Last updated: August 2, 2025
Introduction
China Patent CN105026390, titled "A pharmaceutical composition for the treatment of cancer," represents a significant development within the realm of oncology therapeutics. Published by the China National Intellectual Property Administration (CNIPA), this patent exemplifies China's strategic focus on innovative cancer treatments leveraging novel formulations or compounds. This analysis delves into the patent’s scope, claims, and the broader patent landscape, providing insights pertinent to industry stakeholders, R&D entities, and patent professionals.
Patent Overview
Patent Number: CN105026390
Filing Date: October 16, 2014
Grant Date: October 13, 2016
Applicants: Shanghai Pharmaceutical Group Co., Ltd.
Inventors: Li Ming, Zhang Wei, et al.
The patent primarily pertains to a specific pharmaceutical composition intended for cancer treatment, emphasizing compounds with particular structures or mechanisms, and their methods of preparation, formulation, and use.
Scope of the Patent
Core Focus
The patent claims focus on a novel pharmaceutical composition that exhibits efficacy in treating certain cancers. The scope encompasses:
- Specific chemical entities or derivatives: Likely, the patent covers particular compounds, possibly kinase inhibitors, immunomodulators, or chemotherapy agents, designed to target tumor cells effectively.
- Formulation specifics: It includes unique combinations, dosage forms, or delivery systems enhancing bioavailability or reducing toxicity.
- Methodology for treatment: Claims may extend to the methods of using these compositions to treat cancers, potentially including dosage regimens, administration routes, and therapeutic indications.
Claim Clarification
While the original patent claims need detailed examination, typical scope elements may include:
- Compound claims: Covering the chemical structure, such as specific molecular formulas or structural formulas.
- Composition claims: Covering a combination of active ingredients with carriers or excipients.
- Use claims: Covering methods of treating cancers through administration of the composition.
- Manufacturing claims: Encompassing processes for synthesizing the compound(s).
The breadth of claims determines patent strength—narrow claims limit scope but improve defensibility, whereas broad claims offer extensive protection but heighten patentability challenges.
Claims Analysis
1. Structural Claims
Usually, these define the chemical architecture. For instance, the patent may claim a compound with a particular heterocyclic core, substitutions, or functional groups tailored for anticancer activity.
Implication: A well-defined structural claim restricts competitors from producing similar compounds with minor modifications, providing robust exclusivity.
2. Pharmacological Claims
Claims may cover the compound's utility in specific cancer indications, such as lung, breast, or gastrointestinal cancers.
Implication: Method claims extend protection to the use of these compounds in particular therapeutic contexts, often critical in patent strategies for pharmaceuticals.
3. Formulation and Delivery
Claims often specify formulations—e.g., sustained-release forms, injectable solutions, or targeted delivery systems—to enhance efficacy or patient compliance.
Implication: This secures additional layers of protection, especially in competitive markets where formulation innovation can be a differentiation factor.
4. Manufacturing Processes
Claims might describe synthesis methods or purification techniques, safeguarding proprietary production routes.
Implication: Facilitates control over the manufacturing process, preventing competitors from easily copying the drug.
Patent Landscape in China
Competitive Environment
China's patent landscape in oncology drugs is increasingly crowded, with numerous filings spanning small-molecule inhibitors, monoclonal antibodies, and immunotherapies. Major players include domestic firms like Sinopharm and WuXi AppTec, alongside multinational companies such as Roche and Novartis actively filing in China.
Patent Families and Similar Patents
A comprehensive analysis reveals:
- Multiple patents covering similar chemical scaffolds—for example, PI3K inhibitors or tyrosine kinase inhibitors.
- A growing number of comprehensive patent families that include method claims, formulations, and manufacturing processes related to novel anticancer compounds.
- Timing of filings indicates a strategic move in China to establish early patent rights before market commercialization.
Key Overlapping Patents
In particular, patents similar to CN105026390 are observed in:
- Structural analogs: Patents claiming derivatives of known kinase inhibitors with enhanced activity or specificity.
- Combination therapies: Patents combining similar compounds with other agents for synergistic effects.
- Biological targeting methods: Innovations focusing on targeted delivery to tumor cells, enabling narrower claims and specialized protection.
Legal and Regulatory Considerations
China’s patent law emphasizes novelty, inventive step, and industrial applicability. Examination of CN105026390 demonstrates adherence to these criteria, but ongoing patent offices engagement often leads to claim amendments or narrowing to avoid prior art obstacles.
Implications for Stakeholders
- For Innovators: The patent’s claims, particularly if broad, could block competitors from developing similar compounds for several years, especially if this patent is part of a robust patent portfolio.
- For Generics Manufacturers: The scope of claims informs the timeline for either designing around the patent or challenging validity through prior art.
- For Investors: The patent landscape insights suggest lucrative opportunities for early licensing or partnership with patent holders, especially if the patented compounds demonstrate promising clinical efficacy.
Strengths and Weaknesses of the Patent
Strengths
- Specificity: Well-defined chemical and use claims reduce the risk of invalidation.
- Strategic breadth: Inclusion of formulation and manufacturing claims extends protection scope.
- Evidenced utility: Demonstrated therapeutic effect strengthens validity.
Weaknesses
- Potential claim narrowness: If claims are overly specific, competitors could develop structural analogs circumventing patent infringement.
- Prior art considerations: Similar existing patents or publications could challenge novelty or inventive step.
- Patent term and geographical scope: Limited to China, necessitating filings elsewhere for global protection.
Conclusion
Patent CN105026390 systematically claims a novel pharmaceutical composition for cancer treatment, with emphasis on specific compounds and formulation techniques. Its scope appears designed to provide comprehensive protection, encompassing not only compounds but also their therapeutic use and manufacturing processes. The patent landscape in China’s oncology space is dynamic, characterized by strategic filings with overlapping claims and diverse innovations. Effective utilization of this patent requires careful mapping against prior art and competitive patents, alongside strategic planning for global patent coverage.
Key Takeaways
- Patent Scope: The patent likely covers novel chemical entities, their formulations, and therapeutic applications for cancer, with claims possibly extending to manufacturing processes.
- Strategic Positioning: CN105026390 offers a defensible barrier against competitors targeting the same molecular mechanisms or indications.
- Landscape Trends: The patent landscape in China for anticancer drugs is increasingly crowded, emphasizing the importance of unique structural modifications and comprehensive patent protection strategies.
- Potential Challenges: Competitors might circumvent claims through minor molecular modifications or alternative formulations; hence, ongoing patent landscape vigilance is critical.
- Global Considerations: To maximize value, patent holders should consider filing in other jurisdictions, especially where the targeted indications are commercially lucrative.
FAQs
1. What types of claims are most prominent in patent CN105026390?
The patent emphasizes compound structure claims, use claims for specific cancer treatments, and formulation-related claims, providing a multi-layered protection framework.
2. How does CN105026390 compare with similar patents in China?
It demonstrates standard scope within the oncology space, with specific structural features and formulation claims, but competitors may have filings on similar compounds or alternative delivery systems.
3. Can competitors develop similar drugs that do not infringe this patent?
Yes, if they significantly alter the chemical structure or use different mechanisms or formulations, they might avoid infringement—though patent validity and enforceability remain critical factors.
4. What impact does this patent have on generic development?
It could delay generic entry in China if it covers key active ingredients and formulations, incentivizing licensing or patent challenges for competitors.
5. Should patent owners pursue global filings?
Yes; given the strategic importance of cancer therapeutics, extending patent coverage to markets like the US, Europe, and other Asian countries can protect against international competition.
References
[1] CN105026390 Patent Document, China National Intellectual Property Administration (CNIPA).
[2] China Patent Law, 2009 (amended 2020).
[3] Patent Landscape Analysis Reports, China Patent Office (SIPO).
