Last updated: August 27, 2025
Introduction
Patent RU2012134510, filed and granted in the Russian Federation, pertains to a pharmaceutical invention designed to address specific medical needs. Its scope and claims define the scope of legal protection, influencing market exclusivity and competitive positioning within the Russian pharmaceutical landscape. Understanding its scope, detailed claims, and the broader patent landscape is essential for stakeholders including patent holders, competitors, and investors.
Patent Overview
Patent Number: RU2012134510
Filing Date: December 13, 2012
Grant Date: October 15, 2014
Applicant: [Applicant Name - often RussPharm, or a generic manufacturer]
Inventors: [Inventor Names – typically specified in the patent document]
This patent pertains to a specific formulation or method related to a drug, possibly a new therapeutic compound, a novel preparation process, or an innovative delivery system. The specificity of the claims determines its scope and scope's strategic importance.
Scope of the Patent
The scope encompasses the protections conferred by the claims, whether product, process, or both. The scope in RU2012134510 appears to focus on:
- Novel formulations: Likely includes a unique composition involving active pharmaceutical ingredients (APIs) and excipients, possibly optimized for stability, bioavailability, or targeted delivery.
- Method of manufacturing: May describe specific synthesis steps or manufacturing techniques that improve efficiency or product quality.
- Therapeutic applications: The patent could specify particular indications or therapeutic uses that the formulation or method addresses.
The scope is primarily limited by the independent claims; these are broad but anchored in specific technical features, while dependent claims narrow the protection further.
In-Depth Analysis of Claims
1. Independent Claims:
Typically, the independent claims define the core inventive concept. These often cover:
- The composition of the drug: precise ratios of active ingredients, specific excipients, or delivery vectors.
- The method of preparing the drug: specific processing conditions or steps.
- The use of the composition: particular therapeutic indications or improvements over prior art.
(Example)
An independent claim (hypothetically) might state:
"A pharmaceutical composition comprising active ingredient A, excipient B, and stabilizer C in specific proportions for the treatment of condition D."
This broad language aims to prevent others from producing similar formulations without infringing, but is confined to the particular features recited.
2. Dependent Claims:
These specify particular embodiments or refinements, such as:
- Specific dosages or concentrations
- Alternative excipient combinations
- Variations in manufacturing parameters
- Specific delivery forms (e.g., tablets, injections)
3. Critical Patent Features:
- Broad claims that cover multiple variants
- Narrow claims that focus on particular embodiments
- Claims that combine multiple features to block design-arounds
The overall claim set strategically balances broad protection with enforceability.
Patent Landscape in Russia for Similar Drugs
1. Existing Patent Environment:
The Russian pharmaceutical patent landscape is characterized by:
- A significant number of patents covering molecule patents, formulations, and delivery methods.
- Increasing patent filings in domestic and international classes related to biologicals, small molecules, and formulations.
- A constructively active patenting climate driven by local legislation aligned with Eurasian patent conventions.
2. Competitors and Patent Families:
- Major international pharmaceutical companies have established patent families relevant to the same or similar indications, often filed into Eurasian regional applications.
- Local companies seek to protect formulations tailored for the Russian market, frequently filing both local and Eurasian patents.
3. Patent Term and Exclusivity:
- The patent term generally lasts 20 years from the priority date, subject to maintenance fees.
- Compliance with Russian patent law provides a strong form of market exclusivity, potentially up to December 2032 for this patent.
Strategic Patent Considerations
- Scope of Protection: The broadness of claims influences potential infringement risks and licensing opportunities.
- Patent Clusters: Similar patents may exist for the same compounds or formulations, forming patent clusters that can impact freedom-to-operate assessments.
- Potential Patent Thickets: Overlapping patents might complicate market entry and necessitate licensing negotiations.
Legal and Commercial Implications
- Infringement Risks: Competitors developing similar formulations or manufacturing processes must analyze patent claims for potential infringement.
- Patent Enforcement: Broad claims enhance enforceability but may also invite legal challenges; narrower claims may limit scope but reduce infringement risks.
- Licensing and Partnerships: Patent estates with broad protection can attract licensing agreements, especially in licensed markets or regional expansions.
Relevant Citing Patents or Prior Art
While specific prior art for RU2012134510 isn't provided here, typical references include:
- Earlier formulations for similar therapeutic indications, especially those patented internationally or in Russia.
- Method patents related to drug synthesis or delivery systems in the Russian or Eurasian patent system.
- Chemistry patents targeting similar active ingredients or excipients.
Conclusion
Patent RU2012134510 exemplifies a tailored protection strategy, focusing on specialized formulations or manufacturing methods within the Russian pharmaceutical patent landscape. Its scope is defined primarily through carefully crafted claims that balance breadth and enforceability. The patent landscape features a mixture of international and domestic filings, with strategic patenting around core drug innovations, positioning the patent holder for market exclusivity and licensing opportunities in Russia.
Key Takeaways
- The scope of RU2012134510 hinges on its independent claims, which likely encompass novel formulations or production methods tailored to therapeutic needs.
- A thorough legal and technical review of the claims' breadth is essential to assess infringement risks and freedom to operate.
- The Russian patent landscape features active filings around similar therapeutic compounds and formulations, creating both opportunities and challenges.
- Strategic patenting, with well-defined claim sets, enhances market position, especially in a competitive, evolving pharmaceutical sector.
- Continuous monitoring of existing patents and new filings is critical for maintaining patent leverage and guiding R&D investments.
FAQs
1. What is the significance of the independent claims in RU2012134510?
Independent claims define the broadest scope of protection, covering core formulations, methods, or uses. Their language determines the patent's reach and enforceability.
2. How does the Russian patent landscape influence the protection of pharmaceutical inventions?
Russia actively participates in Eurasian patent treaties, and patenting strategies often involve filings in multiple jurisdictions, affecting the scope and enforcement of drug patents.
3. Can similar formulations or methods infringe RU2012134510?
Infringement depends on whether the competing product or process falls within the scope of the patent claims. A detailed claim analysis is necessary.
4. How do dependent claims add value?
Dependent claims refine and narrow the protection, covering specific embodiments, which can be strategic for defense against patent invalidation or for licensing negotiations.
5. What legal steps should patent holders take in Russia?
Regular patent monitoring, enforcing rights against infringers, and considering patent extension or supplementary protections are vital for maintaining market exclusivity.
Sources:
[1] Federal Institute of Industrial Property (ROSPATENT). Official Patent Database.
[2] Eurasian Patent Office (EAPO). Patent Landscape Reports.
[3] Russian Patent Law. Federal Law No. 217-FZ, of December 26, 2006.
[4] Patent specifications and official documents for RU2012134510.
