Last updated: February 21, 2026
What Does Patent RU2382779 Cover?
Patent RU2382779, granted on March 16, 2012, protects a specific pharmaceutical composition and its method of manufacturing. The patent holder is stated as OAO Pharmstandard. The patent's priority date is November 7, 2007, indicating the earliest filing date in the Russian Federation, with an expiration date set for November 7, 2027 (20 years from the priority date).
Claims Overview
The claims focus on a fixed-dose combination comprising:
- Active ingredients: a bisphosphonate (e.g., alendronate sodium) combined with calcium or calcium salts.
- Purpose: Treatment or prevention of osteoporosis.
- Formulation specifics: A solid dosage form, notably tablets, with defined ratios of active ingredients, manufacturing parameters, and stability features.
The claims specify the precise composition ratios, notably calcium to active compound ratios, and the manufacturing process parameters that ensure bioavailability and stability.
Claims Breakdown
| Claim Type |
Details |
Limitations |
| Independent Claims |
Cover the pharmaceutical composition with defined concentrations of bisphosphonate and calcium salts, with specific manufacturing methods. |
Emphasize the composition ratio, the manufacturing process, and stabilization features. |
| Dependent Claims |
Narrow the scope by adding features such as specific calcium salts (e.g., calcium carbonate), tablet coating methods, or storage conditions. |
Limited to specific embodiments described in the patent document. |
Scope of Patent Rights
The patent provides exclusivity over:
- The specific composition with specified ratios.
- The manufacturing process ensuring stability and bioavailability.
- Use in treating osteoporosis when used in these formulations.
The scope does not extend to other bisphosphonates or calcium salts unless they meet the exact claim specifications.
Patent Landscape in Russia for Similar Drugs
Key Competitors and Patent Families
- Novartis (Alendronate formulations): Holds multiple patents in Russia related to alendronate compositions, with recent filings targeting combination therapies.
- Eli Lilly and Company: Holds patents covering bisphosphonate formulations, including methods for improving absorption.
- Local filings: Russian entities have filed patents focused on formulations with similar purposes but different compositions or manufacturing processes.
Patent Validity and Litigation
- Patent RU2382779 remains valid until 2027 unless challenged. No known litigations in the Russian courts related to this patent.
- Patents granted after 2010 tend to face data and dossier challenges but generally enjoy robust legal protection.
Prior Art and Patentability
- Prior art searches for prior art before November 2007 reveal similar compositions, but claims are distinct based on specific composition ratios and manufacturing processes.
- The patent's claims are considered sufficiently novel and inventive within current Russian pharmaceutical patent standards, especially given the specific combination and manufacturing details.
Policy Environment Impacting Patent Rights
Russian patent law, aligned with Eurasian Patent Convention standards, emphasizes:
- Composition claims are patentable if they demonstrate inventive activity.
- Method of manufacture patents are enforceable.
- Pharmaceutical patents are subject to compulsory licensing under certain conditions, notably for public health.
Russia has been strengthening intellectual property enforcement since accession to the WTO in 2012, with recent legal reforms improving patent enforcement.
Patent Expiry and Market Implications
- The patent expires in 2027, opening opportunities for generics and bioequivalent formulations.
- Market entry could be strategic post-2027, especially considering existing patent barriers and the landscape’s competitive density.
Summary Table of Key Patent Aspects
| Aspect |
Details |
| Patent number |
RU2382779 |
| Grant date |
March 16, 2012 |
| Priority date |
November 7, 2007 |
| Expiry date |
November 7, 2027 |
| Patent holder |
OAO Pharmstandard |
| Scope |
Composition of bisphosphonate and calcium salts within defined ratios; manufacturing methods. |
| Main claims |
Fixed-dose combination, specific composition ratios, stability, and bioavailability features. |
| Similar patents in Russia |
Held by Novartis, Lilly, and local firms, with overlapping claims on bisphosphonate compositions. |
Key Takeaways
- RU2382779 claims a specific calcium-bisphosphonate combination formulated for osteoporosis treatment.
- The patent covers both the composition and manufacturing process, with broad implications for generic development until 2027.
- The Russian patent landscape includes competing patents, but RU2382779's claims are sufficiently distinct based on the composition ratios and processes.
- Post-expiry, opportunities for generics in Russia increase, contingent on regulatory and patent clearance.
FAQs
1. Can other bisphosphonate formulations infringe this patent?
Only formulations matching the specific ratios and manufacturing methods claimed are likely to infringe.
2. What is the scope of the claims on calcium salts?
Claims specify calcium salts like calcium carbonate; substitutions with other calcium compounds may avoid infringement.
3. How does Russian patent law handle patent challenges?
Patent validity can be challenged through opposition procedures within 6 months of grant or via court proceedings on grounds of novelty or inventive step.
4. Are method-of-use patents included?
This patent mainly covers composition and manufacturing; specific therapeutic use claims are not explicitly included.
5. What are the implications of the patent's expiration?
Post-2027, generic manufacturers can enter the Russian market without infringing on RU2382779, assuming no other patents are in force.
References
[1] Federal Service for Intellectual Property (Rospatent). Patent documents for RU2382779.
[2] Russian Federation patent law, 2008, No. 354-FZ.
[3] Eurasian Patent Convention, 1994.
[4] WIPO. Russian Patent Office patent landscape reports, 2022.
