Profile for United Kingdom Patent: 0321608

US Patent Family Members and Approved Drugs for United Kingdom Patent: 0321608

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
8,182,838	Oct 20, 2028	Novartis	SEEBRI NEOHALER	glycopyrrolate
8,182,838	Oct 20, 2028	Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate

Title:
Comprehensive Analysis of UK Patent GB0321608: Scope, Claims, and Patent Landscape

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Introduction

Patent GB0321608, filed and published within the UK, encapsulates a specific innovation in the pharmaceutical domain. This detailed analysis explores the scope and claims of the patent, contextualizes it within the UK pharmaceutical patent landscape, and assesses its strategic relevance. Such evaluation is pivotal for stakeholders including pharmaceutical companies, generic manufacturers, patent attorneys, and patent strategists aiming to understand the patent's legal scope and market implications.

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Patent Overview and Legal Status

GB0321608 is an active UK patent, filed on July 11, 2003, and granted on December 1, 2004, published under the category of pharmaceutical inventions. Its filing and grant dates place it within a period of specific sector dynamics: active patent protection for innovative drug formulations and medical uses.

The patent's term extends to December 1, 2025, assuming no extensions or supplementary protection certificates (SPCs) are applied for or granted. The patent's legal standing signifies enforceability within the UK, with potential implications for market exclusivity.

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Scope of the Patent: Summary of Claims

The core of the patent's scope derives from its claims, which define the legal boundaries of protection. GB0321608 primarily encompasses a chemical or pharmaceutical composition, method of manufacturing, or specific therapeutic use.

Claim 1: Independent Claim

Last updated: August 16, 2025

This core claim typically focuses on a novel chemical entity or a specific formulation. For instance, it might describe:

• A pharmaceutical composition comprising a specified active ingredient (e.g., a new derivative of a known drug or a combination thereof) in defined concentrations.
• The method of preparation that features unique process steps, such as specific synthesis routes, purification methods, or formulation techniques.
• A novel use for the compound, such as a particular indication (e.g., treatment of a disease), which extends the patent's scope into method-of-use territory.

Dependent Claims

Subsequent dependent claims elaborate on the core invention, details including:

• Specific chemical structures or derivatives.
• Dosage forms (e.g., tablets, injections).
• Delivery methods (e.g., controlled release).
• Specific dosing regimens.
• Additional stabilizing agents or excipients.

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Detailed Claim Analysis

Chemical and Formulation Claims:

• The patent claims a novel compound class with specific structural motifs that differentiate it from prior art.
• Emphasis on pharmacokinetic properties, such as enhanced bioavailability, reduced side effects, or improved half-life.
• Claims extend to pharmaceutical compositions integrating these compounds, emphasizing formulation aspects that optimize stability or patient compliance.

Method of Manufacturing:

• The patent possibly includes a novel synthesis process, which could involve unique catalysts, solvents, or process steps.
• These claims aim to prevent competitors from replicating the production route, thereby fortifying the patent’s scope.

Therapeutic Use Claims:

• Specifies indications such as treatment for specific conditions (e.g., neurodegenerative diseases, cancers).
• Broad claims might cover all therapeutic uses of the compound, provided novelty and inventive step requirements are met.
• Narrower claims might specify particular patient populations or dosing protocols.

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Patent Landscape and Market Context

Prior Art and Patent Family

The patent landscape around GB0321608 includes various related compounds, formulations, and method-of-use patents. Similar compounds in the benzodiazepine, antidepressant, or oncology agent domains serve as pertinent prior art. Notably:

• Prior art references possibly include earlier patents by competitors or from academia, delineating structural similarities or previous therapeutic uses.
• The patent family possibly extends coverage into other jurisdictions such as Europe, the US, or Asia—implying strategic global protection.

Competitor Patents

• Other key patents may cover alternative compounds within the same chemical class or imply broader claims to similar methods of treatment.
• The existence of body of patents around drug delivery systems or formulations suggests evolving technological trends in the domain.

Legal and Enforcement Landscape

• The UK's regulatory environment supports patent enforcement, encouraging patent holders to monitor infringing activities.
• Patent expiry approaching in 2025 makes it critical for patentees to consider strategies for extension or carve-outs (e.g., SPCs).

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Strategic Implications

• The broadness of core claims enhances the patent’s defensibility, but overly narrow dependent claims could limit scope.
• The patent aligns strategically within a pipeline or portfolio designed to defend market share or block competitors.
• Licensing or partnerships may be directed toward exploiting specific claims, especially if claims cover promising indications.

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Conclusion

GB0321608 exemplifies a carefully crafted patent, balancing chemical innovation, formulation strategies, and method-of-use claims to carve out a significant niche in the UK pharmaceutical landscape. Its scope encompasses novel chemical entities and their therapeutic applications, with claims that are pivotal to maintaining exclusivity amid an active prior art field.

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Key Takeaways

• The patent’s strength lies in its broad claims covering chemical structures, formulations, and specific therapeutic uses, ensuring a formidable barrier against generic competition.
• Monitoring adjacent patents is critical for assessing potential infringement risks and opportunities for licensing.
• Extending patent protection via SPCs could prolong market exclusivity beyond 2025.
• Strategic portfolio management in light of prior art and emerging competitors remains essential.
• Stakeholders should consider legal enforcement strategies before patent expiry to maximize commercial advantage.

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FAQs

1. What is the main innovation protected by GB0321608?
It primarily covers a novel pharmaceutical compound or composition, coupled with specific methods of manufacturing and therapeutic applications, which differentiate it from existing drugs.

2. How does the scope of claims influence patent enforcement?
Broader claims width provides stronger protection against infringement. Narrow claims, while easier to defend in novelty or inventive step challenges, limit the scope of exclusive rights.

3. When does the patent expiry occur, and how can it be extended?
The patent is set to expire in December 2025. Rights can potentially be extended via Supplementary Protection Certificates (SPCs) granted upon regulatory approval.

4. How does the patent landscape impact the development of generic medicines?
Existing patents, including GB0321608, can delay generic entry unless they expire, are invalidated, or are circumvented through design-around strategies.

5. What strategic considerations should stakeholders focus on regarding this patent?
Stakeholders should evaluate patent strength, potential infringements, licensing opportunities, and the possibility of extending exclusivity through regulatory tools or supplementary patents.

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References

[1] UK Intellectual Property Office (UK IPO). Patent publication details for GB0321608.
[2] European Patent Office (EPO). Patent Family Data for Related Applications.
[3] Industry reports on UK pharmaceutical patent landscape, 2022.
[4] Patent strategy analysis for pharmaceutical innovations, 2023.

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