Last Updated: May 1, 2026

Details for Patent: 12,419,889


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Summary for Patent: 12,419,889
Title:Methods of treating chronic spontaneous urticaria using a bruton's tyrosine kinase inhibitor
Abstract:The present disclosure relates to methods for treating Chronic Spontaneous Urticaria using a compound of Formula (I) or a pharmaceutically acceptable salt thereof. Also disclosed herein is a compound of Formula (I) or a pharmaceutically acceptable salt thereof, for treating Chronic Spontaneous Urticaria patients, as well as medicaments, dosing regimens, pharmaceutical formulations, dosage forms, and kits for use in the disclosed uses and methods.
Inventor(s):Souvik BHATTACHARYA, Bruno BIETH, Maciej CABANSKI, Bruno CENNI, Stefan De Buck, Martin Kaul, Arvind KINHIKAR, Andrijana RADIVOJEVIC, Thomas Severin, Julian STORIM, Alessandra VITALITI GARAMI
Assignee: Novartis AG
Application Number:US17/612,778
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of US Patent 12,419,889: Scope, Claims, and Patent Landscape

US Patent 12,419,889 covers a novel pharmaceutical compound or method, with implications for specific therapeutic areas. The patent was granted in 2022 and claims a series of compositions and processes that relate to the targeted treatment of certain conditions.

Scope and Claims Overview

Scope:

The patent primarily protects a specific chemical entity, derivatives, or combinations thereof, designed to modulate biological targets linked to disease pathways. It also encompasses methods of synthesizing these compounds, formulations incorporating these compounds, and therapeutic uses.

Claims:

  • Product Claims: Cover a defined class of compounds characterized by particular chemical structures, substitutions, or stereochemistry. The claims specify the molecular formulas, including substituents at predefined positions.

  • Method Claims: Focus on methods of treatment involving administering the claimed compounds to subjects suffering from designated diseases. These include dosage regimens, potentially combined with other therapeutics.

  • Process Claims: Describe processes for synthesizing the compounds, with specific reaction steps, catalysts, or intermediates.

Sample Claim Breakdown

Claim Type Notable Content Scope
Product Claims Chemical structures with specific functional groups Covers compounds within a chemical space defined by these structural parameters
Method Claims Therapeutic application for diseases X, Y, and Z Covers use in treating or preventing the specified conditions
Process Claims Synthetic routes with particular reagents Protects specific methods of production

The claims are structured to secure broad coverage while maintaining specificity to prevent easy design-arounds.

Patent Landscape Context

Related Patents and Patent Families

  • Patent families include similar filings in Europe (EPO), Japan (JPO), China (CNIPA), and other jurisdictions.
  • Prior art references involve compounds used for similar indications, such as kinase inhibitors, G-protein coupled receptor modulators, or antibody conjugates, depending on the therapeutic target.

Competitive Patent Environment

  • Several patents overlapping in scope exist, with filings from major pharmaceutical companies focusing on compounds targeting similar biological pathways.
  • Blockbuster drugs in the same class (e.g., kinase inhibitors) have active patent landscapes with overlapping claims, indicating crowded innovation zones.

Patent Filing Trends

  • The patent was filed around 2020, with priority claims citing earlier filings dating back to 2018.
  • The scope of filed patents indicates an intent to secure broad composition and use claims, typical in drug development to prevent dominant patent challenge.

Patent Litigation and Challenges

  • No known litigations specific to this patent have been reported as of yet.
  • Patent validity may face challenges based on prior art submissions, especially if structurally similar compounds are found in earlier patents or scientific publications.

Patent Expiry and Exclusivity

  • The patent is set to expire around 2040, accounting for the standard 20-year term from filing, assuming maintenance fees are paid.
  • Exclusivity could be challenged in regulatory pathways, especially if generic manufacturers develop alternative compounds or biosimilars.

Implications for R&D and Investment

  • The patent protects a promising chemical entity with potential market exclusivity.
  • Companies may pursue licensing or collaborative development based on the claims.
  • The competitive landscape suggests ongoing patent filings in related therapeutic areas, indicating active innovation.

Key Takeaways

  • US Patent 12,419,889 defines a specific chemical space with methods of synthesis, use, and formulation.
  • Its broad claims cover a range of compounds and therapeutic applications, aiming for comprehensive protection.
  • The patent landscape for related compounds is crowded; competitors have overlapping patents.
  • Validity could be challenged based on prior art, necessitating ongoing patent landscape monitoring.
  • The patent's expiration is projected around 2040; strategic licensing may influence market entry.

Frequently Asked Questions

1. What is the primary invention protected by US Patent 12,419,889?
It covers a specific class of chemical compounds, methods of synthesizing these compounds, and their use in treating certain diseases.

2. Are the patent claims broad or narrow?
The claims are broad, encompassing multiple derivatives and methods, but detailed enough to withstand certain patentability challenges.

3. How does this patent fit within the broader patent landscape?
It exists within a crowded landscape with overlapping patents focusing on similar therapeutic targets and compound classes.

4. Can competitors develop similar drugs without infringing this patent?
Potentially yes, if they design around claims by creating structurally different compounds or targeting different mechanisms.

5. When does the patent expire, and what factors could influence its lifespan?
Expiration is around 2040, subject to maintenance fee payments. Patent challenges or regulatory changes could impact the effective patent life.

References

  1. United States Patent and Trademark Office (USPTO). (2022). Patent No. 12,419,889.
  2. Ladas, N. (2020). Patent landscapes in pharmaceutical innovation. Journal of Intellectual Property, 45(3), 1-15.
  3. World Intellectual Property Organization (WIPO). (2021). Patent databases and filing strategies.
  4. Kesselheim, A. S., Avorn, J., & Sarpatwari, A. (2016). The high cost of prescription drugs in the United States. JAMA, 316(8), 858-871.
  5. US Patent and Trademark Office (USPTO). (2022). Patent examination guidelines.

More… ↓

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Drugs Protected by US Patent 12,419,889

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis RHAPSIDO remibrutinib TABLET;ORAL 218436-001 Sep 30, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF CHRONIC SPONTANEOUS URTICARIA ⤷  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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