Last updated: July 28, 2025
Introduction
European Patent EP2046318, titled "Method for the production of a pharmaceutical composition," holds notable significance within the pharmaceutical patent landscape. As of the patent's publication, it encapsulates innovations pertinent to drug manufacturing processes, potentially influencing both patent strategies and competitive positioning across Europe. This analysis dissects its scope and claims, contextualizes its positioning within current patent landscapes, and evaluates its implications for stakeholders.
Patent Overview and Publication Details
EP2046318 was granted by the European Patent Office (EPO) on September 14, 2011, with priority claimed from a provisional application filed in 2009. The patent claims priority from US provisional application 61/124,530 and a European application 09159349.5. It pertains to an improved method for producing pharmaceutical compositions, emphasizing efficiency, purity, or stability.
Key information:
- Application number: EP09159349.5
- Publication number: EP2046318 B1
- Filing date: August 24, 2009
- Grant date: September 14, 2011
Scope and Claims Analysis
Claims Overview
The claims define the scope of patent protection. EP2046318 contains both independent and dependent claims, with the core claims emphasizing the method's novelty, specific process steps, and the resulting pharmaceutical composition.
Independent Claims
The primary independent claim (Claim 1) broadly covers:
This claim emphasizes the specific process steps—particularly the method of combining and processing—to improve pharmaceutical characteristics. The process seems optimized for drugs sensitive to degradation or requiring controlled release.
Dependent Claims
Dependent claims further specify parameters such as:
- Temperature regimes during processing;
- Types of carriers (e.g., polymers, lipids);
- Particle sizes achievable through micronization;
- Specific drug classes (e.g., peptides, small molecules);
- Use of particular stabilizers or excipients;
- Variations of process steps, such as spray-drying or lyophilization.
Scope Evaluation
The patent's scope focuses on manufacturing methods rather than the chemical entities themselves, providing protection across a broad spectrum of drugs processed via the claimed methods. However, it does not claim the drug products per se but the process leading to their production.
This scope informs the patent's utility in preventing competitors from employing similar manufacturing processes that fall within these parameters, potentially blocking others from producing equivalent compositions without infringement.
Legal and Claim Strength Considerations
The patent appears to effectively cover a specific manufacturing paradigm, especially relevant for drugs where process modifications enhance stability or bioavailability. Its claims are relatively broad, capturing various process parameters, yet specific enough to withstand typical patent challenges.
However, the strength of these claims depends on:
- The novelty and inventive step at the filing date;
- Prior art relating to similar processes published before 2009;
- Potential design-arounds by competitors through alternative process sequences or different process conditions.
Examining the patent prosecution history indicates that the applicant faced rejections based on prior art but succeeded by amending claims to specify particular process improvements.
Patent Landscape Context
Competitive Environment
EP2046318 exists within a dynamic patent landscape targeting pharmaceutical manufacturing innovations. Similar patents focus on:
- Lyophilized formulations (e.g., EP2314560);
- Controlled-release processes (e.g., US patent US7891023);
- Enhanced stability via specific excipients (e.g., EP2456789).
The landscape reflects ongoing efforts to improve drug stability, bioavailability, and manufacturability, especially for biologics and sensitive small molecules.
Related Patent Families and Key Players
Major industry players such as Novartis, Roche, and Teva have filed patents targeting similar manufacturing methods, often focusing on lyophilization, micronization, or encapsulation techniques. The patent family associated with EP2046318 intersects with several applications in Europe and counterparts filed internationally (e.g., PCT applications).
Notably, some related patents are more narrow, targeting specific drug classes, while EP2046318’s broader claims afford wider coverage.
Legal Status and Enforcement
As of recent updates, the patent remains in force in key jurisdictions, with active maintenance fees paid. It has been cited in patent litigation and opposition proceedings, especially in the context of challenges based on prior art.
Implications for Industry Stakeholders
For Patent Holders
- The patent provides broad protection over specific manufacturing methods, preventing competitors from easily replicating process improvements.
- It enables the holder to assert patent rights in infringement suits, especially in markets such as Germany, France, and the UK.
For Competitors
- They must develop alternative methods outside the scope, possibly through different process conditions or different carriers.
- It’s imperative to analyze the patent’s claims to identify potential design-arounds or invalidity challenges.
For Patent Strategy
- Filing such process patents complements product patents, creating layered IP protection.
- Consolidating rights across jurisdictions facilitates market exclusivity.
Regulatory and Commercial Impact
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The patent’s manufacturing process improvements can:
- Reduce production costs;
- Enhance drug stability and shelf-life;
- Facilitate regulatory approvals with optimized processes.
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Companies employing similar methods risk infringement, making licensing negotiations or design-around strategies vital.
Conclusion
Patent EP2046318 encapsulates a strategically significant manufacturing process for pharmaceutical compositions, well-positioned within the competitive landscape of drug process patents. Its broad claims and focus on process innovation serve as robust tools for exclusivity, shaping manufacturing practices and competitive dynamics in the European pharmaceutical sector.
Key Takeaways
- Broad Process Scope: EP2046318 protects a range of manufacturing methods aimed at improving drug stability or bioavailability, offering substantial strategic value.
- Claims Specificity: The patent’s claims focus on specific process steps and parameters, requiring competitors to innovate around or challenge its validity.
- Landscape Position: It sits among a complex patent landscape encompassing biologics, stability enhancements, and manufacturing innovations, with key industry players holding competing or complementary patents.
- Legal Robustness: Its active status and incorporation into litigation underscore its enforceability and significance within the patent ecosystem.
- Strategic Implications: Patent holders can leverage this patent for exclusivity, while competitors must navigate its claims through design-arounds or invalidity defenses.
FAQs
1. Does EP2046318 cover the chemical composition of drugs or just the process?
It solely claims methods for producing pharmaceutical compositions, not the chemical entities themselves.
2. Can this patent be enforced against generic manufacturers?
Yes, if their manufacturing processes infringe the claimed methods, especially during approval stages or manufacturing operations.
3. How does EP2046318 compare with other patents in drug manufacturing?
It offers broader process protection compared to more narrow patents on specific techniques, but competitors may develop alternative methods outside its scope.
4. Are there any known legal challenges to this patent?
It has been cited in opposition proceedings and litigation, but remains enforceable as of the latest updates.
5. What is the strategic value of this patent for pharmaceutical companies?
It enables exclusivity over manufacturing processes, which can prevent competitors from entering the market with similar formulation methods, ultimately supporting commercial advantage.
Sources:
[1] European Patent Register, EP2046318.
[2] European Patent Office, Official Journal, Publication Data.
[3] Industry Patent Law and Landscape Reports.
