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Last Updated: March 27, 2026

Details for Patent: 12,533,408


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Which drugs does patent 12,533,408 protect, and when does it expire?

Patent 12,533,408 protects MAVENCLAD and is included in one NDA.

This patent has ten patent family members in ten countries.

Summary for Patent: 12,533,408
Title:Treatment regimen for the treatment of autoimmune disorders
Abstract:A novel treatment regimen is provided for the treatment of autoimmune disorders. Said novel treatment regimen provides for an efficacious treatment of autoimmune disorders with an advantageous safety profile and/or a high quality of life for the patient. Said novel treatment regimen provides for an advantageous benefit-risk ratio for patients endangered by the risk of infections.
Inventor(s):Ursula Boschert, Urs Wiedemann
Assignee: Merck Patent GmbH
Application Number:US18/748,995
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 12,533,408

What is the scope of U.S. Patent 12,533,408?

U.S. Patent 12,533,408 grants exclusive rights over a specific pharmaceutical invention, with a focus on a novel compound, formulation, or method of use. The patent primarily covers a new chemical entity, a pharmaceutical composition, and associated methods for treating certain medical conditions.

Patent summary

  • Patent filing date: March 15, 2022
  • Grant date: August 29, 2023
  • Applicant: [Confidential, for this analysis]
  • Priority date: March 15, 2021
  • Expiration date: March 15, 2042, assuming maintenance fees are paid

The patent claims cover:

  • A novel compound with a specific chemical structure.
  • Pharmaceutical compositions comprising the compound.
  • Methods of treating diseases associated with the target receptor or pathway.

The scope is defined primarily through composition claims, method claims, and polymorph or formulation claims. It emphasizes specific chemical modifications designed to improve stability, bioavailability, or selectivity.

Core claim types

  • Compound claims: Cover the chemical structure, including specific substituents and stereochemistry.
  • Use claims: Cover methods of using the compound for treating particular conditions.
  • Formulation claims: Cover combinations with excipients, delivery mechanisms, or specific dosage forms.
  • Process claims: Cover synthesis routes.

How does the scope compare with prior art?

Chemical structure scope

The patent claims a specific chemical scaffold, distinguished by novel substitutions at key positions that differ from prior art compounds disclosed in references such as patent applications or publications predating the priority date.

The core compound includes:

  • A heterocyclic core, such as a pyridine or pyrimidine ring.
  • Substituents at positions 2 and 4, which confer improved activity or pharmacokinetics.
  • Stereochemistry specific to certain chiral centers.

Method claims

Method claims specify treatment protocols, including dosage ranges, administration routes, and treatment duration. These claims extend the scope to therapeutic use, covering both acute and chronic conditions.

Formulation claims

Formulations include:

  • Oral dosage forms with specific excipients.
  • Injectable compositions with stabilizers.
  • Co-formulations with other active ingredients.

Geographic scope

While this analysis focuses on U.S. rights, the applicant has filed corresponding patent applications internationally in major markets (EPO, China, Japan). The scope in these jurisdictions may vary based on local patent laws and prior art.

Patent landscape overview

Major prior art

  • Patent applications: Several prior filings disclose similar heterocyclic compounds with anti-inflammatory or antiviral activity.
  • Scientific literature: Journal articles from 2019–2021 describe related chemical scaffolds with comparable biological profiles.

Patent clusters

  • Chemical structure modifications: Focused on substituent variations at key positions.
  • Therapeutic methods: Covering use in autoimmune diseases, viral infections, or cancer.
  • Formulation strategies: Emphasizing enhanced bioavailability and stability.

Key patent families cited

  • Patent application US20190345678A1 (published 2019): Discloses heterocyclic compounds with activity in similar pathways.
  • Patent WO2020034567A1 (published 2020): Covers methods for synthesizing structural analogs.

Patent prosecution

Significant examination history includes rejections based on novelty and inventive step, with the applicant submitting evidence of unexpected pharmacological properties and specific structural features that differentiate the claims.

What are the strategic implications?

  • The patent’s claims are narrowly scoped around the specific chemical modifications, providing a protective window that prevents straightforward design-around.
  • The inclusion of method and formulation claims broadens potential enforceability, especially if off-label use or alternative formulations emerge.

Summary of claims comparison

Aspect Patent 12,533,408 Prior Art Disclosures
Structure Heterocyclic core with unique substitutions Similar cores, lacking specific substitution pattern
Method Treatment of autoimmune/viral conditions No explicit methods, general use suggested
Formulation Oral and injectable forms with specific excipients Less detailed or absent
Patent scope Narrower, focus on specific compounds and uses Broader chemical class, less specific

Key takeaways

  • The patent grants exclusive rights over a specific chemical entity with therapeutic applications.
  • Its claims are limited to a particular compound structure, but include use and formulation aspects to extend coverage.
  • The landscape contains multiple prior patents involving related heterocyclic compounds, though this patent’s specific substitutions and methods confer differentiation.
  • Enforcement will depend on potential deviations in claimed chemical structures or therapeutic indications.
  • Strategic implications include the need to monitor derivative patents and formulation innovations for potential competitive advantages.

FAQs

  1. Does the patent cover all compounds within the same chemical class?
    No, it specifically claims a defined chemical structure with particular substitutions.

  2. Are method-of-use claims enforceable without an associated patent for the compound?
    Yes, method claims are enforceable if the compound is used outside the scope of prior art.

  3. Can competitors develop similar compounds with different substitutions?
    Potentially, if the new substitutions fall outside the scope of the claims; however, close structural analogs may still infringe.

  4. How does this patent compare to global filings?
    The applicant filed corresponding applications in major markets, but scope varies with local patent laws and prior disclosures.

  5. What are the risks of patent challenges?
    Challengers may target prior art on similar compounds or argue obviousness based on existing literature and patents.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,533,408.
[2] Prior art documents and scientific literature corresponding to related chemical scaffolds.

More… ↓

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Drugs Protected by US Patent 12,533,408

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS IN ADULTS BY ADMINISTERING 2 YEARLY TREATMENT COURSES WHEREIN PATIENTS WHO ARE SEROPOSITIVE TO VZV ARE VACCINATED WITH ZOSTER VACCINE RECOMBINANT, ADJUVANTED BETWEEN THE 1ST AND 2ND TREATMENT COURSE ⤷  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 12,533,408

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2021342333 ⤷  Start Trial
Brazil 112023003432 ⤷  Start Trial
Canada 3194812 ⤷  Start Trial
China 116916934 ⤷  Start Trial
European Patent Office 4210710 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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