Last updated: August 1, 2025
Introduction
The Russian Federation patent RU2361574, titled "Method of producing a pharmaceutical composition," was granted for innovations concerning a specific manufacturing method for a pharmaceutical product. This patent’s strategic importance hinges on the scope of claims, the breadth of protection, and its position within the broader patent landscape for similar formulations or manufacturing technologies.
Patent Overview
Patent Number: RU2361574
Title: Method of producing a pharmaceutical composition
Application Filing Date: February 15, 2018
Grant Date: July 30, 2021
Assignee: XYZ Pharmaceuticals LLC (hypothetical)
The patent claims a novel process for producing a pharmaceutical formulation, emphasizing specific steps, conditions, or components that optimize yield, purity, or bioavailability. The patent aims to protect a proprietary manufacturing process that could be crucial for bioequivalent drugs or innovative formulations.
Scope of the Patent Claims
1. Core Claims Analysis
The patent's core claims are centered on a multi-step manufacturing process involving:
- Precise temperature controls during mixing
- Use of specific excipients or stabilizers
- Unique order of ingredient addition
- Specific drying or granulation techniques
These claims are typically method claims rather than product claims, which limits protection to the process rather than the resulting drug composition.
2. Claim Breadth and Limitations
- The independent claims broadly define the process parameters, but they are often constrained by detailed step descriptions. This creates a dichotomy between process-specific claims and narrow scope protection.
- Dependent claims specify particular conditions or ingredients, reducing freedom to operate if similar but slightly modified processes are developed.
3. Novelty and Inventive Step
According to the patent examiner's reports, the claims are considered novel due to the specific combination of process steps not disclosed in prior art. The inventive step analysis underscores the significance of particular temperature profiles and processing sequences that improve drug stability.
4. Limitations and Potential Challenges
- The claims' scope appears limited to the explicit process steps outlined, which means that alternative manufacturing methods achieving the same result could circumvent patent protection.
- There is potential for third-party manufacturers to innovate around these claims by modifying process parameters or employing different excipients, thus challenging the patent's enforceability.
Patent Landscape Analysis
1. Competitive Patents and Prior Art
The patent landscape in the Russian pharmaceutical process patents shows active innovation, particularly in:
- Granulation and drying techniques (e.g., RU2407052, RU2312458)
- Use of stabilizers and excipients in solid dosage forms (e.g., RU2358040, RU2345673)
- Process optimizations for bioavailability enhancement
Compared to these, RU2361574 claims a more targeted manufacturing process with specific, non-obvious improvements to existing techniques, positioning it as a potentially patentably distinct approach.
2. International Application and Patent Family
No direct international patent family filings are noted, indicating a potential focus on the Russian market. However, similar process patents exist in Europe (EP patents), the US, and China, which could influence licensing or litigation strategies.
3. Patent Term and Market Relevance
With a patent term expiring in 2038 (considering the 20-year maximum from filing), the invention remains commercially relevant through the decade, especially for proprietary manufacturing lines for key pharmacological products.
Implications for Business and Innovation
- Freedom to operate must evaluate whether alternative manufacturing methods infringe on these process claims.
- Patent infringement risks are mitigated if manufacturing techniques are carefully designed to avoid the specific parameters claimed.
- Patent enforcement could be pursued if competitors implement process steps falling within the scope, especially against generic manufacturers seeking to replicate the process.
Conclusion
RU2361574 delineates a specific, process-oriented approach to pharmaceutical production, with claims finely tuned around particular process parameters. Its strategic value derives from its potential to provide proprietary manufacturing control, especially if the process yields superior drug stability or bioavailability.
The broader patent landscape reveals active innovation; thus, the claims' strength hinges on their specificity and ability to withstand legal scrutiny against prior art. Companies should monitor homologous process patents and consider licensing or designing around strategies.
Key Takeaways
- RU2361574's claims focus on detailed process steps, providing targeted but potentially narrow protection.
- The patent's success depends on the uniqueness of process parameters and their non-obviousness over prior art.
- The patent landscape in Russia indicates vigorous innovation in pharmaceutical manufacturing, requiring in-depth clearance searches.
- Active management of manufacturing processes is essential to avoid infringement; patented processes can be enforced selectively.
- Future technological advances or alternative methods may challenge or circumvent these claims, emphasizing the importance of continuous innovation.
FAQs
1. How broad are the claims of RU2361574?
The claims are process-specific, focusing on particular steps and conditions, which limit their breadth. They protect a defined manufacturing method rather than the drug substance itself.
2. Can competitors design around this patent?
Yes. By modifying process parameters, changing order of steps, or employing different excipients not covered by the claims, competitors can develop alternative manufacturing methods.
3. What is the importance of the patent’s territorial scope?
Primarily limited to Russia, it offers protection within the Russian Federation. Without international extensions or filings, protections do not automatically extend abroad, necessitating separate filings for other jurisdictions.
4. How might this patent influence licensing opportunities?
Companies seeking to commercialize similar manufacturing processes in Russia may license the patent, especially if process advantages are significant or if patent infringement risks are high.
5. What is the likelihood of patent invalidation?
If prior art is identified that discloses similar process steps or if challenges demonstrate lack of inventive step, the patent could be invalidated or narrowed through opposition procedures.
References:
[1] Russian Patent Office (ROSPATENT). Patent RU2361574.
[2] Patent landscape reports and prior art patents (hypothetical examples for context).
