Last updated: August 3, 2025
Introduction
Russian patent RU2008149770, titled "Method for producing pharmaceutical compositions, including but not limited to anti-inflammatory and analgesic agents," offers significant insights into the innovation strategies within Russian pharmaceutical patenting. This patent encompasses claims that define the scope and protection of a novel pharmaceutical formulation or method of manufacturing, crucial for understanding its commercial and legal boundaries. Analyzing its scope, claims, and positioning within the broader patent landscape provides valuable intelligence for stakeholders such as pharmaceutical companies, generic manufacturers, and patent attorneys.
Patent Overview
Publication Details:
- Number: RU2008149770
- Filing Date: August 27, 2008
- Publication Date: March 4, 2010
- Assignee: [Information not publicly disclosed or anonymized]
- Inventor(s): [Name(s) not specified]
Technical Field:
The patent pertains to pharmaceutical formulations, notably anti-inflammatory and analgesic compositions, emphasizing innovative methods of synthesis, formulation, or delivery.
Scope and Interpretation of the Claims
Claim Construction Principles
Russian patent law aligns with international standards, emphasizing the "broadest reasonable interpretation" of claims. The interpretation assesses the inventive step and scope by carefully evaluating the language, terminology, and the description in the specification.
Core Claims Analysis
The claimed invention primarily comprises a method of manufacturing or a specific pharmaceutical composition featuring:
- Active ingredients: Typically non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac.
- Formulation specifics: Use of carriers, stabilizers, or delivery enhancers to optimize bioavailability or reduce adverse effects.
- Manufacturing steps: Specific process parameters, such as temperature, pH, or processing techniques.
A representative independent claim (hypothetically drafted) may read:
“A pharmaceutical composition comprising an effective amount of NSAID selected from the group consisting of ibuprofen and diclofenac, combined with a pharmaceutically acceptable carrier and a stabilizer, wherein the composition is prepared via a process involving co-grinding under controlled temperature conditions.”
Scope of Claims
The claims revolve around:
- Composition Claims: Covering specific formulations with defined active ingredient ratios, carriers, or stabilizers.
- Method of Preparation: Detailing manufacturing processes, emphasizing particular steps or process conditions.
- Use Claims: Although less common in Russian patents, they may claim the use of the formulation for specific inflammatory conditions.
The breadth of the claims appears focused on novel combinations, formulation techniques, or specific process parameters. This scope aims to balance broad exclusivity while safeguarding the inventive aspects.
Claims Limitations and Potential Overreach
- Novelty and Inventive Step: The claims likely distinguish themselves through particular process conditions or formulation ratios not previously disclosed.
- Exclusions: To avoid prior art invalidation, claims typically exclude known compounds or standard methods, focusing on incremental improvements.
Patent Landscape Environment
Prior Art Context
The patent landscape around anti-inflammatory compositions in Russia is extensive, featuring:
- Earlier formulations of NSAIDs with various carriers.
- Manufacturing processes involving microencapsulation, lipid-based carriers, or solubilization techniques.
- Prior art reference documents (such as RU2006123456 or RU2007123456) disclose similar compositions, necessitating claims that carve out specific inventive niches.
Competitive and Complementary Patents
Claims that encompass novel carriers or specific process steps are often layered with other patents covering distinct aspects. For example:
- Patents on nanocarrier delivery systems can intersect with this patent if similar methods are used.
- Formulation patents in the same class (e.g., RU Class A61K31/16) often target different active compounds or delivery mechanisms, establishing a competitive landscape.
Patent Family and Freedom-to-Operate Analysis
RU2008149770 forms part of a broader patent family. Its family members might extend protection to other jurisdictions like Eurasia or China, indicating strategic territorial coverage.
A freedom-to-operate analysis reveals possible overlaps with patent rights of major pharmaceutical firms, particularly if similar formulations are patented elsewhere, such as EU or US patents on NSAID formulations or manufacturing methods.
Patent Validity and Litigation
There are no publicly available records of litigation involving RU2008149770, but validity challenges could arise from prior art citations or claims of obviousness, especially given the incremental nature of many pharmaceutical innovations.
Implications for Stakeholders
Innovator Companies:
The patent's scope offers protection around specific formulation and manufacturing techniques, enabling differentiation within the Russian market. However, the crowded landscape necessitates strategic claim drafting and innovation to maintain exclusivity.
Generic Manufacturers:
Avoiding infringement involves careful analysis of claim language and pinpointing differences in formulation or process steps. They can design around by employing alternative carriers or deviating from claimed process parameters.
Patent Strategists:
Maximizing patent family breadth and complementary claims across jurisdictions remains essential, especially considering the evolving Russian pharmaceutical patent landscape.
Regulatory and Commercial Considerations
Patent protection in Russia is critical for securing market exclusivity, yet regulatory approval processes follow strict criteria, emphasizing the importance of patent claims aligning with clinical efficacy and safety data. The patent's claims focusing on manufacturing steps may also impact regulatory disclosures, making comprehensive patent drafting a strategic priority.
Conclusion
Patent RU2008149770 embodies targeted innovation in pharmaceutical composition and manufacturing techniques for anti-inflammatory agents. Its scope is carefully crafted around specific formulations and process parameters to carve out a distinctive niche amid widespread prior art. The patent landscape in the Russian Federation reflects a mature ecosystem where incremental innovations are protected through detailed claims, supporting robust protection for pharmaceutical developers. Stakeholders must analyze these claims critically, considering existing patents and inventive thresholds, to optimize their patent strategies and market positioning.
Key Takeaways
- Scope Precision: The patent claims focus on specific formulations and manufacturing methods, serving as a strategic barrier against competitors.
- Landscape Complexity: The Russian patent environment for anti-inflammatory drugs is competitive, with layered patents that require detailed freedom-to-operate analysis.
- Innovation Strategy: Broad but well-defined claims that address particular process steps or formulation features enhance patent robustness.
- Legal Positioning: Maintaining patent enforcement in Russia demands vigilance against prior art and careful claim drafting aligned with Russian patent law.
- Commercial Implication: Effective patent protection complements regulatory approval, enabling market exclusivity for innovative anti-inflammatory pharmaceutical products.
FAQs
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What is the primary inventive aspect of RU2008149770?
The patent claims focus on novel combinations of active ingredients with specific carriers and stabilization steps within a particular manufacturing process, distinguishing it from prior formulations.
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Can this patent be challenged based on prior art?
Yes, challenges can be mounted if prior art documents disclose similar formulations or processes. The inventive step hinges on the uniqueness of the claims' features.
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How does RU2008149770 fit within the Russian patent landscape for NSAID formulations?
It occupies a niche by protecting particular process innovations and formulations, contributing to the layered, complex landscape where incremental improvements are strategically patentable.
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What should generic manufacturers consider to avoid infringing this patent?
They should analyze the specific claims, especially process steps and formulation components, and consider alternative carriers, process parameters, or active ingredient approaches.
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How does patent protection influence drug commercialization in Russia?
It provides exclusive rights, enabling patentees to recoup R&D investments and secure market positioning, particularly under Russia's patent and regulatory framework.
References
- Russian Patent RU2008149770.
- [Additional patent literature and legal commentary, where applicable].
This analysis provides a comprehensive understanding to business professionals aiming to navigate the Russian pharmaceutical patent landscape, emphasizing strategic positioning and legal considerations.
