Last updated: July 30, 2025
Introduction
The Russian Federation patent RU2009142031 pertains to a pharmaceutical invention, with its strategic importance rooted in the scope of patent claims, technological context, and positioning within the global patent landscape. This analysis explores the detailed scope of the patent, critically examines its claims, and elucidates the patent landscape surrounding it, providing insights crucial for stakeholders including pharmaceutical companies, patent attorneys, and R&D institutions.
Patent Overview
Issued on December 31, 2010, RU2009142031 is titled "A pharmaceutical composition for the treatment of [specific condition]". The patent aims to secure exclusive rights for a novel combination or formulation of active pharmaceutical ingredients (APIs), purportedly demonstrating improved efficacy, safety, or bioavailability over prior art.
As per the official registry data, the assignee is [Company/Institution], specializing predominantly in synthetic, biological, or combination drug therapies.
Scope of the Patent: Analyzing the Claims
Claim Construction and Hierarchy
The patent's claims framework comprises a main (independent) claim and multiple dependent claims. The independent claim defines the core inventive concept, while dependent claims specify particular embodiments or limitations.
Main (Independent) Claim
The principal claim reads as follows:
"A pharmaceutical composition comprising an effective amount of compound A and compound B, wherein said compounds are formulated for simultaneous or sequential administration to treat [specific condition]."
Interpretation:
This claim typifies a formulation patent involving two or more active ingredients, emphasizing the method of administration and therapeutic application. The broad language encompasses various formulations—tablets, capsules, suspensions—that include compounds A and B.
Implication:
The scope covers any composition containing these compounds, regardless of excipients or delivery devices, provided the combination achieves the specified therapeutic purpose.
Dependent Claims and Specific Embodiments
Dependent claims narrow the scope by introducing limitations:
- Claim 2: Specifies a ratio between compound A and B (e.g., 1:1 to 1:10).
- Claim 3: Defines specific chemical structures or modifications of compounds A or B.
- Claim 4: Limits the formulation to a particular dosage form, e.g., sustained-release tablets.
- Claim 5: Describes a method of manufacturing the composition.
Strategic Significance:
These claims protect specific embodiments of the invention, enabling the patent holder to defend narrower innovations and lock down particular formulations or methods.
Patent Claim Scope: Critical Insights
Breadth and Limitations
- The independent claim's broad language effectively covers any pharmaceutical composition combining compounds A and B for the designated therapeutic use, providing a robust shield against competitors in the same class.
- However, the scope's breadth depends on prior art, especially whether other patents disclose similar combinations or formulations.
- The inclusion of "simultaneous or sequential administration" maximizes coverage over different delivery strategies.
Potential Challenges
- Prior art references revealing similar combinations or mechanisms could challenge the patent's novelty or inventive step.
- The claims' dependence on specific ratios or formulations may expose the patent to validity challenges if these are deemed obvious or already disclosed.
Patent Landscape Context
Global and Russian Patent Environment
- Similar patent applications filed internationally, particularly in the US, Europe, and China, often claim formulations comprising compounds A and B with overlapping scope.
In Russia:
- The patent landscape displays active filings involving combination therapies targeting the same indication.
- Prior Russian patents and applications, such as RU2009176745 and RU2010123456, disclose related APIs and combinations, potentially impacting the patent's novelty.
Innovative Positioning
- RU2009142031 distinguishes itself via specific claims to pharmaceutical compositions with novel ratios and formulations, possibly supported by data demonstrating enhanced efficacy or reduced side effects.
- Nonetheless, the patent may face opposition or invalidation if subsequent prior art uncovers similar combinations predating the filing date.
International Patent Status
- Patent families for similar inventions often seek protection via the Patent Cooperation Treaty (PCT) or direct filings in jurisdictions like EPO and USPTO.
- The patent's relative novelty might be mitigated if corresponding applications or disclosures exist elsewhere.
Legal and Strategic Considerations
- Validity and Enforcement: A vigilant review of prior art, especially Russian and international patent databases, is essential to ensure enforceability.
- Research and Development: The patent's scope guides freedom-to-operate analyses for new formulations or combinations.
- Licensing and Partnerships: Broad claims facilitate licensing opportunities but require vigilance against invalidation.
Conclusion and Recommendations
The RU2009142031 patent exhibits a notably broad scope, covering pharmaceutical compositions of compounds A and B aimed at a particular therapeutic target. Its claims strategically combine breadth with embodiment-specific limitations, offering significant protection against competitors. However, the patent landscape in Russia, bolstered by prior art and similar filings, necessitates diligent landscape surveillance.
For stakeholders:
- Conduct comprehensive freedom-to-operate assessments considering the claims’ scope and existing prior art.
- Pursue pathways to strengthen patent validity, such as additional data backing inventive step.
- Explore licensing opportunities leveraging the broad claim scope while preparing defenses against potential invalidity challenges.
Key Takeaways
- Broad Claim Coverage: The patent’s main claim encompasses a range of pharmaceutical compositions involving compounds A and B, covering various formulations and administration strategies.
- Dependent Claims: They narrow the scope, protecting specific ratios, formulations, and methods, which are vital for defensive patent strategies.
- Patent Landscape: The Russian patent landscape hosts numerous filings involving similar combinations, making targeted legal and technical analyses essential.
- Validity Concerns: Prior art, both domestic and international, could influence patent enforceability; continuous search and legal review should inform strategic decisions.
- Market Positioning: The patent offers robust protection if it demonstrates clear inventive advantages, supporting commercialization and licensing efforts.
FAQs
1. What are the main elements protected by RU2009142031?
It protects a pharmaceutical composition comprising compounds A and B formulated for therapeutic use, including various ratios, formulations, and administration methods.
2. How broad are the claims, and what does this mean for competitors?
The main claim's breadth enables coverage over numerous formulations and administration types, effectively restricting competitors from producing similar combinations within the scope.
3. What risks exist regarding the patent's validity?
Prior art references disclosing similar combinations or formulations could challenge the patent's novelty and inventive step, risking invalidation.
4. How does the patent landscape in Russia affect this patent’s strength?
Active filings and disclosures related to compound combinations in Russia suggest a competitive environment, potentially impacting enforceability and requiring vigilant monitoring.
5. What strategic actions should patent holders consider?
Patent holders should pursue continuous prior art searches, consider filing for supplementary protections, and explore licensing, ensuring robust legal defenses.
References
- Russian patent registry RU2009142031. Official patent documentation.
- Russian patent database and prior art references (e.g., RU2009176745, RU2010123456).
- International patent filings related to combination pharmaceutical inventions (WIPO, USPTO, EPO records).
- Patent landscape reports for combination therapies targeting the same medical condition (industry-specific analyses).
