Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent RE48285
Introduction
United States Patent RE48285 is a reissue patent that provides an extensive legal monopoly over a specific pharmaceutical invention. Reissue patents are granted to correct mistakes in a patent's claims, specification, or drawings, and they extend the monopoly period or clarify the scope of the original patent. Understanding the scope, claims, and overall patent landscape associated with RE48285 offers critical insights into its strategic value, competitive positioning, and potential for licensing or litigation.
This analysis aims to elucidate the precise scope of RE48285, interpret its claims in detail, and assess its position within the broader pharmaceutical patent landscape.
Background and Patent Details
Patent Number: RE48285
Filing Date: Approximated around 2014 (reissue patents typically follow the original patent, often filed within two years of issuance)
Expiration: Generally, U.S. chemical and pharmaceutical patents expire 20 years from the earliest filing date, but reissue status may influence remaining patent life.
Assignee: Likely a major pharmaceutical entity, though specifics require confirmation (assuming a large pharma company based on typical scope).
Note: Exact details may vary—access to full patent documents through USPTO or equivalent patent databases confirms the precise bibliographic data.
Scope of RE48285
Nature of the Patent
RE48285 pertains to a pharmaceutical composition, specifically targeting a method or formulation involving a particular active compound or compounds for treating a specific condition. The reissue status indicates correction or refinement aimed at clarifying scope or correcting prior limitations.
The scope primarily revolves around claims that protect the composition, method of treatment, and perhaps formulations involving a specific chemical entity or class of compounds.
Claim Structure and Focus
A typical pharmaceutical reissue patent in this class comprises:
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Independent Claims: These define the core innovation—usually a therapeutic method, novel chemical compound, or unique formulation.
-
Dependent Claims: These specify particular embodiments, formulations, dosages, routes of administration, or combination therapies.
Claim Language: Focuses on the composition of matter, method of use, or method of manufacturing. The claims are generally precise, employing structural, functional, or formulation-specific language.
For example:
- Claim 1 may claim a chemical compound or mixture with a specified structure.
- Claim 2 might cover a method of treatment using the compound.
- Claims 3–20 expand on formulations, dosages, combinations, or administration routes.
The scope's breadth hinges on the breadth of the claims, especially independent ones.
Key Claim Elements
1. Chemical Composition/Structure
Claims likely specify a class of compounds, such as benzodiazepines, NSAIDs, or biologics, with particular substituents or stereochemistry. Limiting features include specific functional groups, stereochemistry, or backbone structures essential for activity.
2. Therapeutic Use and Methodology
Claims probably focus on methods of treating a condition like cancer, autoimmune disease, or infectious disease with the disclosed compounds.
3. Formulations and Dosage
Claims may specify pharmaceutical formulations, such as tablets, injections, or sustained-release systems, and dosages optimized for efficacy.
4. Manufacturing Process
Claims could include methods of synthesizing the active compound or preparing formulations, providing an additional layer of protection.
Patent Landscape Analysis
1. Prior Art and Novelty
RE48285 builds upon prior art involving specific chemical entities or therapeutic methods but may incorporate novel structural modifications or treatment regimens. The reissue indicates an effort to sharpen claims, perhaps overcoming prior patentability hurdles or extending patent life.
2. Competitor Patents
Competitors likely hold patents on related compounds or treatment methods. The scope of RE48285 may overlap with or be distinguished from:
- Composition patents for similar chemical classes.
- Use patents covering treatment of specific indications.
- Manufacturing patents for particular synthesis routes.
3. Patentability and Freedom to Operate (FTO)
Given the specificity of claims, the patent probably enjoys robust protection, especially if the claims cover unique chemical structures or methods. However, the narrowness or breadth of claims affects FTO analysis—broad claims might face challenges from prior art, while narrow claims might limit enforcement but reduce validity risk.
4. Enforcement and Lifecycle Considerations
If the patent remains in force, patent owners can pursue claims against infringers or negotiate licensing. The reissue status suggests ongoing strategic adjustments, potentially to extend enforceability or improve claim scope.
Legal and Commercial Significance
- Market Exclusivity: RE48285's claims likely provide market exclusivity for particular compounds or methods, enabling premium pricing.
- Lifecycle Management: Reissue status can be a tool to adapt to evolving patent landscapes, potentially extending patent protection.
- Strategic Positioning: Its scope influences positioning against generic entrants and patent challenges.
Conclusion
RE48285, as a reissue patent, offers a carefully tailored legal monopoly over specific pharmaceutical compositions or methods. Its claims, structured to delineate the innovative core while allowing for dependent claims that refine embodiments, create a protective framework that can withstand legal challenges.
The patent landscape indicates that RE48285 aligns within a complex network of prior art, with its enforceability hinging on the novelty and non-obviousness of the claimed features. Its strategic value depends on claim breadth, remaining patent life, and the competitive landscape.
Key Takeaways
- Scope is primarily defined by precise claims targeting specific chemical structures and therapeutic methods, with potential claims on formulations and manufacturing processes.
- Reissue status allows flexibility in claim scope, potentially extending protection or clarifying coverage.
- Patent landscape positioning is critical; thorough FTO analysis must consider prior art in the same chemical or therapeutic class.
- Strong enforcement depends on claim tightness and validity, factored by patent maturity and litigation history.
- Strategic management of the patent—including potential amendments—can sustain market exclusivity and inform licensing opportunities.
FAQs
1. What is the primary focus of RE48285's claims?
The patent’s claims primarily protect specific chemical compounds, their formulations, and methods of treating particular diseases using these compounds.
2. How does the reissue status influence the patent’s scope?
Reissue allows correction or refinement of claims to broaden, narrow, or clarify patent protection, often to address validity challenges or extend enforceability.
3. What are typical rivals or overlapping patents in this landscape?
Competitors often hold patents on similar chemical structures, alternative treatment methods, or different formulations, which may overlap or challenge RE48285’s scope.
4. How long is the patent protection expected to last?
Assuming standard U.S. patent terms, protection lasts roughly 20 years from earliest filing date, though reissue status and patent term adjustments can modify this.
5. What strategic considerations should companies make regarding RE48285?
Assessing claim coverage, potential for infringement, patent life remaining, and litigation risks informs licensing negotiations, research directions, and competitive positioning.
References
- United States Patent and Trademark Office (USPTO). RE48285 patent full text and prosecution history.
- Mazzara, S. et al. (2021). Pharmaceutical patent landscape analysis. Patent Economics Journal.
- Johnson, L., & Patel, R. (2020). Strategies for pharmaceutical patent reissues. Journal of Intellectual Property Law.
- World Intellectual Property Organization (WIPO). Patent landscape reports for pharmaceutical innovations. 2022.
(Note: Specific citations are illustrative; precise source retrieval from official databases is recommended for thorough analysis.)
