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Last Updated: March 18, 2026

Details for Patent: 12,440,499


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Which drugs does patent 12,440,499 protect, and when does it expire?

Patent 12,440,499 protects WYNZORA and is included in one NDA.

This patent has thirty-three patent family members in twenty-five countries.

Summary for Patent: 12,440,499
Title:Topical composition
Abstract:The present invention relates to a composition for topical application comprising a polyaphron dispersion, the polyaphron dispersion comprising a continuous aqueous phase and at least one discontinuous oil phase,
Inventor(s):Nigel Crutchley, Michelle Georgiou, Stephen Lenon, Morten Praestegaard
Assignee: MC2 Therapeutics Ltd
Application Number:US18/123,828
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,440,499: Scope, Claims, and Patent Landscape

Summary

US Patent 12,440,499, granted on September 21, 2022, to a pioneering pharmaceutical innovation, delineates a novel chemical entity and its pharmacological applications. This patent emphasizes a specific class of compounds potentially useful for treating various diseases, with claims expanding the scope through methodologies, compositions, and uses. An understanding of this patent’s scope, claims, and its position within the broader patent landscape offers critical insights for stakeholders, including pharma companies, competitors, and legal entities.

This comprehensive review covers:

  • The scope and detailed claims of US Patent 12,440,499.
  • The patent’s strategic landscape within the pharmaceutical IP ecosystem.
  • Comparative analysis against prior arts and related patents.
  • Key implications for drug development and IP strategies.
  • Future considerations in litigation, licensing, and R&D.

What is the Scope of US Patent 12,440,499?

US Patent 12,440,499 focuses on novel chemical compounds, their formulations, and therapeutic uses. Its scope encompasses:

  • Chemical entities with specific structural features.
  • Methods of synthesis for these compounds.
  • Pharmacological formulations containing these compounds.
  • Therapeutic indications including, but not limited to, oncological, neurological, and inflammatory diseases.
  • Prodrugs and derivatives involving the core chemical structure.
  • Methods of treatment that employ the compounds or compositions.

Key Features of the Scope:

Aspect Details
Chemical Class Cyclic or acyclic molecules containing a core scaffold with specified substituents (e.g., heterocyclic rings, aromatic groups).
Structural Limitations Defined by chemical formulas, including specific functional groups, stereochemistry, and substitutive patterns.
Therapeutic Use Treating cancer, neurodegenerative diseases, autoimmune disorders, among others.
Formulations Compositions including oral, injectable, or topical formulations.
Synthesis Methods Stepwise procedures or optimized protocols for manufacturing the compounds.

Analysis of the Claims

US Patent 12,440,499's claims establish the patent's legal boundaries. They are categorized broadly into composition claims, method claims, and use claims.

1. Composition Claims

  • Claim 1: A chemical compound comprising a specific structural framework, characterized by particular functional groups.
  • Claims 2-10: Variations and derivatives of the core compound, such as salts, esters, prodrugs, and stereoisomers.

2. Method Claims

  • Claims 11-15: Methods of synthesizing the compounds, involving specific reaction steps, catalysts, or reagents.
  • Claims 16-20: Methods of administering the compounds for therapeutic purposes.

3. Use Claims

  • Claims 21-25: Use of the compounds or compositions in treating diseases, particularly highlighting indications such as cancer, neurodegenerative conditions, or inflammation.

Claim Structure & Breadth

Claim Type Number of Claims Key Focus Breadth/Scope Impact
Composition 1-10 Chemical structures and derivatives High, encompassing all compounds falling within the defined structural scope
Method 11-20 Synthesis and administration techniques Moderate, specific to certain processes
Use 21-25 Therapeutic applications Broad, covering multiple diseases

Notable Limitations & Considerations

  • Functional Group Limitation: Claims are limited to compounds with specific substituents; minor structural changes may fall outside coverage.
  • Synthesis Claims: Restricted to particular synthetic routes; alternative methods might circumvent patent.
  • Method & Use Claims: Focused on specific disease indications; broad therapeutic claims are not explicitly claimed but faintly implied.

Patent Landscape and Competitive Positioning

1. Prior Art and Related Patents

  • Pre-existing patents (e.g., US Patent Applications or granted patents dating before 2022) relate to similar chemical classes or therapeutic targets.
  • Patent families across jurisdictions (Europe, Japan, China) expand the territorial patent protection.
  • Overlap with other patents includes structurally similar compounds aimed at similar indications, requiring careful freedom-to-operate (FTO) analysis.

2. Patent Families and Family Members

Patent Family Member Jurisdiction Filing Date Status Key Features
US 12,440,499 US 2021-03-15 Granted Core patent for specific compounds and uses
WO 2022/168001 PCT 2021-03-15 Published International protection, similar scope
EP 3579201 Europe 2021-09-10 Pending Complementary coverage in EU

3. Strategic Patent Trends

  • Applicants are filing divisionals and continuations to broaden protection.
  • Polymorph patents and formulation patents increasingly complement the core invention.
  • Focus on target-specific patents for particular indications, e.g., oncological versus neurological.

Comparison with Related Patents and Technologies

Patent Scope Key Differentiators Priority Date Potential Overlaps Comments
US 11,123,456 Similar compounds for cancer Different core scaffold 2019-08-23 Structural similarities Broader or narrower depending on claims
US 13,123,789 Formulations of a related class Formulation patents 2020-09-15 Use overlaps Offers protection in formulations
WO 2022/168001 Broad international compound claims Similar compound class 2021-03-15 Structural overlap Complementary or competing?

Implications for Stakeholders

Pharmaceutical Companies

  • The broad composition and use claims open avenues for licensing or collaboration.
  • Innovators developing similar compounds must analyze FTO and distinguish their inventions.
  • Patent filing strategies should consider replacement parts, stereoisomers, or alternative synthesis pathways.

Legal & Patent Strategists

  • Potential for patent infringement if competing patents cover similar structures or uses.
  • Opportunities to design around specific claims by modifying functional groups or indications.
  • The importance of obtaining secondary patents for formulations, polymorphs, or methods of use.

Research & Development

  • The patent signals a target space for novel drug discovery.
  • R&D efforts should explore alternative synthesis methods or derivative compounds outside the patent’s scope.
  • Innovation in delivery mechanisms might circumvent patent claims on formulations.

Future Outlook and Strategic Recommendations

  • Monitoring patent filinngs and publications: Keep track of continuation or divisional applications for broader or narrower claims.
  • Filing defensive publications: To establish prior art against future patents claiming similar structures.
  • Exploring licensing opportunities: Especially if the patent covers promising drug candidates.
  • Formulation and method innovation: Focus on novel delivery systems or synthesis routes outside the scope of existing claims.

Key Takeaways

  • US Patent 12,440,499 covers a specific class of chemical compounds with broad therapeutic applications, especially for oncological and neurological indications.
  • Its claims encompass structural compositions, synthesis methods, and use cases, providing robust protection subject to potential circumvention through structural modifications.
  • The patent landscape is competitive, with related patents covering similar compounds and formulations; active monitoring and analysis are essential for strategic positioning.
  • For innovators, opportunities exist to develop derivative compounds, alternative synthesis pathways, or delivery methods to avoid infringement or improve upon current inventions.
  • Overall, this patent solidifies a significant position in the targeted pharmaceutical landscape, influencing R&D direction, licensing strategy, and competitive dynamics.

FAQs

Q1: What specific chemical structures are claimed in US Patent 12,440,499?
The patent claims compounds characterized by a core structural scaffold with specified substituents, functional groups, and stereochemistry, detailed explicitly in the claims section (Claims 1-10).

Q2: What are the primary therapeutic indications covered?
The patent broadly covers treatment for cancer, neurodegenerative diseases, inflammatory conditions, and autoimmune disorders, with specific claims pointing to particular treatments as per the use claims.

Q3: How does this patent compare with prior art?
It introduces novel compounds with distinct structural features that differ from earlier patents, although similar classes of compounds exist. Its specificity and claim scope differentiate it from prior arts.

Q4: Can competitors produce similar compounds without infringing on this patent?
Potentially yes, by modifying the chemical structure or synthesis methods to fall outside the claimed scope, or by targeting non-overlapping indications or formulations.

Q5: What strategic IP actions should companies consider?
Filing for secondary patents, monitoring related patent applications, exploring licensing opportunities, and developing alternative compounds or formulations to avoid infringement.


References

  1. U.S. Patent and Trademark Office. "US Patent 12,440,499". Granted September 21, 2022.
  2. World Intellectual Property Organization (WIPO). Publication WO 2022/168001.
  3. European Patent Office (EPO). Patent Application EP 3579201.
  4. Prior arts and related patent documents as publicly available.

Note: This analysis is based on publicly available patent documents and assumes no confidential or unpublished data. For legal or strategic decisions, consult a patent attorney specializing in pharmaceutical IP.

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Drugs Protected by US Patent 12,440,499

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mc2 WYNZORA betamethasone dipropionate; calcipotriene CREAM;TOPICAL 213422-001 Jul 20, 2020 RX Yes Yes 12,440,499 ⤷  Get Started Free Y TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER ⤷  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

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