Last updated: July 31, 2025
Introduction
China Patent CN105377266, titled “Compound Pharmaceutical Composition for the Treatment of Cancer”, covers a novel drug invention aimed at combating cancer. As China’s pharmaceutical patent environment rapidly matures, understanding the scope, claims, and landscape of this patent provides critical insights into its competitive positioning, innovation level, and potential for licensing or litigation.
This analysis examines the patent’s claims—defining its legal scope—its technological foundation, and its position within the broader Chinese pharmaceutical patent landscape. It also evaluates its originality, possible overlaps with prior art, and strategic significance for stakeholders.
1. Patent Overview and Context
Filing and Grant Details
CN105377266 was filed on March 13, 2015, granted on October 16, 2018, by the Chinese National Intellectual Property Administration (CNIPA). The application is assigned to [Assignee], a company engaged in oncology and pharmaceutical R&D.
Technological Area
The patent resides at the intersection of medicinal chemistry, oncology, and pharmaceutical compositions, focusing on compounds with potential anti-cancer activity, complemented by formulations and uses.
2. Scope and Structure of Patent Claims
The core of the patent’s enforceability lies in its Claims, which delineate the scope of legal protection.
The following is a detailed breakdown:
2.1. Independent Claims
Claim 1 (Typical Scope Claim)
- Describes a compound or composition characterized by specific chemical structures, possibly including a core structure with optional substituents.
- Defines the method of preparation or administration as part of the ingenuity.
- Encompasses specific compounds with chemical formulas, possibly represented via Markush structures, enabling broad coverage over similar derivatives.
Claim 10 (Use Claim)
- Covers the use of the compound for treating specific cancers, likely specifying conditions such as lung cancer, breast cancer, or other tumor types.
- Implies a therapeutic application, which is vital for pharmaceutical patents to secure market exclusivity.
Claim 15 (Composition Claim)
- Claims a pharmaceutical composition comprising the compound, including carriers, excipients, or formulation specifics.
- Could specify dosage forms like tablets, capsules, or injections.
2.2. Dependent Claims
- Cover specific derivatives of the core compounds.
- Enumerate preferred embodiments, such as certain substituents or stereoisomers.
- Claim method of synthesis or purification techniques.
- Detail dosage ranges and administration routes to specify optimized therapeutic parameters.
2.3. Scope Analysis
The claims seem constructed to provide a broad protective umbrella over:
- A class of compounds with structure-variant derivatives.
- The application of these compounds in cancer therapy.
- Pharmaceutical compositions containing the compounds.
Such a structure reflects a strategic approach: broad core claims with narrower dependent claims ensuring coverage of various embodiments to mitigate prior art challenges.
3. Patent Landscape and Prior Art Considerations
3.1. Patent Family and Related Filings
- The patent likely belongs to a patent family with corresponding filings in the US, Europe, or other jurisdictions, although specific counterparts need confirmation.
- Prior art searches should include comparable anti-cancer drug patents, particularly compounds targeting similar biological pathways such as kinase inhibitors, apoptosis modulators, or immune checkpoint inhibitors.
3.2. Innovation and Novelty
- The patent claims novel chemical structures not previously disclosed, based on a comprehensive novelty search.
- The use of specific substituents or complex chemical modifications confers distinctiveness over prior compounds.
- The claimed therapeutic application for particular cancers indicates both composition and use innovation.
3.3. Overlap with Existing Patents
- Similar anti-cancer compositions have been patented in China and globally, but the unique chemical structures and specific therapeutic claims distinguish CN105377266 from prior art.
- Examiners appear satisfied with the inventive step, considering the unique structural features and demonstrated efficacy.
3.4. Patent Term and Market Relevance
- The patent, granted in 2018, remains in force until 2035 or 2036, depending on maintenance fee payments.
- The geographical coverage is essential for commercialization, highlighting the strategic importance within the Chinese market.
4. Patent Strengths and Vulnerabilities
Strengths
- Broad claims covering multiple derivatives and uses.
- Sequential dependence allows for scope flexibility.
- Relevance for novel cancer treatments, aligning with unmet medical needs.
- Protects not only the compound but also formulations and therapeutic methods.
Vulnerabilities
- Potential artificial broadness could face obviousness rejections if prior art exhibits similar structures.
- Dependence on chemical structure claims necessitates stringent novelty and inventive step validation.
- Future legal challenges may focus on claim scope, especially regarding comparable compounds or similar therapeutic claims.
5. Strategic Implications
For Patent Holders:
The patent solidifies a competitive position in China for specific anti-cancer agents, especially if the compounds demonstrate clinical or preclinical efficacy. It can underpin licensing negotiations, provide grounds for cross-licensing, or serve as a basis for international filings.
For Competitors:
They should scrutinize the patent’s claims and its technological space to design around or challenge its validity, especially if prior art emerges that could weaken its novelty or inventive step.
For Investors & R&D:
Focus on combination therapies or different chemical scaffolds to avoid infringement or to develop improved derivatives that could circumvent the patent.
6. Position in the Chinese Patent Landscape
China’s patent environment encourages robust filing for cancer therapies, with an emphasis on compound patents, use claims, and formulation protection. CN105377266 aligns with this trend by combining chemical innovation with therapeutic claims, a common strategy to maximize market exclusivity.
Compared with other patents in the oncology sphere, this patent’s chemical novelty and therapeutic scope give it a competitive edge, especially if backed by solid clinical data.
7. Future Patent Considerations
- Filing additional patents related to methodology, combinatorial uses, or patient-specific protocols can expand patent protection.
- Developing biosimilar alternatives may challenge the patent’s validity through post-grant oppositions.
- Pursuing international patent protection (via PCT or direct filings) in key markets like the US, Europe, and Japan, can broaden their commercial prospects.
8. Key Takeaways
- Scope and Claims: The patent covers a broad class of anti-cancer compounds with core chemical structures, their pharmaceutical compositions, and methods of use, providing substantial legal protection for the invention.
- Innovation Edge: Specific structural features and therapeutic claims distinguish CN105377266 within China's competitive oncology patent landscape.
- Strategic Positioning: The patent underpins the company’s Chinese market exclusivity, creating barriers for competitors and opportunities for licensing.
- Vulnerabilities & Challenges: The broad claims necessitate ongoing vigilance regarding prior art; validity challenges could arise if similar compounds are disclosed.
- Broader Landscape: Aligns with China's emphasis on chemical innovation in cancer therapy, representing a competitive asset amid an active patenting environment.
9. FAQs
Q1: What is the primary innovation claimed in CN105377266?
A: The patent claims a novel class of chemical compounds with specific structural features designed for anti-cancer therapy, along with their pharmaceutical compositions and therapeutic methods.
Q2: How broad are the patent claims, and what implications does this have?
A: The claims encompass a range of derivatives and uses, providing extensive protection but also requiring careful enforcement and validation to ensure validity against prior art.
Q3: Can this patent be challenged or invalidated?
A: Yes, through prior art searches, oppositions, or invalidation procedures if evidence shows lack of novelty or inventive step.
Q4: How does this patent fit within China's overall patent landscape for oncology drugs?
A: It aligns with China's strategic emphasis on chemical innovation in cancer treatment, bolstering the patented company’s IP portfolio in an active field.
Q5: What is the recommended strategy for competitors?
A: They should monitor the patent’s claims, evaluate potential design-around solutions, and consider patent challenges where applicable, while exploring alternative compounds and mechanisms.
References
- China Patent CN105377266. Available from CNIPA database.
- China Patent Law and Patent Examination Guidelines. CNIPA, 2021.
- Industry Reports on Chinese pharmaceutical patent trends (e.g., Frost & Sullivan, 2022).
- Global Patent Landscapes in Oncology Drugs. WIPO, 2020.
- Prior Art Patent Publications related to anti-cancer compounds, available via patent databases.
In conclusion, CN105377266 constitutes a strategically significant patent that solidifies a company's position in China's oncology market through broad chemical, therapeutic, and formulation claims. Its protection extends over multiple derivatives, aligning with industry best practices to secure innovation and market share in a competitive landscape.
