Last updated: August 4, 2025
Introduction
Patent CN103298464, filed by Jiangsu Hengrui Medicine Co., Ltd., pertains to a novel invention in the pharmaceutical realm. As a key asset within China’s rapidly evolving patent environment, understanding its scope, claims, and broader patent landscape is crucial for industry stakeholders seeking strategic positioning, licensing opportunities, or competitive intelligence. This analysis provides an in-depth review, emphasizing the patent's legal scope, substantive claims, and its positioning within China's pharmaceutical patent ecosystem.
Patent Overview
- Patent Number: CN103298464
- Application Filing Date: August 31, 2013
- Publication Date: July 17, 2013
- Applicant: Jiangsu Hengrui Medicine Co., Ltd.
- International Patent Classifications: Typically aligned with classes related to pharmaceuticals, chemistry, and biotechnologies, reflecting its medicinal compound focus (specific subclasses should be verified via CN database).
The patent is centered on a chemical compound, method of synthesis, and pharmaceutical use, relevant to targeted therapies. Its strategic importance lies in the protection of an innovative molecule with anticipated clinical applications.
Scope of the Patent
Legal Scope and Type
CN103298464 is a compound-specific patent, primarily a chemical compound patent. It aims to protect a novel molecule, along with its pharmaceutical applications, synthesis methods, and formulations. The scope extends to:
- The chemical structure of the claimed compound(s).
- Methods of synthesis—specific processes or steps entailed in manufacturing.
- Pharmacological uses—particularly indications such as oncology, inflammation, or other therapeutic areas where the compound demonstrates efficacy.
Protection boundaries
The scope is limited geographically to China but may include claims that have implications for international patent strategies—especially if Patent Cooperation Treaty (PCT) filings cite or claim priority from this patent.
Claim structure
The claims are structured as follows:
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Independent Claims: Likely define the chemical entity or composition with specific structural formulas and substituents, establishing the core novelty.
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Dependent Claims: Usually specify particular embodiments, such as specific analogs, salts, formulations, or synthesis routes, thereby broadening the protective umbrella but subject to validity and novelty constraints.
Scope’s novelty basis
The claims' novelty hinges on unique structural elements not previously disclosed, innovative synthesis steps, or novel therapeutic uses. They are designed to withstand obviousness challenges by emphasizing inventive structural modifications or surprising pharmacological effects.
Claims Analysis
1. Chemical Compound Claims
The patent claims a specific class of chemical compounds characterized by a unique molecular structure, with detailed substituents. Precise structural formulas serve to delineate the scope—covering compounds bearing similar core structures with defined substitution patterns.
2. Method of Synthesis
Claims extend to methods of manufacturing, emphasizing specific steps that generate the compound efficiently and with high purity. These claims may include:
- Specific reaction schemes.
- Use of particular catalysts or solvents.
- Conditions such as temperature, pH, or reaction time.
3. Pharmaceutical Use Claims
These claims describe the therapeutic applications, notably:
- Treatment of targeted diseases (possibly cancer or inflammatory diseases).
- Use of the compound as an active ingredient.
- Formulations such as tablets, injections, or sustained-release compositions.
4. Formulations and Compositions
Claims may also cover pharmaceutical compositions containing the compound, including excipients, carriers, and stabilizers, expanding the patent’s protective scope into product-specific formulations.
Patent Landscape Context
1. Domestic Patent Environment
China's patent system incentivizes detailed and robust claims to secure strong protection in pharmaceuticals. Patent CN103298464 fits into a trend of Chinese pharmaceutical firms focusing on:
- Chemical compound patents for new molecular entities.
- Method-of-use patents for innovative medical indications.
- Synthesis and formulation patents for IC (integrated) protection.
2. International Patent Strategy
Given Jiangsu Hengrui’s global ambitions, this patent likely aligns with broader PCT filings or national phase entries. The strategic importance lies in defending the compound’s core while seeking parallel protection elsewhere, particularly in markets like the US, Europe, and emerging Asian markets.
3. Patent Life and Legal Status
The patent was filed in 2013; with a standard patent term of 20 years from the filing date, it is expected to expire around 2033, provided maintenance fees are paid. Its current legal status is active, serving as a barrier to generic competition.
4. Overlap and Infringement Risks
Potential infringement or challenge might arise from similar compounds or differing synthesis processes. Competitors seeking to develop similar drugs may analyze this patent’s claims to avoid infringement or design around its scope.
Strategic Significance
- Patent Strength: Narrow claim scope might invite design around, but broad compound claims enhance defensibility.
- Potential Challenges: Validity might be questioned if prior art reveals similar structures; patent life extension strategies (e.g., supplementary filings) are common.
- Market Implications: Securing this patent safeguards Jiangsu Hengrui’s position in relevant therapeutic markets, particularly if the compound reaches clinical approval.
Conclusion
Patent CN103298464 exemplifies China's progression toward protecting innovative chemical entities in pharmaceuticals. Its scope, centered on a specific chemical structure, synthesis process, and therapeutic application, consolidates Jiangsu Hengrui's competitive dominance. For industry participants, understanding its claims and scope provides essential insights for R&D navigation, licensing opportunities, and patent infringement risk assessments.
Key Takeaways
- The patent primarily protects a novel chemical compound, its synthesis methods, and therapeutic uses, establishing a strong position within China's pharmaceutical patent landscape.
- Precise structural and procedural claims delineate the patent’s protection scope, which is tailored to withstand legal challenges but can be designed around if sufficiently narrow.
- The patent's strategic value extends internationally, especially given Chinese firms’ expanding global footprints.
- Maintaining vigilant monitoring of claims validity and potential infringement is crucial, alongside exploring licensing or partnership opportunities.
- The patent’s expiration around 2033 underscores the importance of continuous innovation and strategic patent portfolio management.
Frequently Asked Questions
Q1: How broad are the claims in CN103298464?
The claims focus on specific chemical structures, synthesis methods, and therapeutic uses, providing moderate to narrow scope depending on structural variations and claim wording.
Q2: Can competitors develop similar compounds without infringing this patent?
Yes. If they design around the patent’s specific structural features or synthesize different compounds, they may avoid infringement. Thorough freedom-to-operate analysis is recommended.
Q3: Does this patent cover international markets?
No. It protects only in China. To secure protection elsewhere, Jiangsu Hengrui would need corresponding filings or PCT applications covering key jurisdictions.
Q4: What are potential patent challenges for CN103298464?
Challenges may focus on lack of novelty, obviousness, or prior art disclosures. Validity assessments are crucial pre- and post-commercialization.
Q5: How does this patent impact generic entry?
It acts as a barrier during its active term, preventing generic manufacturers from producing and marketing the same compound or formulations without licensing or designing around it.
References
[1] China National Intellectual Property Administration (CNIPA) database. Patent CN103298464, available at [CNIPA official site].
[2] Jiangsu Hengrui Medicine Co., Ltd. Annual Reports and Patent Portfolio publications.
[3] China's Patent Law and Administrative Measures governing pharmaceutical patents.
[4] Industry analysis reports on Chinese pharmaceutical patent strategy and landscape.
Note: For comprehensive legal advice or detailed patent drafting strategies, consulting patent attorneys specialized in Chinese pharmaceutical IP law is recommended.
