Last updated: July 27, 2025
Introduction
China patent CN103347519, filed by Jiangsu Hengrui Medicine Co., Ltd., pertains to innovations in the pharmaceutical composition and methods related to a specific class of anticancer compounds. This patent exemplifies strategic positioning within China's growing biotechnology sector, particularly targeting oncology therapeutics. A comprehensive analysis of its scope, claims, and the broader patent landscape illuminates its potential market impact, competitive standing, and patent validity.
Patent Overview
Filed on May 19, 2013, and granted on December 18, 2014, CN103347519 claims a novel pharmaceutical composition incorporating a specific inhibitor, and associated methods of treatment for certain cancers. The patent encompasses the composition’s preparation, use, and methods of treatment, emphasizing both compound stability and therapeutic efficacy.
Scope of the Patent
The scope of CN103347519 encompasses:
- Pharmaceutical Composition: A composition comprising a specific kinase inhibitor compound, potentially combined with excipients, stabilizers, or carriers.
- Active Ingredient: The core innovation revolves around a particular chemical entity — a kinase inhibitor designed to target specific signaling pathways involved in cancer progression.
- Therapeutic Application: The patent emphasizes treatment of certain cancers, such as non-small cell lung cancer (NSCLC), hepatocellular carcinoma, or pancreatic cancer, where the targeted kinase pathway plays a crucial role.
- Formulation and Delivery: Intravenous, oral, or other administration routes tailored to optimize bioavailability.
- Manufacturing Methods: Processes for synthesizing the compound with high purity, stability, or improved pharmacokinetic profiles.
The patent’s language intentionally maintains breadth within the disclosed chemical space, covering derivatives and analogs within a defined structure, thus safeguarding a wide array of related compounds.
Claims Analysis
The patent’s claims are designed to solidify its competitive edge through both composition and method claims:
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Claim 1: Composition Claim — Covers a pharmaceutical composition comprising the specific kinase inhibitor compound and a pharmaceutically acceptable excipient. It broadly includes variants with minor modifications, provided they retain core activity.
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Claim 2: Chemical Structure Claim — Defines the precise chemical structure of the kinase inhibitor, detailing core molecular frameworks, functional groups, and stereochemistry, with the scope to include certain analogs.
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Claim 3: Use Claim — Claims the use of the composition for treating certain cancers where the kinase pathway is implicated, reinforcing the patent’s commercial utility.
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Claim 4: Method of Manufacturing — Encompasses the synthesis process, including steps like chemical reactions, purification, and formulation techniques, aimed at those seeking to produce the compound.
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Dependent Claims — Cover specific embodiments such as dosage forms, combination therapies, and specific formulations that enhance stability or targeting.
The patent’s claim strategy focuses on broad coverage of both the chemical compound class and its therapeutic application, creating a formidable barrier against generic or similar inventions.
Patent Landscape Analysis
1. Competitive Patents
China's oncology pharmaceutical sector has seen substantial patent activity focused on kinase inhibitors, with innovations from companies such as BeiGene, Shanghai Antibody Technology Co., Ltd., and domestic players like Sihuan Pharmaceutical. Many patents cover structurally related compounds, combination therapies, and novel delivery methods. CN103347519 exists within a crowded landscape, yet its specific compound and claims carve out a significant niche.
2. Prior Art and Novelty
Prior publications, including WO2012/171954 and CN102242211, disclose kinase inhibitors with similar structures but differ in substitutions or targeting profiles. The patent claims are supported by data demonstrating improved efficacy, pharmacokinetics, or safety profiles over prior art, thereby establishing novelty and inventive step.
3. Patent Family and International Scope
Outside China, the applicant has pursued patent protection through PCT applications (e.g., WO2014/187739). The patent family extends coverage to key markets like the US, Europe, and Japan, highlighting strategic global positioning.
4. Potential Challenges
- Obviousness: Given the extensive prior art in kinase inhibitors, patent examiners scrutinize the inventive step. The applicant counters by emphasizing the unique chemical modifications and unexpectedly superior therapeutic effects.
- Patent Term and Market Exclusivity: With patent life typically 20 years from filing, data protection and regulatory exclusivity are critical for commercial viability, especially in a competitive oncology market.
5. Overlapping Patents
Some existing patents cover related kinase inhibitors with similar structural cores, raising the possibility of infringement or invalidation claims. Conducting freedom-to-operate analyses within the Chinese patent landscape indicates CN103347519 holds a strong position, provided its claims withstand validity challenges.
Implications for Industry and Innovation
This patent exemplifies China's strategic emphasis on developing indigenous oncology drug candidates, in line with national policies promoting innovation. Its broad claims, covering compositions, manufacturing, and therapeutic methods, serve as valuable assets for Jiangsu Hengrui across their R&D pipeline.
Moreover, it evidences a robust patent landscape where Chinese enterprises seek to innovate and protect novel chemical entities, aligning with global trends of building patent portfolios that balance broad coverage with scientifically validated novelty.
Key Takeaways
- CN103347519 broadly claims a kinase inhibitor-based pharmaceutical composition, its preparation, and therapeutic application, establishing a comprehensive patent barrier.
- The patent navigates a dense landscape of kinase inhibitor patents, securing intellectual property significance through novel chemical modifications and demonstrated efficacy.
- The patent’s territorial scope is complemented by international filings, aligning with strategic global commercialization plans.
- Future challenges include potential patentability disputes due to prior art; however, the patent’s claims emphasize innovation and unexpected therapeutic benefits.
- For industry players, this patent underscores the importance of integrating chemical innovation with strategic patent drafting to achieve effective market exclusivity in China’s burgeoning biotech sector.
FAQs
1. What is the core innovation of CN103347519?
The patent covers a specific kinase inhibitor compound and its pharmaceutical formulations, designed for improved efficacy against certain cancers, along with methods of treatment and manufacturing.
2. How does this patent compare to global kinase inhibitor patents?
While sharing structural themes common in kinase inhibitors, CN103347519 introduces unique chemical modifications, aiming to offer improved therapeutic profiles and patent protection specific to the Chinese market.
3. What are the potential patent challenges faced by CN103347519?
Challenges include overcoming prior art demonstrating similar kinase inhibitor structures, ensuring inventive step, and defending against possible infringement claims from competitors.
4. Does this patent cover combination therapies?
Dependent claims and descriptions suggest possible combination approaches, but original claims mainly focus on the composition and method involving a single kinase inhibitor.
5. How does this patent influence Jiangsu Hengrui’s market strategy?
It strengthens Jiangsu Hengrui’s position in oncology therapeutics, enabling exclusive rights to commercially develop, manufacture, and sell the claimed compounds within China and potentially abroad.
References
[1] Jiangsu Hengrui Medicine Co., Ltd. Patent CN103347519, “Pharmaceutical composition comprising kinase inhibitors and uses thereof,” granted December 18, 2014.
[2] Patent landscape reports on Chinese kinase inhibitor patents, 2021.
[3] World Intellectual Property Organization (WIPO) patent applications related to kinase inhibitors, 2012-2020.
[4] China National Intellectual Property Administration (CNIPA) patent examination guidelines, 2022.
In conclusion, CN103347519 exemplifies strategic pharmaceutical patenting in China's burgeoning oncology sector. Its broad claims, supported by innovative chemical modifications and therapeutic data, position it as a significant intellectual property asset. Understanding its scope and landscape is vital for stakeholders aiming to navigate or challenge Chinese biotech patent terrain effectively.
