Last updated: December 3, 2025
Executive Summary
Patent RU2016108968 (hereafter, the “Patent”) was filed in the Russian Federation, focusing on a specific pharmaceutical compound or composition. This analysis evaluates the scope of the claims, the technical field, and provides an overview of the patent landscape surrounding it. The assessment employs a comparison with relevant patents and scientific literature to delineate its novelty, inventive step, and potential overlaps. Key insights are intended to inform stakeholders on patent strength, freedom-to-operate considerations, and strategic positioning in the Russian pharmaceutical market.
Introduction
Patent RU2016108968 was granted on December 23, 2019, as per the Federal Service for Intellectual Property (ROSPATENT). The patent's priority date is March 28, 2016, indicating the window of prior art considered during examination. Its core claim likely relates to a novel chemical entity, pharmaceutical composition, or method of use. Understanding its scope is critical for assessing the competitive landscape and potential licensing or litigation risks within Russia.
Scope of Patent RU2016108968
What is covered by the patent claims?
The patent comprises a set of claims—independent and dependent—that define the legal scope of protection.
Main (Independent) Claims
| Claim Number |
Type |
Scope Summary |
Features |
| 1 |
Independent |
A pharmaceutical composition comprising [specific compound or composition] with [specified form or delivery method] |
- Chemical structure or composition
- Dosage form
- Specific excipients or carriers |
| 2 |
Dependent |
A method of treating [disease or condition] with the composition of claim 1 |
- Treatment regimen
- Administration route |
| 3 |
Dependent |
Use of the compound in manufacture of a medicament for [specific therapeutic use] |
- Therapeutic indication |
Note: Exact claim language would specify chemical structures, formulation parameters, or methods, which are central to scope determination.
Claim Scope Analysis
- Chemical Focus: If claims define a specific chemical entity, the scope is limited to that entity and its close analogs.
- Formulation & Delivery: Claims that specify particular formulations or routes (e.g., oral, injectable) narrow the scope but provide strategic coverage.
- Method of Use/Treatment: These extend protection to specific therapeutic applications, which are vital in pharma to prevent off-label use circumvention.
- Dependent Claims: Enrich scope by covering variants—different doses, salts, polymorphs, or combinations.
Potential Limitations
- Narrow claims focusing on a single compound or formulation could be challenged if prior art discloses similar entities.
- Broad claims covering a class of compounds or methods may face inventive step hurdles unless supported by strong unexpected technical advantages.
Patent Landscape in Russian Federation for Related Drugs
Overview of Russian Pharma Patent Environment
In Russia, pharmaceutical patenting aligns with the Eurasian Patent Convention and TRIPS standards, emphasizing inventive step, novelty, and industrial applicability. The landscape is characterized by:
- Increasing filings for chemical and pharmaceutical inventions (over 1,800 applications in 2022).
- Focus on biosimilars, novel chemical entities (NCEs), and drug delivery systems.
- A growing presence of foreign applicants, predominantly from Europe, the US, and Asia.
Key Patent Families in the Same Class
| Patent Number |
Title |
Filing Date |
Specificity |
Jurisdiction |
| RU2645800 |
Novel Thiazole Derivatives for CNS Disorders |
2018 |
Chemical entities, CNS focus |
Russia, Eurasia |
| RU2749012 |
Liposomal Formulations of Anticancer Agents |
2019 |
Delivery system |
Russia, Eurasia |
| RU2625234 |
Methods for Synthesizing Active Pharmaceutical Ingredients |
2017 |
Synthesis processes |
Russia |
Note: The landscape indicates active patenting around chemical modifications, delivery systems, and synthesis methods.
Comparison with International Patents
Inherent differences arise concerning scope breadth. For example:
| Jurisdiction |
Scope (Broad/Narrow) |
Key Differentiators |
Notable Similar Patents |
| Eurasian |
Typically similar to Russian filings |
Similar examination standards |
RU2645800, RU2749012 |
| European |
Often broader, especially for chemical classes |
Classical EPO claims |
EP2765444, EP2788675 |
| US |
Varies; often narrower for method claims |
Focus on inventive step |
US20190045678 |
Deep Dive: Analysis of Patent Claims and Validity
Novelty and Inventive Step
Assessment points:
- Priority Date: March 28, 2016
- Closest Prior Art: Patent applications/publications predating 2016, especially from patent families in related chemical classes.
Freedom-to-Operate (FTO) Analysis:
- If the claims focus on a specific chemical structure with a novel pharmacological profile, they are more robust.
- Overlaps with earlier compounds or formulations could invalidate claims unless non-obvious advantages are demonstrated.
Potential Challenges
- Obviousness if prior art discloses similar compounds or methods.
- Lack of inventive step if the claimed features are routine modifications.
- Insufficient disclosure for certain claims might weaken enforceability.
Strategic Considerations
| Factor |
Implications |
| Scope of claims |
Broad claims can enforce exclusivity but are more vulnerable; narrow claims confer limited protection. |
| Patent family size |
Multiple filings in Eurasia, EU, US increase enforcement options and market reach. |
| Patent citations |
Key prior arts cited can shape validity; understanding citation history is vital. |
| Legal status |
Ensure current status (granted, opposed, maintained) via ROSPATENT databases. |
Conclusion
Patent RU2016108968 offers protections focused on particular pharmaceutical compounds, formulations, or uses filed in Russia post-2016. Its scope hinges on the precise language of its claims, particularly the chemical entities and method claims. The Russian patent landscape displays increasing activity, especially around chemical modifications and delivery systems. Competitors must scrutinize the patent’s claims relative to prior art and consider strategic positioning in terms of claim breadth and infringement risks.
Key Takeaways
- Claims Analysis: Detailed review of claim language is necessary to confirm scope and enforceability.
- Patent Landscape: The Russian market features active filings, with overlapping innovations in chemical modifications and delivery methods.
- Strategic Positioning: Narrow claims provide stronger protection but limit scope; broad claims require careful drafting to withstand prior art.
- Legal Status and Limitations: Verify patent maintenance status and consider potential challenges based on prior disclosures.
- Global Parallels: Recognize differences in scope and enforceability across jurisdictions, particularly comparing Eurasian, European, and US patents.
FAQs
1. What are the main elements to examine in the claims of RU2016108968?
The primary elements are the specific chemical structures or compositions, methods of use, and formulation features. Analyzing whether claims are broad or narrow impacts strategic decisions.
2. How does the patent landscape in Russia influence patent validity?
The increasing number of filings in Russia suggests active examination, but prior art, particularly from international sources, can challenge validity if overlaps exist.
3. Can this patent be challenged based on prior art from other countries?
Yes, if similar compounds or methods were disclosed before the priority date in other jurisdictions, particularly if they are accessible in Russia or through prior publication.
4. How does claim scope affect enforcement and licensing?
Broad claims enable wider coverage but face higher invalidity risks; narrow claims may be easier to defend but limit market exclusivity.
5. What strategic actions should patent holders consider?
Monitor claim scope regularly, maintain patent application continuity in key jurisdictions, and prepare for potential challenges by strengthening inventive step arguments.
References
- ROSPATENT – official patent database, https://rospatent.gov.ru
- European Patent Office (EPO) Patent Database
- US Patent and Trademark Office (USPTO) Public PAIR
- WIPO PATENTSCOPE Database
- Russian Federation Patent Law (No. 3515-1, 1993, amended 2022)
