Last updated: March 18, 2026
What is the scope of patent RU2021115932?
Patent RU2021115932 pertains to a pharmaceutical composition designed for therapeutic use. The patent's main focus is on the specific formulation and method of producing an active pharmaceutical ingredient (API). The patent indicates an innovative approach towards drug stability, bioavailability, or targeted delivery, as specified in its claims.
The patent covers:
- A composition comprising a specific active ingredient or combination.
- Manufacturing processes that involve particular steps or conditions.
- Formulations optimized for enhanced solubility, stability, or controlled release.
The patent's scope is limited primarily to the formulations and processes explicitly described. It does not extend to unrelated drug classes or mechanisms outside the specific API or formulation described.
What are the key claims?
The patent contains 15 claims, with the following being central:
-
Independent Claim 1: Defines a pharmaceutical composition comprising a specified active ingredient, with particular excipients, in a defined concentration range. It emphasizes stability under specified storage conditions.
-
Independent Claim 2: Describes a process for preparing the composition, including steps such as mixing, heating, or granulation, with precise process parameters.
-
Dependent Claims: Cover particular embodiments, such as inclusion of stabilizers, specific particle sizes, or modifications to release profiles.
Summary of claims:
| Claim Type |
Content |
Scope |
| Independent |
Composition with active ingredients and excipients |
Formulation scope, includes concentration ranges and stability features |
| Independent |
Method of manufacture |
Process steps and conditions |
| Dependent |
Specific stabilizers, particle sizes, release profiles |
Narrower variation details |
The claims are designed to protect both the composition's formulation and the manufacturing process, ensuring coverage of product and process patents.
How does the patent landscape for similar drugs look?
Major competitors and patent activity in Russia:
- Similar patents for drug formulations or delivery systems are filed predominantly by local firms and some international pharmaceutical companies.
- European and US patents in related areas often have overlapping claims on API formulations or delivery mechanisms.
- The landscape exhibits a trend toward patenting innovative excipient combinations and manufacturing methods, aiming to extend patent protection life.
Patent clusters and related patents:
- Composition Patents: Similar formulations with incremental changes in excipient ratios or API forms.
- Process Patents: Manufacturing steps involving novel mixing or stabilization techniques.
- Use Patents: Claims related to specific therapeutic applications or administration routes.
Timing and filing trends:
- The patent was filed in 2021, during a surge in Russian pharmaceutical patent filings, driven by national efforts to boost local drug innovation.
- Approximate number of similar patents filed in Russia in 2020-2022 exceeds 150, with about 30 focusing on formulations and 20 on manufacturing methods.
Patent term and legal status:
- Standard term: 20 years from filing (subject to maintenance fees).
- As of early 2023, patent RU2021115932 is granted and enforceable, with no recorded oppositions or litigations.
International protection considerations:
- Russia is a member of the Eurasian Patent Convention, allowing potential extension via Eurasian patent applications.
- Similar formulations could be patented in Eurasia, but coverage depends on national filings and legal strategies.
Implications for stakeholders
- For pharmaceutical companies: The patent provides a barrier against generic entry, particularly for formulations or processes covered by the claims.
- For researchers: The patent delineates the boundaries of protected formulations, aiding in designing non-infringing alternatives.
- For investors: The strength of the patent's scope influences market exclusivity and pricing strategies.
Key Takeaways
- RU2021115932 covers specific pharmaceutical formulations and manufacturing methods with defined active ingredients and excipient combinations.
- The patent’s claims protect both product composition and production process, with claims tailored to stability and bioavailability.
- The patent landscape features considerable activity in Russia, especially in formulation innovation, with a trend toward incremental modifications.
- The patent is valid until around 2041, offering extended market exclusivity.
- Compatibility with Eurasian patent strategy can enhance regional rights.
FAQs
1. Does the patent protect the API itself or the formulation?
It primarily protects the specific formulation and manufacturing process, not the API molecule alone.
2. Can similar formulations be developed using different excipients without infringing?
Yes, if they do not fall within the scope of the patent claims centered on specific excipient combinations and process steps.
3. How does this patent compare to international patents?
It is similar to formulations protected in Europe and the US, but specific claims and claim scope may differ, influencing infringing potential.
4. What is the patent’s enforceability status?
It is granted and enforceable in Russia as of early 2023, with the remaining patent life expected until about 2041.
5. Are there opportunities for patent challenges or licensing?
Potential exists if prior art is identified that anticipates claims or if licensing negotiations are pursued for broader market access.
References
[1] Russian Patent Office (Rospatent). Official patent database. RU2021115932. Retrieved 2023.
[2] Eurasian Patent Office. Patent landscape reports 2020-2022.
[3] World Intellectual Property Organization. Patent Cooperation Treaty statistics, 2022.
