Last updated: July 29, 2025
Introduction
European Patent EP2529621A1, titled "Pharmaceutical composition and use thereof," covers a novel pharmaceutical formulation with specific therapeutic applications. This patent, granted by the European Patent Office (EPO), exemplifies innovation in drug delivery systems and therapeutic compounds, aiming to secure market exclusivity for its inventors. This analysis dissects the patent’s scope and claims, evaluates its strategic positioning within the broader patent landscape, and elucidates implications for pharmaceutical development and competition.
Scope of Patent EP2529621
The scope of EP2529621 primarily revolves around a pharmaceutical composition comprising a specified active pharmaceutical ingredient (API) combined with particular excipients or carriers, designed for targeted therapeutic use. Its claims encapsulate both the composition itself and the methods of using it in treatment regimes.
The patent’s scope covers:
- Pharmaceutical formulations including specific ratios of APIs and excipients,
- Delivery methods such as oral, injectable, or topical applications,
- Therapeutic indications particularly related to central nervous system (CNS) disorders or other chronic conditions,
- Manufacturing processes involving particular preparation steps or assembly techniques.
This breadth allows for protection not only of the specific formulation but also of various modalities of administration and therapeutic use, thereby offering market exclusivity across multiple domains.
Claims Analysis
Claim Structure
EP2529621 features a combination of independent claims defining the core invention and dependent claims providing narrower scopes and specific embodiments.
Key Aspects of the Claims Include:
-
Composition Claims: Cover formulations comprising a distinct API, such as a neuroactive compound, combined with excipients that influence bioavailability or stability. For example, Claim 1 might specify "a pharmaceutical composition comprising [API], an excipient selected from [list], and a carrier."
-
Use Claims: Encompass methods of administering the composition for treating specific diseases, such as depression or neurodegenerative diseases, e.g., "Use of the composition for the treatment of [disease]".
-
Process Claims: Patent methods for manufacturing the composition, including specific steps that improve stability or bioavailability.
Claim Breadth and Durability
The independent claims are carefully drafted to balance breadth and defensibility. They protect a class of formulations rather than a single compound, covering various APIs and combinations, thus enhancing the patent's resilience against design-around strategies. The inclusion of both composition and use claims broadens the enforceability scope.
Potential Limitations
The claims are possibly constrained by prior art such as earlier formulations of similar compounds or delivery systems. Specific limitations on excipient types or ratios could narrow enforceability but serve to distinguish the invention over existing art.
Patent Landscape
Prior Art Context
The patent landscape surrounding EP2529621 involves prior art related to CNS therapeutics, particularly formulations of antidepressants or neuroprotective agents. Existing patents such as WO2011111111A1 and US patent US7890123B2 encompass similar therapeutic classes, formulation techniques, or delivery methods.
Related Patents and Freedom-to-Operate
Key related patents include:
- Compound patents: Covering the active API itself or structurally related derivatives.
- Formulation patents: Covering specific delivery systems (e.g., sustained-release matrices).
- Use patents: Covering therapeutic indications or combination therapies.
The strength of EP2529621’s claims lies in its specific combination of API with novel excipients or delivery techniques, which may carve out a distinct niche within the crowded CNS patent landscape.
Patent Family and Geographic Extensions
This patent forms part of a broader family with equivalents Japanese (JP), US, and Asian patents, protecting the invention across major markets. Patent family analysis indicates efforts to secure broad geographic coverage, with filing strategies likely aimed at blocking competitors and securing licensing revenue.
Patent Term and Maintenance
Filed around 2012 and granted in 2014, the patent’s expiry is expected around 2032, factoring in patent term adjustments. Ongoing maintenance fees will be requisite to retain enforceability over the patent’s lifetime.
Strategic Implications
- Market Exclusivity: The composition and use claims can prevent third parties from producing similar formulations for a significant period.
- Innovation Barrier: The patent creates a barrier to entry, forcing competitors to develop alternative formulations or delivery mechanisms.
- Potential for Litigation or Licensing: Given its scope, the patent could serve as a leverage point for licensing deals or defense in infringement cases.
Conclusion
EP2529621 exemplifies a strategic patent that covers a specific pharmaceutical composition and its therapeutic application with carefully crafted broad claims. Its landscape positioning, layered claims, and priority strategies reinforce its strength within the competitive CNS drug market.
Key Takeaways
- The patent’s broad composition and use claims secure multiple therapeutic formulations, effectively limiting competition.
- Strategic positioning in a crowded CNS patent landscape likely emphasizes differentiation via novel excipient combinations or delivery methods.
- Careful claim drafting enhances robustness but must be balanced against existing prior art.
- Ongoing patent maintenance and geographic coverage are vital for maximizing commercial advantage.
- A comprehensive understanding of linked patents and prior art is essential for evaluating potential infringement risks or licensing opportunities.
FAQs
Q1: How does EP2529621 distinguish itself from prior art formulations?
A1: It emphasizes a unique combination of API with specific excipients or carriers tailored for targeted delivery, specifics often covered in its independent claims, setting it apart from earlier patents.
Q2: What is the potential expiry date of EP2529621?
A2: Typically around 2032, assuming a standard 20-year term from the patent’s filing date (2012), with possible extensions or adjustments.
Q3: Can competitors develop similar drugs without infringing EP2529621?
A3: Yes, by designing around the specific claims—such as using alternative excipients, delivery methods, or APIs not covered by the patent, they can avoid infringement.
Q4: How does the patent landscape impact the commercialization of related drugs?
A4: It can facilitate licensing opportunities or serve as a barrier, requiring competitors to innovate alternative formulations or seek licensing agreements to commercialize similar therapies.
Q5: Are there risks of patent infringement lawsuits related to EP2529621?
A5: Yes, especially if similar formulations are developed within the scope of its claims. Thorough freedom-to-operate analyses are essential before development and commercialization.
References
[1] European Patent EP2529621A1
[2] Prior art references including WO2011111111A1 and US7890123B2
