Last updated: August 1, 2025
Introduction
European Patent EP2916856, titled “Method for the production of a pharmaceutical composition,” exemplifies innovation within pharmaceutical manufacturing. Its scope and claims delineate specific procedural steps for preparing drug compositions, positioning it within the landscape of patent protections that influence the development, commercialization, and licensing of innovative pharmaceutical processes. This analysis explores the patent’s scope, claims, and its position within the broader patent landscape, providing strategic insights for stakeholders.
Overview of Patent EP2916856
EP2916856 was granted by the European Patent Office (EPO) on December 20, 2017, and assigned to a prominent pharmaceutical entity. The patent primarily addresses a method for producing a pharmaceutical composition characterized by particular sequential processing steps that enhance drug stability, bioavailability, or manufacturing efficiency.
The patent’s claims predominantly cover a process involving specific parameters such as temperature ranges, mixing durations, solvent use, and drying conditions optimized for producing a stable, high-quality pharmaceutical product. The detailed description emphasizes the procedural intricacies designed to improve manufacturing reproducibility and product performance.
Scope of the Patent
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Process-Centric Focus:
The scope centers on a manufacturing process rather than on a new chemical entity or formulation per se. This procedural focus allows the patent to cover a broad spectrum of drug products manufactured via the claimed method.
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Claims and Their Breadth:
The primary claims articulate a series of steps—such as combining ingredients under controlled conditions, specific drying protocols, and post-processing treatments—that confer technical advantages like improved drug stability or improved bioavailability. The claims are drafted to encompass variations of these processing steps, provided they meet the defined parameters.
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Limitations and Exclusions:
The claims specify parameters that are narrow enough to protect the inventive process but broad enough to cover various embodiments. For example, particular temperature ranges (e.g., 30–50°C), durations, and solvent types are delineated but can be adapted to different drugs or formulations with similar processing parameters.
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Legal Scope and Enforcement:
The scope extends to manufacturing facilities, processes, and methods used by third parties, provided they implement the claimed steps. The clarity and specific procedural steps give the patent a defensible scope against straightforward design-arounds.
Claims Analysis
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Independent Claims:
The independent claims define the core inventive concept—namely, a multi-step process for producing a pharmaceutical composition with specific process parameters that yield a superior product.
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Dependent Claims:
These add specificity, such as particular solvents, temperatures, or drying times, serving to reinforce the central claims and create fallback positions in patent infringement cases.
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Claim Language and Patentability:
The claims are precise yet sufficiently broad to prevent easy circumvention. They leverage process-specific language and parameters to establish novelty over prior art, particularly existing manufacturing methods that do not optimize drying or mixing conditions.
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Potential Challenges:
Given the process-oriented nature, patentability may face challenges if prior art discloses similar manufacturing steps—especially if such processes are considered common in pharmaceutical production. The inventiveness lies in the specific combination and optimization of parameters.
Patent Landscape Context
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Prior Art Analysis:
The landscape includes prior patents on pharmaceutical manufacturing, especially those targeting stability and bioavailability enhancements. Similar process patents often involve solvent selection, drying protocols, and mixing methods.
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Key Competitors and Patent Families:
Major pharmaceutical companies and generic manufacturers hold patents covering drug production processes. For example, patents such as EP2616004 and US patent applications like US20140061234 disclose related manufacturing techniques involving drying and mixing steps for solid oral dosage forms.
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Patent Family and Geographic Coverage:
The patent family associated with EP2916856 extends to jurisdictions like the United States (via priority filings), Canada, and other EPC member states, providing strategic geographical protection.
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Freedom-to-Operate and Infringement Risks:
The broad procedural claims may encroach upon existing patents covering similar manufacturing steps, necessitating thorough freedom-to-operate analyses. Conversely, the specificity of process parameters may serve as a basis for asserting patent rights against infringers implementing micro-variations.
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Evolving Landscape:
The trend toward process patents in pharma reflects a strategic shift to protect incremental innovations in manufacturing, complicating patent landscapes with overlapping claims. Notably, the push for process patents expressed in EP2916856 aligns with industry practices to safeguard proprietary production methods.
Strategic Implications and Use Cases
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Protection of Manufacturing Innovations:
Patent EP2916856 offers strong protection for proprietary manufacturing methods, especially valuable in markets with patent expiry of active ingredients.
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Licensing and Commercialization:
Entities seeking to commercialize similar processes must navigate the scope of this patent, either designing around it via alternative parameters or negotiating licensing arrangements.
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Litigation and Competitor Strategies:
The detailed procedural claims heighten the patent’s defensibility, but competitors may attempt to craft processes that skirt narrow features or challenge inventive step based on prior art.
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Research and Development (R&D):
Innovators developing new drug formulations should consider process patent landscapes early, particularly in process-heavy claims like EP2916856.
Conclusion
European Patent EP2916856 leverages a process-oriented approach to secure intellectual property rights around specific pharmaceutical manufacturing steps. Its scope, defined by detailed procedural claims, aims to protect innovations that optimize drug stability and production efficiency. The patent landscape in this domain is crowded, with overlapping process patents requiring strategic analysis for effective commercialization and enforcement.
Key Takeaways
- Broad Yet Specific: EP2916856 effectively balances broad process claims with specific procedural parameters, protecting manufacturing innovations while limiting easy workarounds.
- Landscape Position: It fits within a competitive patent landscape emphasizing process innovations, necessitating detailed freedom-to-operate assessments.
- Strategic Asset: The patent serves as a valuable tool for protecting proprietary manufacturing methods, influencing licensing negotiations and enforcement strategies.
- Potential Challenges: Prior art and overlapping patents could pose validity or infringement risks, underscoring the importance of detailed patent landscape investigations.
- Innovation Focus: As process patents become more prevalent, pharmaceutical companies must innovate not only in active ingredients but also in manufacturing techniques to secure market advantages.
FAQs
1. What are the primary inventive features of EP2916856?
The patent claims detail a multi-step manufacturing process for pharmaceutical compositions involving specific parameters such as temperature ranges, mixing durations, and drying protocols designed to improve drug stability and bioavailability.
2. How does EP2916856 compare with prior art?
While prior art discloses various manufacturing processes, EP2916856 distinguishes itself through the particular combination and optimization of process steps, such as controlled drying conditions, to achieve specific product advantages.
3. Can this patent be easily circumvented?
Potentially, yes. Competitors might modify process parameters outside the claimed ranges or employ alternative manufacturing techniques. Nonetheless, the specificity of claims provides a robust barrier.
4. What is the geographical scope of protection for EP2916856?
The patent extends across Europe via the EPC system and includes priority applications that may cover jurisdictions such as the U.S., Canada, and other markets with parallel filings.
5. How should companies incorporate this patent into their R&D strategy?
Firms should evaluate whether their manufacturing processes infringe, explore designing around the claims through parameter variation, or consider licensing agreements to mitigate infringement risk.
References
[1] European Patent EP2916856, “Method for the production of a pharmaceutical composition,” granted December 20, 2017.
[2] Relevant patent landscapes and prior art disclosures on pharmaceutical process patents.
[3] EPO public databases and patent family records.
