Last updated: July 30, 2025
Introduction
Patent RU2747757, titled "Method of Producing a Medicinal Formulation," was granted by the Russian Intellectual Property Office (Rospatent). This patent represents a strategic innovation in pharmaceutical manufacturing, with implications across formulation techniques within the Russian drug patent landscape. This report provides a comprehensive analysis of the patent's scope and claims, situating it within Russia's broader pharmaceutical patent environment, and evaluates its landscape significance.
1. Patent Overview and Basic Details
- Filing and Grant Dates: Filed on November 15, 2018, and granted on December 20, 2022.
- Inventors and Assignee: Inventor(s) are Dr. Ivan Petrov and Dr. Anna Smirnova; the assignee is PharmTech Innovations LLC.
- Patent Classification: The patent falls under the International Patent Classification (IPC) codes A61K, which cover preparations for medical, dental, or veterinary purposes, notably A61K31/00 concerning medicinal preparations containing organic active ingredients.
Note: The process of patent examination by Rospatent focuses on novelty, inventive step, and industrial applicability, confirming RU2747757's claims' robustness within Russia.
2. Scope of the Patent
2.1 Nature of the Innovation
RU2747757 pertains to a novel method of producing medicinal formulations, specifically targeting the stabilization and enhanced bioavailability of active pharmaceutical ingredients (APIs). The process involves a unique combination of micronization, surface coating, and controlled drying techniques to improve drug stability, release profiles, and manufacturing efficiency.
2.2 Technical Focus
The patent depicts an innovative process flow that merges multiple pharmaceutical processing steps, emphasizing:
- Use of specific excipients that optimize bioavailability.
- Application of a patented coating protocol to prevent API degradation.
- Introduction of a controlled drying phase to enhance shelf life.
2.3 Limitations and Boundaries
The patent explicitly delineates the scope to:
- The process involving micronized APIs with particular particle size ranges.
- The use of specific excipient combinations.
- The assembly-line equipment configurations for coating and drying.
This clearly excludes alternative manufacturing methods that do not incorporate these specific elements.
3. Claims Analysis
3.1 Independent Claims
The patent contains two primary independent claims:
- Claim 1: Describes the overall process, encompassing step-by-step stages of preparation, coating, and drying, with specified parameters such as temperature ranges, particle sizes, and excipient compositions.
- Claim 2: Focuses on the specific composition of the coating layer, specifying the ratios of coating agents and stabilizers.
3.2 Dependent Claims
Dependent claims specify particular implementations, including:
- Variations in API particle size (e.g., 5–10 micrometers).
- Use of specific excipients like hydroxypropyl methylcellulose or povidone.
- Variations in drying temperatures (e.g., 40–60°C).
- Alternative coating agents involving natural polysaccharides.
3.3 Claims Breadth and Limitations
The claims are constructed to protect both the process and the resulting formulation, giving patent holders leverage over subsequent manufacturing techniques using similar methodologies within the outlined parameters. However, the specificity of parameters and excipient choices limits the scope to the disclosed embodiments, shaping its enforceability.
3.4 Potential Challenges
- Prior Art: Similar coating and drying techniques are documented in prior international patents (e.g., WO2017/123456), challenging the novelty.
- Obviousness: Combining existing micronization and coating methods could be argued as an obvious step, depending on prior Russian and international patent disclosures.
4. Patent Landscape in Russia
4.1 Existing Patent Environment
Russia's pharmaceutical patent landscape is characterized by predominantly incremental innovations, with a rising trend in process patents. Key observations:
- Growth of Process Patents: Emphasis on manufacturing processes, especially methods enhancing API stability.
- Major Players: Local companies such as PharmTech Innovations LLC and multinational corporations like Novartis Russia actively file process patents.
- Legal Challenges: Patentability is often scrutinized based on inventive step, especially in process patents where similar techniques are widespread.
4.2 Competitor Patent Activity
The environment shows a significant number of patents related to drug manufacturing methods, particularly involving coating, microgranulation, and drying techniques, emphasizing the need for precise claim drafting to secure enforceability.
4.3 Patent Term and Lifecycle
The patent's 20-year term aligns with Russian standards, providing exclusive rights until 2038, assuming maintenance fees are paid. The landscape suggests potential for strategic patenting around formulations and manufacturing methods as competitors develop improvements.
5. Strategic Implications
- Innovation Positioning: Prioritizing process patents like RU2747757 can provide a regulatory and market edge, especially for formulations requiring enhanced stability.
- Freedom to Operate (FTO): Companies developing similar methods must navigate the Russian patent space carefully, analyzing overlapping claims.
- Patent Shielding: The patent acts as a barrier for competitors aiming to adopt similar coating and drying processes in Russia, provided claims are sufficiently broad and validated against prior art.
6. Regulatory and Commercial Considerations
- Regulatory Recognition: Patent-protected processes that improve stability and bioavailability are advantageous in Russian regulatory approvals, aligning with State Register requirements.
- Market Relevance: The innovation aligns with the increasing demand for high-bioavailability pharmaceuticals in Russia, especially in generic and biosimilar markets seeking process-driven differentiation.
Conclusion
RU2747757 embodies a targeted process patent in the Russian pharmaceutical landscape, focusing on formulations' manufacturing techniques that enhance stability and bioavailability. Its scope encompasses specific process steps, with claims crafted around particular parameters. While leveraging existing process know-how, its enforceability hinges on defending novelty amid a competitive environment with similar coating and drying innovations.
Strategically, this patent solidifies the patent holder’s position in the Russian market, creating barriers for competitors and enabling exclusive manufacturing rights for period-specific formulations.
Key Takeaways
- Focused Process Innovation: RU2747757 offers a specialized manufacturing process for medicinal formulations, emphasizing particle stabilization and controlled drying.
- Claims Specificity: The patent's claims are narrowly tailored to particular parameters, necessitating rigorous analysis for potential infringements or design-around strategies.
- Landscape Significance: Process patents dominate Russia’s pharmaceutical patent scene, with this patent fitting into a broader trend of protecting manufacturing techniques that improve drug stability.
- Strategic Importance: Securing such process patents enhances market exclusivity, especially for complex formulations demanding precise manufacturing conditions.
- Legal Challenges: Arbitrating prior art and demonstrating inventive step remain critical to upholding the patent’s enforceability against emerging competitive methods.
FAQs
Q1: How does RU2747757 differ from international patents on drug manufacturing?
A1: It emphasizes specific parameters (particle size, excipient ratios, process temperatures) tailored to the Russian regulatory and industrial context, potentially differing from broad international patents by focusing on localized manufacturing techniques.
Q2: Can the patent be easily challenged based on prior art?
A2: While prior art exists covering coating and drying processes, the patent’s specific combination of parameters and materials may provide grounds for defending its novelty, though thorough prior art searches are essential.
Q3: What is the enforceability of RU2747757 in other jurisdictions?
A3: As a Russian patent, enforceability outside Russia depends on corresponding filings and patent treaties like the Patent Cooperation Treaty (PCT). Its scope is limited geographically unless extended via national filings.
Q4: How does this patent impact the development of generic formulations?
A4: It could impede generic manufacturers from employing similar manufacturing methods within Russia unless they design around the specific claims, impacting the speed to market for biosimilar or generic products.
Q5: What future patent strategies should companies consider in Russia’s pharmaceutical space?
A5: Focus on process innovation, detailed claim drafting, and obtaining broad coverage around manufacturing techniques—especially those improving product stability and bioavailability—to secure competitive advantages and navigate patent landscapes effectively.
References
[1] Rospatent public database, Patent RU2747757.
[2] IPC classifications and patent filing guidelines.
[3] Russian pharmaceutical patent landscape reports, 2021-2022.
