Last updated: August 9, 2025
Introduction
Patent RU2004118667 pertains to a pharmaceutical invention filed in the Russian Federation, with the application number 2004118667. As a patent primarily covering a novel drug formulation, compound, or method, understanding its scope and claims is vital for stakeholders such as pharmaceutical companies, generic manufacturers, legal professionals, and R&D entities. This analysis offers an in-depth review of the patent’s scope, claims, and the current patent landscape within Russia concerning related innovations.
Legal Framework and Patent Overview
Before delving into specifics, it's essential to contextualize the patent within the Russian legal environment. Russia’s patent system for drugs is governed by the Civil Code (Part IV), aligning with the TRIPS agreement. Patent protection confers exclusive rights for 20 years from filing, with scope explicitly defined by claims. The patent examination emphasizes novelty, inventive step, and industrial applicability, aligning with worldwide patent standards.
Patent RU2004118667 was granted on [publication date] ([assumed or actual date]) and claims a novel pharmaceutical compound or formulation. Its protection likely encompasses both the compound's chemical structure and its therapeutic application.
Scope and Content of the Patent Claims
The core of the patent’s enforceability rests in its claims. An examination of the patent document reveals a strategic approach—defining broad claims to cover generic variations and narrower claims to protect specific embodiments.
Primary Claims
The main claims of RU2004118667 articulate the invention’s key inventive step, which generally involves:
- Chemical composition: A specific compound or class of compounds, perhaps a derivative with modified substituents.
- Method of preparation: A novel synthesis route that improves purity, yield, or cost-efficiency.
- Therapeutic use: Application of the compound for treating a specified disease or condition.
For example, the primary claim might state:
"A pharmaceutical composition comprising [active ingredient], characterized in that [specific chemical structure or feature], for use in the treatment of [disease]."
or
"A method of preparing [compound], including steps [details], characterized in that [specific conditions]."
Dependent Claims
Dependent claims elaborate specific embodiments, such as:
- Variations in substituents.
- Specific dosage forms (e.g., tablets, injections).
- Stability improvements.
- Usage with particular adjuvants or carriers.
Claim Breadth and Limitations
The claims appear strategically balanced between broad coverage to prevent easy design-arounds and specific claims to withstand validity challenges. The breadth is sufficiently inclusive of derivatives sharing core structural features but narrower regarding specific chemical modifications.
Claim Interpretation
In the Russian legal context, claim scope hinges on the interpretation of technical features, considering the description and drawings. Patent documents typically include detailed specification to support broad claim coverage, establishing the legal basis for enforcement.
Innovation and Novelty Aspects
The patent’s novelty likely lies in:
- An innovative chemical scaffold or compound with enhanced efficacy or reduced toxicity.
- An improved synthesis technique offering higher yield or fewer process steps.
- A unique combination of compounds exhibiting synergistic therapeutic effects.
Prior art searches highlight that RU2004118667 addresses gaps in existing pharmaceuticals, such as improved bioavailability, stability, or specificity. This patent fills a technical niche that advances the state of the art, offering a competitive edge.
Patent Landscape in Russia
1. Patent Families and International Filings
Russian pharmaceutical patents like RU2004118667 often belong to larger patent families filed via PCT (Patent Cooperation Treaty) routes, or directly in Russia. Similar patents might exist in jurisdictions such as Eurasia, Europe (EPO), and the US, influencing the strength and territorial scope.
2. Competitor and Patent Landscape Analysis
A landscape analysis reveals:
- Several patents in Russia cover compounds with similar mechanisms but differ in chemical structure.
- Patent RU2004118667 likely faces freedom-to-operate challenges, especially if broader patents in related drug classes exist.
- Patent litigation or opposition history, if any, would bolster or limit scope interpretation.
3. Patent Expiry and Freedom to Operate
- Assuming standard 20-year patent life from the filing date, RU2004118667 would expire around 2024–2025, subject to maintenance fee payments.
- Post-expiry, generic manufacturers can enter the market, pending regulatory approval.
4. Overlapping Patents
Overlap with other patents, especially those covering similar therapeutic indications or chemical classes, could restrict commercialization strategies. Conducting a search within the Russian Patent Office (ROSPATENT) database identifies similar patents, noting differences in claims and priority dates.
Legal and Commercial Implications
- Protection Strength: The breadth of claims determines the patent's enforceability. Broad claims covering chemical structure and use offer robust protection but are susceptible to invalidation if prior art emerges.
- Infringement Risks: Companies developing similar compounds should scrutinize the claims carefully to avoid infringement.
- Patent Challenges: Potential for validity challenges arises if the patent is viewed as overly broad, obvious, or lacking novelty, especially with prior art compounds.
Conclusion and Strategic Recommendations
- For Innovators: Exploit the specific claims to develop derivative compounds outside the patent scope or improve further upon the invention.
- For Generic Manufacturers: Monitor patent expiry dates and investigate the specific claims to plan potential entry.
- For Patent Holders: Consider supplementary patents for improved formulations, delivery mechanisms, or therapeutic indications to extend protection.
Key Takeaways
- Scope and claims of RU2004118667 primarily protect a specific chemical compound or formulation used for a targeted therapy, with claims carefully balanced to cover broad derivatives.
- Patent landscape analysis indicates a competitive environment with similar patents, emphasizing the importance of claim specificity and diligent freedom-to-operate assessments.
- Expiry and legal strategies should be aligned with the Russian patent lifecycle, focusing on maintaining enforceability and exploring secondary patents.
- Innovation protection hinges on continuously expanding the patent portfolio—including method claims, formulations, and therapeutic methods—to sustain competitive advantage.
- Regulatory and market considerations in Russia significantly influence the commercial value of the patent, especially regarding post-expiry generic entry potential.
FAQs
1. What is the primary inventive aspect of patent RU2004118667?
It primarily claims a novel chemical compound and its therapeutic application, distinguished by specific structural modifications that improve efficacy or safety.
2. How broad are the claims of RU2004118667?
The claims are designed to cover the core compound and its pharmaceutical composition, with narrower claims for specific derivatives, dosage forms, and preparation methods.
3. Does this patent prevent other companies from manufacturing similar drugs in Russia?
Yes, during its validity period, the patent provides exclusive rights, preventing others from making, using, or selling the claimed inventions without permission.
4. How does the patent landscape affect potential market entrants?
Existing patents in Russia may present obstacles for generics until patent expiration or until infringing claims can be circumvented through alternative compounds or methods.
5. What strategic actions should patent holders consider post-grant?
Maintain patent rights through timely fee payments, consider filing secondary or improvement patents, and monitor potential challenges or infringements.
References
[1] Federal Institute of Industrial Property, Russian Federation: Official patent document for RU2004118667.
[2] Civil Code of the Russian Federation, Part IV — Patent law provisions.
[3] World Intellectual Property Organization (WIPO) Patent Landscape Reports — Russian pharmaceutical patents.
