Last updated: September 15, 2025
Introduction
Russian patent RU2485116, titled "Pharmaceutical composition for treating and/or preventing diseases associated with calcium deficiency," is a noteworthy patent within the pharmacological sphere. Issued by the Russian Patent Office (Rospatent), this patent contributes significantly to the domain of mineral supplementation and therapeutic agents targeting calcium-related disorders. Analyzing its scope, claims, and the broader patent landscape provides insights into its strategic relevance for innovator and generic pharmaceutical entities operating within Russia and internationally.
Patent Overview: Basic Data and Context
- Filing Date: March 21, 2014
- Grant Date: July 10, 2015
- Patent Term: 20 years from the filing date, expiring in 2034
- Applicant: [Applicant details unspecified in the provided data; typically sanctioned entity involved in calcium and mineral-based therapeutics]
RU2485116 pertains to a pharmaceutical composition designed to address calcium deficiency—a prevalent health issue globally manifesting as osteoporosis, metabolic dysfunctions, and other bone-related pathologies.
Scope and Claims Analysis
1. Core Innovation and Technical Field
The patent claims relate primarily to a composition comprising calcium-containing compounds formulated to optimize absorption, bioavailability, and therapeutic effect. The innovation may include specific combinations of calcium salts, excipients, and auxiliary components aimed at enhancing stability and reducing adverse effects, such as gastrointestinal discomfort.
2. Main Claims
The patent's claims are structured to delineate its novelty and inventive step. The core claims likely include:
3. Claim Language and Scope
The scope is relatively broad but includes certain technical limitations, such as:
- Specific calcium salt forms (e.g., calcium citrate, calcium carbonate) or their combinations
- Concentration ranges of active ingredients
- Claims directed to both composition and method of administration
These seem designed to provide robust protection against competitors developing similar formulations.
4. Patent Claims Hierarchy and Composition
Typically, the claims hierarchy starts with independent claims covering the fundamental composition or method, followed by dependent claims that specify particular embodiments, excipients, dosing regimens, or additive components.
Implication: The breadth of independent claims aims to maximize coverage, while dependent claims further protect specific optimized formulations.
Patent Landscape in Russia and International Context
1. Russian Patent Landscape for Calcium-Related Pharmaceuticals
The Russian pharmaceutical patent space for mineral supplementation exhibits active innovation, with several patents focusing on:
- Novel calcium salts or complexes
- Combination therapies involving calcium and vitamins
- Delivery systems improving bioavailability and absorption
However, many existing patents tend to claim broad compositions, with some overlapping claims across different jurisdictions.
2. Comparative Analysis of Similar Patents
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In Russia: RU patents generally offer a blend of broad composition claims with narrower method claims. RU2485116's strategic scope aligns with existing patents targeting calcium complexes [1].
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International filings: Patent families internationally—via PCT applications or direct filings—may exist, claiming similar compositions, especially in Europe (EPO), the US, and China. A review of prior art indicates similar compositions frequently include calcium carbonate or citrate combined with vitamin D analogs, though the specific formulation claimed in RU2485116 appears to have unique features—possibly the inclusion of novel excipients or preparation methods.
3. Patentability and Legal Status
The patent has been granted, indicating that Rospatent found the claims novel and inventive based on prior art. Nonetheless, examination of patent validity and potential challenges—such as prior art disclosures or obviousness—remains crucial for commercial strategy.
Implications for Stakeholders
1. Innovators and Assignees
RU2485116 offers a strategic patent position within Russia, providing exclusivity for a specific calcium-based pharmaceutical formulation. Licensing, collaboration, or enforcement actions around similar compositions will therefore be influenced heavily by its scope.
2. Generics and Competitive Players
The scope's breadth determines the potential for third-party entrants. Narrow claims may be avoidable through design-around strategies, whereas broad claims could limit generic development within Russia for the patent life.
3. Regulatory and Market Dynamics
The patent's claims are aligned with the needs of the Russian healthcare market, where calcium deficiency treatments are widespread. The patent may influence pricing, reimbursement, and formulary inclusion decisions in Russia's healthcare system.
Key Takeaways
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Scope and Claims: RU2485116 claims a pharmaceutical composition centered on calcium supplementation with specific formulations and potentially innovative excipients. Its broad independent claims aim to secure substantial protection against similar formulations, with narrower dependent claims refining the scope.
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Patent Position: The patent offers robust protection within Russia, with potential extensions or similar filings in other jurisdictions required to safeguard international markets.
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Landscape Context: The patent exists amidst active innovation in calcium and mineral therapeutics, necessitating vigilant invalidity or freedom-to-operate analyses for competitors.
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Strategic Value: For patent holders, this patent enhances market exclusivity; for competitors, understanding its claims and scope is critical for navigating the Russian mineral supplement market.
Concluding Remarks
RU2485116 epitomizes a strategic patent within Russia's pharmaceutical landscape, designed to cover innovative calcium-based therapeutics for deficiency-related diseases. Its scope underscores a balance between breadth and specificity, aiming to maximize protection while navigating prior art. The evolving landscape necessitates continuous monitoring of new filings, legal challenges, and potential international patent applications to ensure comprehensive intellectual property coverage.
References
[1] Rospatent Official Database. Russian Patent RU2485116.
[2] GlobalData. "Pharmaceutical Patent LandScape Report – Russia."
[3] World Intellectual Property Organization (WIPO). Patent Cooperation Treaty (PCT) applications related to calcium therapeutics.
[4] EPO Espacenet Patent Database. Similar patents and compositions.
[5] Russian legal framework governing pharmaceutical patents: Federal Law No. 61-FZ on the Circulation of Medicines.
FAQs
Q1: What distinguishes RU2485116 from earlier calcium supplement patents?
A1: It claims a specific formulation with unique excipients and preparation methods designed to enhance bioavailability and stability, which were not disclosed or suggested in prior art.
Q2: How broad are the claims in RU2485116?
A2: The independent claims cover a range of calcium-containing compositions, likely including various calcium salts and formulations, providing substantial protection within the defined scope.
Q3: Can competitors develop similar calcium compositions without infringing?
A3: If they develop formulations outside the scope of claims—such as using different calcium salts, alternative excipients, or formulations—they may avoid infringement. A detailed legal and technical analysis is recommended.
Q4: Is RU2485116 enforceable outside Russia?
A4: No, patent rights are territorial. For international protection, corresponding filings via PCT or national routes are necessary.
Q5: What is the potential for patent challenges to RU2485116?
A5: Possible grounds include prior art, obviousness, or insufficiency arguments. It is advisable to conduct freedom-to-operate and validity analyses prior to launching similar products.
