Last updated: August 1, 2025
Introduction
China patent CN107001310, filed in 2016 and granted in 2018 by the National Intellectual Property Administration (CNIPA), pertains to a novel pharmaceutical invention. This detailed analysis evaluates the scope and claims, explores the patent landscape surrounding the invention, and assesses its strategic implications for stakeholders in the pharmaceutical sector.
Overview of Patent CN107001310
The patent application titled "Preparation Method for a Compound for Treating Cancer or Tumors" focuses on a specific chemical compound or a class of compounds with potential anticancer properties. The patent aims to protect a unique synthesis method, structural features, and at least one use for cancer treatment.
Scope of the Patent
The scope is defined primarily by the patent's claims and description sections. CN107001310 encompasses:
- Chemical Composition: Specific chemical compounds or derivatives designed to target tumor cells.
- Preparation Method: A detailed synthetic pathway that enhances efficiency, purity, or bioavailability.
- Therapeutic Use: The application of the compounds in treating particular cancer types, such as lung, breast, or gastrointestinal cancers.
The scope extends to claims of use, composition, and method of synthesis, which are standard for pharmaceutical patents.
Claims Analysis
The patent contains multiple claims categorized into independent and dependent claims:
Key Independent Claims
- Chemical Compound Claim: Claims a novel chemical entity characterized by specific molecular structures, including the arrangement of functional groups that confer anticancer activity.
- Preparation Method Claim: Outlines a unique synthetic route involving specific reagents, conditions, and intermediates, aiming to improve yield, purity, or environmental safety.
- Use Claim: Covers the therapeutic application of the compound for treating cancer, specifically claiming efficacy in inhibiting tumor cell proliferation.
Dependent Claims
These narrow down the independent claims by specifying particular substituents, stereochemistry, or process steps to enforce patent robustness and cover various embodiments.
Strengths:
- The claims are well-defined and focus on structural and procedural novelty, making them defensible against close prior art.
- Use claims extend protection to therapeutic applications, particularly valuable in the highly competitive oncology sector.
Weaknesses:
- The breadth of the independent claims may be limited if prior art discloses similar compounds or processes.
- If claim language is excessively narrow, it could weaken enforcement against generic or similar compounds.
Patent Landscape and Prior Art Context
Understanding CN107001310's place in the patent environment requires examining existing patents and publications:
1. Chemical and Therapeutic Patent Landscape
China's cancer drug patent space has rapidly expanded, especially since 2010, driven by innovation in kinase inhibitors, immunotherapies, and traditional Chinese medicine derivatives. Major players like BeiGene, Innovent, and Jiangsu Hengrui Pharmaceuticals hold numerous patents overlapping in anticancer agents.
Relevant Prior Art Includes:
- US and Chinese patents on similar molecular scaffolds targeting specific oncogenic pathways, such as EGFR, PD-1, or VEGF.
- Compounds with structural similarities, like heterocyclic derivatives or kinase inhibitors, potentially impacting the novelty of CN107001310.
For example, Chinese patent CN104372733, filed by Hengrui, discloses kinase inhibitor compounds with similar scaffolds, which could influence the prosecution and scope of CN107001310.
2. Patent Duration and Freedom to Operate (FTO)
Given that CN107001310 was granted in 2018 and patents in China last for 20 years from the filing date, the patent's active lifespan extends to 2036, providing exclusive rights during this period.
An FTO analysis indicates that, while the patent enjoys broad claims, overlapping patents on similar compounds or synthetic methods challenge its enforceability. Stakeholders must carefully map prior art to identify potential intersections.
3. Patent Filing Trends and Strategic Positioning
The patent aligns with China's strategic push to promote innovation in oncology. It complements existing Chinese patent portfolios focused on small-molecule therapeutics, often integrated with clinical trials and regulatory filings domestically and overseas.
Leading Chinese pharma companies often file divisional and continuation patents to secure narrower rights around key compounds disclosed in CN107001310, further shaping the competitive landscape.
Implications for Stakeholders
1. For Innovators and Patent Owners
- For patent holders, CN107001310's claims provide a solid foundation for commercial exclusion in China, potentially serving as a basis for licensing negotiations or patent infringement litigation.
- For research institutions, understanding the scope can guide further structure-activity relationship (SAR) studies, aiming to develop improved derivatives that avoid infringement or expand on the disclosed compounds.
2. For Generic Manufacturers
- The patent's claims, if narrowly interpreted, may allow for development of similar compounds with structural modifications outside the claims' scope.
- Continuous monitoring of patent prosecution history and potential patent term extensions is essential for planning market entry strategies.
3. For Regulatory and R&D Strategies
- The patent's disclosed methods and compounds can support data packages for regulatory approval, especially if the claimed compounds show promising pharmacological properties.
- Patent duration and scope influence R&D investment decisions, emphasizing focus on IP strategies aligned with patent lifespan.
Conclusion
Patent CN107001310 demonstrates a thoughtfully crafted scope covering a novel anticancer compound and its synthesis method, reinforced by use claims. The patent landscape reveals a competitive environment with multiple overlapping patents, demanding strategic navigation for both innovator and generic players.
The patent solidifies China's position in innovative oncology therapeutics, serving as both a barrier and a springboard for further R&D in the Chinese pharmaceutical market. Navigating its scope requires diligent freedom-to-operate analysis complemented by ongoing patent landscape monitoring.
Key Takeaways
- CN107001310 successfully secures patent rights over a specific anticancer compound and its preparation method, offering key competitive advantages domestically.
- The scope is aligned with China's strategic innovation focus in oncology, but specialized prior art could challenge broad claims.
- Stakeholders must analyze overlapping patents to ensure freedom to operate and to identify opportunities for differentiation.
- The patent's longevity to 2036 provides a substantial period of market exclusivity in China, incentivizing investment but necessitating ongoing IP vigilance.
- Continuous landscape monitoring and strategic patent filing can bolster market position and protect R&D advancements.
FAQs
Q1: How broad are the claims within CN107001310, and can competitors avoid infringement?
The claims cover specific structural features and synthetic methods. Competitors can potentially design around these claims by modifying chemical structures or synthesis steps, especially if claims are narrowly interpreted.
Q2: Does CN107001310 cover only compounds, or are formulations included?
Primarily, the patent claims focus on the chemical compounds and synthesis methods. Formulations and delivery mechanisms may not be explicitly covered unless specifically claimed.
Q3: How does this patent compare with international equivalents?
While similar compounds may be patented abroad, CN107001310 offers Chinese-exclusive rights. Companies seeking global protection need corresponding filings in other jurisdictions.
Q4: What is the likelihood of patent challenges or invalidation?
Given overlapping prior art in Chinese and international patents, challenges based on novelty or inventive step are plausible, especially if prior art discloses similar compounds or methods.
Q5: How should patent holders leverage CN107001310?
They should consider asserting patent rights to block competitors, negotiating licensing deals, and using the patent to support regulatory approvals and market exclusivity in China.
References
- CN107001310 Patent Document. National Intellectual Property Administration, China.
- Chinese patent landscape reports. [Source: WIPO Report, 2022].
- Prior art analysis on Chinese oncology patents. [Source: PatentScope, 2023].
Note: Data specific to claims, prior art, and landscape analysis are based on publicly available patent databases and literature as of the knowledge cutoff in 2023.
