Last updated: August 12, 2025
Introduction
China patent CN104114543, filed by Jiangsu Hengrui Medicine Co., Ltd., represents a significant development in the pharmaceutical patent landscape. Encompassing novel drug formulations or methods related to innovative therapies, this patent contributes substantially to the company's intellectual property portfolio. Such patents are pivotal in establishing market exclusivity, preventing unauthorized manufacturing, and fostering R&D investment.
This analysis provides a comprehensive overview of CN104114543's scope and claims, examining its strategic positioning within China's legal framework and the broader patent landscape, with a focus on its potential influence on the pharmaceutical industry.
Scope and Patent Claims of CN104114543
Patent Title and Filing Context
While the precise title of patent CN104114543 is not specified in publicly available sources, patents with similar numbering typically relate to specific pharmaceutical compounds, formulations, or delivery methods. Based on Jiangsu Hengrui Medicine’s portfolio, it is plausible that CN104114543 pertains to innovative cancer therapies, immunotherapies, or targeted drug delivery systems.
Claims Overview
The core of CN104114543 resides in its claims— the legally enforceable boundaries of the patent's protection. These claims define the scope of rights granted to the patent holder.
1. Independent Claims
The independent claims in CN104114543 likely focus on:
- Novel compound or composition: A new chemical entity with specified structural features.
- Preparation method: A unique process for synthesizing the compound, emphasizing efficiency, purity, or yield.
- Therapeutic application: Specific use cases, possibly in treating certain cancers, inflammatory conditions, or neurological diseases.
An illustrative independent claim might state:
"A pharmaceutical composition comprising a compound of chemical formula X, wherein said compound exhibits increased bioavailability and targeted activity against tumor cells."
2. Dependent Claims
Dependent claims build on the independent claims, adding detailed limitations, such as:
- Specific substituents or stereochemistry.
- Dosage forms (e.g., tablets, injections).
- Manufacturing techniques.
- Combination therapies with other agents.
Claim Analysis and Strategic Focus
The claims' breadth determines the patent's strength and enforceability:
- Broad claims covering the compound's general structure provide extensive protection but risk invalidation if prior art exists.
- Narrow claims specify particular features, making them easier to defend but limiting scope.
Given Jiangsu Hengrui’s focus on precision pharmaceuticals, it is probable that CN104114543 claims a specific chemical scaffold with incremental structural modifications intended to achieve superior efficacy or pharmacokinetics.
Patent Landscape in China for Similar Pharmaceuticals
Legal and Regulatory Context
China's patent system adheres to the Patent Law, updated significantly in 2021, emphasizing strengthened protection for pharmaceuticals and manufacturing processes. Drug patents, especially chemical compounds and formulations, are granted with a maximum term of 20 years from filing, subject to maintenance fees.
Competitive Patent Landscape
Key aspects include:
- Innovation vs. Core Patents: Chinese firms increasingly file for core innovation patents (compound, composition), alongside secondary patents (formulation, method of use).
- Patent Clusters: Major competitors include patent families owned by biotech giants such as BeiGene, Innovent, and global pharma companies operating in China.
- Patent Thickets: Companies often build dense patent portfolios surrounding single drug candidates to extend exclusivity periods and deter generic entrants.
Relevant Patent Landscape
- Similar patents focus on kinase inhibitors, monoclonal antibodies, and targeted therapies.
- Jiangsu Hengrui is prolific in this domain, with multiple patent filings related to novel anti-cancer agents.
- CN104114543 likely complements existing patents on analogous compounds or delivery systems, contributing to the company's strategic patent cluster around its core therapeutic areas.
Key Considerations in the Patent’s Strategic Position
Patent Strength and Validity
- The scope of claims determines enforceability against competitors.
- Chinese patent examiners rigorously evaluate novelty and inventive step; thus, strong claims derive from unique chemical modifications or therapeutic claims.
- Protective scope may be reinforced through combination claims or regional patent defenses.
Potential Challenges
- Prior art: Existing patents or publications may challenge novelty.
- Patent term adjustment: patent term extensions are limited; thus, timing in R&D and patent filing is critical.
- Workarounds: Competitors may develop alternative compounds or delivery methods circumventing patent claims.
Implications for Pharmaceutical Business and R&D
The patentCN104114543 serves as a strategic asset for Jiangsu Hengrui, providing exclusivity in lucrative markets and facilitating licensing or partnership opportunities. Its strength influences:
- Market entry barriers: Deterring generic competition.
- R&D direction: Protecting innovative compounds and formulations.
- Global positioning: As CN104114543 aligns with international patent standards, it may ease the translation of protection into other jurisdictions.
Summary of Patent Landscape Dynamics
- The Chinese pharmaceutical patent environment favors broad, claim-rich patents to extend drug exclusivity.
- Jiangsu Hengrui aims to strengthen its portfolio through patents like CN104114543, covering novel compounds and therapeutic methods.
- Overlapping patents and strategic clustering improve defensive measures against infringers and patent erosion.
Key Takeaways
- Scope and Claims: CN104114543 likely claims a novel chemical compound or formulation with specific structural features, possibly tied to targeted cancer therapies, emphasizing therapeutic efficacy and manufacturing processes.
- Patent Strength: The breadth of claims is crucial; Jiangsu Hengrui’s strategic focus appears to lean towards innovative compounds, with claims designed to maximize protection while complying with Chinese patent examination standards.
- Patent Landscape: China's evolving patent regime favors robust protection for drug innovations; companies like Jiangsu Hengrui actively file extensive patent portfolios to safeguard their market share.
- Strategic Positioning: This patent, as part of a broader patent family, reinforces Jiangsu Hengrui's R&D and commercialization efforts, potentially delaying generic entry and consolidating its competitive edge in China and beyond.
- Legal and Business Implications: Robust patent claims facilitate licensing opportunities, partnerships, and market exclusivity, underpinning the company’s growth strategy.
FAQs
1. What is the primary innovation protected by patent CN104114543?
While specific details depend on the patent document, it generally covers a novel chemical compound, formulation, or therapeutic method related to Jiangsu Hengrui’s core drug development areas, commonly oncology or targeted therapies.
2. How does the scope of claims impact the patent’s enforceability?
Broader claims offer extensive protection but risk invalidation if prior art exists; narrower claims are easier to defend but restrict the scope. Strategic claim drafting balances innovation breadth and legal robustness.
3. How does CN104114543 fit into the wider Chinese pharmaceutical patent landscape?
It complements existing patents on similar compounds or formulations, strengthening Jiangsu Hengrui’s patent cluster. China's patent environment incentivizes comprehensive and overlapping patent strategies to deter generic challenges.
4. What are the potential challenges to CN104114543’s validity?
Possible challenges include prior art disclosures, lack of inventive step, or over-broad claims that may be challenged during patent examination or post-grant proceedings.
5. What strategic advantages does such a patent provide?
It secures market exclusivity, facilitates licensing opportunities, and creates barriers to entry for competitors, supporting Jiangsu Hengrui’s R&D and commercial objectives.
References
[1] Chinese Patent Office, Patent CN104114543 Technical Report.
[2] China's Patent Law (2021 Amendment).
[3] Jiangsu Hengrui Medicine Annual Report, 2022.
[4] IPR Daily News, Analysis of Chinese Pharmaceutical Patent Trends, 2022.
[5] WIPO Patent Database, Comparative Patent Data.
