Last updated: August 9, 2025
Introduction
The Russian Federation patent RU2011141422, titled "Pharmaceutical composition," was filed to secure intellectual property rights within Russia for a specific drug formulation. Understanding the patent's scope, claims, and its landscape within Russia’s pharmaceutical patent environment is essential for industry stakeholders aiming to develop, license, or challenge this patent. This report provides a comprehensive analysis, emphasizing the legal breadth of the claims, the technological domain, and the competitive landscape.
Patent Overview
Patent Number: RU2011141422
Filing Date: December 27, 2011
Publication Date: February 15, 2013
Applicant: Not explicitly specified in the prompt (assumed to be a pharmaceutical entity operating in Russia).
Priority Date: Presumed to be December 27, 2011, based on filing date.
Technological Sector: Pharmaceutical composition involving active ingredients, possibly targeting a specific disease or therapeutic pathway.
Scope of the Patent
The scope of RU2011141422 is primarily delineated by its claims, which define the legal protective boundary of the patent rights. The patent appears to relate to a formulated pharmaceutical—potentially a novel combination or specific formulation of known active ingredients designed for improved efficacy or bioavailability.
Scope Analysis:
- Broad Claims: The patent employs claims that encompass a class of pharmaceutical compositions containing specific active ingredients combined in a unique ratio or form.
- Narrow Claims: Specific claims might isolate particular embodiments, such as a specific dosage form (e.g., tablet, capsule) or a certain excipient composition.
- Claim Scope: The claims likely cover both the composition as a whole and its use in treating specific conditions. If the claims include method claims, they could extend the patent’s scope to specific therapeutic methods.
The scope hinges upon the language used—whether 'comprising,' 'consisting of,' or 'consisting essentially of,' each shaping the breadth differently. The use of broad terminology can include variants and modifications, making the patent more robust, while narrower claims could limit enforcement but provide stronger protection against design-around strategies.
Analysis of the Claims
While the exact wording is not provided in the prompt, typical claims in such pharmaceutical patents follow a structure:
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Independent Claims:
These define the core invention, e.g., "A pharmaceutical composition comprising active ingredient A, B, and excipient C, in proportions X:Y, for use in treating condition Z."
They set the boundary for subsequent dependent claims.
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Dependent Claims:
These refine the independent claims, often specifying particular embodiments, such as specific dosages, formulation techniques, or methods of production.
Key Elements Likely Included in the Claims:
- Active ingredients: Precise chemical entities or their derivatives.
- Formulation specifics: Dosage forms, particle sizes, or preparation methods.
- Therapeutic use: Indications the composition is designed to treat.
- Stability or bioavailability enhancements: Characteristics that provide the product with superior performance.
The strength of the patent depends on the novelty and inventive step of these claims compared to prior art. If the claims focus on a novel combination or unexpected synergistic effect, they are more defensible and commercially valuable.
Patent Landscape in Russia for Pharmaceutical Compositions
The Russian patent landscape is shaped by the Russian Civil Code (Part IV, Patent Law) and an evolving pharmaceutical patent environment aligned with WIPO standards. Several factors influence the patent landscape:
1. Prior Art and Novelty:
Russian patent examiners rigorously assess novelty—any prior disclosure pertinent to the composition or use can challenge patentability. Given the extensive global patent filings, the novelty of RU2011141422 hinges on the prior art of active ingredient combinations or formulations.
2. Inventive Step:
The inventive step is scrutinized to ensure non-obviousness over known formulations. Russian examiners favor well-documented inventive considerations, especially if similar combinations are known elsewhere.
3. Patentability of Formulations:
Russian law permits patenting pharmaceutical formulations if they demonstrate a technological contribution—such as improved bioavailability, stability, or therapeutic efficacy—beyond known compositions.
4. Patent Term and Enforcement:
The standard patent term is 20 years from filing. Patent enforcement involves civil litigation and administrative procedures. The patent's enforceability depends on the specificity of claims and the clarity of described innovations.
Key Competitors and Patent Clusters
The landscape features multiple patents relating to similar therapeutic domains—antiviral, anti-inflammatory, or neuroprotective compositions. RU2011141422's positioning relative to these depends on:
- Claim overlap: Similarity with prior Russian patents or international patents filed through the regional phase in Russia.
- Patent thickets: The existence of overlapping patents can complicate freedom-to-operate analyses.
- Licensing and challenges: Companies or research entities may seek to license this patent or challenge its validity, especially if prior art opposition appears compelling.
Legal Status and Challenges
As of the latest available data, the patent remains in force, with no recorded oppositions or nullification proceedings. Nevertheless, patent challengers often scrutinize pharmaceutical patents in Russia due to the country's rigorous examination process, especially with regard to inventive step.
Potential Risk Factors:
- Prior art: Discovery of prior similar compositions could invalidate the patent.
- Claim interpretation: Narrow interpretation limits scope; broad claims invite legal challenge.
- Patent expiry: If the patent is close to expiry, secondary patenting strategies may be necessary to maintain market exclusivity.
Implications for Industry Stakeholders
- Innovators: The patent offers a strong protective avenue for commercializing the specific formulation within Russia, provided claims are sufficiently broad and enforceable.
- Generics: Competitors must analyze the claims for any loopholes or design-around opportunities, potentially exploring alternative formulations.
- Licensing: Licensing negotiations should consider the scope of the claims and whether modifications can circumvent the patent.
- Legal strategists: Vigilance around prior art and ongoing patent examination processes is critical for safeguarding or challenging the patent rights.
Key Takeaways
- RU2011141422 covers a pharmaceutical composition with specific active ingredients and formulation features, protected under Russian patent law.
- The patent’s scope largely depends on the breadth of its claims, which likely encompass the composition itself and its therapeutic uses.
- The Russian pharmaceutical patent landscape emphasizes novelty and inventive step, requiring continuous monitoring of prior art to defend or challenge the patent.
- The patent remains enforceable unless challenged or invalidated, representing valuable IP rights for its holder.
- Stakeholders must assess claim language for potential design-arounds and monitor ongoing patent landscape developments in Russia.
FAQs
Q1: How does Russian patent law define the patentability of pharmaceutical compositions?
A: Russian patent law permits patenting pharmaceutical compositions if they demonstrate novelty, inventive step, and industrial applicability—especially when they exhibit unexpected technical effects or improvements over prior art.
Q2: What are common challenges faced when patenting drug formulations in Russia?
A: Challenges include demonstrating sufficient inventive step over prior art, clearly claiming the composition scope, and distinguishing the formulation from existing patents or disclosures.
Q3: Can existing international patents affect the validity of RU2011141422?
A: Yes. If prior art from international applications (e.g., PCT or EP patents) discloses similar compositions, they can be cited against the Russian patent during examination or enforcement proceedings.
Q4: What strategies can be employed to ensure broad patent protection for drug formulations in Russia?
A: Drafting broad independent claims, including multiple embodiments, and securing claims that cover various dosage forms and uses can maximize scope.
Q5: How does the patent landscape influence drug commercialization in Russia?
A: A strong patent like RU2011141422 provides exclusive rights, encouraging investment and partnering opportunities, whereas weak or challenged patents can delay or complicate market entry.
References
[1] Russian Civil Code (Part IV, Patent Law)
[2] Federal Service for Intellectual Property (ROSPATENT) database and official publications
[3] Prior art documents and patent databases relevant to pharmaceutical compositions in Russia
