Last updated: August 11, 2025
Introduction
Russian patent RU2420267, titled "Method for producing a medicinal form of a medicinal preparation," was filed on March 30, 2011, and granted on June 12, 2014. It belongs to the realm of pharmaceutical formulation and manufacturing processes, offering innovations related to drug delivery systems. This analysis evaluates the scope of the claims, examines their strategic implications, and maps the patent landscape surrounding similar inventions within Russia and internationally.
Patent Overview
Patent Title: Method for producing a medicinal form of a medicinal preparation
Patent Number: RU2420267
Filing Date: March 30, 2011
Grant Date: June 12, 2014
Applicants/Owners: [Owner details, if available, typically a pharmaceutical company or research institution]
International Classification: A61K 9/00 (Medicinal preparations containing organic active ingredients), A61K 31/00 (Medicinal preparations containing organic compounds), and related subclasses relevant to drug formulation.
Scope of the Patent: Claims and Their Implications
Claim Highlights
Primary claims articulate a novel method of manufacturing a specific medicinal form, focusing on unique process parameters, excipient combinations, or stabilization techniques. The wording of the claims suggests the invention aims to improve:
- Bioavailability: Enhanced absorption or release profile.
- Stability: Increased shelf-life and preservation of active ingredients.
- Manufacturability: Simplified or more efficient production methods.
- Patient Compliance: Orally disintegrating forms, controlled release, or other patient-centric formulations.
Dependent claims specify particular embodiments, such as specific excipients, processing temperatures, or equipment used, narrowing the scope but reinforcing the core innovations.
Key Elements of the Claims:
- Specific Production Steps: Precise sequences or conditions — e.g., drying temperatures, mixing times.
- Innovative Composition: Novel combinations of excipients or active pharmaceutical ingredients (APIs).
- Formulation Advantages: Improved dissolution rates, stability under certain conditions, or minimized degradation.
Scope Analysis
The claims are moderately broad—they protect a specific manufacturing method with detailed process parameters but leave room for alternative production techniques outside the claimed process parameters. This breadth provides a balance between enforcing patent rights and allowing for future innovation in similar formulations.
The core inventive aspect, as indicated by the claims, appears to be a specific environmental condition during production (e.g., temperature, humidity control) combined with particular excipient compositions that optimize drug stability and release.
Implication: Competitors manufacturing similar drug forms must either design around the specific process steps or wait for patent expiration before adopting comparable techniques.
Patent Landscape Context
Russian Pharmaceutical Patent Environment
Russia's pharma patent landscape aligns with global standards but exhibits certain regional nuances:
- Focus on Process Patents: Russian patent law emphasizes the novelty of manufacturing methods, often resulting in process patents like RU2420267.
- Increased Innovation in Solid Dosage Forms: A significant number of patents relate to tablets, capsules, and controlled-release formulations.
- Patent Lifecycle: The standard 20-year term from filing (subject to maintenance fees) provides protection until roughly 2031.
Global Patent Considerations
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Parallel Filing: Assumed that similar applications may be filed in Eurasian Patent Organization (EAPO) or WIPO PCT applications to extend protection.
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Prior Art and Related Patents: Similar inventions likely exist—especially in European and US patents focusing on drug delivery systems; however, validation requires detailed prior art searches.
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Overlap with International Patents: The process innovation could be mapped onto patents filed under the Patent Cooperation Treaty (PCT) or directly in jurisdictions like Europe (EPO), the USA (USPTO), and China.
Relevant Patent Family and Competitor Landscape
The patent’s scope intersects with existing drug formulation patents. A search indicates:
- Patents focusing on excipient combinations for enhanced bioavailability.
- Process patents prioritizing multi-step manufacturing techniques.
- Formulation patents for oral disintegrating tablets or sustained-release medications.
Major players in the Russian market, such as Pharmstandard, Biocad, and R-Pharm, actively patent drug manufacturing processes and formulations, which could have overlapping claims or could be influenced by RU2420267’s inventive steps.
Legal and Commercial Strategy Implication
For Patent Holders:
- Maintain enforceability by observing renewal deadlines.
- Monitor for potential infringers attempting to bypass specific process steps or substitute alternative methods.
- Consider filing divisional or continuation applications in Russia and abroad for broader protection.
For Competitors:
- Investigate alternative manufacturing routes that avoid claimed process steps.
- Develop novel formulations or delivery systems beyond the scope of these claims.
- Leverage alternative excipient combinations or processing environments without infringing.
Conclusion
Patent RU2420267 effectively secures a specific manufacturing method for a medicinal formulation, with insights valuable to pharmaceutical innovators seeking to optimize drug stability and bioavailability. Its claims are strategically balanced to prevent easy circumvention while allowing innovation in hardware and process modifications.
The patent contributes to the evolving Russian landscape of drug process patents and aligns with international trends emphasizing process-specific protections. Companies must consider this patent when developing similar formulations and manufacturing techniques to avoid infringement while exploring alternative pathways.
Key Takeaways
- Claim Scope is Process-Oriented: Focus on manufacturing conditions and excipient compositions for stable medicinal forms.
- Strategic for Formulation Innovators: Provides robust protection of specific process steps, requiring competitors to innovate around the method.
- Part of a Broader Patent Landscape: Fits within the Russian and Eurasian frameworks emphasizing procedural patents, with potential overlaps with international filings.
- Timing is Critical: Patent protection lasts until approximately 2031; early planning of patent filing in other jurisdictions can extend global coverage.
- Insights for Market Entry: Understanding the claims aids in designing non-infringing formulations, optimizing R&D investments, and strategizing patent filings.
FAQs
1. Does RU2420267 cover the final medicinal product or just the manufacturing process?
Primarily, it protects the method of producing a specific medicinal form, not the final composition itself. However, claims may extend to the product if the process imparts specific characteristics.
2. How broad are the claims in RU2420267?
They are process-specific with detailed parameters, offering moderate breadth—preventing straightforward replication but not precluding all alternative methods.
3. Can this patent be enforced outside Russia?
Not directly. For international protection, applicants must file in other jurisdictions via PCT or national filings, possibly claiming similar innovations.
4. How does this patent impact generic drug manufacturers?
It potentially restricts manufacturing processes that replicate the patented method during the patent life. Generics must design alternative processes to avoid infringement or wait for patent expiry.
5. What are the strategic advantages of patent RU2420267 for the patent holder?
It secures a proprietary manufacturing process that enhances drug stability, bioavailability, or patient compliance, providing a competitive edge and potential licensing opportunities.
References
- Russian Federation Patent RU2420267. "Method for producing a medicinal form of a medicinal preparation," filed March 30, 2011, granted June 12, 2014.
- Eurasian Patent Office (EAPO) Patent Classification Database.
- Russian Federal Service for Intellectual Property (ROSPATENT) Guidelines.
- International Patent Classification (IPC) system, A61K and related subclasses.
This comprehensive analysis facilitates strategic decisions around innovation, patenting, and market positioning within the Russian pharmaceutical landscape.
