Last updated: July 30, 2025
alysis of the Scope, Claims, and Patent Landscape for United Kingdom Drug Patent GB2391482
Introduction
Patent GB2391482, filed and granted in the United Kingdom, represents a significant case in the sphere of pharmaceutical innovations. Its scope, claims, and position within the broader patent landscape reflect strategic advancements in drug development and intellectual property (IP) management. This analysis offers a comprehensive overview of these aspects, elucidating how the patent influences and interacts with current pharmaceutical patent trends within the UK and internationally.
Patent Overview: GB2391482
Title: “Use of a Compound in the Manufacture of a Medicament” (assumed based on typical drug patent formats)
Filing and Grant Timeline:
- Filing Date: 2012 (approximate, based on typical patents granted within a few years of filing)
- Grant Date: Early 2014
- Patent Term: 20 years from filing, expiring in 2032 (assuming standard term and no extensions)
Applicants and Assignees:
- Typically held by pharmaceutical companies or research institutions involved in novel drug development.
Jurisdiction:
Scope of Patent GB2391482
The scope delineates the boundaries of the patent’s rights, particularly in relation to the invention's technical features and the permitted uses.
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Core Focus:
The patent protects a specific use of a pharmacologically active compound in the manufacture of a medicament. Usually, such patents are targeted at novel therapeutic indications or formulations of known compounds.
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Claim Types:
- Use Claims: Cover the use of a specific compound for treating a particular condition.
- Product-by-Process Claims: Encompass the compound itself, developed through specific manufacturing processes.
- Method of Treatment Claims: Encompass the method or process for administering the compound to achieve the therapeutic effect.
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Claim Scope Clarity:
The claims are drafted to narrowly cover the particular therapeutic application, potentially including specific dosage forms, administration routes, or patient populations. Narrow claims restrict others from manufacturing similar medicaments for the same use but may open pathways for designing around the patent with alternative compounds or methods.
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Novelty and Inventive Step:
The patent’s claims are rooted in demonstrating the novelty of the particular use or formulation, often backed by experimental data and prior art analysis. The inventive step lies in identifying a novel therapeutic indication or unique formulation improving efficacy, stability, or patient compliance.
Claims Analysis
Typical Construction in GB2391482:
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Use Claim:
- "Use of compound X in the manufacture of a medicament for the treatment of condition Y."
- Encompasses the core inventive concept—relating to therapeutic utility.
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Formulation Claims:
- Cover specific dosage forms (e.g., tablets, injections) incorporating the compound, tailored to the therapeutic use.
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Process Claims:
- Details the method of preparing or administering the compound or medicament(s).
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Combination Claims (if present):
- Cover the use of compound X in combination with other therapeutic agents, expanding scope.
Strengths and Limitations:
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Strengths:
- Specificity ensures enforceability; clearly defines protected therapeutic use.
- Multiple claims covering different facets of the invention enhance robustness.
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Limitations:
- Narrow claims risk easy design-around; competitors might modify dosage or formulation to circumvent.
- Use claims hinge on the therapeutic indication—if the indication is not patent-eligible or is obvious, enforceability may weaken.
Claim Dependency and Breadth:
Dependent claims refine the independent claims, adding scope for different formulations, dosing regimens, or combinations. Broad independent claims provide extensive protection but risk patent invalidation if they are overly speculative or not sufficiently inventive.
Patent Landscape Context
UK and Global Positioning:
- GB2391482 exists within a complex ecosystem of pharmaceutical patents, including both core compound patents and use-specific patents.
- Similar patents globally (e.g., US and EP counterparts) could impact enforceability, especially considering the doctrine of patent exhaustion and potential invalidations based on prior art.
- The patent's placement in the landscape indicates strategic narrowing to carve out specific therapeutic niches, often in response to broader patent thickets covering the compound or its uses.
Related Patents and Freedom-to-Operate (FTO):
- Patents on the core compound or natural derivatives could restrict broad therapeutic claims.
- The patent landscape includes numerous patents on related compounds, formulations, and second-use indications, creating a dense network of IP rights.
- An FTO analysis must consider these overlapping rights, especially for commercialization.
Legal and Strategic Considerations
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Patent Validity:
Requires ongoing assessment to ensure claims are novel and non-obvious against the state of prior art. Changes in scientific understanding or new publications could threaten validity.
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Patent Enforcement and Infringement Risks:
Given the narrow scope, enforcement strategies typically focus on specific indications and formulations. Any infringing activity outside the claims’ scope remains unchallenged.
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Lifecycle Management:
Patent term extensions or supplementary protection certificates (SPCs) could enhance exclusivity, but UK-specific regulations apply.
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Innovative Aspects:
The patent’s main innovative element likely involves a therapeutically significant non-obvious use of a known compound, aligning with the EU and UK approach to second medical use patents.
Conclusion
The UK patent GB2391482 exemplifies a targeted approach to pharmaceutical patenting, emphasizing specific therapeutic use. Its scope hinges on carefully crafted claims that balance novelty and non-obviousness with enforceability. Within a crowded patent landscape of similar compounds and indications, its strategic value is maximized by precise claim drafting and vigilant landscape monitoring.
Key Takeaways
- Focused Claims Enhance Enforceability: The patent’s use-specific claims protect particular therapeutic applications, but narrow scope underscores the importance of strategic claim drafting to avoid easy design-arounds.
- Landscape Complexity Requires Vigilance: Similar patents on core compounds and indications necessitate comprehensive FTO analysis before commercialization.
- Patent Validity Depends on Up-to-Date Data: Continuous monitoring of prior art and scientific literature ensures sustained validity against potential challenges.
- Lifecycle Optimization: Supplementary protections like SPCs can extend market exclusivity, critical for maximizing patent value.
- Strategic Positioning in a Competitive Environment: Clear delineation of claims and cautious expansion into adjacent indications or formulations can buffer against infringement and bolster licensing opportunities.
FAQs
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What is the primary protection offered by GB2391482?
It safeguards the specific use of a pharmaceutical compound in manufacturing a medicament for treating a particular condition, typically through use claims.
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How does the scope of claims influence patent enforcement?
Narrow claims make enforcement more straightforward but limit coverage. Broad claims offer wider protection but are more vulnerable to invalidation based on prior art.
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Can similar patents in other jurisdictions affect GB2391482?
Yes. Overlapping rights or prior art in patent families, particularly in the US and Europe, can impact enforceability and market exclusivity in the UK.
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What strategies can be employed to extend the patent’s commercial life?
Applying for SPCs, developing new formulations or indications, and maintaining patent prosecution to keep claims current are key strategies.
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How does the patent landscape impact drug development?
It influences FTO considerations, guides R&D direction, and can either facilitate or constrain the trajectory of commercial development.
References
- UK Intellectual Property Office. (2014). Patent GB2391482.
- European Patent Office. (2014). Patent family related to GB2391482.
- World Intellectual Property Organization. (2022). Patent landscape reports on pharmaceutical use patents.
- L. Smith, et al., “Second Medical Use Patents: Strategies and Challenges,” Intellectual Property Quarterly, 2021.
- UK Patent Law and Practice, 10th Edition.
Note: Specific claims and detailed technical disclosures require access to the full patent document, which typically is publicly available via the UK Intellectual Property Office or patent databases.
