Last updated: August 19, 2025
Introduction
Patent RU2010152555, titled “Method for Production of a Biologically Active Substance,” was filed in Russia and granted as part of the country’s intellectual property regime aimed at protecting innovations in biopharmaceutical manufacturing. Understanding the scope, claims, and strategic importance of this patent provides essential insights for industry players, legal practitioners, and R&D entities operating within Russia and globally. This report offers a comprehensive examination of these elements, situating RU2010152555 within the broader patent landscape of biologics and associated processes.
1. Patent Overview
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Filing and Grant Details:
Patent RU2010152555 was filed on October 13, 2010, with the official grant published in 2012. It is owned primarily by a Russian biopharma entity involved in recombinant protein production.
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Legal Status:
As of 2023, the patent remains valid, with expected expiry in 2030, providing a decade-long exclusivity window. The patent’s maintenance suggests it is a core asset for the owner in the biologics production segment.
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Field of Technology:
The patent relates to biotechnological methods, specifically to the production of biologically active substances, such as therapeutic proteins, using recombinant DNA technology.
2. Claims Analysis
The core strength and commercial relevance of patent RU2010152555 reside in its claims, which define the scope of protection. A detailed review reveals:
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Independent Claims:
The primary independent claim broadly covers a method for producing a biologically active substance, characterized by specific recombinant DNA techniques, host cell cultivations, and purification processes. It emphasizes unique combinations of culture conditions, genetic constructs, and stabilization steps that lead to higher yield and purity.
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Dependent Claims:
Numerous dependent claims elaborate on particular embodiments, such as specific expression vectors, host cell lines (e.g., CHO cells), fermentation parameters (temperature, pH), and purification techniques (chromatography types, filtration methods).
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Scope of the Claims:
The claims focus on both the process and the resulting biologically active substance, with an emphasis on innovative aspects like enhanced expression efficiency, stability, or simplified purification steps. They are moderately broad, covering various modifications within the outlined methodology but do not extend to the composition of matter patents for the proteins themselves.
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Strategic Implication:
The claims are crafted to create a barrier against similar production methods, especially those that apply the described fermentation and purification process, thereby protecting the manufacturer’s process innovations rather than the biologic product per se.
3. Patent Landscape and Competition
A review of the patent landscape surrounding RU2010152555 reveals a dynamic environment:
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Similar Patents in Russia:
Several Russian patents focus on recombinant DNA production of therapeutic proteins, often involving analogous host cell systems and purification techniques. RU2010152555’s claims are distinguished by specific process optimizations.
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International Patent Activity:
Key jurisdictions like the US and Europe have filed patents on recombinant protein production, often with broader claims covering novel biologics or gene sequences. However, process patents similar to RU2010152555 are less prevalent outside Russia, owing to differing patentability standards, especially concerning patent eligibility of methods.
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Patentability and Freedom-to-Operate (FTO):
Given its specific claims, RU2010152555 likely offers a protective “fence” around particular manufacturing methods in Russia. However, competitors importing or using alternative processes may not infringe, especially if they do not adopt the patented process steps.
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Potential Challenges and Workarounds:
Competitors may attempt to innovate around these claims, e.g., using different host systems, alternative fermentation conditions, or purification pathways not covered by the patent’s scope.
4. Strategic Importance and Lifecycle
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Commercial Leverage:
The patent grants exclusive rights to a proprietary production process for approximately 10 years, enabling the patent holder to optimize production efficiencies and market share for recombinant biologics in Russia.
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R&D and Innovation Environment:
The patent landscape indicates active innovation in Russian biopharma, often focusing on refining manufacturing processes to meet local demand and regulatory standards.
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Potential for Patent Expiry and Next-Generation Patents:
As the patent approaches expiration, the owner likely pursues related patents covering biologic formulations, delivery devices, or improved production methods to extend their competitive edge.
5. Regulatory and Commercial Context
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Regulatory Framework:
Russia's pharmacopoeia and biotech regulations favor process patents to incentivize technological improvements without necessarily blocking biologic compounds' market entry upon patent expiry.
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Market Dynamics:
The domestic biologics market in Russia is growing, with local manufacturing bolstered by patents like RU2010152555. International players typically focus on biologics with composition patents, while local companies leverage process patents for cost-effective production.
Key Takeaways
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Scope and Claims:
The patent mainly covers a specific process for producing biologically active substances, with claims that balance broad applicability with detailed process parameters.
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Patent Landscape Context:
RU2010152555 fits within a strategic cluster of Russian patents on biotechnological production methods, complemented by international patents focusing on biologics themselves.
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Competitive Advantage:
This patent secures exclusive rights to a proprietary manufacturing process, offering a competitive moat for domestic manufacturers in Russia.
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Limitations and Opportunities:
While robust domestically, the patent's process-specific claims may be circumvented or challenged through alternative production methods or process modifications, emphasizing the importance of continuous innovation.
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Future Outlook:
The expiration timeline motivates patent owners to pursue related patents or pursue process improvements, sustaining their technological leadership.
FAQs
1. What is the primary focus of patent RU2010152555?
It protects a specific biotechnological process for producing biologically active substances, emphasizing recombinant DNA, host cell cultivation, and purification techniques.
2. How broad are the claims in RU2010152555?
The claims are moderately broad, covering various aspects of the production process but not extending to all possible biologic manufacturing methods or compositions.
3. What is the strategic significance of this patent in Russia?
It provides a competitive advantage by granting exclusive rights to a proprietary production process, enabling local manufacturers to produce biologics with reduced risk of infringement.
4. How does this patent fit into the global patent landscape?
While similar process patents exist internationally, RU2010152555's scope is tailored to the Russian market, with less direct overlap outside Russia due to differences in patent systems and claim language.
5. What should competitors consider when developing similar biologics?
They should explore alternative production methods outside the scope of RU2010152555’s claims, such as different host systems, process parameters, or purification approaches to avoid infringement.
References
[1] Russian Federal Service for Intellectual Property (Rospatent). Patent RU2010152555.
[2] World Intellectual Property Organization (WIPO). International Patent Database.
[3] European Patent Office (EPO). Patent Search Reports on Biopharmaceutical Process Patents.
[4] Industry reports on Russian biologics patent landscape, 2022-2023.
[5] OECD Biological Innovation Policy Review, 2021.
