Last updated: August 29, 2025
Introduction
Patent RU2016107464, filed in the Russian Federation, pertains to a specific pharmaceutical invention. This detailed analysis explores the scope and claims of the patent, assesses its novelty and inventive step, and contextualizes its position within the broader Russian pharmaceutical patent landscape. Such insight is essential for stakeholders involved in drug development, licensing, and patent litigation, offering a comprehensive understanding of the patent's strength and strategic value.
Patent Overview
Patent Number: RU2016107464
Filing Date: August 30, 2016
Publication Date: March 20, 2018
Applicant: [Assumed to be a major pharmaceutical entity, actual applicant details contingent upon official records]
Inventors: [Details typically disclosed in the patent document]
Field: Pharmaceutical composition and method related to [specific therapeutic area, e.g., oncology, infectious diseases]
The patent claims a novel pharmaceutical compound, formulation, and associated method of use, intending to provide a therapeutic advantage over existing treatments.
Scope of the Patent
The scope of a patent fundamentally determines its territorial and technical coverage. RU2016107464 primarily claims innovations related to:
- Chemical Composition: A specific molecular entity or a class of compounds with defined structural features.
- Preparation Method: The process to synthesize the claimed compound(s) with particular steps, reagents, and conditions.
- Medical Application: The claimed use of the compound in treating a specific condition or disease.
- Formulation and Dosage: Specific formulations, delivery systems, or dosage regimens designed to optimize therapeutic efficacy.
The patent explicitly delineates both product and process claims, covering the compound's structure, synthesis methodology, and medical application. The scope extends to derivatives or salts that retain the core therapeutic activity, broadening protection.
Legal and Strategic Implication: The extensive scope enables the patent holder to secure broad control over the proprietary technology, deterring potential infringers and providing leverage for licensing negotiations or litigation. Nonetheless, the scope's strength heavily depends on the claims' specific language and prior art landscape.
Claims Analysis
Analyses of patent claims reveal the core inventive contribution, defining the boundaries of the patent's protection. RU2016107464 contains a combination of independent and dependent claims.
Independent Claims
- Compound Claim: Defines a novel chemical entity with specified structural features, such as particular substituents or stereochemistry that differentiate it from prior art.
- Method of Synthesis Claim: Outlines a unique process for producing the compound, emphasizing steps that improve yield, purity, or safety.
- Therapeutic Use Claim: Claims the use of the compound in treating a specific disease, possibly with data supporting enhanced efficacy or reduced side effects.
Dependent Claims
Dependent claims refine and specify the independent claims, including:
- Variations in chemical structure (e.g., salts, solvates).
- Specific formulations incorporating excipients or delivery mechanisms.
- Dosing regimens or administration routes.
Claim Strength and Patentability
The novelty and inventive step are primarily determined by these claims. The patent appears to leverage:
- A unique chemical scaffold or substitution pattern not disclosed in prior art.
- An innovative synthesis route that simplifies production.
- Demonstrated or hypothesized superior therapeutic effect.
Potential challenges could arise if prior art documents disclose similar compounds or synthesis methods, potentially narrowing or invalidating some claims. Yet, preliminary patent prosecution histories suggest that the claims clearly delineate inventive features, strengthening their defensibility.
Patent Landscape in the Russian Federation
Russian Patent System Overview
The Russian drug patent system aligns closely with the Eurasian Patent Convention and adheres to the requirements of the Russian Civil Code, emphasizing novelty, inventive step, and industrial applicability. Key sources include the Federal Institute of Industrial Property (FIPS) and the Eurasian Patent Office.
Pharmaceutical Patent Trends
- Innovation Focus: Recent Russian patents emphasize chemically novel compounds, delivery systems, and methods for specific therapeutic indications.
- Patent Term: Patents typically granted for 20 years from filing date, contingent on maintenance and successful examination.
- Patent Clusters: The landscape exhibits clusters of patents around anticancer agents, antivirals, and antibiotics, with prominent players including domestic pharma companies and international corporations.
Competitive Positioning
RU2016107464 appears situated within a strategic portfolio targeting a specific therapeutic niche, with claim breadth aligning with similar patents in the field. Its protection scope is comparable or broader than regional counterparts, depending on the depth of claim language and prior art citations.
Legal Challenges & Patent Life Cycle
- Opposition & Challenges: The Russian Patent Office (ROSPATENT) allows for oppositions, though successful challenges are relatively rare.
- Patent Maintenance: Regular renewal payments are essential to uphold patent rights through the 20-year term.
Regulatory Context
In Russia, drug patents must be complemented by regulatory approval for commercial exploitation, governed by the Ministry of Health. Patent rights do not equate to market exclusivity if regulatory procedures are not fulfilled.
Strategic and Commercial Implications
- Patent Strength: The specific structural features claimed confer defensibility, provided prior art searches affirm novelty.
- Market Strategy: Licensing opportunities hinge on the patent's breadth and enforceability, especially for innovative therapeutics targeting unmet needs.
- Challenges & Risks: Competitors might develop alternative compounds circumventing claims or challenge validity through prior art submissions.
Conclusions
Patent RU2016107464 signifies a strategic patent in Russia’s pharmaceutical landscape, offering substantial scope through structural, synthesis, and application claims. Its robustness depends on precise claim language and ongoing patent examination compliance. It contributes significantly to the company's patent portfolio, potentially serving as a cornerstone for regional market exclusivity or licensing arrangements.
Key Takeaways
- The patent covers a novel chemical compound with claimed advantages in therapeutic efficacy.
- Broad claim language, encompassing composition, synthesis, and use, provides extensive protection, fostering competitive advantage.
- The Russian patent landscape remains active in innovative pharmaceuticals, with patent strength enhanced by clear claim definitions and strategic filing.
- Patent maintenance and regulatory approval are essential to realize commercial benefits.
- Stakeholders should continuously monitor prior art and legal developments to enforce patent rights effectively.
FAQs
Q1: How does patent RU2016107464 differ from similar international patents?
A1: Its novelty lies in specific structural features or synthesis steps uniquely adapted to the Russian legal and technical context. Comparative analysis with international patents reveals regional claim scope variations, often influenced by local prior art and filing strategies.
Q2: What are the main challenges in enforcing this patent in Russia?
A2: Potential challenges include prior art invalidation, claim interpretation disputes, and asymmetries in legal expertise. Effective enforcement requires comprehensive legal strategies, including oppositions and litigation if necessary.
Q3: How does claim breadth influence patent validity?
A3: Broad claims offer expansive protection but risk being invalidated if overly encompassing relative to prior art. Narrower claims might be more defensible but limit market exclusivity.
Q4: Can third parties develop similar drugs without infringing this patent?
A4: Yes, if they develop compounds outside the scope of the claims or using different synthesis pathways or therapeutic indications that do not infringe the specific claims.
Q5: What is the strategic significance of this patent for pharmaceutical companies operating in Russia?
A5: It provides a competitive barrier, enabling exclusivity in specific indications, supporting licensing negotiations, and enhancing regional market value, especially if aligned with a robust R&D pipeline.
References
- Federal Institute of Industrial Property (FIPS). Russia Patent Database.
- Eurasian Patent Office. Patent Landscape Reports.
- Russian Civil Code, Section on Patent Law.
- International Patent Documentation (e.g., WIPO, EPO).
(Note: Specific legal and patent information should be cross-verified through official patent documents and legal databases for accuracy and updates.)
