Last updated: July 29, 2025
Introduction
Patent RU2004121464, issued by the Russian Federation, represents an important asset within the pharmaceutical patent landscape. This patent delineates proprietary rights over a specific drug invention, including its novel features, scope, and claims. Analyzing its scope and claims, along with understanding the broader patent landscape, is vital for stakeholders involved in drug development, licensing, and market strategy in Russia.
This article provides an in-depth examination of RU2004121464, focusing on its claims, scope of protection, and the relative patent landscape. Such insights are essential for evaluating patent strength, competitive positioning, and potential for commercialization or infringement risks within Russia.
Patent Overview and Background
Patent RU2004121464 was granted for a pharmaceutical invention, most likely targeting a particular therapeutic compound, formulation, or manufacturing process. Specific details about the inventive subject matter, such as chemical structures or method claims, are essential to understand its scope fully.
The patent's filing and grant dates suggest it was filed in the early 2000s, placing it within a period of active pharmaceutical patenting in Russia, especially following its accession to the WTO in 2012, which prompted strengthening of patent rights.
Scope of the Patent: Claims Analysis
1. Types of Claims
Russian drug patents generally include product claims (covering the drug itself), composition claims (covering formulations or combinations), and method claims (pertaining to manufacturing or therapeutic methods). Patent RU2004121464 most likely encompasses a combination of these.
2. Claim Structure
- Independent Claims: These define the core invention, typically detailing the drug’s chemical entity, formulation, or process. They are broad and set the boundaries of the patent protection.
- Dependent Claims: Narrower claims that specify particular features or embodiments, providing fallback positions and added details.
3. Scope of Protection
The breadth of the claims determines the extent of exclusivity:
- Chemical/Compound Claims: If the patent covers a specific chemical entity, its scope includes all uses, formulations, and methods involving that compound.
- Method Claims: Cover uses or treatments involving the compound, with scope limited to described methods.
- Formulation Claims: Cover specific compositions, including excipients, dosages, or delivery systems.
The specific language of claim wording critically influences scope. Precise, broad claims can prevent competitors from producing similar drugs, whereas narrow claims risk easy design-around.
4. Critical Elements of Claims
Given typical pharmaceutical patents, claims likely include:
- The chemical structure or formula of the active ingredient.
- Specific impurities or derivatives.
- Formulation parameters such as excipients, dosage forms, or stabilization methods.
- Method claims covering synthesis or therapeutic application.
The patent must balance biological activity (efficacy, safety) with chemical novelty to establish patentability.
Patent Landscape in Russia
1. National Patent Environment
Russia’s patent system aligns with the Russian Civil Code and the Animation Patent Law. Since 2008, the country has substantially modernized its IP laws, harmonizing with the European Patent Convention (EPC).
2. Patent Families and Related Applications
- The patent likely belongs to a patent family, with counterparts filed in other jurisdictions such as the EPO, US, or China.
- Russian patents may serve as regional backbones before global patent applications, especially for pharmaceutical exclusivity.
3. Patent Validity and Term
- Expected 20-year term from the filing date, provided annual fees are paid.
- Patent term adjustments or extensions are rare for drugs in Russia, especially post-approval, as cumulative regulatory data exclusivity does not directly extend patent terms.
4. Overlapping Patents and Freedom-to-Operate
- The Russian patent landscape shows a growing number of pharmaceutical patents, often overlapping in active ingredients or formulations.
- Freedom-to-operate analyses must consider prior art, patent families, and potential patent thickets around similar compounds or therapeutic methods.
5. Legal Challenges and Patent Status
- The patent’s enforceability hinges on maintenance, non-obviousness, and novelty.
- Invalidation proceedings or oppositions by competitors may arise, especially if prior art surfaces.
Implications for Stakeholders
- Pharmaceutical developers should scrutinize the claims' breadth to assess risks of infringement or opportunity for licensing.
- Generics companies may explore workarounds if claims are narrowly drafted.
- Patent holders can leverage the scope to extend market exclusivity, considering possible patent term extensions or supplementary protection certificates (SPC) where applicable.
Key Legal and Strategic Considerations
- Claim Breadth: Broader claims fortify patent rights but are more vulnerable to challenge. Narrow claims may ease infringement defenses.
- Patent Lifecycle: Monitoring expiry dates and potential extensions is critical for market planning.
- Patent Landscape Dynamics: Competitors’ filings around similar compounds necessitate vigilant landscape monitoring.
- Regulatory Factors: Russian regulatory changes influencing patent term extensions or data exclusivity impact patent utility.
Conclusion
Patent RU2004121464 offers a defined scope of protection over a pharmaceutical invention, with claims likely encompassing specific compounds or formulations pertinent to the protected drug. Its position within the Russian patent landscape underscores the importance of robust claim drafting and strategic patent management to maximize exclusivity and mitigate infringement risks.
For innovators and patent owners, understanding the precise scope and positioning of this patent informs licensing, litigation, and market entry strategies. Continuous landscape monitoring and potential legal challenges should be considered as part of comprehensive patent lifecycle management.
Key Takeaways
- The scope of RU2004121464 heavily depends on the specificity and breadth of its claims, which should be critically analyzed to evaluate patent strength.
- Russian pharmaceutical patents are increasingly harmonized but remain susceptible to challenges; strategic claim drafting is essential.
- Understanding the patent landscape helps identify potential infringement issues and opportunities for license or innovation.
- Patent expiry and legal enforceability determine long-term market protection, especially within the context of rapidly evolving pharmaceutical regulation.
- Proactive monitoring and legal strategies are essential for maintaining patent integrity and securing market advantage.
FAQs
1. How does claim breadth influence the enforceability of RU2004121464?
Broader claims provide stronger protection but are more vulnerable to invalidation. Narrow claims may be easier to defend but offer limited exclusivity.
2. Can RU2004121464 be extended beyond 20 years?
In Russia, pharmaceutical patents generally last 20 years; however, extensions are limited compared to EU or US systems. Data exclusivity might offer additional market protection but does not prolong patent life.
3. How does the Russian patent landscape compare with international markets?
Russia’s system is harmonized with EPC standards but is less expansive than the US or EU. Patent protection in Russia may require specific national filings for comprehensive coverage.
4. What are common challenges to pharmaceutical patents like RU2004121464?
Prior art, obviousness, and lack of novelty are primary grounds for invalidation. Patent holders must demonstrate the invention’s inventive step and novelty rigorously.
5. What strategic actions should patent owners consider?
Regular landscape monitoring, strategic claim drafting, potential patent term extensions, and proactive enforcement are vital for maintaining market exclusivity.
Sources:
[1] Russian Civil Code, Part IV, Patent Law Regulations.
[2] Federal Service for Intellectual Property (ROSPATENT) Official Gazette.
[3] World Intellectual Property Organization (WIPO) Patent Scope Database.
[4] European Patent Office (EPO) Guidelines on Patentability.
[5] Russian Federation Patent Law, 2008 Amendments.
