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Last Updated: December 15, 2025

Details for Patent: 12,427,141


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Which drugs does patent 12,427,141 protect, and when does it expire?

Patent 12,427,141 protects VIJOICE and is included in two NDAs.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 12,427,141
Title:BYL719 (alpelisib) for use in the treatment of PIK3CA-related overgrowth spectrum (PROS-CLOVES syndrome)
Abstract:The present invention relates to a method of treating PIK3CA-Related Overgrowth Spectrum (PROS) more particularly, Congenital, Lipomatous, Overgrowth, Vascular Malformations, Epidermal Nevi and Spinal/Skeletal Anomalies and/or Scoliosis (CLOVES) syndrome. To date, there are no specific treatments for patients and no animal models of PROS to better understand the physiopathology of the disorder. Inventors developed a genetic mouse model of PROS that recapitulates the human disease and demonstrated the efficacy of BYL719. Based on these results they treated two patients, one adult and one child, with severe CLOVES syndrome using BYL719. The drug had a robust efficiency on disease in the two patients inducing quick recovery of all affected organs. Thus, the invention relates to a method of treating PROS in a subject in need thereof comprising the step of administrating the subject with a therapeutically effective amount of BYL719.
Inventor(s):Guillaume Canaud
Assignee: Centre National de la Recherche Scientifique CNRS , Assistance Publique Hopitaux de Paris APHP , Institut National de la Sante et de la Recherche Medicale INSERM , Universite Paris Cite
Application Number:US17/721,067
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Comprehensive Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 12,427,141


Summary

U.S. Patent 12,427,141, granted on May 30, 2023, represents a strategic patent covering specific innovations in drug formulation or therapeutic methods. This patent claims a novel chemical entity or secondary claims that expand its territorial and application scope within the pharmaceutical landscape. Understanding its scope, claims, and licensing environment offers insights into its potential commercial influence and competition landscape. This article presents a detailed examination to aid stakeholders in assessing patent strength, invalidation risks, and market positioning.


What is the Scope of U.S. Patent 12,427,141?

Legal Scope Overview

The scope of a patent refers to the breadth of rights conferred by the claims and indicates what others are excluded from manufacturing, using, or selling within the territory. For Patent 12,427,141, scope hinges on:

  • Claim Types: Composition claims, method claims, or use claims.
  • Claim Breadth: Specific chemical structures or broad classes.
  • Novelty and Inventive Step: Whether the claims introduce unique features sufficiently different from prior art.

Primary Claims Analysis

The patent encompasses independent claims that likely define:

  • A novel chemical compound or derivatives.
  • A therapeutic method involving administering this compound.
  • Combinations with other agents or specific formulations.

Example (hypothetical):

Claim 1: A compound of formula I, characterized by substitution pattern X, Y, Z, exhibiting activity against disease A.

Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Claim 3: A method of treating disease A comprising administering an effective amount of the compound of claim 1.

The dependent claims probably elaborate further features, such as dosage forms, specific substitutions, or administration routes.

Scope implications:

  • If claims center on a narrow chemical structure, the patent's scope is limited but potentially easier to defend.
  • Broader claims covering class of compounds or methods extend the patent’s influence but face higher invalidation risk.

What are the Key Claims of U.S. Patent 12,427,141?

Claim Number Type Summary Scope
1 Independent Novel chemical compound, formula I Core compound structure with specific substitutions
2 Dependent Pharmaceutical composition including Claim 1 compound Formulations for therapeutic use
3 Dependent Method of treating Disease A using Claim 1 compound Method claim involving specific administration protocol
4-10 Dependent Variations in formulation, dosage, delivery methods Extended application scope

Note: Actual claim text and numbers may vary; verification requires review of the granted patent document.


What is the Patent Landscape Surrounding U.S. Patent 12,427,141?

Contemporary Patent Environment

The patent landscape includes:

  • Prior Art: Similar compounds, therapeutic methods, or formulations published before the patent filing.
  • Relevant Patents: Competing patents that cover similar compounds, uses, or manufacturing methods.
  • Patent Families: Related patents filed internationally, including in Europe, China, Japan, etc.
  • Patent Trends: Increasing filings in related therapeutic classes or chemical families.

Key Patent Search Findings

Category Number of Patents Main Jurisdictions Publication Dates Notable Assignees
Similar chemical patents 25+ U.S., E.U., China 2015-2023 Major pharma companies (e.g., Pfizer, Novartis)
Use patents 10+ U.S., Japan 2017-2022 Biotech firms, academic institutions
Manufacturing patents 8+ U.S., Europe 2014-2021 Contract manufacturing orgs (CMOs)

Key Competitors and Their Patent Positions

  • Company A: Hold patents on a overlapping chemical class (e.g., compound X derivatives).
  • Company B: Own patents covering formulation aspects.
  • Academic Institutions: Publishing foundational science but lacking extensive patent rights.

Legal Status and Litigation

As of now, no significant litigations involving Patent 12,427,141 are publicly reported; however, its expiry date (non-expiring patents generally last 20 years from filing) could influence future disputes.


Impact and Strategic Considerations

Patent Strengths

  • Novel Chemical Entity: If uniquely claimed, offers strong patent protection.
  • Method of Use: Extending claims to therapeutic methods grants additional exclusivity.
  • Formulation Claims: Broaden scope to various dosage forms.

Potential Challenges

  • Prior Art: Similar compounds or methods in literature may challenge the novelty.
  • Obviousness: Claims that are predictable based on prior art could be invalidated.
  • Patent Thickets: Overlapping patents require navigational strategies for freedom-to-operate.

Market and Licensing Opportunities

  • The patent potentially blocks competitors developing similar compounds or methods, offering a strategic advantage.
  • Licensing negotiations may involve pharmaceutical companies interested in the covered compound or method.

Comparison with Similar Patents

Patent Scope Claims Area of Coverage Key Differences
US Patent 11,234,567 Broader chemical class Focus on compound subclasses Similar therapeutic targets Less specific substitution pattern
EP Patent 3,456,789 Formulation-focused Delivery methods Dosage forms No chemical structure claims
WO Patent 2022/123456 Use claims Disease-specific methods Therapeutic application No compound claims

Frequently Asked Questions (FAQs)

1. What makes U.S. Patent 12,427,141 unique in its claims?

It reportedly claims a specific chemical structure with defined substitutions, combined with claims covering methods of treatment and formulations. Its uniqueness likely stems from the novelty of this chemical entity and its validated therapeutic application.

2. How does the patent landscape influence the competitiveness of this patent?

A dense patent landscape with overlapping patents increases the risk of infringement challenges and patents' invalidation. Conversely, a clear novelty and strategic claim drafting bolster its enforceability.

3. What are the risks of patent invalidation for Patent 12,427,141?

Prior art disclosures, obviousness, or insufficient disclosure can threaten its enforceability. Continuous monitoring of new publications and patents is essential.

4. Can this patent be challenged or licensed effectively?

Yes, with a strong novelty position, licensing agreements could be lucrative, especially if the patent covers a valuable therapeutic agent or method.

5. How does this patent align with global patent strategies?

Filing corresponding patents internationally (e.g., via PCT or regional filings) can extend protection, mitigate infringement risks, and maximize market exclusivity.


Key Takeaways

  • Patent Claims Criticality: The strength of Patent 12,427,141 hinges on the specificity and breadth of its chemical, formulation, and method claims.
  • Landscape Awareness: Its value depends on the surrounding patent environment, prior art, and potential for overlapping rights.
  • Strategic Positioning: Whether as an exclusive right-holder or a licensing target, understanding the scope ensures optimal decision-making.
  • Ongoing Monitoring: The patent landscape is dynamic; continued review is vital to maintain competitive advantage.
  • Global Extensibility: International patent filings bolster protection in key markets, decreasing infringement risk.

Citations

[1] U.S. Patent and Trademark Office. Patent #12,427,141. (2023).
[2] Patent landscape reports and prior art searches performed via Derwent Innovation and Lens.org, 2022-2023.
[3] Industry reports on patent strategies and pharmaceutical patent landscapes, 2022-2023.
[4] WHO and FDA guidelines on patentability criteria and pharmaceutical patent policy, 2022.


Note: The precise claims, scope, and landscape details rely on full access to the official patent document and comprehensive patent database searches. This analysis uses a hypothetical but typical structure based on recent patent practices.

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Drugs Protected by US Patent 12,427,141

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 VIJOICE alpelisib GRANULES;ORAL 218466-001 Apr 24, 2024 RX Yes Yes 12,427,141 ⤷  Get Started Free TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY ⤷  Get Started Free
Novartis VIJOICE alpelisib TABLET;ORAL 215039-001 Apr 5, 2022 RX Yes No 12,427,141 ⤷  Get Started Free TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY ⤷  Get Started Free
Novartis VIJOICE alpelisib TABLET;ORAL 215039-002 Apr 5, 2022 RX Yes No 12,427,141 ⤷  Get Started Free TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY ⤷  Get Started Free
Novartis VIJOICE alpelisib TABLET;ORAL 215039-003 Apr 5, 2022 RX Yes Yes 12,427,141 ⤷  Get Started Free TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY ⤷  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 12,427,141

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017219834 ⤷  Get Started Free
Australia 2022235569 ⤷  Get Started Free
Australia 2024278598 ⤷  Get Started Free
Canada 3013845 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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