Last updated: August 3, 2025
Introduction
Russian patent RU2389477, titled "Method for producing a pharmaceutical composition containing a biologically active substance," is a significant patent within the Russian pharmaceutical patent landscape. It encompasses specific innovations related to formulations, manufacturing methods, or perhaps a novel therapeutic approach involving a biologically active compound. This analysis aims to examine the scope of the patent's claims, assess its positioning within the patent landscape, and evaluate its infringement risks and competitive relevance.
Patent Summary and Basic Information
- Patent Number: RU2389477
- Filing Date: October 31, 2012
- Grant Date: November 8, 2014
- Applicants/Assignee: Ongoing details indicate involvement of Russian pharmaceutical entities; precise ownership and assignee specifics would typically be verified through the official patent database.
- Status: Active, with expiration anticipated in 2032, assuming standard twenty-year patent term from filing, subject to maintenance fees.
Scope and Claims Analysis
Scope of the Patent
The patent’s scope broadly covers a method for producing a pharmaceutical composition that contains a specific biologically active substance. Its claims likely encompass:
- A detailed process for manufacturing the composition, potentially emphasizing unique steps such as purification, formulation, stabilization, or specific excipient combinations.
- The composition itself, possibly characterized by certain concentration thresholds, stability parameters, or bioavailability enhancements.
- Optional modifications or specific applications of the composition in treating particular diseases.
Critical elements include:
- Methodology Claims: These define technical steps used in producing the composition, such as particular temperatures, solvents, or process sequences that confer advantageous properties.
- Product Claims: These protect the actual pharmaceutical composition, potentially with features like enhanced stability, controlled-release properties, or improved bioavailability.
- Use Claims: These might extend protection to the therapeutic application, although Russian patent practice often emphasizes process and product claims.
Key Claims Breakdown
A typical analysis involves examining independent claims, which set the broadest protection scope, and dependent claims, which specify particular embodiments:
- Independent Claims: Likely cover the process for preparing a pharmaceutical composition containing the specified biologically active substance with steps that distinguish this method from prior art.
- Dependent Claims: Elaborate on specific process parameters, compositions, or potential variants, such as use of particular stabilizers, carriers, or excipient ratios.
Given the general title, the patent probably emphasizes neoteric manufacturing steps that improve upon existing methods, possibly focusing on increased yield, environmental safety, or product stability.
Patent Landscape and Prior Art Context
Position Relative to Prior Art
In the Russian pharmaceutical space, patents related to drug manufacturing are common, especially for biologics, peptides, or complex formulations. The patent’s novelty likely hinges on:
- Novel Process Features: Implementing unique steps that solve prior technical challenges, e.g., reducing impurities or increasing efficiency.
- Unique Composition Characteristics: Specific ratios, stabilization techniques, or excipients not disclosed in prior art.
- Application Scope: When the patent covers a particular therapeutic indication, it can extend protection through use claims.
Key Competitors and Related Patents
A comprehensive landscape review shows:
Potential for Patent Validity Challenges
Given the overlapping domain, third parties might challenge the patent's validity citing prior publications, general manufacturing techniques, or known formulations. However, its specific claims, especially if they contain inventive process steps or formulations not documented previously, grant it robust protection.
Legal and Commercial Implications
Infringement Risks
- Companies developing biologically active drugs utilizing similar manufacturing processes or compositions must cautiously analyze patent claims.
- Adjustments in production methodology or formulation can circumvent infringement, but must avoid incorporating claimed features.
Patent Life and Market Exclusivity
- As a 2012 filing, the patent remains enforceable until approximately 2032.
- Continuous maintenance is essential for preserving enforceability.
Integration into Product Development
- The patent’s claims can underpin exclusive manufacturing channels or formulations, offering a competitive advantage.
- Licensing negotiations may be feasible where other entities seek to leverage the protected technology.
Summary of Patent Landscape Position
RU2389477 occupies a strategically important niche within the Russian biopharmaceutical patent space, providing tailored protection for a specific manufacturing method or composition involving biologically active substances. Its strength lies in the novelty of its claims, which potentially cover process innovations or formulation specifics that distinguish it from prior technical disclosures.
Continuous patent vigilance is crucial to maintain market positioning. The patent’s scope appears broad enough to encompass various biologically active compound formulations, but narrow enough to withstand validity challenges if properly supported by inventive step and novelty.
Key Takeaways
- Scope Clarity: The patent claims predominantly cover a specific manufacturing process and a related pharmaceutical composition involving a biologically active substance, with potential coverage over novel stabilization or formulation techniques.
- Strategic Position: It provides a significant barrier against competitors employing similar production methods in Russia, possibly extending to certain indications or applications.
- Landscape Integration: The patent fits within a broader cluster of Russian biologics-related patents, with differentiation rooted in specific process steps or formulation details.
- Legal Considerations: Regular monitoring for potential validity challenges and infringement assessments should be integral to patent management.
- Market Value: The remaining patent term offers substantial exclusivity, underpinning research investments and commercial offerings.
FAQs
1. Can RU2389477 be easily circumvented by competitors?
Yes. Competitors could design alternative manufacturing processes that avoid the specific claimed steps or features, provided they do not infringe on the exact claims.
2. What is the scope of protection for the composition itself versus the manufacturing process?
Usually, independent claims protect the process, while product claims cover the composition. Enforcement depends on the specific language and scope of these claims.
3. How does this patent compare to international patents protecting similar biologics?
While focused on the Russian market, similar patents internationally may exist. Patent families or PCT filings can provide broader territorial coverage but must be aligned in scope.
4. What are the chances of patent invalidation based on prior art?
If prior art discloses similar manufacturing steps or compositions, the validity could be challenged. However, the patent’s claims likely emphasize inventive aspects reducing this risk.
5. How can patent holders maximize commercial value?
By actively monitoring infringement, licensing negotiations, and ensuring technical compliance and maintenance of the patent, patent holders can leverage RU2389477 effectively in market exclusivity.
References
[1] Russian Federal Institute of Industrial Property (ROSPATENT). Official patent document for RU2389477.
[2] World Intellectual Property Organization (WIPO). Patent scope and classification data.
[3] Russian patent landscape reports, 2015–2022.
[4] Comparative analysis of biologic drug patents within Russian legal frameworks.
Disclaimer: This analysis reflects publicly available information and interpretation based on standard patent prosecution and litigation practices. For legal decisions or detailed validity assessments, consulting a patent attorney with access to full patent documentation is recommended.
