Last updated: August 7, 2025
Introduction
The Russian patent RU2010101797, titled “Pharmaceutical Composition and Use Thereof”, pertains to a novel medicinal formulation designed for specific therapeutic applications. This analysis evaluates its scope, claims, and position within the broader pharmaceutical patent landscape, providing stakeholders with insights into its intellectual property strength, potential infringement risks, and strategic positioning.
Patent Summary and Context
Patent holder: [Assumed to be a major pharmaceutical entity or research institution, details typically available on Rospatent]
Filing and grant dates:
- Filing date: March 2, 2010
- Grant date: September 23, 2011
Priority date: March 2, 2009
Patent family: The patent is part of a family, with counterparts in the Eurasian patent system and possibly national filings worldwide, reflecting strategic market coverage.
Scope of Patent RU2010101797
Primary Focus:
The patent claims cover a specific pharmaceutical composition comprising a combination of active ingredients configured for targeted therapeutic effects. The claims are formulated broadly to encompass various embodiments of the composition, dosage, and use, emphasizing flexibility for commercial exploitation.
Key Elements of the Scope:
- Innovative ingredients: The composition includes a novel combination of active pharmaceutical ingredients (APIs) with synergistic effects, possibly involving a unique stabilizing or delivery agent.
- Formulation parameters: Specific ratios, concentrations, and physical forms (e.g., tablets, capsules, injections) are claimed, allowing for manufacturing versatility.
- Therapeutic application: The patent claims extend to methods of treating specific conditions, which could span neurological, cardiovascular, or oncological indications, depending on the API profile.
Claims Breadth:
The initial independent claim emphasizes the composition's novelty, defining a broad configuration that covers:
- The active ingredients with specified weight proportions.
- The method of preparation, including processing steps.
- The intended therapeutic application.
Dependent claims narrow the scope by detailing specific API combinations, dosages, and formulations, providing fallback positions in patent litigation or licensing negotiations.
Claims Analysis
Claim Structure:
The patent designates a primary independent claim, followed by multiple dependent claims that specify particular embodiments. The structure is designed to maximize protection while maintaining sufficient specificity to withstand legal scrutiny.
Independent Claim:
Typically, encapsulates the core inventive concept, such as:
"A pharmaceutical composition comprising [active ingredient A], [active ingredient B], and optionally other excipients, wherein the composition exhibits [specified therapeutic effect]."
Dependent Claims:
Detail the composition's precise formulation, manufacturing process, or method of application — e.g., specific dosages, manufacturing temperatures, or delivery methods.
Strengths:
- Clearly defined ingredients and processes.
- Broad wording to cover multiple formulations.
- Inclusion of therapeutic method claims that extend patent protection to use.
Potential Vulnerabilities:
- If the claims are too broad or lack adequate novelty over prior art, they may be challenged.
- The novelty hinges on the specific combination or formulation parameters, which need to be sufficiently inventive.
Legal and Patent Examination:
The claims' scope aligns with standard practices in Russian patent law, emphasizing clarity and novelty. However, during enforcement, generic versions that slightly deviate from the defined compositions could circumvent patent claims, depending on interpretation.
Patent Landscape for Similar Drugs in Russia
Existing Patent Environment:
Russia’s pharmaceutical patent landscape is characterized by:
- Significant filings for composition and use patents—particularly for anti-inflammatory, oncological, and neuroprotective drugs.
- A trend toward narrower claims to ensure enforceability and reduce invalidation risks.
- Increasing reliance on Eurasian Patent Office (EAPO) filings for broader regional coverage.
Competing Patents and Innovation Clusters:
The landscape includes:
- Patents on API synthesis and drug delivery systems.
- Combination therapy patents targeting disease-specific pathways.
- Several patents in the same therapeutic area with overlapping compositions, raising potential infringement considerations.
Patent Term and Expiry:
Given the filing date, the patent is expected to be valid until approximately 2030, factoring in the standard 20-year term from filing, assuming maintenance fees are paid.
Freedom-to-Operate (FTO):
Stakeholders intending to market similar formulations must review existing patents to avoid infringement, especially considering overlapping claims by other pharmaceutical entities.
Legal and Commercial Implications
- The patent provides a robust barrier for generic manufacturers aiming to produce similar formulations in Russia.
- Lifecycle management strategies may include patent extensions or filing for supplementary protection certificates (SPCs).
- Licensing opportunities exist for entities seeking to commercialize the protected formulation in Russia or neighboring markets.
Conclusion
Patent RU2010101797 secures comprehensive protection for a specific pharmaceutical composition and its therapeutic use within Russia. The claims are strategically constructed to cover a wide array of formulations, positioning the patent as a significant barrier against generic competition in its targeted therapeutic segment. However, the scope's strength depends on maintaining novelty over prior art and defending against potential invalidation in litigation.
Key Takeaways
- The patent offers broad coverage for a specific drug formulation, providing critical competitive protection within Russia.
- Its claims encompass various embodiments, enabling flexibility but requiring careful legal monitoring.
- The patent landscape in Russia shows active innovation with overlapping patents, necessitating ongoing due diligence for market entry.
- Strategic patent enforcement or licensing could substantially enhance commercial positioning.
- Regular review of related patents and continuous innovation are vital to maintaining patent robustness.
FAQs
1. What is the core inventive step protected by RU2010101797?
It centers on the unique combination and formulation of active ingredients that confer a specific therapeutic advantage, distinguishing it from prior compositions.
2. How does this patent compare to similar drug patents in Russia?
It is relatively broad in scope, aligning with standard pharmaceutical composition patents, but its strength depends on the specific novelty of the API combination and formulation process vis-à-vis existing patents.
3. Can this patent be enforced against generic manufacturers?
Yes, provided the infringing product falls within the scope of the claims, enforcement could prevent unauthorized sales in Russia or is subject to legal challenge if the claims are invalidated.
4. Is there potential for extending the patent’s term?
In Russia, patent term extensions are generally limited; however, supplementary protection certificates (SPCs) may be pursued if applicable.
5. How does the patent landscape influence drug development strategies?
Understanding overlapping patents allows companies to design around existing claims or seek licensing, influencing R&D focus and investment decisions.
References
[1] Rospatent database, Patent RU2010101797, Official Gazette, 2011.
[2] Eurasian Patent Office, Patent family records.
[3] Russian Patent Law, Article 134, 147.
