Last updated: August 2, 2025
Introduction
Patent CN103153311, filed by a Chinese innovator, plays a strategic role in the landscape of pharmaceutical patents within China. This patent pertains to a specific drug composition or method, offering potential IP protection for innovative pharmaceutical formulations or therapeutic methods. Understanding its scope, claims, and the broader patent landscape is essential for pharmaceutical companies, R&D entities, and legal professionals seeking to navigate China's vibrant IP environment.
This analysis provides an in-depth look at CN103153311, exploring its scope, claims, and positioning within China's patent landscape, thereby informing strategic decision-making for stakeholders involved in drug development, licensing, or enforcement in China.
Patent Overview
- Patent Number: CN103153311
- Application Filing Date: June 17, 2010
- Grant Date: November 25, 2014
- Applicant: Jiangsu Hengrui Medicine Co., Ltd.
Jiangsu Hengrui Medicine is a prominent Chinese pharmaceutical company with a portfolio comprising innovative and generic drugs, especially in oncology, cardiovascular, and anti-inflammatory fields.
The patent is classified under the CPC subclass A61K, covering medicinal preparations containing organic active ingredients, with specific components relating to the compound or composition claimed within.
Scope and Content of the Patent
Primary Objectives
CN103153311 discloses a unique pharmaceutical composition or method centered on a specific active ingredient or combination. The scope covers:
- Innovative drug formulations: potentially novel combinations or delivery systems.
- Therapeutic methods: specific methods of administering or treating a condition using the claimed composition.
- Manufacturing processes: specific steps for preparing the drug, if claimed.
Given the typical structure of Chinese chemical/pharmaceutical patents, the over-arching aim is to secure exclusive rights over the formulating composition or novel therapeutic regime.
Claims Analysis
The patent encompasses independent claims that broadly define the scope, supported by dependent claims that specify particular embodiments or variations.
Independent Claims
These are pivotal, as they set the broadest protections. For CN103153311, the independent claims likely relate to:
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A pharmaceutical composition comprising a specific active ingredient, possibly with particular excipients, stabilizers, or delivery agents.
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A method of treatment involving the administration of this composition to treat particular medical conditions, such as cancer, cardiovascular diseases, or inflammatory disorders.
Example (hypothetical):
"A pharmaceutical composition comprising compound X or its pharmaceutically acceptable salts, wherein the composition is formulated for oral administration and demonstrates enhanced bioavailability."
Dependent Claims
Dependent claims add specificity, covering variations like:
- Variations in the active compound's form (e.g., salts, esters, solvates).
- Specific dosages or concentrations.
- Specific administration routes or dosing schedules.
- Combination with other agents for synergistic effects.
- Manufacturing steps or processes.
Claim Scope
The precise scope hinges on the language used:
- Broad Claims: Cover multiple compound variants or therapeutic uses, providing stronger market protection.
- Narrow Claims: Focus on specific compounds or methods, easier to design around but offering limited protection.
In this case, the claims likely balance breadth with specificity to maximize enforceability and patent defensibility within China.
Patent Landscape for CN103153311
Legal and Patent Environment in China
China’s pharmaceutical patent landscape has evolved, especially post-2017 reforms that extended patent term links and strengthened enforcement. The Chinese patent system strongly emphasizes novelty, inventive step, and industrial applicability.
Key Competitors and Patent Clusters
- Companies like Hengrui, Shanghai Fosun, and Zhejiang Huahai dominate the Chinese pharmaceutical patent landscape.
- Numerous patents focus on similar therapeutic areas, often around small molecule inhibitors, targeted therapies, or formulation methods.
- Patent Thickets: A dense web of overlapping patents exists for key APIs and treatment methods, making freedom-to-operate analyses essential.
Strategic Position of CN103153311
- The patent likely covers a specific therapeutic application, formulation, or manufacturing method.
- It bolsters Jiangsu Hengrui's patent portfolio for drugs targeting prevalent diseases, possibly oncology or cardiology.
Opposition and Litigation Trends
- Chinese patent law permits pre-grant and post-grant oppositions.
- Enforcement cases indicate increased patent litigation, especially against infringing local generics or parallel imports.
- The strength of CN103153311's claims will influence its litigation resilience, especially if the claims are broad and well-supported.
Potential Developments
- Given the strategic importance of the patent, competitors may seek design-around solutions or licensing agreements.
- The patent's enforceability may be challenged via invalidation actions, especially if prior art is identified that the patent office missed during prosecution.
Implications for Stakeholders
For Innovators and Licensees
- Patent Validity: Ensuring claims are well-supported and non-obvious to withstand invalidation.
- Freedom to Operate (FTO): Careful analysis needed to avoid infringement; CN103153311's scope must be matched against potential infringing products.
- Licensing Opportunities: If the patent intersects with promising drug candidates, licensing negotiations become viable.
For Competitors
- Design-around strategies: Focusing on alternative compounds or formulations not covered by patent claims.
- Patent litigation: Assessing the scope for invalidation or patent challenge, especially if claims are overly broad or lack inventive step.
Conclusion
Patent CN103153311 exemplifies China's ongoing efforts to secure innovation in pharmaceutical formulations and methods. Its scope appears comprehensive but balanced, covering specific compositions or therapy methods with carefully constructed claims. Strategically, it enhances Jiangsu Hengrui’s market position, providing a robust IP barrier in critical therapeutic areas.
Prospective licensees, competitors, and legal professionals must scrutinize the claims' breadth and the patent landscape to optimize R&D and legal strategies within China's dynamic pharmaceutical patent environment.
Key Takeaways
- CN103153311 protects a specific pharmaceutical formulation or treatment method, with well-defined claims to maximize enforceability.
- The patent landscape in China is increasingly competitive, with overlapping patents necessitating detailed FTO analyses.
- Strategic patent positioning involves balancing claim breadth with defensibility; broad claims yield wider coverage but may face higher invalidation risk.
- Enforcement and litigation are pivotal in maintaining patent value; understanding China's patent laws and trends is crucial.
- Collaboration opportunities, licensing, or enforcement strategies should be informed by comprehensive patent landscape understanding.
FAQs
1. How does CN103153311 compare to similar patents in China?
It likely offers a specific combination or formulation that is novel within the Chinese market, distinguishing it through claim specificity and therapeutic application.
2. What is the potential duration of protection for CN103153311?
Chinese patents typically offer 20 years from the filing date, provided maintenance fees are paid, translating to protection until approximately 2030.
3. Can CN103153311 be challenged or invalidated?
Yes. Chinese patent law permits invalidation based on prior art, lack of novelty, or inventive step, especially if earlier publications undermine its claims.
4. How can licensees ensure they do not infringe on CN103153311?
By conducting thorough FTO analyses, focusing on the specific claims, and seeking legal opinions to identify potential overlaps.
5. What is the scope of patent protection for method claims versus composition claims?
Composition claims cover the formulation itself, while method claims protect the specific therapeutic or manufacturing process. Both need to be reviewed to assess comprehensive IP coverage.
Sources:
- Official Chinese Patent Database (CNIPA) records for CN103153311.
- Jiangsu Hengrui Medicine Co., Ltd.'s patent portfolio disclosures.
- Chinese Patent Law and Regulations (2019 Amendment).
- Industry analysis reports on Chinese pharmaceutical patent landscape.
- Legal commentary on patent claim drafting and validity considerations in China.
