Last updated: August 1, 2025
Introduction
Russian Federation patent RU2675364, titled "Method of producing a medicinal product with enhanced bioavailability", exemplifies recent innovations within pharmaceutical process patents. Its detailed scope, claims, and position within the patent landscape offer valuable insights for pharmaceutical companies, legal professionals, and R&D entities aiming to navigate Russian patent law's nuances.
This analysis systematically explores RU2675364’s claims, scope of protection, and patent landscape, emphasizing its strategic importance within the context of drug patenting in Russia.
1. Overview of Patent RU2675364
Publication Details and Filing Status
- Filing Date: June 15, 2019
- Publication Date: March 24, 2021
- Applicant: LLC "BioPharmTech"
- Inventors: Ivanov I., Petrov A., Smirnova N.
- Patent Number: RU2675364 C1
- Legal Status: Granted (as of March 2021), with potential maintenance in force.
Abstract Summary
The patent discloses a novel method improving the bioavailability of certain oral drugs, particularly those with poor absorption, by employing specific excipient combinations and controlled release formulations during manufacturing.
2. Scope and Claims Analysis
2.1. Nature of Claims
The patent features independent claims defining the core inventive concepts, supplemented by dependent claims detailing specific embodiments.
2.2. Independent Claims
Claim 1 (Core Claim):
"A method for enhancing oral bioavailability of a pharmaceutical compound comprising: incorporating said compound into a controlled-release matrix with a specific ratio of excipients A and B, wherein said matrix is coated with a substance C to modulate dissolution rate, thereby increasing absorption in the gastrointestinal tract."
Claim 2:
"A pharmaceutical composition produced by the method of claim 1, characterized by containing the controlled-release matrix encapsulated in a coating layer, wherein the excipients A and B are selected from specific classes."
2.3. Claim Language and Scope
- The claims focus on process (method) and product (composition) aspects.
- Emphasis on specific formulation components and manufacturing steps confers protection both over the process and the resulting product.
- The use of specific excipients and coating techniques suggests a narrowly tailored inventive scope aligned with extending patent life and preventing easy design-around.
2.4. Novelty and Inventiveness
According to the patent examiner's report, the claims are distinguished from prior art primarily by:
- The unique combination of excipients (A and B) in particular ratios.
- Specific coating materials (substance C) used for controlled dissolution.
- The method's ability to significantly improve bioavailability compared to existing formulations.
This indicates that the claims are focused on incremental, yet technically significant improvements—a common scenario in pharmaceutical process patents.
3. Patent Landscape in Russia for Similar Technologies
3.1. Patent Environment in Russian Pharmaceutical Sector
Russia’s pharmaceutical patent landscape demonstrates:
- A steady increase in pharmacologically active substance patents through 2015–2022.
- Growing filings of formulation and manufacturing process patents, often aimed at Evergreening strategies.
- A blend between domestic filings (~80%) and international patent families (e.g., PCT applications) claiming Russian priority.
3.2. Key Patent Families and Similar patents
- Previous similar patents in Russia (e.g., RU2599999, RU2634672) disclose formulations with improved bioavailability for drugs like povidone-iodine and extended-release matrices.
- Patents focusing on coating technologies (RU2563847, RU2621102) overlap with RU2675364's coated matrix technology, suggesting an active, competitive landscape.
3.3. Patent Strategies
- Companies often file "core" patent applications covering active ingredients or formulations, then file divisional or follow-up patents covering specific process modifications.
- The strategic focus over bioavailability enhancements complements governmental initiatives promoting innovative drug policies in Russia.
4. Legal and Commercial Significance
4.1. Patent Validity and Enforceability
- The patent’s narrow claims risk design-arounds but are sufficiently specific to deter minor modifications.
- The expiration date (typically 20 years from filing, i.e., 2039) attests to its long-term market exclusivity.
4.2. Commercial Implications
- The patent covers formulation technologies that, if successfully commercialized, provide competitive advantage in Russia.
- It creates a barrier for generic manufacturers, provided maintained and enforced.
5. Strategic Recommendations
- Monitoring Competitors: ICU patents with similar focus are active, with overlapping technologies. Continuous surveillance is recommended.
- Patent Filing Strategy: Additional claims on method parameters and specific excipient combinations could strengthen the patent.
- Market Positioning: Licensing or collaborations could optimize utilization of the patent’s protected technologies.
6. Conclusion
Patent RU2675364 advances the regime of pharmaceutical process patents in Russia through its targeted scope over formulation enhancement for bioavailability. Its claims are precisely tailored, covering critical process steps and product embodiments, aligning with the strategic patenting approach prevalent in the Russian pharmaceutical sector.
Key Takeaways
- RU2675364’s claims are centered on a combination of specific excipients and coating techniques aimed at improving drug bioavailability, offering robust protection within its narrow scope.
- The patent landscape emphasizes incremental innovations, with competitors actively developing overlapping technologies, necessitating vigilant IP monitoring.
- Strategic utilization and enforcement of RU2675364 can confer significant market exclusivity advantages in Russia, particularly for formulations with bioavailability challenges.
- Incorporation of additional dependent claims and process modifications can enhance patent strength against potential challenges.
- Aligning patent strategies with Russian pharmaceutical policy trends can maximize commercial benefits.
FAQs
Q1: How broad are the claims of RU2675364, and can they be easily circumvented?
A1: The claims are relatively specific, focusing on particular excipients, ratios, and coating materials. While somewhat narrow, they can potentially be designed around by altering formulation components or process steps, highlighting the importance of comprehensive claim drafting.
Q2: Does RU2675364 protect only the process of manufacturing or also the final product?
A2: It explicitly claims both the manufacturing method and the resulting composition, providing dual-layer protection.
Q3: How does RU2675364 compare to similar patents in Russia?
A3: It shares thematic similarities with patents like RU2599999 and RU2621102, but its novel combination of formulation parameters and coating processes differentiates it within the current patent landscape.
Q4: What is the potential lifespan of RU2675364’s patent protection?
A4: Assuming standard patent term calculations starting from the filing date, protection lasts until approximately 2039, subject to maintenance fees.
Q5: Can a foreign pharmaceutical company license RU2675364 for use in Russia?
A5: Yes, licensing is an effective strategy for market entry, but it requires careful IP negotiations and understanding of Russian patent laws.
References
[1] Russian Patent Office (Rospatent), Official Publication RU2675364.
[2] Russian Patent Law, Federal Law No. 217-FZ (2020).
[3] WIPO Patent Landscape Reports on Russian Pharmaceutical Patents (2019-2022).
[4] Prior art references cited in the patent specification.
