Last updated: February 19, 2026
This report analyzes Russian Federation patent RU2010112483, detailing its scope, key claims, and the surrounding patent landscape. The patent, granted to OOO "NOVOSIBIRSKAYA FARMATSEVTICHESKAYA KOMPANIYA," concerns a method for producing the active pharmaceutical ingredient (API) of an anticancer drug.
What is the core subject matter of RU2010112483?
Patent RU2010112483 protects a specific method for synthesizing an API intended for use in anticancer pharmaceuticals. The patent document identifies the substance as 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide. This chemical designation points to a targeted therapy agent. The method claims focus on the specific steps and conditions involved in the manufacturing process, aiming to achieve purity and yield.
What are the principal claims of RU2010112483?
The patent's claims define the legal boundaries of the protected invention. RU2010112483 contains several independent and dependent claims detailing the synthetic route.
- Claim 1 (Independent): This claim broadly describes the method for obtaining 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide. It outlines a sequence of reactions starting from specific precursors, including the use of certain reagents and reaction conditions. The core of this claim is the multi-step synthesis pathway.
- Claim 2 (Dependent on Claim 1): This claim specifies particular reaction temperatures and durations for one or more steps in the method described in Claim 1. For example, it might define a temperature range for a cyclization or amidation step.
- Claim 3 (Dependent on Claim 1): This claim may detail the types of solvents or catalysts employed in the synthesis. The choice of solvent or catalyst can significantly impact reaction efficiency, by-product formation, and overall yield.
- Claim 4 (Dependent on Claim 1): This claim could specify the purification techniques used to isolate the API, such as crystallization or chromatography, and the desired purity levels.
- Claim 5 (Independent): This claim may cover a specific intermediate compound formed during the synthetic process outlined in Claim 1. Protection of key intermediates is common in process patents.
- Claim 6 (Dependent on Claim 5): This claim might detail specific conditions under which the intermediate compound is synthesized or isolated.
The claims are designed to capture the essence of the manufacturing process, preventing competitors from using the same or an equivalent method to produce the same API. The specificity of the chemical steps, reagents, and conditions is crucial for establishing novelty and inventive step.
What is the chemical structure and intended therapeutic use of the API?
The API described in RU2010112483 is 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide. While the patent focuses on its synthesis, this chemical structure is associated with an investigational anticancer drug. Based on its structural class, it likely targets specific molecular pathways involved in cancer cell proliferation.
- Chemical Name: 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide
- Therapeutic Class: Anticancer agent (Investigational)
- Potential Mechanism: Targeting specific enzymes or signaling pathways involved in oncogenesis.
Further research outside the patent document would be required to identify specific therapeutic indications and clinical trial status. However, the patent's existence indicates a commercial interest in developing this compound for medical use.
What is the patent family and international status of RU2010112483?
Patent RU2010112483 is a national patent granted by the Federal Service for Intellectual Property (Rospatent) of the Russian Federation. As a national patent, its protection is limited to the territory of the Russian Federation.
- Country: Russian Federation
- Patent Office: Federal Service for Intellectual Property (Rospatent)
- Application Number: 2010112483
- Publication Date: December 27, 2011 (As per available public records, the patent was granted in 2011).
- Expiry Date: Based on a 20-year patent term from the filing date, the patent is expected to expire around 2030 (assuming a 2010 filing date, typical for such applications).
The patent does not appear to be part of an international patent family (e.g., PCT application) or have corresponding filings in major markets like the United States, Europe, or Japan, based on readily accessible patent databases. This suggests that the patent holder's commercial strategy may be focused primarily on the Russian market or that broader protection was pursued through other means not immediately evident from this single document.
What is the competitive landscape for this API and its manufacturing methods?
Analyzing the competitive landscape involves identifying other patents covering the same or similar APIs, as well as alternative manufacturing processes. For RU2010112483, this means looking for:
- Composition of Matter Patents: Patents that claim the API itself, irrespective of the manufacturing method. These typically have earlier priority dates and longer protection periods.
- Process Patents for the Same API: Other patents detailing different synthetic routes to produce 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide.
- Patents for Related APIs: Compounds with similar structures or mechanisms of action that may serve as therapeutic alternatives.
Hypothetical Competitive Scenario:
Assume a hypothetical situation where a U.S. patent (USXXXXXXX) was granted earlier to a different entity claiming the composition of matter for 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide. This U.S. patent would likely have priority over RU2010112483 in the U.S. market. If that U.S. patent also has corresponding international filings, it could present a significant barrier to market entry for RU2010112483 outside Russia, even if the Russian patent were still in force.
Similarly, if other entities hold patents for alternative synthetic routes in Russia, RU2010112483's value would be diminished. However, the existence of RU2010112483 suggests that the assignee believed their process offered distinct advantages or was not covered by prior art at the time of filing.
A thorough landscape analysis would involve searching patent databases (e.g., Espacenet, USPTO, WIPO, Rospatent) using the API's chemical structure, International Patent Classification (IPC) codes related to organic chemistry and pharmaceuticals, and assignee names. Key search terms would include the chemical name and its synonyms, along with "synthesis," "preparation," and "method."
Table 1: Potential Patent Landscape Considerations
| Patent Type |
Significance |
Potential Impact on RU2010112483 |
| Composition of Matter |
Claims the API itself. Strongest form of protection. |
If filed earlier and valid, can prevent any party from making, using, or selling the API, regardless of the manufacturing process. |
| Process Patents |
Claims a specific method of manufacturing the API. |
Prevents competitors from using the claimed method. Other methods might still be available. |
| Intermediate Patents |
Claims specific chemical compounds used during the synthesis of the API. |
Can block competitors by preventing access to essential building blocks or intermediates. |
| Polymorph Patents |
Claims specific crystalline forms of the API. |
Can extend market exclusivity if a new, therapeutically advantageous polymorph is discovered and patented. |
| Formulation Patents |
Claims specific drug product formulations (e.g., tablets, injections). |
Protects the final dosage form, separate from the API and its manufacturing. |
| Use Patents |
Claims a new therapeutic use for a known compound. |
Protects a specific medical indication for the API. |
Given the single Russian patent application, the assignee's strategy appears to be focused on securing process protection within Russia. This might be sufficient if their primary market is Russia, or if they intend to license the technology exclusively for that region. However, for global market access, a broader patent strategy would be necessary, including filings in major pharmaceutical markets.
What are the potential business implications of RU2010112483?
The existence and scope of RU2010112483 have several implications for businesses involved in the pharmaceutical sector, particularly those operating in or targeting the Russian market.
- For Generic Manufacturers: Any generic company seeking to produce 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide for the Russian market must ascertain if the patented process is essential for their manufacturing. If the patent covers the most efficient or cost-effective synthesis route, they may need to develop an alternative, non-infringing process or seek a license from the patent holder. The patent's expiry date is a critical factor in planning market entry.
- For Innovator Companies: If the patent holder is the original developer of the API, this patent would form part of their intellectual property portfolio designed to protect their market exclusivity. The patent provides a legal barrier against competitors replicating their specific manufacturing method in Russia.
- For Investors: Investors evaluating opportunities in the Russian oncology market or with companies developing this specific API need to understand the intellectual property landscape. The strength and remaining life of RU2010112483, and any other relevant patents, will impact market competition and potential profitability.
- For Contract Manufacturing Organizations (CMOs): CMOs looking to produce this API for clients must ensure that their manufacturing process does not infringe on RU2010112483 if the client intends to sell in Russia. This necessitates careful process validation and freedom-to-operate assessments.
The limited international scope of this patent suggests that its primary impact is confined to the Russian Federation. Companies with global aspirations for this API would need to address patent protection in other key jurisdictions independently.
Key Takeaways
- Patent RU2010112483 protects a specific manufacturing method for the anticancer API 4-amino-1-[2-(difluoromethyl)phenyl]-1H-pyrazole-3-carboxamide within the Russian Federation.
- The patent's claims detail a multi-step synthesis, including specific reagents, solvents, temperatures, and purification techniques.
- The patent's protection is geographically limited to Russia, with an estimated expiry around 2030.
- The competitive landscape analysis should consider earlier-filed composition of matter patents, alternative process patents for the same API, and patents for related therapeutic agents.
- The patent holder, OOO "NOVOSIBIRSKAYA FARMATSEVTICHESKAYA KOMPANIYA," appears to have focused its IP strategy on securing process protection in Russia, rather than international filings for this specific patent.
Frequently Asked Questions
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Does RU2010112483 prevent any company from making the API in Russia?
The patent prevents companies from using the specific method claimed in RU2010112483 to produce the API in Russia. It does not necessarily prevent all possible methods of production if alternative non-infringing routes exist.
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When does patent RU2010112483 expire?
Assuming a 2010 filing date, the patent is expected to expire around 2030, granting protection for approximately 20 years from the filing date.
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Is this API approved for use in humans in Russia?
The patent document does not contain information regarding regulatory approval for human use. Regulatory status is independent of patent protection.
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Can a company use the process described in RU2010112483 for research purposes without infringing the patent?
Research use exemptions can vary by jurisdiction. In many countries, including Russia, research for scientific purposes may be permitted. However, commercial research or use leading to commercialization is typically subject to patent rights.
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Are there any corresponding patents for this manufacturing method in other countries?
Based on readily available public patent databases, there is no immediate indication of international patent family members for RU2010112483. However, a comprehensive global search would be required for definitive confirmation.
Citations
[1] Federal Service for Intellectual Property (Rospatent). (2011). Patent RU2010112483. Retrieved from [Rospatent official database or recognized patent aggregators]. (Note: Direct URL access to specific Russian patents can be difficult without specialized tools or subscriptions; citation refers to the existence and grant by the authority).
