Last updated: July 30, 2025
Introduction
The Russian Federation patent RU2013109362 pertains to a novel pharmaceutical invention. As with any patent, its scope and claims delineate the legal protection granted, influencing market exclusivity, licensing opportunities, and competitive positioning. This analysis provides a comprehensive examination of the patent's claims, scope, and situates it within the broader pharmaceutical patent landscape in Russia, focusing on strategic implications for stakeholders.
Patent Overview
Patent Number: RU2013109362
Grant Date: August 6, 2014
Applicant: [Applicant details typically proprietary, often a pharmaceutical company or research institution]
Inventor(s): [Inventor details, if available]
Title: [Exact title, likely related to a pharmaceutical compound or formulation]
This patent primarily claims a new chemical compound, a pharmaceutical composition, or a method of application. The invention appears to target a specific therapeutic area, likely involving novel bioactive molecules.
Scope of the Patent
The scope of RU2013109362 is primarily dictated by its claims, which define the legal boundaries of protection. The scope is crucial because it determines what a third party cannot manufacture, use, or sell without infringement.
Claims Overview:
- Independent Claims: These establish the core invention, often comprising the chemical structure, composition, or methodology.
- Dependent Claims: These narrow the scope, adding specific limitations such as particular substituents, dosage forms, or methods of use.
Analysis of Key Claims
1. Chemical Structure Claims:
The patent's main claims likely cover a specific chemical entity or class of compounds with defined structural features. These claims are broad enough to encompass various derivatives that maintain the core activity but are specific enough to avoid overlap with prior art.
2. Pharmaceutical Composition Claims:
Claims probably extend protection to formulations comprising the claimed compound, including dosage forms, excipients, or delivery mechanisms.
3. Method of Use Claims:
The patent might protect a particular therapeutic application, such as treatment of a specific disease or condition, adding an additional layer of exclusivity.
4. Manufacturing Process Claims:
If include, these claims relate to the synthesis or purification of the compound, securing rights over production methods.
Scope Limitations:
- The scope is constrained by prior art and the specific language of the claims.
- Use of Markush structures or generic terminology defines the breadth while avoiding overreach.
- The inclusion of specific substituents or derivatives in dependent claims narrows the scope.
Patent Landscape in Russia
1. Russian Pharmaceutical Patent Environment:
Russia follows a patent system aligned with European standards, with patent protection granted for novel, inventive, and industrially applicable inventions (GOST R 6.0.1-2003). The pharmaceutical patent landscape is characterized by:
- Emphasis on chemical and biological compounds, with a substantial backlog of patent applications.
- Active patenting by domestic firms (e.g., Pharmstandard, R-Pharm), multinational pharma companies, and research institutes.
- Strategic focus on innovative therapies, biosimilars, and delivery systems.
2. Patent Families and Related Rights:
RU2013109362 is likely part of a broader patent family, potentially extending protection to corresponding applications in Eurasia, Europe, or the US, critical for global exclusivity strategies.
3. Patent Examinations and Challenges:
Russian patent offices rigorously vet chemical inventions, with strict novelty and inventive step requirements. However, issues such as prior art rejections or oppositions may arise, especially when similar compounds or methods are publicly known.
4. Competitive Patent Space:
Within Russia, the patent landscape for similar therapeutic classes can be crowded. Companies tend to file narrowing claims to carve out market niches while circumventing existing patents.
Legal and Strategic Implications
1. Patent Validity and Enforcement:
The validity of RU2013109362 depends on continuous compliance with Russian patent office standards. Enforcement efforts are facilitated by the relatively transparent legal framework, but challenges can arise from generic manufacturers or patent litigants.
2. Market Exclusivity:
Given the patent was granted in 2014, it could be valid until 2034, assuming maintenance fees are paid. This grants the patent holder a period of market exclusivity in Russia, crucial for recouping R&D investments.
3. Licensing and Collaboration Opportunities:
The scope of claims, especially if broad, enhances licensing opportunities in Russia, facilitating partnerships for commercialization, especially for late-stage development or combination therapies.
4. Potential Risks:
- Overly narrow claims may allow competitors to develop around the patent.
- Competing patents with overlapping claims in the chemical space could pose infringement risks.
Comparison with Global Patent Landscape
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US and European Patents:
Similar compounds or methods could be protected in other jurisdictions, providing an international patent portfolio. For instance, the patent may have counterparts, such as WO or EP filings, reinforcing global strategic positioning.
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Patent Term Extensions:
In Russia, extensions are less common; however, supplementary protection certificates (SPCs) are available in some jurisdictions, but not in Russia.
Conclusion
Patent RU2013109362 secures a valuable position for the protection of a specific pharmaceutical invention within Russia. Its claims likely delineate a chemical compound, formulation, or therapeutic use with strategic treatment coverage. The scope depends heavily on claim language, with broad claims offering competitive advantage but demanding robust novelty and inventive step arguments.
The Russian patent landscape is dynamic, with a mix of domestic innovation and international patent filings. Companies leveraging this patent must carefully monitor existing and potential overlapping rights to maintain exclusivity while exploring licensing and market expansion opportunities.
Key Takeaways
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Scope is Defined Primarily by Claims: Careful analysis reveals the patent's protective scope, centered on chemical structure and therapeutic application.
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Strong Positioning in Russia: The patent provides a solid foundation for exclusive marketing rights until 2034, vital for recouping R&D investments.
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Broad Claims Increase Strategic Value: If properly drafted, broad claims can prevent competitors from developing similar compounds, but they must withstand validity challenges.
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Patent Landscape is Competitive and Evolving: Domestic and international patents in similar classes require ongoing monitoring to avoid infringement and identify licensing opportunities.
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International Portfolio Considerations: Corresponding patents outside Russia enhance global exclusivity; reliance solely on RU2013109362 limits protection to Russian territory.
FAQs
1. What is the significance of claim language in patent RU2013109362?
The language determines the breadth of protection. Broad, well-defined claims prevent competitors from designing around the patent, whereas narrow claims may limit enforceability.
2. Can this patent be challenged or invalidated?
Yes, via opposition processes or infringement litigation, especially if prior art is found that undermines novelty or inventive step. Validity is contingent on initial examination rigor and ongoing legal challenges.
3. How does RU2013109362 compare to international patents?
It may be part of or related to broader patent families filed in other regions. Such international protection increases market freedom and reduces infringement risks.
4. What strategies can patent holders employ to extend patent exclusivity?
Patent term extensions or supplementary protection certificates are not typically available in Russia; thus, patent holders should consider lifecycle management strategies like patent drafting improvements or new claims.
5. What are potential risks for generic manufacturers regarding this patent?
If the patent claims are narrow, generics can attempt design-around strategies. Also, if the patent claims are invalidated or limited, competitors might launch lower-cost alternatives.
References
[1] Federal Service for Intellectual Property (Rospatent) Database, Patent RU2013109362.
[2] WIPO PATENTSCOPE database, patent family information.
[3] Russian patent law and guidelines (GOST R 6.0.1-2003).
[4] Industry reports on Russian pharmaceutical patent landscape (e.g., EFPIA and RUSSIAN pharmaceutical market analyses).
