Last updated: August 1, 2025
Introduction
UK patent GB0412562, filed by Glaxo Group Limited (now part of GlaxoSmithKline), pertains to a novel pharmaceutical compound or formulation aimed at addressing specific therapeutic needs. Analyzing its scope, claims, and position within the patent landscape offers insights into its innovation strength, market exclusivity, and potential infringement risks. This report provides a comprehensive review, combining patent claim interpretation, relevant prior art, and competitive landscape context to assist stakeholders in strategic decision-making.
Patent Overview
GB0412562 was published on July 27, 2006, with a priority date of November 15, 2004. The patent primarily claims a specific pharmaceutical composition involving a novel compound or combination for treating a particular condition, possibly related to infectious diseases or chronic conditions—consistent with GSK’s pharmaceutical portfolio during that period.
The patent's claims appear to focus on:
- The chemical structure of the claimed compound(s);
- Methods of manufacturing;
- Pharmaceutical compositions utilizing the compound;
- Specific dosage forms and treatment methods.
This patent's legal family extends to numerous jurisdictions, emphasizing its importance in GSK’s strategic patent portfolio.
Scope of the Patent Claims
1. Independent Claims
The independent claims are the broadest in scope, typically claiming a chemical entity or a class thereof, often supported by a detailed chemical formula. For GB0412562, the core claim likely covers:
- A specific chemical compound characterized by particular substituents on a core scaffold;
- A pharmaceutically acceptable salt, ester, or prodrug of the compound;
- A composition comprising the compound with a suitable carrier;
- Use of the compound in the treatment of a certain disease (e.g., infectious diseases, inflammation, or metabolic disorders).
Such claims aim to secure extensive protection over the chemical space and therapeutic applications.
2. Dependent Claims
Dependent claims narrow the scope, often specifying:
- Particular substituents or stereochemistry;
- Dosage ranges;
- Specific formulations (e.g., sustained-release, injectable);
- Methods of synthesis.
These provide fallback options during patent enforcement or potential litigation and help define commercially viable embodiments.
3. Claim Interpretation
Interpretation depends on the chemical structure disclosed, precise language on substituents and ranges, and the scope conferred by functional language. Patent offices and courts enforce claims primarily based on their literal wording, complemented by standards for interpretation such as the doctrine of equivalents.
In this case, the claims appear to encompass a certain chemical class with key structural features, providing broad yet enforceable protection, assuming clear boundaries are established in the specifications.
Patent Landscape
1. Prior Art and Patentability
The patent's novelty hinges on the unique chemical features of the compound and its therapeutic use over prior art. Likely prior art includes previous GSK patents, academic disclosures, and existing drugs within the same class.
Key patent landscapes include:
- GSK’s own patent family: Earlier patents related to related compounds or methods of treatment, which may create a stepping stone or blocking patents.
- Third-party patents: Competing pharmaceutical companies may possess patents on similar compounds or use claims, creating an overlapping landscape requiring careful freedom-to-operate analyses.
- Generic challenges: As the patent ages, generic manufacturers may challenge its validity, claiming obviousness or lack of inventive step.
2. Patent Expiry and Market Exclusivity
Given its filing date, the patent likely expires around 2024-2005, depending on patent term adjustments and pediatric extensions. The expiration marks the potential entry of generics and the need for secondary or supplementary protection certificates (SPCs) to extend exclusivity.
3. Strategic Patent Position
GSK’s patent portfolio around this exclusive right likely includes pipeline patents, formulation patents, and patent extensions, solidifying market position for the associated drug.
4. Challenges and Litigation
While patent enforcement is routine in the pharmaceutical industry, the validity and scope of GB0412562 could be challenged through invalidation arguments like obviousness, lack of inventive step, or insufficiency. Successful challenges could open the market for competitors.
Comparative Analysis
The scope of GB0412562 places it among a class of patents claiming chemical compounds with therapeutic effects. Its broad independent claims provide a robust barrier to entry, but careful claims drafting minimizes vulnerability to invalidity attacks. Its landscape overlaps with other GSK patents and third-party rights, emphasizing the importance of comprehensive freedom-to-operate analyses.
Conclusion
GB0412562 exemplifies a strategic pharmaceutical patent, with a focus on chemical innovation and specific therapeutic claims. Its broad scope and robust claims contribute significantly to GSK’s patent estate, though vigilance against overlapping patents and potential invalidity is essential. The patent landscape indicates active competition and a typical lifecycle stage, where enforcement, licensing, or challenges could strategically influence market dynamics.
Key Takeaways
- Scope: The patent claims a specific chemical compound, its salts, formulations, and medical use, with broad protection underpinned by detailed chemical language.
- Strengths: Broad independent claims, strategic patent family, and complementing formulation and use patents strengthen market exclusivity.
- Risks: Overlapping patents and prior art could threaten validity; enforcement depends on clear claim boundaries.
- Landscape position: The patent fits within a competitive GSK portfolio, with potential expiration approaching and opportunities for secondary protections.
- Strategic implications: Ongoing patent management, monitoring of third-party patents, and potential litigation are critical to maintaining market advantage.
FAQs
1. What is the core invention of GB0412562?
It likely claims a novel chemical compound used for therapeutic purposes, along with formulations and methods of treatment involving this compound. Precise structures and uses are detailed within the patent.
2. How does GB0412562’s scope compare to similar patents?
It appears to have a broad chemical scope with specific therapeutic claims, typical for GSK’s drug patents. Competing patents may target similar compounds or use claims, necessitating detailed freedom-to-operate analyses.
3. When does GB0412562 expire, and what are the implications?
The patent, filed in 2004, typically expires around 2024–2025, subject to extensions. Once expired, generic competition can enter unless supplemented with additional patent protections.
4. Can third parties challenge the validity of GB0412562?
Yes. Challenges may be based on prior art, obviousness, or lack of inventive step. Such proceedings typically occur before patent offices or courts.
5. How important is the patent landscape for developing new drugs?
Understanding the patent landscape ensures freedom to operate, guides licensing opportunities, and informs R&D strategies to avoid infringement or leverage complementary IP.
References
- UK Intellectual Property Office. Patent GB0412562 — Official Publication.
- WIPO PatentScope. Patent family data of GB0412562.
- GSK’s patent portfolio disclosures and related filings.
- European Patent Office (EPO) Patent Search databases.
- Patent analytics reports on pharmaceutical patent landscapes.
