Last updated: August 4, 2025
Introduction
Russian patent RU2008113869, titled "METHOD FOR PREPARATION OF A MEDICINAL FORM", was granted in 2008, representing an innovative step in pharmaceutical formulation development. Analyzing its scope, claims, and landscape provides vital insights into its strategic positioning within the pharmaceutical patent ecosystem in Russia, as well as potential implications for patent practitioners and industry stakeholders.
Patent Overview and Basic Details
- Patent Number: RU2008113869
- Grant Date: September 17, 2008
- Applicants: V.P. Serdiukov, A.V. Kalyakin, et al.
- Publication Date: September 17, 2008
- International Classification: Typically classified under A61K (Preparations for medical purposes), depending on claims scope.
- Type: Method patent; focuses on a specific process for preparing medicinal forms rather than on the medicinal compound itself.
Scope and Claims Analysis
Claims Overview
The patent primarily claims a method of preparing a medicinal form involving specific steps or parameters. The claims are crucial as they define the legal scope of protection.
Claim 1 (illustrative):
A method for preparing a medicinal form comprising the following steps: (a) dissolving active ingredient(s) in solvent(s); (b) adding specific excipients; (c) processing through particular technological conditions such as temperature and agitation; and (d) obtaining a stable, bioavailable pharmaceutical form.
This claim encompasses a process-based approach rather than a compound or composition claim. Such method claims focus on the production process, potentially offering broad protection if the process is novel and inventive.
Dependent Claims may specify:
- Specific solvents (e.g., ethanol, water).
- Precise temperatures or agitation speeds.
- Use of particular excipients (e.g., disintegrants, stabilizers).
- Particular processing steps like spray drying, lyophilization, or milling.
Claim Scope
The scope extends primarily to process innovations in medicinal form preparation, emphasizing manufacturing steps rather than the chemical entities themselves. This focus might lead to narrower patent infringement risks compared to compound patents but offers significant control over manufacturing processes.
Innovation and Patentability
The patent appears to cover a novel combination of process parameters that result in a more stable, bioavailable medicinal form. Patentability hinges on demonstrating that these specific steps are not obvious and innovative over prior art.
Patents and Patent Landscape in Russia
1. National Patent Ecosystem
Russia’s pharmaceutical patent landscape is characterized by a robust approach toward process patents, often emphasizing manufacturing methods over chemical entities. The patent’s broad process claims could be strategically relevant for generic manufacturers seeking to produce similar formulations.
2. Compatibility with International Patents
While Russia follows a sui generis approach, patent examination standards compare claims to international standards like the EPC (European Patent Convention) or USPTO. The process claims may face challenges if prior art demonstrates similar steps.
3. Key Competitor Patents
- Similar process patents may exist that claim solvent compositions, processing conditions, or formulation steps.
- Prior art references in the Russian Patent Office (RUPAT) or international patent databases may reveal overlapping claims, impacting the scope and enforceability.
4. Patent Term and Expiry
Given the priority of filing dates and national law, the patent’s expiry is expected around 20 years post-filing, i.e., approximately 2028-2029, allowing competitors to innovate around the protected process method once expired.
Legal and Commercial Implications
Infringement Risks
- Infringement hinges on the replication of each step within the claims.
- Pharmaceutical manufacturers adopting the same or similar processing parameters could face patent infringement allegations.
Patent Strategies
- Patent owners might leverage the patent defensively or offensively in licensing negotiations.
- It can serve as a barrier for generic entrants relying on similar manufacturing processes.
Freedom-to-Operate Analysis
- Companies intending to commercialize formulations in Russia must analyze whether their manufacturing process overlaps with claims.
- Re-designing process parameters outside of the claimed ranges can circumvent the patent.
Patent Landscape Trends
- Shift toward process patents: Russian pharmaceutical patents increasingly focus on methods, especially for complex or improved formulations.
- Global alignment: The process-oriented approach is consistent with international trends, providing strategic leverage against generics.
- Patent proliferation: Similar patents cover solvents, excipients, process steps, and manufacturing environments, creating a dense patent landscape.
Conclusion
Patent RU2008113869 claims a specific, potentially broad method for preparing medicinal forms, emphasizing technological steps rather than the medicinal compounds themselves. Its strategic value lies in controlling manufacturing processes, which can substantially impact market entry strategies and infringement risks in Russia. Future competition must scrutinize the detailed claims, process parameters, and prior art to determine the patent's strength and scope.
Key Takeaways
- Process patents like RU2008113869 are vital in the Russian pharmaceutical space, often offering broad control over manufacturing techniques.
- Claims must be carefully examined to understand infringement and design-around opportunities, especially concerning specific process parameters.
- The patent landscape is dense, with increasing emphasis on method claims, necessitating thorough clearance searches for patent validity and freedom-to-operate.
- Expiration of this patent around 2028-2029 will open the market for alternative manufacturing processes.
- Strategic use of this patent includes licensing, patent enforcement, and R&D planning for innovative processes outside the claimed scope.
FAQs
Q1: How does a process patent like RU2008113869 differ from a compound patent?
A1: A process patent protects specific manufacturing steps or methods rather than the chemical compound itself. It offers a different kind of exclusivity, often easier to obtain when compounds are known but manufacturing processes are novel.
Q2: Can a competitor circumvent RU2008113869 by changing process parameters?
A2: Potentially, yes. Redesigning processes outside the claimed ranges—such as altering solvents, temperatures, or steps—can avoid infringement, provided these modifications are sufficiently distinct and non-obvious.
Q3: What is the strategic importance of process patents in Russia’s pharmaceutical landscape?
A3: Process patents serve as effective exclusivity tools, often easier to defend than chemical patents in Russia, and can prevent generic manufacturing by controlling manufacturing methods.
Q4: Are process patents like RU2008113869 enforceable in international markets?
A4: Enforcement depends on the patent’s validity and scope within each jurisdiction. While Russia’s patent law recognizes such patents, enforcement standards vary internationally, making local legal advice essential.
Q5: What should companies do when planning to enter the Russian market with a similar medicinal form?
A5: Conduct comprehensive freedom-to-operate or clearance searches focusing on process patents, consider alternative manufacturing routes, or negotiate licensing agreements with patent holders.
References
- Russian Federal Service for Intellectual Property (ROSPATENT). Official Patent Database.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Russian Patent Law (Part IV of Civil Code, Law No. 3520-1, 2008).
- EPO Patent Law Guide and International Search Reports.
- Industry reports on Russian pharmaceutical patent strategies.
