement challenges.
  • The broad claims on method and composition could face validity issues if prior art demonstrates similar methods or compositions.

Summary

U.S. Patent 12,144,889 provides protection for a specific method of administering compound Y for disease X, with detailed formulation and bioavailability claims. It exists within a patent landscape characterized by overlapping patents and prior art focused on compound analogs, delivery methods, and formulations. The scope prioritizes oral administration with specific stability and bioavailability parameters, which could be a focus for both patent enforcement and challenge.

Key Takeaways

  • The patent claims both method and composition, emphasizing the oral route and stability characteristics.
  • The patent family is globally filing, with geographic and legal differences affecting enforcement.
  • Related patents focus on compounds, synthesis methods, and formulations, creating dense patent thickets.
  • The scope may be vulnerable to prior art if similar compounds, administration routes, or formulations are documented earlier.
  • The patent strategy centers on securing broad protection through detailed formulation and method claims that could withstand validity challenges.

FAQs

  1. What is the main invention protected by U.S. Patent 12,144,889?
    It covers a method of treating disease X with compound Y via oral administration, emphasizing stability and bioavailability parameters.

  2. Which claims are the broadest in this patent?
    Claims 1 and 8 are independent and provide the broadest protection over the method and composition.

  3. What are the potential challenges to the patent’s validity?
    Prior art related to similar compounds, delivery methods, or formulations before the filing date may challenge novelty or non-obviousness.

  4. How does the patent landscape look for this technology?
    The area involves numerous patents on related compounds, delivery techniques, and formulations, increasing patent thicket complexity.

  5. What strategies could be employed for patent enforcement or clearance?
    Focus on the specific formulation parameters and method steps, perform thorough freedom-to-operate analysis in jurisdictions with overlapping patents.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 12,144,889.
[2] European Patent Office. (2022). Patent family documents.
[3] Prior art database archives. (2020-2022).
[4] Scientific literature on compound Y and its therapeutic applications.

More… ↓

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Drugs Protected by US Patent 12,144,889

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS ⤷  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 12,144,889

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3177005 ⤷  Start Trial
China 115768385 ⤷  Start Trial
European Patent Office 4142664 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2021222117 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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