Last updated: August 5, 2025
Introduction
Patent CN104146948, titled "Method for treating cancer using Ubenimex", protected a novel therapeutic approach employing the compound Ubenimex (also known as Bestatin) for oncological indications. This patent provides insights into the strategic patenting activity within the Chinese pharmaceutical landscape, specifically in the realm of cancer treatment and immunomodulation. Herein, we deliver a detailed analysis of its scope and claims, followed by its positioning within the current patent landscape.
Scope of Patent CN104146948
Legal Scope
The scope of CN104146948 covers the use of Ubenimex as an active pharmaceutical ingredient for treating certain types of cancer, with particular emphasis on method claims involving its administration in specific dosage forms, regimens, and combinations. The patent aims to secure proprietary rights over novel therapeutic applications of Ubenimex, especially those demonstrated to modulate immune responses against tumors.
Technical Scope
The patent claims extend to:
- The use of Ubenimex in the preparation of anti-cancer medicaments.
- Specific dosage and administration methods that optimize its therapeutic effect.
- Combination therapies, particularly Ubenimex coupled with other chemotherapeutic agents or immunomodulators.
- Targeted cancer types, primarily solid tumors such as gastric, colorectal, and lung cancers, where immune modulation is beneficial.
Geographical and Therapeutic Significance
Securitization within China’s robust patent environment offers exclusivity in the rapidly expanding Chinese biotechnology and pharmaceutical sectors. The scope aligns with China’s strategic emphasis on innovative anticancer agents and immunotherapies.
Claims Analysis
Claim Hierarchy & Focus
The patent encompasses a combination of independent and dependent claims, with the primary claim(s) centered on the use of Ubenimex for treating cancers. A typical independent claim can be summarized as:
"Use of Ubenimex in the manufacture of a medicament for the treatment of cancer, wherein the medicament is administered in a specific dosage regimen."
Key Elements of Claims
- Compound Specification: The claims specify the active ingredient as Ubenimex, highlighting its chemical structure and purity standards, aligning with clinical-grade preparations.
- Therapeutic Method: Emphasizes administration routes (oral, injectable) and dosing schedules that demonstrate improved outcomes.
- Cancer Types: Broadly includes solid tumors such as gastric, lung, and colorectal cancers, tying into studies indicating immune system activation.
- Combination Therapy: Many claims refer to the concurrent use of Ubenimex with chemotherapeutic agents such as cisplatin or targeted therapies like EGFR inhibitors.
Claim Limitations and Scope
The claims are method-based rather than product-based, which somewhat limits the scope to the use of the compound for specified therapeutic purposes, rather than exclusive rights over the compound itself. The inclusion of specific dosing strategies and combination therapies broadens the patent’s protective scope, covering different therapeutic protocols.
Patent Landscape Context
Patent Environment for Ubenimex and Cancer Therapies in China
China's pharmaceutical patent landscape is highly active for immunomodulatory agents and combination therapies targeting cancer. Many patents focus on:
- Novel uses of existing drugs (second medical use patents) [1].
- Combination regimens with immunotherapy or chemotherapy.
- Dosing improvements and administration routes.
Comparison with Global Patents
While Ubenimex (Bestatin) has been known for decades, recent Chinese patents, such as CN104146948, focus on novel therapeutic regimes rather than the compound per se. Similar strategies are observed in U.S. and European patents, though Chinese patent filings have increased notably post-2015, reflecting policy encouragement of innovative drug development.
Related Patent Families
The patent sits within a family of patents, including applications related to:
- Novel indications of Ubenimex in immune-related diseases.
- Use of Ubenimex in combination with checkpoint inhibitors.
- Formulation patents enhancing bioavailability or stability.
This family positioning offers a layered IP strategy, providing both broad and specific protections.
Strengths and Limitations
Strengths
- Focused claim scope that secures rights over specific uses, improving enforceability.
- Combination therapy claims enhance patent robustness, covering more therapeutic protocols.
- Alignment with Chinese healthcare priorities, such as immunomodulation and cancer therapy.
Limitations
- Use-claims are inherently narrower compared to product claims, potentially vulnerable to non-infringing alternative methods.
- The claims may lack genus breadth for the compound alone, limiting protection if new derivatives emerge.
- Regulatory challenges in substantiating claims for specific cancer indications may affect enforceability upon commercialization.
Strategic Implications
For patent holders and licensees, CN104146948 offers a valuable foothold in China's lucrative oncology market. Its claims enforce rights over specific therapeutic modes, facilitating potential litigation or licensing. However, competitors might develop alternative uses or formulations that circumvent the claims, underscoring the importance of continuous patent portfolio expansion and innovation.
Conclusion
Patent CN104146948 exemplifies China's focus on securing method-of-use claims for existing drugs, particularly within cancer immunotherapy. Its scope covers Ubenimex’s application in oncological treatments, particularly combination therapies and dosing regimens, aligning with contemporary China’s strategic priorities for innovative cancer therapeutics. The patent landscape reflects a dynamic environment where method patents complement broader product patents, reinforcing market positioning in one of the world's fastest-growing pharmaceutical markets.
Key Takeaways
- Claims Scope: Focused on Ubenimex’s use in cancer therapy, including dosing, administration routes, and combination therapies; primarily method claims.
- Patent Positioning: Strong within China’s intellectual property ecosystem due to targeted use claims aligned with national priorities.
- Innovation Strategy: A blend of combination therapy and administration improvements bolsters patent strength and market exclusivity.
- Competitive Landscape: Increasing filings in immunomodulatory cancer therapies require ongoing patent portfolio expansion for sustained protection.
- Regulatory Considerations: Validation of therapeutic claims for specific cancers remains critical for commercial success and enforceability.
FAQs
Q1: Does CN104146948 claim Ubenimex as a new chemical entity?
A1: No. The patent focuses on the use of existing Ubenimex in specific cancer treatments, not on claiming the compound itself.
Q2: Can this patent be licensed for use in other diseases?
A2: Claims are specific to cancer treatment; applying Ubenimex for non-cancer indications would require separate patents or licensing agreements based on different claims.
Q3: How does this patent influence competitors developing similar immunotherapy agents?
A3: It restricts the use of Ubenimex for cancer therapy within its claims scope but leaves room for alternative compounds or different therapeutic methods.
Q4: What types of cancers are primarily targeted by this patent?
A4: The patent specifies solid tumors, especially gastric, lung, and colorectal cancers.
Q5: Is this patent likely to withstand challenges based on prior art?
A5: Given the focus on specific medical use claims and combination regimens, it is potentially robust, although close scrutiny of prior art regarding Ubenimex’s therapeutic uses could pose challenges.
Sources
- WIPO. "Patent Landscape Report: Immunomodulatory Agents." 2020.
