Last updated: August 4, 2025
Introduction
Patent RU2458692, titled "Method of producing a dry powder inhalation preparation," filed by Valery Fedorovich Mirzalaev, was granted in Russia on June 13, 2012. This invention pertains to pharmaceutical formulations, specifically inhalable dry powder products intended for pulmonary delivery. In the context of inhaled medications, such innovations hold significant commercial and therapeutic implications, particularly in respiratory diseases like asthma, COPD, and emerging respiratory viruses.
This analysis examines the scope and claims of RU2458692, underlying inventive matter, potential landscape overlaps, and the strategic patent environment within Russia and internationally. Such an assessment enables stakeholders—pharmaceutical companies, generic manufacturers, and patent strategists—to understand patent strength, freedom-to-operate considerations, and avenues for future innovation.
Scope and Claims of RU2458692
Claim Structure and Key Elements
The patent’s core claims delineate the scope of protection.
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Main claim (Claim 1):
The patent covers a method for producing a dry powder inhalation preparation, involving specific steps:
- Preparation of a pharmaceutical composition containing an active pharmaceutical ingredient (API) and excipients.
- Drying and milling to obtain a powder with defined particle size distribution optimally suited for inhalation.
- Processing into a dry powder form suitable for inhalation use.
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Dependent claims specify particular parameters:
- Types of API (e.g., bronchodilators, corticosteroids).
- Particular excipients used (lactose, magnesium stearate, etc.).
- Conditions for drying (temperature, pressure).
- Particle size ranges (typically 1-5 micrometers) that optimize deep lung delivery.
- Optional inclusion of stabilizers or dispersing agents.
Scope Analysis
The scope of RU2458692 centers on the methodology of preparing inhalation powders, rather than specific formulations or APIs. This lends broad applicability, covering:
- Production processes—from pharmaceutical mixture preparation to drying and milling.
- Particle size control techniques, assuming critical for inhalation efficacy.
- Choice of excipients and process parameters—if within the claimed parameters.
The somewhat broad procedural claim ensures coverage over various APIs within the specified process boundaries, conferring a relatively wide protection covering commercially relevant inhalable powders.
Strength and Limitations
The claims' strength derives from the detailed process parameters, which are sufficiently specific to prevent easy workarounds but broad enough to encompass multiple formulations. However, the patent might be limited if prior art discloses similar drying/milling methods, especially those employing comparable parameters.
Patent Landscape and Competitive Environment
Russia's Pharmaceutical Patent Environment
Russia’s pharmaceutical patent landscape is characterized by a mix of domestic innovations and international filings, with a trend toward aligning with the Patent Cooperation Treaty (PCT) system. The patent system emphasizes process innovations, particularly manufacturing methods, which are critical in inhalation therapy due to manufacturing challenges.
Inhalation Drug Patents in Russia
Inhalation drug patents often focus on:
- Formulation stability.
- Particle size manipulation.
- Delivery efficiency.
Noteworthy is RU2428378, granted for a powdered inhalation composition with specific excipients, and RU2294579, related to inhalation devices. Compared to RU2458692, these patents encompass formulation specifics rather than manufacturing processes, indicating that process patents like RU2458692 fill a vital niche.
International Context and Overlap
Russia's patent system relies heavily on national filings; however, similarities with international counterparts are common. Potential overlaps may exist with patents filed in Europe (EPO), the US, or China related to dry powder inhalation processing. For instance, US patents such as US5558944 (“Aerosol preparation and method for producing the same”) cover similar methods but with different process specifics—highlighting the importance of process nuances.
Freedom-to-Operate Considerations
While RU2458692 offers broad process coverage in Russia, the landscape of inhalation manufacturing patents is highly competitive. Companies must assess:
- Existing process patents in Russia and abroad.
- Whether local manufacturing processes infringe upon these rights.
- Opportunities for designing around the claim scope, e.g., adjusting process parameters or excipient choices outside the claimed ranges.
Strategic Implications
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Patent Strength: The detailed process claims confer a robust position domestically, making infringement enforcement based on process steps feasible.
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Innovation Buffer: As inhalation technologies evolve with nanotechnology and formulation science, future process modifications may circumvent claims, emphasizing the importance of continuous innovation.
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Patent Liberties: For generic manufacturers, RU2458692’s broad procedural scope necessitates careful analysis before process commercialization in Russia.
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Global Expansion: Given the localized nature of RU2458692, companies targeting international markets must rely on corresponding international patents, if any, to avoid infringement.
Key Takeaways
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Broad Process Coverage: RU2458692 discloses a methodical approach to producing dry powder inhalation drugs, with specific parameters that, if respected, serve as strong protection in Russia.
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Niche Positioning: It complements existing formulation patents and fills a strategic gap concerning manufacturing methods.
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Competitive Landscape: The inhalation patent environment is crowded, with other patents focusing on formulations, devices, and production methods; due diligence is crucial for freedom-to-operate analyses.
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Innovation and Enforcement: To maintain competitive advantage, patent owners should monitor evolving process technologies and consider international equivalents to safeguard global market interests.
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Regulatory and Commercial Considerations: Patent protection enhances R&D investment security but must be paired with ongoing innovation and strategic patent portfolio management.
FAQs
1. Does RU2458692 cover specific API formulations or just manufacturing processes?
It primarily protects the manufacturing process for dry powder inhalation preparations, irrespective of the API, provided process steps and parameters fall within the claimed scope.
2. How does RU2458692 compare with international inhalation device patents?
It focuses on formulation preparation methods, not device design; thus, it complements device patents, which govern inhaler hardware.
3. Can a company modify process parameters to avoid infringement of RU2458692?
Potentially, if modifications fall outside the scope of the claims, especially in process conditions and particle size ranges, reducing infringement risk. Careful analysis of claim language is essential.
4. Is the patent still enforceable or has it expired?
As granted in 2012, its validity would generally last 20 years from filing, likely expiring around 2030 unless maintenance fee issues arise.
5. Are there additional Russian or European patents covering similar inhalation process innovations?
Yes, similar process patents exist but vary in scope and specificity; comprehensive patent landscaping is recommended to identify overlaps and avoid infringement.
References
[1] Patent RU2458692. Method of producing a dry powder inhalation preparation.
[2] Patent RU2428378. Powdered inhalation composition (analogous formulation patent).
[3] Patent US5558944. Aerosol preparation and process (comparable international process patent).
[4] Russian Federal Service for Intellectual Property (FIPS) Publications.
[5] WIPO Patent Database.
This detailed patent landscape insight equips pharmaceutical IP professionals with clarity on RU2458692’s coverage, competitive positioning, and strategic considerations critical for R&D and commercialization.
