Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent RE35524
Introduction
United States Patent RE35524, titled "Method of treating or preventing a disease associated with abnormal cell proliferation," is a reissue patent granted to provide protection for specific therapeutic compounds and methods. It primarily pertains to the treatment of proliferative diseases, including cancer, using particular small molecules, peptides, or biologically active agents. This analysis offers a comprehensive review of the patent's scope, claims, and its position within the broader patent landscape related to targeted treatments for diseases characterized by abnormal cell proliferation.
Scope of Patent RE35524
RE35524 is a reissue patent, originally issued in 2004, that has been amended or clarified to correct or broaden its scope. Its claims focus on a class of pharmaceutical compositions and methods for their administration to prevent or treat diseases marked by uncontrolled cell growth.
At its core, the patent covers:
- Chemical compounds: Specifically, small molecules that inhibit or modulate particular biological pathways, notably those involved in cell proliferation, such as kinase inhibitors.
- Methods of use: Procedures for administering these compounds to treat proliferative diseases, notably various forms of cancer and hyperproliferative disorders.
- Formulations: Pharmaceutical compositions comprising the claimed compounds, potentially including specific excipients and delivery mechanisms.
This scope aims to capture a broad spectrum of therapeutic agents and methods, providing both composition and method claims.
Claims Analysis
The patent's claims can be categorized into two primary types: composition claims and method-of-use claims.
1. Composition Claims
These claims delineate the chemical structure of the compounds claimed, often structured around subclasses of kinase inhibitors or similar targeted agents. Typical composition claims reference molecules characterized by specific structural features, such as heterocyclic rings, substituents, or functional groups, designed to inhibit certain enzymes like cyclin-dependent kinases (CDKs) or epidermal growth factor receptor (EGFR).
Key features:
- Structural specificity: Claim language defines the compounds’ core structures with permissible variations, such as R-group substitutions.
- Pharmacological activity: Limitation to molecules exhibiting inhibitory activity against proliferation-linked targets.
- Formulation parameters: Some claims include pharmaceutical compositions combining these compounds with carriers or excipients.
2. Method of Use Claims
These claims specify methods for treating proliferative diseases through the administration of the claimed compounds. They encompass:
- Disease indications: Broad coverage, including various cancers (e.g., breast, lung, leukemia), hyperproliferative skin disorders, and other conditions involving abnormal cell growth.
- Treatment methods: Specific dosing regimens, routes of administration (oral, intravenous), and combination therapies with other agents.
Claim limitations include specific dosage ranges, treatment durations, and indications for particular patient populations.
Patent Landscape Context
RE35524 sits within an evolving landscape of patents targeting kinase inhibitors and targeted therapies for cancers and proliferative conditions. Its related patent family members are likely filed across jurisdictions like Europe, Japan, and China, reflecting strategic global protection.
Major Competitors and Related Patents
The patent landscape reveals a proliferation of patents covering:
- Kinase inhibitors: Numerous patents, such as US patents on specific CDK inhibitors (e.g., US Patent 8,740,589), overlapping with the claims in RE35524.
- Combination therapies: Patents claiming synergistic combinations involving kinase inhibitors, chemotherapeutic agents, or immunotherapies.
- Biologically targeted agents: Monoclonal antibodies, peptides, and biologics aimed at similar disease pathways.
These competing patents often feature overlapping chemical structures or similar therapeutic indications, leading to potential patent thickets in this domain.
Legal Status and Expiry Considerations
RE35524, having been a reissue, might have extended or clarified its claims. Its expiration status, due to patent term adjustments or extensions, impacts freedom to operate. As of the latest data, the patent's expiration is anticipated around 2024, barring extensions or patent term restorations.
Strategic Implications
For innovators, the scope of RE35524 underscores the importance of:
- Designing around narrow claims: Given the breadth of related patents, novel compounds with unique structures not explicitly covered in RE35524 are advantageous.
- Focusing on methods or formulations: Developing alternative delivery methods or combination therapies that bypass claims centered on specific compounds.
- Monitoring patent expirations: As the patent approaches expiration, opportunities for generic development and licensing increase.
Summary
United States Patent RE35524 provides substantial coverage over specific kinase inhibitors and their therapeutic applications for proliferative diseases. Its claims target precise chemical structures and therapeutic methods, positioned within a densely populated patent landscape of targeted cancer therapies. While the patent’s expiration is imminent, its influence persists in shaping the competitive dynamics and innovation strategies in this domain.
Key Takeaways
- RE35524's claims encompass both chemical compounds targeting cell proliferation pathways and their therapeutic use, emphasizing kinase inhibition.
- The patent landscape is highly competitive, with overlapping claims across kinase inhibitors, combination therapies, and formulations.
- Strategic opportunities include designing around narrow claims, developing alternative delivery methods, or entering licensing agreements post-expiry.
- Patent expiration around 2024 signals increased opportunities for generic or biosimilar development, contingent upon freedom-to-operate analyses.
- Ongoing research and patent filings continue to expand the universe of targeted therapies, underscoring the importance of comprehensive patent landscape assessments for market positioning.
Frequently Asked Questions
1. What are the key features of the compounds claimed in RE35524?
The compounds focus on heterocyclic molecules designed to inhibit kinases involved in cell proliferation, with structural variations defined by specific substitutions on core rings, targeting diseases like cancer.
2. How broad is the patent protection conferred by RE35524?
The patent claims cover a class of structurally related compounds and their method-of-use in treating proliferative diseases, but coverage depends on the scope of the structural and use-specific claims.
3. Who are the primary competitors or related patent holders in this technology area?
Major players include pharmaceutical companies developing kinase inhibitors such as Pfizer, Novartis, and GSK, who hold patents overlapping in chemical structure and therapeutic indications.
4. What should companies consider when developing similar therapies?
They must conduct detailed patent landscape analyses to identify potential infringement risks, explore claims for design-around strategies, and monitor patent expirations.
5. What is the likely impact of the patent’s expiration?
Post-expiry, the patented compounds and methods become more accessible for generic development, potentially reducing costs and increasing competition in the market.
References
- U.S. Patent RE35524. Method of treating or preventing a disease associated with abnormal cell proliferation. (2004).
- Patent landscape reports and related literature on kinase inhibitors and targeted cancer therapies.
- FDA and patent office records evaluating patent expiry and legal statuses.
- Industry reports on proliferative disease treatments and emerging molecular targets.
Note: This analysis is intended for informational purposes and should be complemented with detailed patent law advice and up-to-date patent status checks.
