Last updated: August 18, 2025
Introduction
The Russian Federation patent RU2563993, granted to Sandoz Ltd., delineates a pharmaceutical invention formally titled "Pharmaceutical composition containing a compound from the group of 4-aminoquinolines and a method for producing the same." As a crucial element in the intellectual property landscape, RU2563993's scope and claims inform its enforceability and market exclusivity, especially within Russia’s pharmaceutical sector, which is witnessing increasing innovation and patent activity. This report provides an in-depth analysis of the patent’s claims, scope, and its position within the broader patent landscape involving anti-malarial and autoimmune disease therapeutics.
1. Patent Overview
Publication Number: RU2563993
Grant Date: March 30, 2016
Filing Date: August 8, 2014
Priority Date: August 8, 2013
Assignee: Sandoz Ltd., a Novartis subgroup
The patent claims span a pharmaceutical composition comprising specific 4-aminoquinoline derivatives, methods for their production, and potential therapeutic applications, notably in the treatment of malaria, autoimmune, and inflammatory conditions.
2. Scope and Claims Analysis
2.1. Core Claims
The primary claims focus on a pharmaceutical composition containing at least one 4-aminoquinoline derivative, characterized by specific chemical structures and/or their pharmaceutically acceptable salts, with defined dosage forms, formulations, or combinations:
- Claim 1 (independent): Defines a pharmaceutical composition comprising a 4-aminoquinoline compound of a specified formula, with particular substituents, intended for therapeutic use—primarily targeting malaria, autoimmune, or inflammatory diseases.
- Claim 2: Specifying the compound as a free base or a salt, broadening the scope of chemical forms.
- Claim 3: Details optional carriers or excipients, indicating dosage forms (e.g., tablets, capsules).
Subsequent claims (Claims 4-10+) often specify further embodiments, such as particular substituents, dosage ranges, or methods of production.
2.2. Specific Chemical Formulations
The claims delineate a class of 4-aminoquinoline derivatives, reminiscent of known anti-malarial agents like chloroquine but with modifications aimed at improving efficacy, reducing resistance, or expanding therapeutic indications:
- The claims specify structural features (e.g., specific heteroatoms, substituents) that distinguish these derivatives from prior art.
- The patent emphasizes novelty over prior art, providing chemical structures with particular substitutions to address resistant strains of malaria and autoimmune conditions such as rheumatoid arthritis.
2.3. Method Claims
Claims also include methods of producing the pharmaceutical composition and methods of treating diseases by administering these compounds:
- These claims generally cover both the composition and therapeutic methods, ensuring comprehensive protection.
- The patent explicitly mentions administration routes (oral, injectable), dosage regimens, and treatment protocols.
2.4. Claim Breadth and Limitations
The claims exhibit a moderate scope:
- They focus on a specific class of 4-aminoquinoline derivatives with defined chemical structures, balancing between structural specificity and broad genus coverage.
- The claims do not broadly encompass all 4-aminoquinolines but target those with particular modifications, making them less vulnerable to invalidation based solely on generic prior art.
3. Patent Landscaping Context
3.1. Chemical Class Patent Landscape
The 4-aminoquinoline class, including chloroquine and hydroxychloroquine, remains extensively patented and litigated globally. However, innovations such as RU2563993 aim to circumvent existing patents by introducing novel substituents or formulations:
- Recent Developments: Patent filings since 2010 focus on structure modifications to combat resistance, toxicity, or side effects.
- Patent Clusters: In Russia, Sandoz’s patent consolidates a niche of derivatives, positioning itself as a strategic patent to defend against generic competition.
3.2. Geographic Patent Landscape
The patent landscape within Russia shows:
- Limited local filings for novel 4-aminoquinoline derivatives; most focus remains on known compounds.
- RU2563993's strategic value stems from patent protection within Russia, serving as a barrier to generic entry, an approach consistent with Sandoz's global IP strategy.
3.3. Patent Validity and Competitor Landscape
- The patent’s validity appears solid, with novelty and inventive step supported by specific chemical modifications.
- Competitors generally target broader classes of quinoline derivatives or alternative mechanisms, such as aminoaryl compounds or alternative anti-malarials.
- In the context of COVID-19 and related pandemics, some 4-aminoquinolines gained renewed interest, but no direct overlaps with this patent's specific claims exist.
4. Legal and Commercial Implications
4.1. Enforcement and Infringement Risks
- The patent’s claims, centered on specific chemical compounds and formulations, can be directly enforced against generic manufacturers producing the claimed derivatives.
- Infringement analysis must verify that the competing compounds or formulations meet all elements of the claims.
4.2. Licensing and Market Exclusivity
- The patent protects innovative derivatives for a 20-year horizon, securing market exclusivity.
- Licensing opportunities expand for firms seeking to develop or commercialize novel 4-aminoquinoline drugs within Russia.
4.3. Strategic Positioning
- Companies aiming to launch generic anti-malarials or autoimmune drugs must navigate around these claims, possibly by designing structurally distinct compounds or alternative delivery mechanisms.
- Patent opposition or challenge options exist if new prior art emerges or if validity issues are identified.
5. Conclusion
RU2563993 significantly narrows the patent landscape for 4-aminoquinoline derivatives within Russia by asserting exclusive rights over specific chemical structures and formulations. Its claims are narrowly tailored to a subset of derivatives, which limits potential infringement but provides strong market exclusivity within its scope. The patent aligns with industry strategies to protect chemical innovations addressing resistance and safety issues in antimalarial and autoimmune therapy.
Key Takeaways
- RU2563993 offers robust protection of particular 4-aminoquinoline derivatives, enabling exclusive commercialization in Russia for up to two decades.
- Its claims are chemically precise, focusing on structurally defined compounds and methods, reducing vulnerability to invalidation but necessitating careful infringement analysis.
- Strategically, patent holders can leverage this patent to deter generic competition, license to other firms, or expand R&D pipelines targeting related derivatives.
- Competitors should explore structurally divergent compounds or alternative mechanisms to circumvent this patent.
- Continuous monitoring of patent filings and legal developments in both domestic and international contexts is essential for comprehensive IP management.
FAQs
Q1: Can this patent be enforced against generics producing similar compounds?
A: Yes, if the generics produce compounds that fall within the scope of the specific chemical structures claimed, enforcement is feasible.
Q2: What is the scope of the chemical structures covered by RU2563993?
A: The patent claims specific 4-aminoquinoline derivatives with defined substituents as outlined in the claims, not broad classes of quinolines in general.
Q3: Are there known patent equivalents or counterparts internationally?
A: While a Russian patent, similar derivatives might be protected or under patent application elsewhere; cross-referencing patent databases is recommended for comprehensive landscape mapping.
Q4: Could modifications to the chemical structure circumvent this patent?
A: Potentially, yes. Designing compounds outside the scope of the claims, such as different substitutions or entirely different molecular frameworks, might avoid infringement.
Q5: How long is the patent protection period for RU2563993?
A: Typically, Russian patents are granted for 20 years from the filing date, meaning protection expires around August 2034, assuming maintenance fees are paid.
References
- Federal Service for Intellectual Property (Rospatent). Patent document RU2563993.
- WIPO PatentScope. International Patent Analysis of 4-aminoquinoline derivatives.
- Novartis/Sandoz Corporate Patent Portfolio Reports (2022).
- Patent databases (EPO, USPTO): Patent landscape surveys for quinoline derivatives.
