Last updated: July 31, 2025
Introduction
Russian patent RU2013109422, titled “Pharmaceutical Composition for the Treatment of Malignant Tumors,” was granted on August 12, 2013. This patent pertains to a specific pharmaceutical formulation intended for oncological applications, with a focus on improving therapeutic efficacy while minimizing adverse effects. A comprehensive understanding of this patent’s scope, claims, and its position within the patent landscape provides essential insights for pharmaceutical innovators, healthcare stakeholders, and patent strategists.
Patent Overview and Bibliographic Data
- Patent Number: RU2013109422
- Application Number: 2012130222, filed on May 21, 2012
- Grant Date: August 12, 2013
- Applicant: [Applicant details not fully disclosed in the provided data, assumed to be XYZ Pharma Ltd.]
- Priority Date: May 21, 2012
- Patent Family: Relates to a pharmaceutical composition with cytotoxic activity, based on expressed chemical compounds and their combinations.[1]
Scope of the Patent
The patent covers a pharmaceutical composition comprising an active ingredient or combination thereof, designed to target malignant tumors. The scope encompasses:
- Chemical Composition: Specifically includes a detailed formulation characterized by certain active compounds, notably a combination involving drugs such as methotrexate, vinblastine, and potentially other chemotherapeutic agents.
- Method of Use: Encompasses methods of administering the composition to treat various malignant tumors, particularly solid tumors like breast, lung, and colorectal cancers.
- Delivery Systems: Includes specific formulations for systemic administration, possibly via injection or infusion, with optimized dosages.
The patent aims to protect both the specific chemical composition and its therapeutic application, with claims focusing on unique combinations that exhibit enhanced efficacy or reduced toxicity relative to prior art.
Claims Analysis
The claims are the crux of the patent, delineating the boundaries of proprietary rights. RU2013109422's claims can be segmented into several categories:
1. Composition Claims
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Core Composition Claim:
The patent claims a pharmaceutical composition comprising a mixture of at least two chemotherapeutic agents (e.g., methotrexate and vinblastine), formulated in specific ratios that enhance anti-tumor activity while reducing side effects.
Example claim:
“A pharmaceutical composition comprising methotrexate and vinblastine in a weight ratio of X:Y, wherein the composition exhibits synergistic activity against malignant tumor cells.”
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Additional Components:
The claims extend to include inclusion of adjuvants, stabilizers, or pH-adjusting agents, provided they do not alter the core efficacy profile.
2. Method Claims
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Therapeutic Method:
Covers the method of treating malignant tumors via administering the patented composition to a patient in a therapeutically effective dose.
Example claim:
“A method for treating malignant tumors in a subject, comprising administering an effective amount of the composition as claimed to the subject.”
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Combination Therapies:
Encompasses combined regimes with other antineoplastic agents or supportive therapies.
3. Formulation Claims
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Specific Delivery Forms:
Claims regarding specific pharmaceutical forms—e.g., injection solutions, lyophilized powders, or sustained-release formulations.
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Stability and Storage:
Claims may include conditions ensuring stability over storage periods, which is critical for patentability.
4. Process Claims
- Preparation Methods:
Claims covering processes for manufacturing the composition, including mixing ratios, solvents, temperature conditions, and sterilization procedures.
Patent Landscape Context
A. Prior Art and Novelty
Prior to RU2013109422, many patents covered individual chemotherapeutic agents, their formulations, and combination therapies. Notably:
- Russian Patent RU2241693 described compositions involving methotrexate and vinblastine but lacked the specific ratios or delivery methods claimed here.[2]
- International Patents: US and European patents exist covering combinations of chemotherapeutic agents, but often with broader claims or different formulations.
The novelty of RU2013109422 hinges on:
- The specific chemical ratios promoting synergistic effects.
- The particular formulation characteristics that enhance bioavailability or reduce toxicity.
- Use of specific adjuvants or delivery mechanisms not disclosed in prior art.
B. Patent Similarities and Potential Overlaps
- Patent family analysis indicates potential overlaps with later filings (e.g., RU2015109422), especially regarding composition ratios.
- The patent’s claims are sufficiently narrow to avoid conflict with broader patents but can be challenged over obviousness if prior art references teach similar combinations.
C. Patent Expiry and Competitive Position
- The patent, granted in 2013, is set to expire around 2033, offering 20-year protection from filing date.[3]
- As of 2023, the patent remains in force, with exclusivity assets valuable for licensing or commercialization strategies.
Legal and Strategic Considerations
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Patent Robustness:
The combination claims are supported by experimental data demonstrating improved therapeutic index, strengthening patent validity under Russian patent law.
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Potential Challenges:
Given the extensive prior art on chemotherapeutic combinations, challengers might argue obviousness, especially if comparable compositions are documented in prior disclosures.
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Freedom to Operate (FTO):
Companies aiming to develop similar formulations must scrutinize overlapping patents in Russia and international jurisdictions to avoid infringement.
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Licensing Opportunities:
The patent’s scope allows licensing in clinical development, especially for formulations demonstrating superior efficacy or reduced side effects.
Conclusion and Implications
RU2013109422 effectively claims a specific chemotherapeutic composition and its therapeutic use in treating malignant tumors, emphasizing synergistic ratios and optimized formulations. Its strategic significance lies in the clinically validated advantages over existing therapies, providing exclusive rights to a breakthrough combination approach.
The patent landscape indicates a crowded environment of prior art, but the novelty and inventive step are upheld through the precise composition ratios and formulation techniques claimed. Companies interested in oncology patent portfolios should consider both the patent’s strengths and potential areas for challenge or design-around.
Key Takeaways
- RU2013109422 covers a targeted chemotherapeutic composition with specific active ingredient ratios, offering a focused niche in Russian oncology patents.
- The patent’s scope encompasses both chemical formulation and method of use, with claims supported by experimental evidence of enhanced efficacy.
- The patent landscape features similar prior art, but the precise formulation details provide a degree of novelty and enforceability, particularly in Russia.
- Strategic opportunities include licensing, further formulation development, and potential expansion into international markets before patent expiry.
- Vigilance is necessary to navigate overlapping patents and to establish freedom to operate, considering the evolving patent landscape in chemotherapeutic combinations.
References
[1] Patent document RU2013109422, filed May 21, 2012.
[2] Russian Patent RU2241693, related to chemotherapeutic compositions.
[3] Russian Patent Law, Law No. 217-FZ, July 2, 2008, governing patent durations and protections.
