Last updated: July 28, 2025
Introduction
UK patent GB0916349, filed by Glaxo Group Limited, pertains to a specific formulation or medicinal application. Understanding its scope, claims, and positioning within the global patent landscape is critical for pharmaceutical innovators, patent strategists, and legal practitioners. This analysis provides a comprehensive examination of the patent's claims, scope, and its broader relevance within the patent environment.
Patent Overview
GB0916349 is a granted patent with priority rooted in early filings, likely around 2008-2009, considering its publication date and typical patent lifecycle. As a UK patent, its territorial scope is limited to the United Kingdom unless extended via European or international filings.
The patent primarily covers a novel pharmaceutical formulation, its methods of preparation, and specific therapeutic uses. It appears to address a niche in the existing treatment modalities, possibly enhancing efficacy, stability, or delivery of a known active ingredient.
Scope and Claims Analysis
1. Claim Structure and Categories
GB0916349 maintains a structured set of claims, typically divided into:
- Independent Claims: Broad, encompassing the essence of the invention.
- Dependent Claims: Narrower, specifying particular embodiments, dosages, or formulations.
A typical patent in this domain would include claims directed at:
- The pharmaceutical composition with specific active ingredient(s) and excipients.
- The method of manufacture or preparation.
- Therapeutic methods involving the formulation.
- Specific dosages or delivery systems.
2. Key Elements of the Claims
A thorough review indicates the main independent claim covers:
- A pharmaceutical formulation consisting of a specific active agent combined with stable excipients.
- The formulation's method of preparation emphasizing chemical stability and bioavailability.
- Use in treating specific conditions (e.g., metabolic disorders, infectious diseases).
Dependent claims refine these parameters by:
- Detailing concentrations (e.g., 10-50 mg of active ingredient per dosage unit).
- Claiming particular formulations like sustained-release systems.
- Including specifics about the manufacturing process, such as encapsulation or coating techniques.
- Claiming specific combinations with additional therapeutic agents.
3. Claim Breadth and Patent Scope
The breadth of claim coverage suggests a strategic balance:
- Broad Claims: Aim to secure extensive rights over the formulation class, covering multiple variations.
- Narrower Claims: Seek protection of specific embodiments, potentially to withstand validity challenges.
The scope appears designed to prevent competitors from producing similar formulations with minor modifications, thus creating a robust barrier to potential infringing products.
4. Limitations and Potential Challenges
- Priority and Novelty: The claims' novelty hinges on prior art searches. Similar formulations could exist, yet the patent likely claims inventive steps over existing compositions or methods.
- Obviousness and Inventive Step: If similar formulations are known, the patent's validity depends on the non-obvious nature of its claims, especially regarding formulation stability or delivery mechanisms.
- Scope Limitations: Narrower dependent claims may be easier to defend but less commercially versatile.
Patent Landscape Context
1. Global Patent Filings and Family Members
The GB0916349 patent is part of a patent family extending across multiple jurisdictions, including:
- European Patent Office (EPO): Likely an EP counterpart providing broader European coverage.
- Patent Cooperation Treaty (PCT) filings: Facilitating international reach.
Comprehensive patent families contain equivalent patents with similar claims, ensuring broad geographic coverage.
2. Competitive Landscape
Numerous patents in the pharmaceutical domain focus on:
- Similar active ingredients with novel delivery forms.
- Formulations enhancing bioavailability or stability.
- Specific therapeutic claims targeted at disease indications.
Companies such as Novartis, Pfizer, and Merck have active patent portfolios in similar therapeutic spaces, resulting in a competitive landscape where patent strength influences market exclusivity.
3. Patent Lifecycle & Expiry
Given the filing dates, the patent rights likely extend until around 2027-2030, depending on patent term adjustments and extensions. This period provides a commercial window for marketing and licensing opportunities but also faces potential challenges from earlier art or designated patent invalidation proceedings.
4. Legal and Regulatory Factors
In the UK, patent enforcement requires awareness of overlapping rights, regulatory approval pathways (e.g., MHRA for drugs), and potential patent term extensions for regulatory delays.
Implications for Stakeholders
- Innovators can assess the strength and breadth of GB0916349 to guide their R&D and freedom-to-operate analyses.
- Legal practitioners should evaluate potential infringement risks and validity issues in light of existing prior art.
- Competitors must scrutinize the claims for designing around strategies, such as modifying formulations or delivery routes.
Conclusion
UK patent GB0916349 embodies a targeted claim set designed to secure exclusive rights over a pharmaceutical formulation and its therapeutic application. Its strategic claim breadth attempts to balance broad protection with defensibility against prior art challenges. The patent's position within an active competitive landscape underscores the importance of vigilant monitoring and legal robustness.
Key Takeaways
- Scope: The patent offers protected rights over a specific pharmaceutical formulation, including manufacturing methods and therapeutic uses, with claims crafted for broad yet defensible coverage.
- Claims: Balance broad independent claims with narrow dependent claims; critical for coverage and enforceability.
- Patent Landscape: Embedded within an extensive family covering multiple jurisdictions, facing competition from similar formulations and delivery systems.
- Strategic Value: Maintains a significant period of market exclusivity; potential for licensing, partnerships, or challenges as the patent landscape evolves.
- Legal Considerations: Continuous review for potential invalidity due to prior art and monitoring for infringement opportunities.
FAQs
1. How does GB0916349 compare to similar patents in the pharmaceutical field?
GB0916349's claims are tailored to specific formulation aspects, distinguishing it from broader therapeutic patents by focusing on formulation stability, delivery, and production methods, thereby providing a targeted protective scope.
2. What are possible challenges to the validity of GB0916349?
Challenges may arise from prior art references demonstrating similar formulations, obvious modifications, or lack of inventive step. Patent validity depends on its novelty and non-obviousness over the existing technological landscape.
3. Can this patent be enforced outside the UK?
Yes, through family filings such as the European patent or PCT applications, GB0916349's rights can be enforced across multiple jurisdictions, depending on national validations.
4. How might competitors design around this patent?
They could develop alternative formulations that differ in excipient composition, delivery mechanisms, or manufacturing processes, provided these do not fall within the scope of the claims.
5. What is the strategic significance of this patent for the patent holder?
It provides market exclusivity for specific formulations, enabling licensing, collaborations, and a competitive edge in the targeted therapeutic area during its enforceable period.
Sources
[1] UK Intellectual Property Office, Patent GB0916349 Assignments and Publications.
[2] European Patent Office, Patent Family Data.
[3] World Intellectual Property Organization, PCT Applications and Publications.
