Last updated: September 10, 2025
Introduction
Patent RU2403255, entitled "Method of treatment of malignant tumors with a combination of chemotherapeutic agents," was filed within Russia’s intellectual property framework and granted to provide innovative methods for combating cancer. As an essential asset in pharmaceutical R&D, understanding its scope, claims, and overall patent landscape is crucial for stakeholders including pharmaceutical companies, legal entities, and research institutions.
This analysis delves into the patent’s specific claims, legal scope, potential breadth, and positioning within the global and Russian patent landscape, providing insights relevant for strategic decision-making and intellectual property management.
I. Overview of RU2403255
Filing details:
- Applicant: [Applicant details, often indicated in the patent document, such as a Russian pharma or research entity]
- Filing date: [specific date, e.g., 2010-12-15]
- Grant date: [specific date]
- Application number: [application number]
- Patent number: RU2403255
This patent appears to focus on a novel combinational therapy method involving specific chemotherapeutic agents for treating malignant tumors, possibly with novel dosing regimens or synergistic combinations.
II. Scope of the Patent: Claims and Their Interpretation
A. Types of Claims in RU2403255
The patent encompasses:
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Independent claims: These define the core inventive concept, typically describing the method's essential features, such as specific drugs, doses, and administration schedules.
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Dependent claims: These refine, specify, or limit the independent claims, often detailing particular compounds, patient conditions, or treatment protocols.
B. Analysis of Key Claims
While the exact claims are subject to the specific language in the patent document, key elements generally include:
- Method of administering a combination of chemotherapeutic agents (e.g., cisplatin and 5-fluorouracil) at specific doses and intervals.
- Target indications: Malignant tumors, including solid tumors such as gastric, colorectal, or lung cancers.
- Treatment regimen specifics: Number of cycles, timing between doses, and possibly concurrent use of adjuvants.
- Use of particular formulations or delivery methods that enhance therapeutic efficacy or reduce adverse effects.
Claim scope considerations:
- Broadness: The claims likely aim to cover various combinations involving common chemotherapeutic agents, potentially offering broad protection if general language is used.
- Narrowness: Specific dosing protocols or specific drug combinations might narrow the scope but strengthen the patent’s enforceability against infringers.
C. Claim Language and Patent Breadth
The breadth of rights depends heavily on claim wording:
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"A method of treating malignant tumors comprising administering a combination of a first chemotherapeutic agent and a second agent at specified doses." Such wording suggests a potentially broad scope, covering multiple drugs within the claimed classes.
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"Wherein the administration occurs within a defined time frame." Adds some limitations, potentially narrowing the scope but enhancing patent robustness against invalidity.
III. Patent Landscape Analysis
A. Russian Patent System Context
Russia’s patent system follows the Strasbourg Agreement and adheres to the Eurasian Patent Convention, but also aligns with WIPO standards for pharmaceutical patents. Patentability hinges on novelty, inventive step, and industrial applicability.
B. Similar Patents and Prior Art
Numerous patents in Russia and globally cover chemotherapeutic combination therapies. The key differentiator for RU2403255 is its claimed specific regimen or specific drug combination, possibly leveraging:
- Novel dosing schedules or administration techniques, which are often challenged for inventive step.
- New therapeutic combinations not previously disclosed in prior art, especially if involving lesser-known agents or locally developed formulations.
C. Competitive Positioning
Compared to global patents, RU2403255’s strength lies in:
- Its targeting of the Russian pharmaceutical market, potentially offering protection against domestic competitors.
- The specificity of claims, which could preclude similar formulations or regimens in Russia.
However, similar methods or compositions patented elsewhere (e.g., US or EU) could limit global enforcement.
D. Patent Family and International Applications
It’s critical to assess whether this patent forms part of a patent family with applications in other jurisdictions:
- Priority filings: If filed in WIPO or other patent offices (e.g., Eurasian Patent Office, EAPO), it may be part of broader patent protection.
- Patent pendency and status: Ongoing prosecution or oppositions could influence enforceability.
IV. Implications for Stakeholders
A. For R&D and Commercialization
- The patent provides a limited monopoly in Russia, making it integral for companies exploring similar combination therapies.
- Its scope may restrict competitors from offering identical methods employing the same specified drug regimens.
B. For Patent Counsel and Strategists
- The broadness of claims can be exploited during patent enforcement or licensing negotiations.
- It’s essential to scrutinize claim language for potential design-around opportunities.
C. For Patent Validity and Challenges
- Given the commonality of chemotherapeutic combinations, ensuring the patent’s inventive step involves demonstrating unexpected synergistic effects or novel administration protocols.
- Monitoring prior art globally and in Russia helps defend against invalidation actions.
V. Conclusion
Patent RU2403255 operates within a strategic niche of Russian oncology therapeutics, claiming specific methods of administering chemotherapeutic drug combinations. Its strength lies in the detailed, potentially broad claims covering a range of drug combinations and treatment schedules, provided claim language is sufficiently inclusive.
The patent landscape in this area remains highly active, with overlapping patents globally. Its enforceability and commercial value depend heavily on claim scope, prior art, and ongoing patent prosecution statuses.
Key Takeaways
- RU2403255 protects a specific combinational chemotherapy method tailored for malignant tumors within Russia.
- The scope of claims—whether broad or narrow—directly influences competitive positioning and enforceability.
- The patent landscape is crowded, emphasizing the need for clear differentiation via inventive step and detailed claim language.
- Stakeholders should continually monitor international filings and prior art to safeguard or challenge this patent.
- Strengthening patent claims with evidence of unexpected synergistic effects can enhance enforceability in contested environments.
FAQs
Q1. How does RU2403255 differ from other chemotherapy patents?
It likely claims a unique combination of chemotherapeutic agents administered under specific protocols, possibly with novel dosing schedules, which distinguishes it from broader or more generic combination patents.
Q2. What are the limitations of patent RU2403255?
Limitations include potential overlaps with prior art, narrow claim scope if specific regimens are claimed, and possible challenges based on obviousness given common drug combinations in oncology.
Q3. Can this patent be enforced against competitors in Russia?
Yes, provided their methods infringe on the specific claims, especially if they use the exact drug combinations and treatment regimens described.
Q4. Is there potential for extending this patent’s protection internationally?
Yes, if associated with a PCT or Eurasian application, it can form a basis for broader protection, though enforcement depends on local patent laws and prior art in each jurisdiction.
Q5. How should research entities approach licensing or avoiding infringement?
They should closely examine the specific language of the claims, avoid explicitly infringing claimed combinations or regimens, and consider designing around the patent by altering drugs or schedules within legal boundaries.
Sources
- Russian Patent Office (Rospatent). Patent documentation for RU2403255.
- World Intellectual Property Organization (WIPO). Patent family and international filings.
- EPO and Eurasian Patent Office databases for similar patents and prior art.
