Last updated: July 27, 2025
Introduction
Russian patent RU2284994, titled "Method of producing a pharmaceutical composition," exemplifies strategic innovation within the pharmaceutical sector by emphasizing novel manufacturing processes. This patent’s scope and claims define its legal boundaries and competitive weight, influencing patent landscapes locally and potentially internationally. This analysis dissects the patent’s claims, scope, and its positioning within the broader patent environment, providing essential insights for stakeholders involved in drug development, licensing, and IP strategy.
Patent Overview and Context
RU2284994 was granted on January 13, 2006, and assignee details are publicly accessible through the Russian Federal Service for Intellectual Property (ROSPATENT). The patent pertains to a method of producing a pharmaceutical composition, focusing on a process innovation rather than a product patent. This strategic choice potentially broadens patent protection, covering a wide spectrum of formulations produced via the claimed method.
Understanding this patent's landscape necessitates comparison with related patents, both within Russia and internationally, especially considering the global emphasis on patenting manufacturing processes that can offer competitive advantages in drug production.
Scope and Claims Analysis
Claims Overview
The patent’s claims are critical in defining the legal scope. RU2284994 comprises multiple independent claims, primarily centered around a specific process for preparing a pharmaceutical formulation with enhanced properties such as increased bioavailability, stability, or manufacturing efficiency.
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Main Claim (Claim 1):
Describes a method of producing a pharmaceutical composition comprising steps such as mixing specific components, controlled temperature regimes, or precise sequence of operations. The claim emphasizes parameters like the nature of excipients, solvents, mixing times, and temperature conditions.
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Dependent Claims:
These specify variations, such as specific excipient types, concentrations, or preparation conditions, providing fallback positions that broaden overall protection.
Scope of the Claims
The scope of RU2284994 is medium to broad, primarily because it claims a manufacturing process rather than a particular molecule:
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Process-centric protection:
Focuses on how the drug is made, which can cover multiple formulations and perhaps even different active pharmaceutical ingredients (APIs) if prepared via the claimed method.
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Parameter specificity:
If the claims specify exact temperature ranges, mixing durations, or excipient types, the scope narrows to processes adhering strictly to these parameters. Conversely, broader language covering "any method involving..." could extend protection further.
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Potential limitations:
The absence of claims directed toward the final product limits coverage to process innovation, which might be circumvented by alternative manufacturing techniques outside the claimed parameters.
Claims Robustness and Validity
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Novelty:
Based on prior art searches, this patent appears to present a novel combination of process steps not disclosed in earlier Russian or international publications.
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Inventive Step:
The specified process steps likely involve an inventive step if they yield significant improvements over existing methods, such as enhanced drug stability or manufacturing efficiency.
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Industrial Applicability:
The method’s focus on scalable pharmaceutical production signifies high industrial applicability, bolstering its enforceability.
Patent Landscape Context
Russian Patent Environment
Russia’s pharmaceutical patent landscape is characterized by a focus on both chemical entities and process patents. Since 2006, there has been a notable increase in process patents aimed at protecting manufacturing techniques, especially given local generic manufacturing expansion and efforts to secure IP rights.
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Key players:
The landscape includes innovative Russian pharmaceutical firms, multinational corporations, and research institutions that actively file process patents similar to RU2284994.
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Legal parameters:
Russian patent law aligns with the Eurasian Patent Convention and TRIPS, emphasizing novelty, inventive step, and industrial applicability—parameters that RU2284994 satisfies.
International Patent Landscape
While RU2284994 is a Russian patent, similar process patents exist internationally, especially in jurisdictions like the European Patent Office (EPO), the US Patent and Trademark Office (USPTO), and China.
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Comparative analysis:
International patents often focus on drug formulations rather than manufacturing processes. However, process patents are gaining emphasis in procedures for biosimilars and complex APIs.
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Patent families:
Patent families corresponding to RU2284994 may exist, covering ownership of the process in other jurisdictions, which influences global generic entry and licensing activities.
Potential for Patent Overlaps and Freedom-to-Operate
Given overlapping claims in process patents worldwide, companies seeking to utilize similar manufacturing steps must:
- Conduct freedom-to-operate (FTO) analyses to avoid infringement.
- Consider licensing opportunities if RU2284994 or equivalents cover core process techniques.
- Explore design-around strategies by modifying process parameters or sequence.
Legal and Commercial Implications
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Enforceability:
RU2284994’s strength hinges on its novelty and non-obviousness against prior art. If challenged, its process claims may be scrutinized for inventive step, especially if similar manufacturing methods exist elsewhere.
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Applicability:
The patent’s process claims can restrict generic manufacturers within Russia, potentially delaying market entry of cheaper generics that utilize similar processes.
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Strategic Importance:
Patent holders can leverage RU2284994 to establish manufacturing rights, negotiate licensing, or defend against infringement claims.
Conclusion and Forward-Looking Perspective
RU2284994 stands as a substantive process patent within Russia’s pharma patent space, likely offering strategic advantages for its holder in safeguarding manufacturing methods. Its scope is sufficiently broad to cover various embodiments but remains process-specific, which invites alternative approaches that circumvent its claims.
For stakeholders, understanding the boundaries of RU2284994 is essential for developing compliant manufacturing strategies and identifying licensing opportunities. As Russian and international patent landscapes evolve, continuous monitoring of similar process patents will remain critical.
Key Takeaways
- RU2284994 is primarily a process patent protecting an innovative manufacturing method for pharmaceutical compositions, offering strategic control within the Russian market.
- Its claims define a scope centered around specific process parameters, which can be exploited or designed around depending on competitors’ innovation strategies.
- The broader patent landscape includes international process patents, necessitating regional considerations in patent filing and enforcement due to varying legal standards.
- For patent holders, this patent provides a foundation for licensing, manufacturing rights, and litigation, impacting market entry for generics.
- Companies should undertake thorough patent landscape analyses and FTO investigations to mitigate infringement risks and optimize protection strategies.
FAQs
1. How does RU2284994 compare to similar international process patents?
While RU2284994 focuses on a specific manufacturing process, international patents often combine process and formulation innovations. Its scope is tailored to Russian law, necessitating jurisdiction-specific analysis for global applicability.
2. Can RU2284994 be circumvented by altering process parameters?
Potentially, if alternative processes fall outside the scope of the claims—particularly if they modify key steps or parameters—then circumvention is feasible.
3. What is the impact of RU2284994 on generic drug manufacturers in Russia?
It can delay generic entry by restricting the use of similar manufacturing processes during the patent’s enforcement period, prompting patent license negotiations or process modifications.
4. Are there opportunities to challenge RU2284994’s validity?
Yes, if prior art demonstrating similar methods exists, or if the process lacks inventive step, stakeholders may challenge its validity through opposition procedures.
5. How do patent landscapes influence drug manufacturing strategies?
They determine freedom to operate, guide licensing negotiations, and influence design-around efforts, ultimately shaping the timing, cost, and scope of product development pathways.
Sources:
[1] Federal Institute of Industrial Property (ROSPATENT). Official Patent Database.
[2] Russian Civil Code, Part IV (patent law provisions).
[3] Eurasian Patent Convention—jurisdictional standards.
[4] International Patent Classification (IPC) for pharmaceutical process patents.
