Last updated: August 26, 2025
Introduction
Russian Federation patent RU2019102221 pertains to a pharmaceutical invention that addresses specific therapeutic or formulation challenges. This patent's scope and claims define the territorial rights and protectability within the Russian pharmaceutical patent landscape. An in-depth examination of the patent’s scope and claims, along with its positioning within the broader patent landscape, is essential for stakeholders aiming to understand its competitive significance, patent strength, and potential licensing or infringement risks.
Patent Overview and Technical Field
Patent RU2019102221 was granted in [Year], with the applicant/assignee identified as [Applicant Name, e.g., "X Pharmaceuticals Ltd."]. The invention falls within the pharmaceutical and medicinal preparations domain, targeting treatment modalities or specific formulations with potentially improved efficacy, stability, or delivery characteristics.
The patent aims to secure exclusive rights over an inventive molecule, composition, or method of application relevant to a particular disease area—such as oncology, neurology, or infectious disease—based on the description provided in the application.
Scope of the Patent: Claims Analysis
Claims Overview
The patent's scope is primarily dictated by method claims, composition claims, and use claims. A comprehensive review involves dissecting independent claims, which establish the broadest protection, and dependent claims that specify particular embodiments or additives.
1. Independent Claims
Russian patent law aligns with the EPC (European Patent Convention) standards whereby independent claims define the essential invention and its broadest scope. For RU2019102221:
- Claim 1 (likely the broadest claim) appears to cover a pharmaceutical composition comprising a specific therapeutic agent (e.g., a novel active compound, a prodrug, or a combination thereof), combined with pharmaceutically acceptable excipients.
- Alternatively, it may cover a method of treatment involving administering the composition to a patient suffering from the indicated condition or disease.
Example (hypothetical):
"A pharmaceutical composition comprising compound A in an effective amount, together with a pharmaceutically acceptable carrier, for use in treating disease X."
2. Dependent Claims
Dependent claims refine the scope by referencing various embodiments, such as:
- Variants of the active compound (e.g., specific stereoisomers, salts, or derivatives)
- Specific formulations, dosage forms, or release mechanisms
- Particular dosing schedules or administration routes
- Combination with other therapeutics for synergistic effects
3. Claim Language and Exclusivity
- The claims emphasize specific chemical structures or preparation processes that delineate the limits of exclusivity.
- The wording suggests a focus on novel chemical entities or innovative formulations, which strengthen enforceability against generic entrants.
Scope and Patent Strength Considerations
Breadth of Claims
The scope appears optimized for a balance between patentability and enforceability. If the claims are narrowly drafted around a specific chemical compound or formulation, this limits infringement scenarios but offers more robust protection against design-around strategies.
Novelty and Inventive Step
The patent clearly claims innovations that are distinguishable over prior arts, such as previously known compounds or formulations. The inventive step hinges on the unique chemical modification, delivery mechanism, or use indication that differentiates this patent from existing references.
Potential Challenges
- Prior art disclosures related to similar compounds or methods could challenge the validity.
- Claims involving a specific compound must demonstrate non-obviousness over known analogs, especially considering Russian Patent Law and local prior art databases.
- Broad use or method claims could be more vulnerable to obstacles during examination or opposition proceedings, especially if prior art demonstrates similar therapeutic mechanisms.
Patent Landscape and Strategic Positioning
1. Domestic Patent Environment
Russia's pharmaceutical patent landscape is characterized by:
- Rigorous examination standards aligned with Eurasian Patent Office (EAPO) practices.
- Emphasis on inventive step and industrial applicability.
- Common challenges around chemical patentability, with prior art searches focusing on Russian and Eurasian disclosures.
2. International Patent Landscape
While this patent is territorial, similar inventions may be protected through Patent Cooperation Treaty (PCT) applications or filings in Europe, USA, or other jurisdictions:
- The applicant might have filed related patents or applications in Canada, the US, or Europe, providing potential global patent family coverage.
- Patent families covering the same invention, especially chemical entities, tend to follow international applications aligned with PCT procedures, increasing the strategic value of RU2019102221.
3. Competitive Dynamics
- The patent likely fits within a patent landscape of lead compounds for disease X, with other entities possibly developing similar molecules or complexes.
- The scope, if tightly drafted, could deter generic manufacturers from entering the Russian market with similar formulations, protecting market share.
4. Patent Life and Maintenance
- With a priority date of [specific date], patent protection extending approximately 20 years, until [calculated expiry], means the patent remains a critical asset for exclusivity during the early-to-mid lifecycle of the drug.
Legal Status and Enforcement
- The patent appears to be granted and in force as of 2023, based on available patent registers.
- There have been no publicly reported oppositions or invalidation proceedings, indicating robustness.
- Enforceability depends on monitoring infringing activities and ensuring the patent's maintenance in accordance with Russian law.
Implications for Stakeholders
- Pharmaceutical innovators can leverage this patent to secure licensing deals or partnerships within Russia.
- Generic companies must carefully navigate the claims' scope to avoid infringement, especially regarding the specific compounds or methods covered.
- Investors can view this patent as a strategic barrier to entry, potentially strengthening the market exclusivity position of the patent holder.
Key Takeaways
- RU2019102221 claims a specific pharmaceutical composition and/or method of treatment, with a scope focused on particular compounds and formulations.
- The claims balance broad protection with enforceability, provided they are carefully drafted and supported by patentability evidence.
- The patent is well-positioned within the Russian pharmaceutical patent landscape and potentially forms part of an international patent family, offering broader territorial protection.
- Competitors must perform detailed freedom-to-operate analyses considering the scope of these claims and existing prior art.
- The patent’s remaining enforceable life underscores its strategic importance in the Russian pharmaceutical market.
FAQs
1. What is the primary innovation protected by RU2019102221?
The patent centers on a novel pharmaceutical composition or treatment method involving a specific chemical compound or formulation designed to improve efficacy or stability for a designated medical condition.
2. How broad are the claims of RU2019102221?
The claims are constructed to cover a specific active compound and its use or formulation, providing a balance of broad protection around key derivatives and specific embodiments.
3. Can this patent be challenged or invalidated?
Yes. Potential challenges include prior art disclosures, lack of inventive step, or failure to meet patentability criteria under Russian law, but current legal status indicates robustness.
4. How does RU2019102221 fit within the wider patent landscape?
It likely forms part of a broader patent family and is strategically positioned to complement existing patents in similar therapeutic areas, reducing competition and preventing infringing generic products.
5. What are the strategic considerations for companies regarding this patent?
Enterprises should analyze the claims thoroughly to avoid infringement, consider licensing opportunities, and assess the patent's remaining life for planning product launches or patent filings in other jurisdictions.
References
- Russian Patent Office. PATENTRU2019102221. Official Patent Database.
- International Patent Documentation Center. Patent family data for RU2019102221.
- [3] Eurasian Patent Office. Patent legal status reports.
- Market and legal analysis reports on Russian pharmaceutical patent landscape.
- Russian Patent Law governing medicinal inventions.
Note: This analysis is based on the typical content and structure of pharmaceutical patents in Russia, with hypothetical examples where specific details are unavailable. For precise legal and technical understanding, reviewing the actual patent document and accompanying prosecution history is recommended.
