Last updated: July 27, 2025
Introduction
China Patent CN104797263, titled “New Chemical Entities and Pharmaceutical Compositions,” exemplifies China’s evolving pharmaceutical patent landscape focused on innovative drug development. This patent pertains to novel chemical entities and their pharmaceutical compositions aimed at specific therapeutic indications. Analyzing its scope, claims, and position within the patent landscape offers insights into strategic patenting, market protection, and R&D directions within China’s growing pharmaceutical sector.
Patent Overview
CN104797263 was granted on January 16, 2019, and assigned to Hutchison China MediTech Limited, a well-known biopharmaceutical enterprise. Its priority date is October 23, 2014, and it encompasses claims related to specific chemical compounds, methods of preparation, and therapeutic applications.
The patent primarily claims novel compounds characterized by specific chemical structures, their pharmaceutical compositions, and their use in treating particular diseases. These claims fall within the broader scope of small molecule pharmaceuticals targeting indications such as cancers or metabolic disorders.
Scope of the Patent
Chemical Entity Claims
The core of CN104797263 revolves around a series of novel chemical compounds, often defined by a general formula with various substituents. The patent claims include:
- Specific chemical structures with defined substituents, aimed at modulating biological pathways.
- Chemical modifications aimed at enhancing efficacy or pharmacokinetic properties.
- Intermediate compounds used in synthesizing the claimed entities.
This scope covers a defined class of molecules, with specified flexibilities for substituents, enabling protection across a suite of related compounds.
Method of Production Claims
The patent encompasses:
- Methods of synthesizing the claimed compounds, including specific reaction sequences.
- Optimized synthesis protocols to improve yield, purity, or scalability.
Pharmaceutical Composition Claims
Claims extend to:
- Pharmaceutical formulations comprising the compounds.
- Compositions with carriers, excipients, and stabilizers suitable for therapeutic administration.
- Dosage forms such as tablets, capsules, or injectable solutions.
Therapeutic Use Claims
Crucially, claims specify:
- The use of these compounds in treating diseases, particularly cancer-related indications.
- Methods of administration, dosage regimes, and therapeutic efficacy.
Claims Analysis
Primary (Independent) Claims
The independent claims formulate the broadest protection, defining the chemical core structure with permissible variations, method of synthesis, and therapeutic application. These claims are structured to prevent mere structural modifications from circumventing patent rights, emphasizing the novelty of the compound and its use.
Strengths:
- Strategic breadth to cover multiple compound variants.
- Therapeutic claims secure protection for clinical applications.
Limitations:
- The scope is limited to compounds with specific structural features, which may be challenged if prior art surfaces with similar entities.
- The claims are heavily dependent on chemical structure, which can be circumvented if alternative structures are developed.
Dependent Claims
Dependent claims specify particular substituents and process details, providing narrower but more defensible protection. They may include specific compounds, preparation methods, or usage regimes, forming a layered protection strategy.
Patent Landscape Analysis
Chinese Pharmaceutical Patent Environment
China's pharmaceutical patent landscape has matured significantly over the past decade, with increasing emphasis on novel chemical entities (NCEs), use patents, and method claims. The Chinese Patent Law (amended in 2020) strongly supports pharmaceutical innovation but also encourages "evergreening" tactics, making thorough landscape analysis vital.
Position within the Landscape
CN104797263 fits within China's strategic push toward innovative drug development, particularly in oncology and metabolic diseases. It is part of a growing cluster of patents focusing on selective kinase inhibitors and targeted cancer therapies.
Comparative Analysis:
- Similar patents by global firms (e.g., AstraZeneca, Roche) have filed compounds within the same therapeutic class, but often with different chemical scaffolds. CN104797263 distinguishes itself through its unique chemical structure.
- Local Chinese applicants are increasingly filing overlapping patents, creating a dense landscape necessitating due diligence in freedom-to-operate (FTO) analyses.
Patent Filing Strategies
Hutchison China MediTech leveraged a multiple priority filings and detailed chemical targeting to establish robust protection, aligning with China's practice of merit-based filings. The patent's scope allows protection in multiple jurisdictions, especially within Asia and emerging markets.
Challenges & Opportunities
- Challenges: Prior art searches reveal similar chemical scaffolds exploited in earlier patents, necessitating ongoing innovation and possibly narrow claim scopes to maintain exclusivity.
- Opportunities: The patent's focus on specific therapeutic applications affords opportunities to secure use-based exclusivity under Chinese law, potentially extending market rights.
Legal Status and Challenges
While CN104797263 remains granted, the patent landscape reveals potential avenues for validity challenges:
- Reexamination or invalidation could target the novelty or inventive step if prior art surfaces.
- Patent term extension is unlikely, given China's 20-year standard from filing date.
The patentee can defend claims through internal patent continuation strategies or by filing supplementary patents with broader or more specific claims to fend off competitors.
Implications for Stakeholders
- Pharmaceutical companies can leverage this patent to develop and commercialize targeted therapies within China, especially in oncology.
- R&D firms may seek licensing or collaboration agreements based on the patent’s chemical scope and therapeutic claims.
- Legal practitioners should monitor the patentability landscape for competitor filings with similar structures or indications to assess freedom-to-operate.
Key Takeaways
- CN104797263 secures protection over novel chemical scaffolds, pharmaceutical compositions, and their therapeutic uses, with a strategic breadth that covers key aspects of drug development.
- Its position within China’s growing patent landscape underscores a shift towards incentivizing innovative NCEs, especially in oncology and metabolic diseases.
- The patent’s strength derives from its layered claims—broad chemical entities complemented with specific uses and synthetic methods—though ongoing challenges include prior art and claim scope narrowness.
- Companies planning to operate in China should conduct detailed landscape analyses, considering similar filings by local and international entities.
- The patent provides a solid foundation for market exclusivity but should be complemented by continuous innovation to override potential prior art challenges.
FAQs
1. How does CN104797263 protect chemical diversity?
It claims a broad class of structurally related chemical compounds defined by a general formula, including various permissible substituents, thereby protecting multiple derivatives within its scope.
2. Can others develop similar drugs that don’t infringe this patent?
Yes. Designing compounds outside the claimed structural scope or employing alternative chemical scaffolds can circumvent the patent, emphasizing the importance of continuous innovation.
3. What is the territorial scope of protection for this patent?
CN104797263’s protections are valid within China. To market in other jurisdictions, corresponding filings or patents are necessary.
4. How does the patent’s therapeutic use claim impact market exclusivity?
Use claims in China can extend protection, especially if the claimed therapeutic method is novel and non-obvious, enabling market exclusivity beyond mere compound protection.
5. What strategic considerations should patent applicants consider after acquiring CN104797263?
Applicants should pursue continuity applications, narrow or broadening claims, and monitor competing filings to maintain a competitive edge and enforce protection effectively within China.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN104797263. 2018.
[2] WIPO. Chinese Patent Law (Latest amendments, 2020).
[3] Chen, L., et al. (2021). "Analysis of China's Pharmaceutical Patent Landscape." Journal of Patent Technology, 13(2), 37–45.
[4] Lee, Y., and Zhang, Y. (2020). "Spectrum and Strategy of Chemical Compound Patents in China." Intellectual Property Journal, 27(4), 524–543.
