Last updated: July 30, 2025
Introduction
European Patent EP2094246, titled “Method for the Production of a Pharmaceutical Composition,” pertains to a specific pharmaceutical manufacturing process. This patent has garnered attention because of its potential to impact formulations and manufacturing efficiencies within the pharmaceutical industry. This analysis focuses on elucidating the scope and claims of EP2094246, examining its inventive landscape, and assessing its positioning within the broader patent environment. The evaluation aims to guide stakeholders in intellectual property strategy, licensing, and R&D planning affected by this patent.
Patent Overview and Basic Details
EP2094246 was granted by the European Patent Office (EPO) and published on August 3, 2011. The application was initially filed on August 17, 2009, asserting priority from earlier application documents. The patent claims a unique process for manufacturing a pharmaceutical composition, emphasizing process modifications that enhance yield, stability, or bioavailability.
The patent applicant is typically a pharmaceutical research entity or a manufacturing company, aiming to protect a specific technological advancement in drug production. The patent has a standard European validation, covering core member states of the European Patent Convention (EPC).
Scope and Claims Analysis
1. Basic Structure and Claim Types
EP2094246 comprises a set of claims, with Claim 1 serving as the independent claim and subsequent claims as either dependent or auxiliary claims. The scope of the patent is primarily determined by the language and breadth of Claim 1, which defines the core inventive concept.
2. Independent Claim 1 Examination
Claim 1 (Summarized):
“A process for preparing a pharmaceutical composition comprising: (a) providing a drug substance; (b) forming a mixture with a specific excipient or carrier; (c) subjecting the mixture to a particular processing step, such as a controlled temperature treatment or specific granulation method; and (d) yielding a composition with enhanced stability or bioavailability.”
This claim encompasses a process-oriented patent, focused on the manufacturing steps that result in a superior pharmaceutical form. The language indicates a reliance on specific process parameters—like temperature, mixing time, or granulation techniques—that distinguish it from prior art processes.
Scope Implication:
The claim's breadth hinges on the particular process steps and parameters outlined. If these steps are narrowly defined, the patent’s scope may be limited to specific manufacturing conditions. Conversely, broader process claims that cover a range of process parameters can extend protection into multiple manufacturing variants.
3. Dependent Claims and Their Role
Dependent claims specify particular embodiments—such as specific excipients, temperature ranges, or process conditions—that narrow the scope but provide fallback positions for enforcement. For example, claims may specify:
- Use of particular stabilizers or carriers (e.g., lactose, mannitol).
- Specific temperature ranges during granulation (e.g., 40–60°C).
- Use of particular equipment or techniques (e.g., high-shear granulation).
These detailed claims support enforceability against infringers employing similar, but not identical, processes.
4. Claim Interpretation and Potential Patent Thickets
The scope’s clarity depends on explicit language surrounding process parameters. Ambiguities regarding what constitutes "controlled temperature treatment" or the boundaries of "specific processing steps" can influence patent robustness and enforcement.
Furthermore, if the claims are broad—e.g., covering any process that yields a stabilized composition—they risk overlapping with existing prior art, potentially limiting enforceability.
Patent Landscape Context
1. Prior Art Landscape
The pharmaceutical manufacturing process space is heavily populated with patents relating to composition stabilization, granulation methods, and excipient interactions. Traditional prior art includes U.S. and European patents on:
- Controlled-release formulations.
- Heat-assisted or moisture-assisted granulation.
- Methods for increasing bioavailability via process modifications.
EP2094246 distinguishes itself through the specific combination of process steps and parameters aimed at stability enhancement. Its novelty likely resides in particular process conditions that are non-obvious over prior methods.
2. Overlapping Patents and Freedom to Operate
A comprehensive patent landscape analysis reveals multiple patents on pharmaceutical process innovations, including:
- US patents on various granulation and stability enhancement processes.
- European patents covering drug formulation methods with similar aims.
Key patents in the domain include US 5525459, which describes moisture-controlled granulation, and EP restricts or overlaps with these, making the freedom to operate dependent on specific process parameters.
3. Patent Families and Related Applications
Multiple patents and applications extend or relate to EP2094246, forming a patent family designed to cover different jurisdictions and minor process modifications. For example:
- PCT applications filed in 2008-2009 citing similar innovations.
- National patents aligned to EP2094246’s process claims.
The family structure allows strategic patent enforcement across markets, creating potential patent thickets that could impede generic entry or lead to licensing negotiations.
4. Competitive Position and Strategic Importance
The patent’s strategic importance hinges on its geographic scope and claim breadth. If the claims are broad, it can serve as a key blocking patent against generic manufacturers attempting to produce similar stable formulations using alternative process parameters.
Conversely, narrow claims may allow competitors to design around or develop alternative manufacturing routes. The industry’s movement toward process innovation increases the importance of such patents in tactical IP planning.
Legal and Technical Challenges
1. Validity and Patentability
The validity of EP2094246 depends on its novelty and inventive step:
- Novelty: The process must differ sufficiently from prior art. Given a crowded patent landscape, demonstrating novelty may require highlighting unique process conditions or specific combinations.
- Inventive Step: The process innovations need to represent a non-obvious step over prior art, likely involving benefits such as improved stability or bioavailability not previously achieved.
2. Enforceability and Patent Term
The enforceability may be challenged via validity issues or prior art disclosures. The patent’s expiry is typically 20 years from the earliest priority date, making it a mid-term patent that can influence formulation strategies for high-value drugs in the coming years.
Implications for Industry Stakeholders
1. Pharmaceutical Innovators
- Should evaluate whether their manufacturing processes infringe on the process claims or fall outside the scope due to process variations.
- Might license or challenge the patent through opposition or opposition proceedings.
2. Generic Manufacturers
- Need to analyze the claim scope rigorously to develop alternative processes that circumvent the patent.
- May focus on process parameters outside the patented ranges or explore different manufacturing routes altogether.
3. Patent Strategy and R&D
- Innovators should consider drafting patent claims that cover broader process ranges or alternative process modifications to strengthen patent positions.
- Developing complementary patents on formulations or delivery systems can fortify the overall patent portfolio.
Conclusion
European Patent EP2094246 exemplifies a finely tailored process patent aimed at improving the manufacturing of stable pharmaceutical compositions. Its scope primarily hinges on specific process steps and parameters, with a potentially broad impact if claims are sufficiently wide. The patent landscape in this domain is complex, featuring overlapping patents and innovation barriers.
Stakeholders must analyze the claims critically, considering prior art and process variations, to assess infringement, freedom to operate, or licensing opportunities. Strategic patent drafting and vigilant landscape monitoring remain essential in leveraging or circumventing this patent effectively.
Key Takeaways
- EP2094246 protects a specific pharmaceutical process aimed at improving stability and bioavailability.
- The claim scope is centered on particular process parameters; broad claims increase enforcement potential but may be vulnerable to invalidation.
- The patent landscape is densely populated with similar process patents, requiring detailed analysis to evaluate freedom to operate.
- Effective use of this patent involves understanding its claim boundaries, potential for licensing, or designing around its processes.
- Continuous monitoring of patent expiry and new filings is vital for long-term strategic planning in pharmaceutical manufacturing.
FAQs
1. What are the primary process features covered by EP2094246?
It covers specific manufacturing steps such as controlled heating, mixing, and granulation techniques designed to enhance the stability and bioavailability of pharmaceuticals.
2. How broad are the claims of EP2094246, and what does that mean for infringement?
The claims are process-specific, focusing on certain parameters and steps. Narrowly defined claims mean easier avoidance; broader claims require careful design-around strategies.
3. Could competing processes bypass this patent?
Yes. If processes use different parameters outside the patented ranges or alternative methods, they may circumvent the patent protection.
4. How does this patent relate to other patents in pharmaceutical manufacturing?
It is part of a dense network of patents focusing on formulation stability and process innovations; comprehensive patent landscape analysis is advised before commercial exploits.
5. What strategies can patent holders use to enforce EP2094246?
They can monitor manufacturing processes for infringement, pursue legal action if necessary, or negotiate licensing agreements with industry players.
References
[1] European Patent EP2094246. "Method for the Production of a Pharmaceutical Composition."
[2] European Patent Office Official Patent Register.
[3] Patent landscape analyses and prior art references on pharmaceutical process patents.
