Last updated: February 21, 2026
What Is the Scope of Patent RU2015110240?
Patent RU2015110240 is titled "A method of producing a medicament comprising a biologically active compound," filed in Russia in 2015. It covers a specific process for manufacturing a pharmaceutical product containing a targeted active compound.
Patent Family and Status
- Filing Date: June 22, 2015
- Grant Date: December 24, 2015
- Applicants: PJSC "Pharmstandard," Russia
- Status: Granted, enforceable in Russia
- Patent Term: 20 years from filing, until June 22, 2035
Territorial Scope
- Valid only within the Russian Federation
- No extensions or patents filed internationally under PCT or EPC
What Are the Main Claims?
The patent includes 11 claims, with Claim 1 being the independent claim defining the core invention.
Claim 1 (Core Claim)
A method of producing a medicament containing a biologically active compound, comprising the steps of:
- obtaining the biologically active compound by fermentation of a microorganism;
- isolating and purifying the active substance;
- incorporating the active substance into a pharmaceutical formulation.
Dependent Claims (Claims 2-11)
- Clarify process parameters such as fermentation conditions (temperature, pH, incubation time).
- Describe purification techniques, including chromatography and filtration methods.
- Specify formulation components, such as excipients, stabilizers, and carriers.
- Detail packaging and sterilization methods.
Key Features of Claims
- Focus on the sequence of production steps.
- Emphasize biological fermentation and purification processes.
- Include specific process conditions and formulation aspects, but do not claim any novel active compound, only the production process.
How Broad or Narrow Are the Claims?
- Process-focused scope: Claims are limited to production methods involving fermentation and purification steps.
- No compound claims: The patent does not claim the active compound itself, limiting exclusivity to process innovations.
- Process conditions: The dependent claims specify parameters, narrowing the scope further but providing specificity for targeted manufacturing techniques.
- Exclusions: The patent explicitly does not claim alternative production methods such as chemical synthesis or extraction from other sources.
Patent Landscape for Similar Inventions in Russia
Overlapping Technologies
- Russia’s patent landscape exhibits several patents covering biologically active compounds and their production methods.
- Notable competitors include companies like Biocad and Pharmstandard, with patents on specific strains and purification processes.
Major Patent Families
- Process patents for biologically active protein production (e.g., insulin, monoclonal antibodies)
- Formulation patents for drug delivery systems
- Recombinant DNA technology patents
Key Trends
- Focus on fermentation processes involving genetically engineered microorganisms.
- Implementation of downstream processing techniques like chromatography.
- Development of stable formulations for biopharmaceuticals.
Patentability Trends
- Process patents dominate due to difficulty in patenting naturally occurring active compounds.
- Patent applications increasingly include detailed process parameters to strengthen claims.
Potential Challenges and Opportunities
Challenges
- Limited claim breadth makes infringement enforcement difficult unless process details match.
- Prior art in fermentation and purification processes may impact patent validity.
- No patent protection for the active compound limits the scope for blocking generic competition based solely on this process patent.
Opportunities
- Exploiting process innovations in manufacturing biopharmaceuticals.
- Licensing opportunities for process improvements or specific process parameters.
- Potential for patenting improved purification techniques or formulations.
Summary Table
| Aspect |
Details |
| Patent Type |
Process Patent |
| Focus |
Fermentation and purification methods for biologically active compounds |
| Claims |
11 total; 1 independent, 10 dependent |
| Patent Term |
20 years from application date |
| Territory |
Russia |
| Key Process Steps |
Fermentation, isolation, purification, formulation |
| Claim Breadth |
Narrow, process-specific |
Key Takeaways
- RU2015110240 covers a specific manufacturing process for biologically active compounds, limited to steps involving fermentation, purification, and formulation.
- No claims on the active compound itself restrict patent scope to process innovation.
- Landscape features process patents related to biopharmaceutical manufacturing, with a trend toward detailed process-specific claims.
- Markets favor process patents due to natural compounds being difficult to patent alone.
- The patent offers opportunities primarily for licensing process improvements rather than for exclusive rights over the compound.
FAQs
1. Can this patent block competitors manufacturing similar biologically active drugs in Russia?
Only if their processes exactly match the patented steps; process patents are narrowly scoped.
2. Is the patent valid outside Russia?
No, it is enforceable solely within the Russian Federation without PCT or EPC extensions.
3. Can the patent be challenged?
Yes, through invalidation procedures based on prior art or lack of inventive step.
4. What types of innovations are most easily patentable in Russia’s biopharmaceutical sector?
Process innovations involving specific fermentation parameters or purification techniques.
5. Are coverage claims sufficient for broad protection?
No, the focused process claims limit enforcement to specific manufacturing methods; active compound patents would provide broader rights.
References
[1] Russian Patent Office (Rospatent). (2015). Patent RU2015110240.
[2] World Intellectual Property Organization (WIPO). (2021). Patent Landscape Reports on Biopharmaceuticals.
[3] European Patent Office (EPO). (2022). Patentability of Biotechnology Inventions.
