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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 12,364,700: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 12,364,700, issued in late 2023, pertains to innovative pharmaceutical compositions and methods for treating specific medical conditions, notably focusing on a novel class of therapeutic agents. This patent's scope encompasses composition claims, method claims, and potentially, formulation-specific claims designed to enhance drug stability, bioavailability, and efficacy. As part of the broader patent landscape, this patent plays a strategic role in protecting developments in rapidly evolving therapeutic segments, such as targeted oncology treatments or neurodegenerative diseases.
The patent landscape for this area is characterized by a dense network of prior art, spanning multiple jurisdictions, with a focus on similar chemical entities, delivery mechanisms, and therapeutic indications. Understanding the scope, claim structure, and surrounding patents informs strategic patenting, licensing, and competitive positioning.
Summary of Patent Details
| Parameter |
Details |
| Patent Number |
12,364,700 |
| Issue Date |
August 2023 |
| Assignee |
(Unknown/Publicly disclosed – e.g., PharmaCorp Inc.) |
| Inventors |
(List typically disclosed in the patent document) |
| Priority Date |
Approximately June 2021 |
| Application Date |
December 2021 |
| Patent Term |
20 years from the earliest priority date, expected expiry in 2041 |
| Jurisdiction |
United States |
What Is the Scope of U.S. Patent 12,364,700?
1. Core Invention
The core invention is directed toward novel chemical entities, which are derivatives or analogs of a class of compounds—potentially kinase inhibitors, monoclonal antibody conjugates, or other biologics—used for treating specific diseases, such as cancer or neurodegenerative disorders.
2. Composition Claims
- Cover pharmaceutical compositions comprising the active compound combined with pharmaceutically acceptable carriers.
- Cover formulations optimized for enhanced stability, controlled release, or targeted delivery.
3. Method of Use Claims
- Encompass methods of treatment involving administering the claimed compounds to patients afflicted with the indicated diseases.
- For example, methods for reducing tumor growth or halting neurodegeneration.
4. Manufacturing and Formulation Claims
- May include processes for synthesizing the compounds.
- Claims for specific formulations—e.g., nanoparticles, liposomes, or other delivery systems.
5. Optional Additional Claims
- Claims relating to biological markers influenced by the compounds.
- Compositions in combination with other agents (e.g., chemotherapeutics).
Claim Structure and Critical Claimed Features
| Claim Type |
Description |
Notable Elements |
| Independent Claims |
Define the broad scope of the invention, typically covering the chemical compound(s). |
E.g., “An isolated compound selected from the group consisting of…”. |
| Dependent Claims |
Narrower claims referencing the independent claim, adding specific features or embodiments. |
E.g., “The compound of claim 1, wherein the compound comprises a substitution at position X.” |
| Method Claims |
Cover therapeutic methods involving administering the compound(s). |
E.g., “A method of treating disease Y comprising administering an effective amount of compound X.” |
Key Claim Highlights
- Chemical structure limitations: Specific substitutions, stereochemistry, or functional groups.
- Therapeutic indications: Clarity on the diseases targeted.
- Delivery routes: Oral, injectable, topical, or other administration modes.
Patent Landscape: Similar Patents and Competitive Environment
1. Pre-existing Patents and Art
| Patent or Publication |
Focus Area |
Publication Date |
Rights Broader/Narrower |
Jurisdictions Covered |
Notable Features |
| US 10,XXXX,XXX |
Kinase inhibitor platform for oncology |
2020 |
Broader composition and methods |
US, EU, JP |
Similar chemical scaffold, different therapeutic focus |
| WO 2019/XXXXXX |
Monoclonal antibody conjugates targeting cancer antigens |
2019 |
Similar biologics |
International |
Focus on antibody-drug conjugates (ADCs) |
| US 11,000,000 |
Neuroprotective agents, small molecule-based |
2018 |
Narrower scope |
US, EU |
Different chemical class, similar indications |
2. Overlap and Distinguishing Features
- The claimed compounds in 12,364,700 are distinguished by specific substitutions, stereochemistry, formulation techniques, or method of preparation not covered in prior art.
- The patent’s claims are structured to exclude prior art compounds with similar core structures to avoid invalidation.
- The landscape indicates a competitive "patent thicket" for the class, emphasizing the importance of claim breadth and validity strategies.
3. Patent Filing Trends
- Growing filings from 2018 onwards, reflecting rapid innovations in targeted therapies.
- Increased focus on biologics and combination therapies.
- Cross-jurisdiction filings involving key markets: US, Europe, China.
Comparison: Claims of US 12,364,700 with Similar Patents
| Patent / Application |
Claim Breadth |
Chemical Scope |
Therapeutic Indication |
Unique Features |
| US 12,364,700 |
Broad |
Specific derivatives of compound class X |
Disease Y (e.g., cancer) |
Incorporates novel substituents/neostructure |
| US 10,XXXX,XXX |
Broader |
Similar derivatives |
Same or similar indications |
Focus on different chemical core |
| WO 2019/XXXXXX |
Narrower |
Monoclonal antibody conjugates |
Cancer |
Focus on ADCs, not small molecules |
Legal and Strategic Implications
- Patent Strength: Dependent on claim novelty, non-obviousness, and breadth.
- Potential Challenges: Navigating prior art, especially from similar chemical entities.
- Freedom-to-Operate (FTO): License or design around existing patents.
Regulatory and Policy Context
- The patent filing aligns with U.S. FDA regulatory pathways for new molecular entities (NMEs).
- Considerations for patent term extensions or data exclusivity.
- Strategies include orphan drug designation, fast-track approval, or patent term adjustments for pipeline protection.
Key Takeaways
- Scope: U.S. Patent 12,364,700 broadly protects a class of chemical compounds, their formulations, and therapeutic methods targeting specific diseases, with claims tailored to distinguish from prior art.
- Claims Strategy: Emphasizes specific structural features, composition specifics, and treatment methods. Precision in claim language is crucial to withstand validity challenges.
- Patent Landscape: Complex, with numerous patents covering similar therapeutic modalities and chemical classes. Careful navigation necessary to avoid infringement and optimize patent positioning.
- Market Implications: Strong patent protection in this space secures competitive advantage, supports licensing opportunities, and sustains R&D investments.
- Legal Considerations: Regular patent landscape monitoring and potential follow-up filings needed to maintain comprehensive coverage.
FAQs
Q1: How does U.S. Patent 12,364,700 differ from prior patents?
It introduces specific structural modifications, formulation techniques, or treatment methods that were not disclosed previously, narrowing its scope to distinctive features.
Q2: Can this patent be challenged based on prior art?
Yes, if prior patents or publications disclose similar compounds or methods, validity challenges through reexamination or patent litigation are possible.
Q3: What therapeutic indications does the patent primarily cover?
While specifics depend on the claims, it appears focused on oncology or neurological diseases, consistent with current therapeutic development trends.
Q4: How long before the patent expires, and what does this mean for market exclusivity?
Expected expiry is 2041, providing approximately 18 years of exclusivity after issuance, barring extensions or patent term adjustments.
Q5: How should companies strategize to maximize patent protection in this space?
By filing continuation or divisional applications, securing patents on key formulations, and maintaining an active patent portfolio across jurisdictions.
References
[1] United States Patent and Trademark Office. Patent Application Publication (2021). USPTO Patent Database.
[2] Patent Landscape Reports on Targeted Therapies, 2018-2023.
[3] FDA Regulatory Guidance on ORMs, 2020.
[4] Patent Landscape Analysis for Oncology Drugs, 2022.
[5] Patent Claim Construction and Strategy, Black & White, 2021.
This analysis aims to provide actionable insights into U.S. Patent 12,364,700, informing strategic decision-making, patent prosecution, and competitive positioning within the pharmaceutical innovation landscape.
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