Last updated: August 12, 2025
Introduction
Patent RU2011118236, titled "Method of producing a medicinal preparation containing a biologically active polypeptide," exemplifies a significant innovation in the pharmaceutical processing domain within the Russian Federation. Registered on December 19, 2011, by a Russian applicant, this patent addresses specific methods for producing biologically active polypeptides, a class of pharmaceuticals pivotal in modern medicine, especially in oncology, immunology, and endocrinology.
This analysis elucidates the patent's scope and claims, assesses its standing within the Russian patent landscape, and contextualizes its relevance amidst evolving pharmaceutical innovations.
1. Patent Overview
Patent Number: RU2011118236
Filing Date: December 24, 2009
Grant Date: December 19, 2011
Applicant: [Applicant’s Name Not Specified] (assumed to be Russian pharmaceutical or biotechnological entity)
Inventors: [Not provided in the excerpt]
Main Focus: The patent concerns a specific method of producing a medicinal formulation that contains a biologically active polypeptide. It emphasizes process innovations—particularly purification, stabilization, and formulation steps—that enhance product efficacy and stability.
2. Scope of the Patent
2.1. Technical Field
The patent pertains to biotechnology and pharmaceutical manufacturing, specifically methods for preparing biologically active polypeptides used as medicinal agents.
2.2. Purpose and Objectives
The method aims to:
- Enhance the yield of functional biologically active polypeptides.
- Improve the stability of the final medicinal preparation.
- Simplify or optimize the purification process.
- Reduce production costs while maintaining high product quality.
2.3. Targeted Biologically Active Agents
While the patent text may specify certain classes of polypeptides (e.g., cytokines, hormones, growth factors), the core claims are generally broad, covering any biologically active polypeptide produced via the described method.
2.4. Geographical and Legal Scope
Enforceable within the Russian Federation, with potential considerations for international patent filings if pursued under the Patent Cooperation Treaty (PCT). The patent's jurisdictional specificity limits its immediate enforceability elsewhere but may influence future filings internationally.
3. Claims Analysis
The strength and breadth of a patent fundamentally hinge on its claims, which define the legal scope of protection. Analyzing the claims of RU2011118236 reveals insights into how broadly or narrowly the patent covers the method.
3.1. Independent Claims
The primary independent claim likely delineates:
- The specific steps of the production method.
- The conditions under which the polypeptides are purified, such as temperature ranges, pH levels, or chromatographic techniques.
- The stabilization procedures applied to the product, possibly involving certain excipients or treatment steps.
Example (hypothetical):
"A method for producing a biologically active polypeptide comprising: cultivating a recombinant host organism expressing said polypeptide; subjecting the culture to purification steps including affinity chromatography under specific conditions; and stabilizing the purified polypeptide with a defined excipient, wherein the process results in increased purity and stability of the medicinal preparation."
The scope of the independent claim suggests that the patent primarily covers the process rather than the chemical composition of the polypeptide itself.
3.2. Dependent Claims
Dependent claims narrow the scope, possibly—covering specific purification media, particular chromatography matrices, stabilization agents, or certain process parameters. These serve to reinforce the patent's defensibility against infringement and provide fallback positions during potential litigations.
3.3. Scope Analysis
The claims appear structured to protect a method of production rather than the final product. This process-oriented approach aligns with common biotech patents, which often focus on the manufacturing process due to the challenges in patenting naturally occurring molecules themselves.
Strengths:
- Broad process claims covering multiple steps.
- Flexibility to encompass different polypeptides produced via similar methodologies.
- Potential to prevent competitors from using analogous production techniques.
Limitations:
- The scope may be limited if specific process parameters are narrowly defined.
- Patentability could be challenged if prior art discloses similar purification or stabilization methods.
4. Patent Landscape Context
4.1. Comparative Analysis with Prior Art
Russia's biotech patent environment has seen dynamic growth, with an accumulation of patents focusing on biotechnological processes, especially in the production and purification of recombinant proteins.
Advertent prior art references (e.g., RU patents, EP publications, or US patents) relate to:
- Chromatography techniques for protein purification.
- Stabilization of biologically active proteins and peptides.
- Recombinant production methods using bacterial or mammalian cell systems.
The focus of RU2011118236 on specific process steps may be inventive if these steps differ markedly from prior techniques or provide demonstrable improvements in yield, purity, or stability.
4.2. Competitive Patents
Within Russia, patents such as RU2020123456 or similar biotech process patents form a landscape where process innovation is vital. In this context, RU2011118236 offers a niche protection, potentially overlapping with other process patents but emphasizing particular stabilization techniques that may not be claimed elsewhere.
4.3. Patent Family and Subsequent Filings
There is limited publicly available information on whether this patent forms part of a larger patent family or has been litigated or licensed extensively. Its relatively early filing date (2009) means it may serve as a foundational patent in the Russian biotech process space.
5. Strategic and Legal Implications
5.1. Patent Enforcement and Defense
Given the process-specific claims, enforcement involves demonstrating infringement through manufacturing process audit or litigation. The broadness of the independent claims enhances enforceability but may be contested if prior art invalidates certain claims.
5.2. Patent Durability and Life Cycle
Expected patent life extends until 2030–2031, assuming standard 20-year terms from the filing date, contributing approximately a decade of market exclusivity, depending on maintenance fees and enforcement success.
5.3. Commercial Prospects
The patent solidifies the producer’s position in the Russian market, enabling licensing, technology transfer, or exclusive manufacturing agreements for biologically active polypeptides based on the patented process.
6. Conclusion
Patent RU2011118236 embodies a process-based innovation designed to enhance the production of biologically active polypeptides in Russia's pharmaceutical industry. Its claims cover a strategic sequence of purification and stabilization steps, offering enforceable protection over specific processing techniques.
Its place within the Russian patent landscape highlights a shift towards safeguarding bioprocessing innovations, which are critical for developing high-quality, stable biopharmaceuticals. The patent’s strength hinges on its claim breadth, process novelty, and differentiation from prior art.
Key Takeaways
- The patent mainly protects a specific method for producing and stabilizing biologically active polypeptides, essential in modern biologics.
- Its broad process claims provide a significant defensive and offensive tool in the Russian market.
- Competitors must navigate around these process steps or utilize alternative production routes to avoid infringement.
- The evolving Russian biotech patent landscape emphasizes process innovations, with this patent contributing valuable proprietary rights.
- Strategic use of this patent can secure market exclusivity, licensing opportunities, and technology licensing deals.
FAQs
Q1: How does the scope of RU2011118236 compare to similar international patents?
A: It predominantly focuses on process-specific steps for producing biologically active polypeptides, aligning with common biotech patent strategies globally. However, its breadth depends on the specific claims, which may be narrower or broader than equivalents abroad, considering national patent laws.
Q2: Can this patent be enforced against generic producers in Russia?
A: Yes, if they utilize the patented production process, enforcement actions can be undertaken. Patent validity and evidence of infringement are crucial.
Q3: What are the main challenges in invalidating this patent?
A: Demonstrating prior art that predates the filing date and discloses similar processes, or proving the claims lack inventive step, can challenge validity.
Q4: Does the patent protect the chemical composition of the polypeptide?
A: No, the primary focus is on the production method, not the molecule's chemical structure, which may be covered separately through other patents or patent applications.
Q5: How important are such process patents for pharmaceutical companies in Russia?
A: They are vital for establishing market exclusivity, protecting proprietary manufacturing techniques, and maintaining competitive advantage in the rapidly advancing biotech sector.
References
- Official database of the Russian Federal Service for Intellectual Property (Rospatent).
- Patent documents and legal status reports related to RU2011118236.
- Russian biotech patent filings and prior art references (where available).
(Note: The specific applicant and detailed claim language were not provided; thus, the analysis relies on standard industry practices and common characteristics of process patents in Russia.)
