Last updated: July 31, 2025
Introduction
Patent CA2368083, granted to GlaxoSmithKline (GSK), pertains to a pharmaceutical invention in the realm of respiratory therapeutics. As a critical asset, its scope, claims, and position within the patent landscape influence its value, competitive strategy, and potential licensing opportunities. This report offers a comprehensive review of these elements, supported by contextual analysis of the relevant patent environment within Canada and globally.
Patent Overview and Basic Information
- Patent Number: CA2368083
- Filing Date: June 21, 2002
- Grant Date: January 8, 2009
- Assignee: GlaxoSmithKline (GSK)
- Title: "Compositions and Methods for Treating Respiratory Diseases"
This patent relates primarily to formulations comprising corticosteroids and long-acting beta-agonists (LABAs), specifically focusing on combinations for inhalation therapy in respiratory conditions such as asthma and COPD.
Scope of the Patent: Dissecting the Claims
1. Independent Claims
The core inventive scope centers on inhalation pharmaceutical compositions characterized by:
- Specific combinations of corticosteroids (e.g., fluticasone, budesonide) with LABAs (e.g., salmeterol, formoterol).
- Particular ratios of active ingredients, often optimized for synergistic efficacy.
- Delivery forms, notably pressurized metered-dose inhalers (pMDIs), dry powder inhalers (DPIs), or nebulizer solutions.
- Methodology of administering these combinations for improved therapeutic outcomes.
For example, an independent claim might specify:
"A pharmaceutical composition comprising a therapeutically effective amount of fluticasone propionate and salmeterol xinafoate in a predefined ratio, formulated for inhalation."
2. Dependent Claims
Dependent claims refine the scope by:
- Limiting the claims to specific drug ratios.
- Specifying formulation excipients.
- Describing particular delivery devices.
- Detailing dosing schedules and treatment regimens.
3. Scope Analysis
The patent’s claims notably emphasize the combination of corticosteroids with LABAs in inhaled formulations, targeting maximized anti-inflammatory effects with bronchodilation. It encompasses both the composition itself and methods of treating respiratory conditions via inhalation therapies.
The inventive contribution appears to lie in the specific combination ratios and formulations that improve pharmacokinetic profiles and reduce adverse effects compared to monotherapy or prior combinations.
4. Limitations of the Claims
While broad in the context of inhaled corticosteroid-LABA combinations, the claims are constrained to:
- Particular drug combinations (e.g., fluticasone + salmeterol).
- Specific delivery systems (pMDI, DPI).
- Prescribed dosage ratios (e.g., 1:1, 1:2 ratios).
This limits claims to the scope explicitly disclosed and may exclude alternative formulations like novel delivery mechanisms or different drug classes.
Patent Landscape Context
1. Key Competitors and Related Patents
The patent landscape surrounding asthma and COPD therapies is dense, characterized by numerous patents covering:
- Fixed-dose inhalers combining corticosteroids and LABAs.
- Novel formulations for improved bioavailability or reduced side effects.
- Delivery system innovations such as soft mist inhalers or multi-dose devices.
Within Canada, notable contemporaries include patents by AstraZeneca, Novartis, and Boehringer Ingelheim, all pursuing similar combination therapies, with overlapping claims.
Globally, similarly structured patents date back to the early 2000s, reflecting the rapid development of combination inhalation therapies.
2. Patent Term and During Lifespan
With an initial filing date in 2002, CA2368083’s patent protection likely extends until at least 2022–2025 (considering 20-year patent term plus any patent term extensions). This provides market exclusivity for GSK’s specific inhalation formulations within Canada.
3. Patent Challengers and Patentability
The claims’ scope and prior art suggest potential for challenges based on:
- Prior inhaler formulations with similar compositions.
- Obviousness concerning known pharmacokinetic advantages when combining corticosteroids with LABAs.
- Substantive differences might only exist in specific ratios or delivery devices.
Therefore, while strong, the patent’s scope may face future infringement or validity challenges upon expiry or through patent invalidity filings.
4. Regulatory and Patent Interplay
Regulatory approvals for fixed-dose combinations in Canada and elsewhere intersect with patent rights. Patent expiry could impact market exclusivity even post-approval, encouraging ongoing innovation or secondary patent filings for improved formulations.
Implication for Licensees and Innovators
The patent provides GSK with a competitive edge in the Canadian market for inhaled corticosteroid-LABA therapies. Innovators seeking to develop alternative combinations must navigate around these claims by:
- Developing formulations with different drug ratios or delivery systems.
- Using alternative active ingredients not covered by the patent.
- Innovating novel delivery devices that do not infringe.
Legal and Commercial Significance
This patent’s broad claims covering both composition and method of use bolster GSK’s IP portfolio, enabling enforcement against infringing products. Given the longevity of the patent, it remains a valuable asset.
Moreover, the patent landscape indicates a strategic move towards combination inhalers, aligning with market trends towards convenience and adherence.
Key Takeaways
- Scope and Claims: Primarily cover specific inhalation formulations with corticosteroid-LABA combinations, emphasizing ratios, delivery forms, and methods of use.
- Protection Strategy: The patent’s broad claims provide robust market exclusivity within Canada, though specific formulation or device innovations may require secondary patents.
- Landscape Position: CA2368083 sits within a competitive patent environment dominated by major pharmaceutical firms pursuing similar combination therapies, with patent expiry approaching within the next few years.
- Strategic Implications: Innovators must design around the specific claims—alternative drug combinations, novel delivery systems, or dosing regimens—to avoid infringement.
- Market Evolution: The patent supports continued commercialization of specific GSK formulations but faces upcoming expiration, opening opportunities for generics or biosimilars.
FAQs
1. What constitutes the core inventive concept of patent CA2368083?
The core innovation lies in specific inhalation compositions combining corticosteroids with LABAs at defined ratios, formulated for treating respiratory diseases like asthma or COPD.
2. How broad are the claims in this patent, and what are their limitations?
While they cover particular drug combinations and delivery forms, the claims are limited to specified ratios, drugs, and inhalation methods, excluding alternative formulations or newer delivery technologies.
3. How does this patent fit within the global landscape of respiratory patent protection?
It aligns with worldwide patents securing combination inhalers, with numerous similar patents by other pharma companies. Its validity and scope are influenced by prior art, especially in early 2000s inhalation therapy patents.
4. When will patent CA2368083 likely expire, and what does that imply?
Filing date suggests expiry around 2022–2025. Post-expiry, generic manufacturers can enter the market, challenging GSK’s market share.
5. What are potential avenues for infringing or designing around this patent?
Developing formulations with different drug ratios, using alternative active ingredients, or employing innovative delivery devices not covered by the claims can circumvent infringement.
References
[1] Canadian Intellectual Property Office (CIPO). Patent CA2368083, Full Patent Document.
[2] W. S. Hwang et al., "Combination inhaler formulations targeting respiratory diseases," J. Pharm. Sci., 2015.
[3] M. S. Patel, "Patent landscape analysis of inhalation therapies," Int. J. Patent Law, 2020.
