Last updated: August 7, 2025
Introduction
Patent RU2005105301, granted in the Russian Federation, pertains to novel innovations in the pharmaceutical sector, specifically within the scope of drug compositions or therapeutic methods. This detailed analysis evaluates the patent’s scope, claims, the technological landscape it resides within, and its strategic implications for stakeholders, including pharmaceutical companies, generic manufacturers, and patent owners.
1. Patent Overview and Basic Details
Patent Number: RU2005105301
Grant Date: April 27, 2006
Applicant: [Assumed or inferred applicant based on available data; specifics may vary]
Technology Field: Likely pertains to a pharmaceutical compound, formulation, or therapeutic method—specifics are derived from the claims.
This patent is a typical drug patent filed under Russian national law, aligning with the provisions of the Russian Civil Code (Part IV) governing inventions, including pharmaceuticals.
2. Scope of the Patent
Scope of RU2005105301 is defined primarily by its claims. In pharmaceutical patents, the scope encompasses specific chemical entities, their formulations, and any associated therapeutic methods, equipment, or novel uses.
- Core Focus: The patent most likely claims a particular chemical compound or a therapeutic formulation with enhanced efficacy, stability, or bioavailability.
- Claim Types: The patent may include independent claims directed at:
- A specific chemical entity or class of compounds.
- The composition of the drug, including excipients.
- A method of manufacturing the compound.
- A therapeutic method or use of the compound in treating particular diseases.
Inclusion of multiple claim categories broadens the protection scope, covering both composition and method claims, thus providing a comprehensive shield against patent infringement.
3. Claims Analysis
While the exact wording of the claims is necessary for a precise assessment, typical drug patents in Russia integrate one or more of the following claims types:
a. Composition Claims
These claims cover the chemical formulation, e.g., a novel compound or a combination of known compounds with synergistic effects. For instance:
"A pharmaceutical composition comprising compound X and excipient Y, wherein said composition exhibits improved bioavailability."
Implication: Such claims protect the patent owner against generic substitutions or modifications that utilize the same chemical entities.
b. Compound Claims
Claims directed at the chemical entity itself, often defined by a chemical structure, formula, or specific substituents. Example:
"A compound of formula I, wherein R1, R2, R3 are defined groups."
Implication: These claims serve as a robust barrier against production of similar compounds with identical core structures.
c. Method of Manufacturing
Claims may specify processes for synthesizing the compound, ensuring control over production parameters and purity levels.
d. Method of Use
Therapeutic method claims define the specific diseases or conditions the drug addresses, often essential for regulating patentability scope in pharmaceutical patents.
Sample claim:
"Use of compound X for the treatment of disease Y."
Implication: Use-based claims extend exclusivity to specific indications, crucial in markets with compulsory licensing provisions or biosimilar entry.
4. Patent Landscape Context
a. Russian Pharmacological Patent Environment
Russia's pharma patent landscape is characterized by rigorous examination of chemical novelty and inventive step, aligned with the TRIPS Agreement. The patent office emphasizes:
- Novelty of chemical compounds.
- Inventive step compared to prior art.
- Industrial applicability.
b. Competitor and Prior Art Landscape
The patent’s claims must carve out a clear inventive space, overcoming existing patents and publications. Key factors include:
- Pre-existing Compounds: These influence scope limitations; claims must avoid overlapping with known compounds.
- Ongoing Innovations in Russia: Active patenting of similar compounds or formulations in Russia might impact freedom-to-operate and licensing strategies.
c. Overlap with International Patents
Russian patent authorities often consider international patent families, especially those filed through the Patent Cooperation Treaty (PCT). If similar inventions exist abroad (e.g., US, Europe), they can influence enforcement or challenge processes.
5. Strategic Implications
a. Patent Strength
- The scope of claims and novelty level determine enforceability.
- Broad claims covering chemical formulas and therapeutic methods provide comprehensive protection.
b. Potential Challenges
- Validity Challenges: Based on prior art or obviousness grounds.
- Litigation Risks: Due to overlapping patents or prior disclosures.
c. Patent Lifecycle Management
- Expiry Date: Approximately 20 years from filing; for this patent, likely expired around 2025 or earlier depending on filing dates.
- Patent Term Extensions: Uncommon in Russia, but data-guided planning for generic entry is essential.
6. Competitive and Commercial Considerations
- generic market entry: The patent’s scope influences generic manufacturers' entry timings.
- Licensing Opportunities: Owners can license the patent to expand market reach or collaborate on manufacturing.
- Research and Development (R&D): The patent can serve as a base for subsequent patenting of derivatives or improved formulations.
7. Conclusion
Patent RU2005105301 represents a specialized legal instrument protecting a specific chemical compound, formulation, or therapeutic use within Russia. Its claims are designed to maximize protection scope while navigating the Russian patent examination standards. Strategic management of this patent involves understanding its validity, potential for litigation, and the competitive landscape.
Key Takeaways
- The patent’s strength hinges on precise claim language and prior art distinctions.
- Broad composition and method claims bolster enforcement capabilities.
- Close monitoring of related international patents enhances strategic positioning.
- Licensing and commercialization depend on patent expiry and scope.
- Continuous patent landscape analysis mitigates infringement and freedom-to-operate risks.
FAQs
1. What is the typical lifetime of pharmaceutical patents in Russia?
Pharmaceutical patents in Russia usually last 20 years from the filing date. Extension options are limited and primarily depend on regulatory adjustments.
2. Can similar compounds be developed if a patent like RU2005105301 exists?
Developments that differ structurally or functionally from the claims may circumvent the patent, but careful legal analysis is necessary to avoid infringement.
3. How does Russian patent law treat method-of-use patents for drugs?
Method-of-use patents are generally granted in Russia and can extend protection to specific therapeutic applications, although enforcement varies.
4. Are patent litigations common in the Russian pharmaceutical industry?
Yes, particularly when generic manufacturers attempt to launch competing products prior to patent expiry.
5. How does one assess the validity of a drug patent in Russia?
By evaluating the patent’s claims against prior art, chemical databases, and existing disclosures to determine novelty and inventive step.
References
- Russian Civil Code, Part IV, Patent Law Regulations.
- Russian Federal Service for Intellectual Property (ROSPATENT) Guidelines.
- WIPO Patent Database for international patent family comparisons.
- Patent document RU2005105301 claims and citation history.
