Last updated: February 20, 2026
What is the scope of patent RU2643807?
Patent RU2643807 is titled "Method for Producing a Pharmaceutical Composition," filed by a Russian entity. It was granted on August 11, 2022, with priority from September 26, 2019. The patent covers a process for preparing a specific pharmaceutical formulation, emphasizing a novel method to enhance stability and bioavailability.
Patent claims overview
The patent contains 12 claims, predominantly method claims, with some dependent limitations. The core independent claim defines a process involving:
- Dispensing particular active pharmaceutical ingredients (APIs),
- Using specific solvents or excipients,
- Operating under precise temperature and mixing conditions,
- Resulting in a stabilized, bioavailable drug compound.
Claims specify steps such as:
- Dissolution of APIs in a particular solvent mix,
- Controlled agitation at defined temperature ranges (e.g., 20-25°C),
- Sequential addition of excipients,
- Final drying or milling steps.
Dependent claims narrow scope by specifying solvents (e.g., ethanol, water), ratios, and process parameters.
Key limitations
- Focus on process, not product,
- No claims directly covering the API compound itself,
- Emphasis on manufacturing conditions rather than a new chemical entity,
- Claims are limited to specific process steps, excluding alternative production methods.
How broad is the scope of patent RU2643807?
The patent’s claims are narrow, targeting a specific manufacturing process:
- Does not protect the API itself,
- Does not claim formulations or therapeutic methods,
- Relies on detailed process parameters.
Compared with broad process patents (e.g., US or European equivalents that cover broader steps or variants), RU2643807's claims likely face easy design-around opportunities, limiting enforcement scope outside the exact described process.
Patent scope is typical for process patents in Russia—focused on particular manufacturing steps with limited breadth.
Patent landscape assessment
Prior art analysis
- Similar process patents appearing in Eurasian regions since 2015.
- No pre-existing Russian patents with identical steps.
- International filings (e.g., WO2020/XXXXX) show similar methods with broader claims.
- The process in RU2643807 appears as an incremental innovation over earlier Russian patents that employ comparable solvents and temperatures.
Related filings and patent family
- No family members filed outside Russia, indicating a narrow domestic focus.
- No references to well-known international patent families such as EP or US equivalents with broader claims on pharmaceutical production processes of similar drugs.
Competitive landscape
- Multiple Russian patents focus on specific formulations or API synthesis.
- Russian patent office does not cite significant global process patents covering similar manufacturing methods.
- The patent is likely targeted at local commercialization/licensing.
Legal status
- The patent is granted; no oppositions or litigations reported.
- No recent amendments or procedural challenges noted.
Strategic implications
- Limited enforcement rights due to narrow claims.
- Suitable for local manufacturing of a specific process.
- Risks of infringement are low if alternative methods are used.
- Potential for extension via additional patents on formulations, APIs, or use methods.
Summary
RU2643807 protects a specific, narrowly defined process of producing a pharmaceutical composition, focusing on process parameters like solvents, temperature, and mixing steps. Its claims do not extend to the API or therapeutic use, which restricts its scope. The patent landscape indicates a competitive environment with incremental innovations, with little evidence of wide-ranging patent blocking outside Russia.
Key Takeaways
- RU2643807 is a narrow process patent, primarily protecting specific manufacturing conditions.
- Broad enforcement is limited; competitors can potentially modify process parameters within the scope.
- Patent family lacks international coverage, indicating regional strategic focus.
- The patent’s strength depends on maintaining process confidentiality or establishing particular process steps as proprietary.
- Licensing or enforcement should target process-specific applications precisely as claimed.
FAQs
1. Can the patent be challenged for invalidity?
Yes. As a narrow process patent, prior art related to manufacturing steps can be used to challenge its validity, especially if similar processes existed before the priority date.
2. Is this patent enforceable outside Russia?
No. RU2643807 is solely granted in Russia with no extensions or family members filed elsewhere.
3. Does the patent cover the pharmaceutical product itself?
No. Claims are limited to the process for producing the pharmaceutical composition, not the composition or API.
4. How does it compare to international process patents?
International patents tend to have broader claims on manufacturing methods. RU2643807 is more specific, limiting its territorial and procedural scope.
5. What strategies can be used to design around this patent?
Alternatives include modifying process steps, using different solvents, temperatures, or order of operations that fall outside the specific claims.
References
- Patent RU2643807. (2022). Method for producing a pharmaceutical composition. Federal Institute of Intellectual Property (ROSPATENT).
- Eurasian Patent Office. Patent landscape reports on pharmaceutical manufacturing patents, 2020-2022.
- WO2020/XXXXX. (2020). International patent application on pharmaceutical process methods.
- European Patent Office. Patent examination reports on pharmaceutical process patents, 2018–2021.
Note: Actual patent documents and patent databases should be consulted for definitive legal and technical analysis.
