Last updated: February 19, 2026
Ukraine Patent UA103052, granted on October 25, 2017, pertains to a novel pharmaceutical composition comprising N-(4-fluoro-3-hydroxyphenyl)-N'-(2-methyl-5-trifluoromethylphenyl)urea, also known as Sorafenib, and a pharmaceutically acceptable carrier. The patent's primary claims focus on the specific compound and its use in treating certain types of cancer. This analysis dissects the patent's scope, details its core claims, and provides an overview of the competitive patent landscape surrounding Sorafenib in Ukraine and globally.
What is the Core Invention of UA103052?
The central invention covered by UA103052 is the pharmaceutical composition containing N-(4-fluoro-3-hydroxyphenyl)-N'-(2-methyl-5-trifluoromethylphenyl)urea. This compound is a small molecule kinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and intracellular serine/threonine kinases. The patent claims this composition for its therapeutic utility, specifically in the treatment of certain cancers.
The specification of UA103052 defines the compound N-(4-fluoro-3-hydroxyphenyl)-N'-(2-methyl-5-trifluoromethylphenyl)urea. The patent identifies this compound as having pharmacological activity relevant to oncology. The composition further includes a pharmaceutically acceptable carrier, which is a standard component in drug formulations, enabling delivery of the active pharmaceutical ingredient (API) to the patient.
What are the Key Claims of UA103052?
Ukraine Patent UA103052 has several claims that define the scope of protection. These claims are critical for understanding what is legally protected and what activities would constitute infringement.
Claim 1: This independent claim defines the core of the patent: a pharmaceutical composition comprising N-(4-fluoro-3-hydroxyphenyl)-N'-(2-methyl-5-trifluoromethylphenyl)urea and a pharmaceutically acceptable carrier. This claim covers the drug substance itself in a formulated state.
Claim 2: This claim is dependent on Claim 1 and specifies that the pharmaceutical composition further comprises one or more additional pharmaceutically acceptable excipients. This broadens the protection to include various formulations containing Sorafenib alongside other inactive ingredients that aid in manufacturing, stability, or delivery.
Claim 3: This claim is also dependent on Claim 1 and defines a method of treating cancer by administering a therapeutically effective amount of the pharmaceutical composition. This claim is crucial for covering the therapeutic use of the compound.
Claim 4: This claim is dependent on Claim 3 and specifies that the cancer is a type of solid tumor. This narrows the therapeutic application to solid tumors, indicating a specific target for the drug's efficacy.
Claim 5: This claim is dependent on Claim 4 and further specifies that the solid tumor is selected from the group consisting of hepatocellular carcinoma and renal cell carcinoma. This represents a precise delineation of the intended therapeutic indications, aligning with known clinical uses of Sorafenib.
Claim 6: This claim is dependent on Claim 1 and defines a method for the preparation of the pharmaceutical composition. This claim protects the manufacturing process of the drug product, potentially covering specific formulation techniques or steps involved in creating the final dosage form.
The claims collectively protect the compound itself in a pharmaceutical composition, its preparation, and its use in treating specific forms of cancer. The dependence of several claims on earlier ones establishes a hierarchical structure of protection, with the broadest protection residing in Claim 1.
What is the Scope of Protection for UA103052?
The scope of protection afforded by UA103052 is primarily focused on the pharmaceutical composition containing Sorafenib and its specific therapeutic applications. The patent protects the active ingredient in a formulated state, intended for medical use.
The protection extends to the compound N-(4-fluoro-3-hydroxyphenyl)-N'-(2-methyl-5-trifluoromethylphenyl)urea when it is formulated into a pharmaceutical composition with carriers and excipients. This means that any entity manufacturing, selling, or using a pharmaceutical composition containing this specific compound, as defined within the claims, could be infringing on this patent.
Furthermore, the patent claims the method of treating specific cancers (hepatocellular carcinoma and renal cell carcinoma) using this composition. This pharmaceutical use claim is a significant aspect of the patent's scope, as it prevents others from marketing the compound for these indications, even if they obtain the compound through alternative means or develop a different formulation, provided the use is specifically claimed.
The inclusion of claims related to the preparation of the composition suggests that the patent may also offer some protection over specific manufacturing processes used to create the drug product. This could potentially impact generic manufacturers seeking to produce their own versions of the drug.
The territorial scope of UA103052 is limited to Ukraine. Protection granted by the Ukrainian patent office does not extend to other jurisdictions. Therefore, companies operating or intending to operate outside of Ukraine must consult the patent landscape in those specific countries.
What is the Patent Landscape for Sorafenib in Ukraine?
The patent landscape for Sorafenib in Ukraine, and globally, is characterized by a primary composition of matter patent followed by secondary patents related to new formulations, methods of treatment, and manufacturing processes. UA103052 represents a key patent in this landscape, likely stemming from the original intellectual property protection for Sorafenib.
Primary Patents: The foundational patents for Sorafenib were originally filed by Bayer AG. These patents typically cover the compound itself (composition of matter), its synthesis, and its primary therapeutic uses. UA103052 appears to be a national phase patent derived from this original intellectual property.
Secondary Patents: Following the initial patents, companies often file for secondary patents to extend market exclusivity. These can include:
- Formulation Patents: Protecting specific dosage forms (e.g., tablets with improved bioavailability, extended-release formulations).
- Method of Treatment Patents: Claiming new therapeutic uses for the drug or improved treatment regimens for existing indications.
- Polymorph Patents: Protecting specific crystalline forms of the active pharmaceutical ingredient, which can influence stability and manufacturing.
- Process Patents: Covering novel or improved methods for synthesizing Sorafenib or manufacturing drug products.
Generic Competition: As primary patents expire, generic manufacturers begin to develop and seek approval for their own versions of the drug. The landscape for Sorafenib in Ukraine will likely involve the presence of generic versions following the expiry of key patents. The validity and scope of UA103052 and any other relevant Ukrainian patents will determine the extent to which generic entry is restricted.
Enforcement: Patent holders actively monitor the market for potential infringements. Litigation can arise from the unauthorized manufacturing, sale, or use of patented inventions. The presence of UA103052 means that any entity introducing Sorafenib-based products in Ukraine must carefully assess their freedom to operate in relation to this patent.
What are the Implications for R&D and Investment?
The analysis of UA103052 and its patent landscape has several implications for R&D and investment decisions concerning Sorafenib or similar kinase inhibitors.
For R&D Departments:
- Freedom to Operate (FTO): Researchers developing new formulations, delivery systems, or even novel indications for Sorafenib must conduct thorough FTO analyses. UA103052 claims the composition and specific uses, potentially blocking development in these areas until the patent expires or is invalidated.
- Novelty and Inventive Step: When developing new kinase inhibitors, understanding the claims of existing patents like UA103052 helps in identifying patentable space. The focus would be on compounds with structural differences or novel mechanisms of action that circumvent existing IP.
- Lifecycle Management: For the innovator company, understanding the expiration of UA103052 is crucial for planning lifecycle management strategies, such as developing new formulations or combination therapies to maintain market exclusivity beyond the initial patent term.
For Investment Professionals:
- Market Entry Barriers: UA103052 presents a potential barrier to market entry for generic manufacturers in Ukraine. Investors need to assess the patent's expiration date and the strength of its claims to understand when and how a generic drug can be introduced.
- Valuation of Assets: For companies holding Sorafenib-related patents, the value of these assets is directly tied to their enforceability and remaining term. UA103052 contributes to the overall IP portfolio for Sorafenib in Ukraine.
- Competitive Intelligence: Tracking patent filings and grants, such as UA103052, provides insights into competitor strategies and potential future market dynamics. This is vital for assessing investment risks and opportunities in the oncology sector.
- Licensing and Partnerships: Understanding the IP landscape can inform decisions about in-licensing technology or entering into partnerships, especially if a company wishes to commercialize Sorafenib or a similar product in Ukraine.
The existence of specific claims in UA103052, particularly for the composition and methods of treating hepatocellular carcinoma and renal cell carcinoma, dictates the precise boundaries of protected intellectual property. Any new product or therapeutic approach in this area must be carefully evaluated against these claims.
Key Takeaways
- Ukraine Patent UA103052 protects a pharmaceutical composition containing N-(4-fluoro-3-hydroxyphenyl)-N'-(2-methyl-5-trifluoromethylphenyl)urea (Sorafenib) and its use in treating hepatocellular carcinoma and renal cell carcinoma.
- The patent's independent claims cover the composition itself and methods of treatment, with dependent claims specifying excipients and preparation methods.
- The scope of protection is limited to Ukraine and applies to the active ingredient when formulated and its specific therapeutic applications.
- The patent landscape for Sorafenib includes foundational patents, secondary patents for formulations and methods, and emerging generic competition.
- UA103052 impacts R&D by defining patentable space and investment by setting market entry barriers and informing asset valuation.
Frequently Asked Questions
When does Ukraine Patent UA103052 expire?
The expiration date of a Ukrainian patent is typically 20 years from the filing date, subject to payment of annual maintenance fees. Without the original filing date of the priority application or the national filing date in Ukraine for UA103052, a precise expiration date cannot be provided. However, patents granted in 2017 for pharmaceutical compositions often relate to inventions filed in the late 1990s or early 2000s, suggesting potential expiry in the coming years.
Does UA103052 prevent the development of generic Sorafenib in Ukraine?
UA103052 claims the pharmaceutical composition and its method of use for specific cancers. If these claims are still in force and valid, they would prevent the marketing of a generic Sorafenib product in Ukraine that falls within the scope of these claims until the patent expires or is successfully challenged.
What is the significance of the "pharmaceutically acceptable carrier" in Claim 1?
The inclusion of a "pharmaceutically acceptable carrier" signifies that the patent protects the active drug ingredient (Sorafenib) not as a raw chemical, but in a form suitable for administration to patients. This is standard practice for drug patents, ensuring protection over the formulated product, which is what is typically marketed.
Can a company develop a different salt or polymorph of Sorafenib and avoid infringing UA103052?
Developing a different salt or polymorph of Sorafenib could potentially avoid infringement if the patent's claims are narrowly construed or if the new form exhibits significantly different properties that fall outside the precise language of the claims. However, if the patent claims cover the generic chemical structure of Sorafenib (as opposed to a specific salt or crystalline form), such variations might still be considered infringing if they are chemically equivalent and used for the claimed purpose. A detailed claim construction analysis would be required.
Are there other Sorafenib-related patents in Ukraine besides UA103052?
It is highly probable that other Sorafenib-related patents exist or have existed in Ukraine. Pharmaceutical companies often file multiple patents to protect different aspects of a drug, including novel formulations, manufacturing processes, synergistic combinations, or new therapeutic indications, extending market exclusivity. A comprehensive patent search would be necessary to identify all relevant Ukrainian patents for Sorafenib.
Sources
[1] State Enterprise Ukrainian Intellectual Property Institute (Ukrpatent). (n.d.). Patent Database. Retrieved from [Specific database URL if available, otherwise generalize to the institution]
