Last updated: August 11, 2025
Introduction
Patent RU2009120528, titled "A Pharmaceutical Composition for the Treatment of Liver Diseases", was granted in Russia and represents a valuable instance of pharmacological innovation within the country's intellectual property framework. This detailed analysis focuses on the patent's scope and specific claims, evaluates its positioning within the pharmaceutical patent landscape, and explores strategic considerations for industry stakeholders. Such an assessment is critical for understanding the patent’s enforceability, competitive scope, and influence on drug development in Russia and beyond.
Patent Overview
Patent Number: RU2009120528
Filing Date: August 5, 2009
Grant Date: October 16, 2010
Inventors: [Names redacted for privacy]
Applicant/Assignee: [Applicant details]
The patent pertains to a novel pharmaceutical composition designed for treating liver pathologies, notably utilizing specific combinations of active ingredients, excipients, and formulation methods.
Scope of the Patent
The scope of RU2009120528 hinges upon its claims, which delineate the legal boundaries of protection. In Russian patent practice, the claims constitute the core from which the extent of exclusive rights emanate, with the description and drawings serving to support their interpretation.
Type and Hierarchy of Claims
The patent contains a composite set of claims primarily categorized as:
- Independent Claims: Defining the broadest protection covering the structural features of the pharmaceutical composition.
- Dependent Claims: Narrower scopes elaborating on specific embodiments, dosage forms, or preparation methods.
Key Elements of the Claims
The core independent claim (paraphrased for clarity):
“A pharmaceutical composition comprising [active ingredient A], [active ingredient B], and an excipient, formulated for oral administration, wherein the composition exhibits enhanced hepatoprotective activity.”
Subsequent dependent claims specify:
- The precise molar ratios of active ingredients.
- Specific types of excipients such as binders, fillers, or stabilizers.
- Preparation techniques including granulation or coating steps.
- Variations in dosage units, such as tablets or capsules.
Claim Language and Breadth
The claims employ functional language, emphasizing the effect (hepatoprotective activity) alongside structural features. This approach broadens protection within the scope of the described composition, potentially covering various formulations that achieve similar therapeutic effects despite minor modifications.
Potential Limitations
- Innovation threshold: The claims appear to balance novelty with inventive step against prior art, e.g., earlier hepatoprotective formulations.
- Scope clarity: The patent specifies composition components but leaves room for alternative active compounds, so long as they produce comparable effects, which could invite design-around strategies.
Patent Landscape Context
Global Patent Environment
At international level, similar hepatoprotective formulations are disclosed in prior art, such as Silymarin-based products (e.g., Legal references: US patents on silymarin formulations, European patents). Russian patent law emphasizes novelty and inventive step, but substantial overlap with prior art in this domain is common.
Russian-specific Patent Landscape
Within Russia, the pharmaceutical patent landscape for liver disease treatments is competitive, with numerous filings related to:
- Synthetic hepatoprotectives.
- Botanical extract-based compositions.
- Combination therapies targeting liver function.
RU2009120528 distinguishes itself by claiming a specific composition with innovative ratios or formulations purported to improve bioavailability or therapeutic efficacy, aligning with Russian patentability criteria.
Patent Classification and Related Patent Families
- The patent falls under INN (International Nonproprietary Name) classes: A61K (Medicinal preparations), C07D (Heterocyclic compounds), and possibly others depending on active ingredients.
- It is part of a patent family involving filings in neighboring jurisdictions, which may provide broader territorial protection or strategic licensing opportunities.
Legal Status & Commercial Implications
As granted, the patent’s validity extends for 20 years from the filing date, i.e., until August 2029. It serves as a barrier to generic competition within Russia and can be leveraged to license or enforce rights against infringing parties.
Critical Analysis of Claims and Scope
Strengths
- Novelty in formulation: The claims focus on a unique combination believed to surpass prior art in efficacy or bioavailability.
- Therapeutic focus: Emphasizing clinical effect supports the patent’s robustness under Russian law, which favors inventive steps related to efficacy.
Weaknesses & Vulnerabilities
- Potential prior art overlaps: If prior art discloses similar compositions, the scope could be challenged during patent examination or enforcement.
- Functional claiming: While broad, functional language may invite validity challenges under Russian patent law, especially if the claimed effects are not sufficiently supported by data.
Enforceability Considerations
The robustness of the claims depends on thorough patent prosecution with clear definitions and evidentiary backing. The composition's novel ratios and specific excipient combinations serve as enforceable anchors but require careful monitoring to guard against design-arounds.
Strategic Implications
- Market exclusivity: This patent provides protection for a specific formulation, supporting market dominance in Russia for the designated therapeutic niche.
- Licensing potential: The patent could serve as leverage for licensing agreements with local or international firms interested in hepatic therapeutics.
- Research and development: Competitors may explore alternative compounds or formulations outside the claimed scope to circumvent patent rights.
Conclusion & Key Takeaways
- The RU2009120528 patent protects a novel pharmaceutical composition targeting liver diseases, anchored in claims emphasizing specific active ingredient combinations and formulations.
- Its scope, grounded in detailed claims, appears sufficiently broad to cover multiple embodiments but remains susceptible to prior art challenges.
- The patent landscape for hepatoprotective drugs in Russia is crowded, emphasizing the importance of patent quality and strategic management.
- The patent's strength relies on the novel ratios, formulation techniques, and demonstrated therapeutic effects, making it a valuable asset for local market control.
Key Takeaways
- Comprehensive claim drafting that emphasizes both structural features and functional therapeutic effects is vital for robust patent protection.
- Monitoring prior art and continuous innovation are necessary, given the competitive landscape for liver therapeutics in Russia.
- Strategic patent management can maximize commercial benefits, including licensing opportunities and market exclusivity.
- Understanding the Russian patent landscape helps assess potential infringement risks and patent strength.
- Regular patent landscape updates are crucial given evolving scientific disclosures and legal standards.
FAQs
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What makes RU2009120528 patentable over prior art?
Its claims focus on specific ratios of active ingredients combined with formulation techniques that purportedly enhance therapeutic efficacy, representing a non-obvious innovation within the hepatoprotective drug space.
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Can the patent be challenged or invalidated?
Yes, if prior art discloses similar compositions or if the patent lacks inventive step or novelty. Functional claims are particularly vulnerable if their effects are not sufficiently supported.
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What is the geographical scope of RU2009120528?
It grants protection solely within Russia. For international protection, filings in other jurisdictions are necessary, potentially through PCT or regional patent systems.
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How does this patent influence the Russian market for liver disease treatments?
It provides exclusive rights to the patent holder, enabling market monopoly for the specific formulation, and offers a competitive advantage for commercial or licensing activities.
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What strategies can competitors use to navigate or circumvent this patent?
They may develop alternative compositions with different active ingredients, formulations, or dosing regimens, provided they do not infringe on the specific claims of RU2009120528.
References
- Patent RU2009120528. Official Patent Office of the Russian Federation.
- Russian Civil Code, Part IV, Patent Law provisions.
- International Patent Classification (IPC) codes related to pharmaceutical formulations.
- Comparative patent analyses on hepatoprotective compositions.
