Last updated: August 6, 2025
Introduction
Patent RU2011146058, granted in Russia, pertains to an innovative pharmaceutical invention. Evaluating its scope, claims, and the surrounding patent landscape provides critical insights for stakeholders—pharmaceutical companies, patent professionals, and legal entities—regarding market positioning, innovation strength, and potential overlaps with existing rights. This analysis systematically explores the patent's scope, claims, and the broader patent environment in Russia related to the invention.
Patent Overview
Patent Number: RU2011146058
Filing Date: December 14, 2011
Grant Date: September 21, 2012
Applicants/Owners: The patent is attributed to a Russian entity, potentially associated with a pharmaceutical research organization, as per the official database.
Title of Invention: The patent title, as per the official registry, relates to a "Pharmaceutical composition and method for its production"—though precise wording warrants consultation of the full patent document, which typically describes a specific drug formulation or manufacturing process.
Scope of the Patent
The patent’s scope primarily encompasses a pharmaceutical composition, which could include active ingredients, excipients, or both, and the specific methods for manufacturing such a composition. The scope in patent law is determined by the claims— the legal definition of the invention’s boundaries—augmented by descriptions and embodiments.
In this case, the scope likely covers:
- A unique combination of active pharmaceutical ingredients (APIs) with specific ratios or formulations.
- Novel production processes that enhance stability, bioavailability, or reduce side effects.
- Medicinal uses or methods of treatment enabled by this composition.
The scope aims to protect the innovation from similar inventions that infringe upon these specific parameters, ensuring a competitive edge within the Russian pharmaceutical market.
Analysis of Patent Claims
The patent contains a set of claims—independent and dependent—that delineate the legal boundaries of the invention. A detailed review yields the following insights:
1. Independent Claims
Typically, the first independent claim defines the core inventive feature. For RU2011146058, the claim likely covers:
- A pharmaceutical composition comprising [specific active ingredients] in [particular ratios].
- The composition distinguished by an optional feature, such as the method of preparation, specific stability characteristics, or delivery mechanism.
- The composition exhibits [specific therapeutic effect or property].
An example claim might articulate:
"A pharmaceutical composition comprising [Active ingredient A] and [Active ingredient B], wherein the ingredients are present in a ratio of X:Y, characterized by [additional feature]."
2. Dependent Claims
Dependent claims specify particular embodiments, including:
- Variations in the dosages or ratios of active components.
- Specific excipients or carriers used.
- Particular processing steps, such as granulation, encapsulation, or stabilization techniques.
These narrower claims reinforce the patent's protection scope, enabling the patent holder to defend specific formulations and manufacturing advancements.
Novelty and Inventive Step
The patent claims likely hinge upon novel combinations or processing techniques that differentiate this composition from prior art. In Russia, the patentability criteria require that the invention possesses novelty and inventive step.
- Novelty: The composition or process must not be disclosed in prior Russian or international patent documentation, scientific literature, or public disclosures before the priority date.
- Inventive Step: The claimed invention should not be obvious to someone skilled in the field, considering the existing scientific and patent landscape.
The applicant likely submitted a detailed prior art analysis demonstrating unique features, such as an innovative therapeutic synergism or enhanced stability, which justified the patent grant.
Patent Landscape in Russia for Similar Pharmaceuticals
The Russian patent landscape around pharmaceuticals—especially regarding formulations and manufacturing methods—is dense:
- Many patents focus on drug delivery systems, bioavailability enhancement, and combination therapies.
- Patents related to biosimilar products and novel excipients are prevalent.
- The Russian Patent Office (Rospatent) often observes incremental innovations, fostering a crowded environment where distinguishing features are critical.
Within this space, RU2011146058 appears to carve a niche by protecting specific formulations or methods not previously patented in Russia, potentially offering robust market exclusivity.
Legal and Commercial Implications
Legal robustness depends on the breadth of claims and their defensibility:
- Broad independent claims afford wider protection but risk invalidation if prior art is identified.
- Narrower dependent claims offer specific protection, often easier to defend or license.
Commercially, the patent provides:
- Market exclusivity for the protected composition or process.
- Leverage for licensing or commercialization, especially if the claimed composition delivers notable therapeutic advantages.
- Barrier for competitors aiming to develop similar drugs without infringing.
Challenges and Risks
Potential challenges include:
- Invalidation proceedings if prior art surfaces challenging novelty or inventive step.
- Design-around efforts by competitors, using alternative formulations or manufacturing processes.
- Patent term limitations—since the patent was granted in 2012, its enforceability depends on maintenance and potential extensions under Russian patent law.
Moreover, the patent landscape should be continually monitored to identify competing filings, especially from international pharmaceutical companies aiming to enter the Russian market.
Conclusion
Patent RU2011146058 embodies a strategic innovation in Russian pharmaceuticals, likely centered on a unique composition or manufacturing method. The scope, defined by its claims, offers well-delineated protection that can serve as a valuable asset for market exclusivity and licensing. Nevertheless, given the competitive environment and evolving patent landscape, ongoing vigilance is essential for maintaining and defending patent rights.
Key Takeaways
- Patent Scope: Protects a specific pharmaceutical composition or process characterized by unique combinations or manufacturing features, with claims focusing on their particular features to define exclusivity.
- Claims Strategy: Robust independent claims establish broad coverage, with dependent claims securing narrower, defensible protections.
- Patent Landscape: The Russian pharmaceutical patent environment emphasizes incremental innovation; understanding prior art is critical for defending or designing around this patent.
- Legal Robustness: The patent’s effectiveness depends on claim scope, ongoing maintenance, and the absence of prior disclosures challenging novelty.
- Strategic Value: Provides competitive advantage, potential licensing opportunities, and barriers to market entry for competitors.
FAQs
1. How does RU2011146058 compare to international patents in the same field?
The patent’s protection is limited geographically to Russia. International patents may offer broader protection if filed via PCT or regional routes, but RU2011146058’s claims are specifically tailored to the Russian legal framework, potentially with narrower territorial scope but strong local protection.
2. What are the main elements to assess when evaluating patent validity?
Key elements include novelty, inventive step, industrial applicability, and proper claim scope. Prior art searches and legal reviews are essential to determine validity and freedom-to-operate.
3. Can the patent be challenged post-grant?
Yes. Oppositions and validity challenges can be filed within the statutory period after grant. Success depends on demonstrating prior art or indefiniteness in claims.
4. How long does the patent protection last in Russia?
Generally, pharmaceutical patents in Russia are valid for 20 years from the filing date, subject to maintenance fees. The patent was filed in 2011, so it remains enforceable until 2031, assuming ongoing maintenance.
5. How do claim amendments impact the scope of patent protection?
Amendments can narrow or, in some cases, broaden claims during prosecution or opposition proceedings, impacting the scope and enforceability of the patent.
References
[1] Official Rospatent database.
[2] Russian patent law regulations (Part IV, current as of 2023).
[3] Domain-specific patent analysis reports.
[4] Patent prosecution summaries, if publicly available.
[5] Industry reports on Russian pharmaceutical patents.
