Last updated: September 18, 2025
Introduction
China patent CN101228135, filed by Jiangsu Hengrui Medicine Co., Ltd., pertains to innovations in pharmaceutical formulations and processes, specifically targeting an aspect of drug delivery or composition. As part of the broader landscape of pharmaceutical patents in China, this patent reflects strategic efforts by Chinese biotech firms to secure intellectual property exclusivity over innovative drug formulations and manufacturing methods. This analysis endeavors to dissect the scope and claims of CN101228135, contextualize its position within China's patent landscape, and elucidate implications for industry stakeholders and research entities.
Patent Overview and Context
Filed in 2009 and granted in 2010, CN101228135 embodies Jiangsu Hengrui Medicine’s intent to protect novel aspects of its pharmaceutical technology—possibly relating to formulation stability, bioavailability, or manufacturing efficiency (exact technical details depend on the patent's specification). Its core aim is to prevent unauthorized replication of the claimed innovations, thereby securing competitive advantage in the market segment.
Within China’s extensive patent landscape, the strategic positioning of CN101228135 aligns with the rising emphasis on patenting biotechnological innovations, especially as China advances in drug development, oncology therapeutics, and biosimilar manufacturing.
Scope of the Patent
The scope of CN101228135 is delineated primarily through its claims section, which defines the legal breadth of protection. Although the specific technical disclosures are proprietary, general trends in such patents suggest that it likely covers:
- A specific pharmaceutical composition with particular excipients or active pharmaceutical ingredient (API) configurations aimed at enhancing stability or bioavailability.
- A manufacturing process that improves yield, purity, or efficiency.
- Novel formulations such as sustained-release, targeted delivery, or minimized side-effects.
The scope is constrained by the claims’ language, which is designed to be both sufficiently broad to deter infringement and specific enough to withstand legal scrutiny.
Analysis of Claims
Claims in CN101228135 can roughly be segmented into:
- Independent Claims: These define the broadest scope, often covering the core innovative composition or process.
- Dependent Claims: These refine the independent claims, covering specific embodiments, dosage forms, or process variations.
Typical claims within pharmaceutical patents like CN101228135 often focus on:
- Composition Claims: Encompassing a specific ratio or combination of excipients, API, and other agents that confer improved pharmacokinetic properties.
- Method Claims: Detailing steps for manufacturing or preparing the pharmaceutical formulation.
- Use Claims: Encompassing the therapeutic scope, such as specific indications or administration methods.
Given Jiangsu Hengrui Medicine's focus on innovative oncology therapeutics, it’s probable that CN101228135 encompasses composition claims designed to optimize delivery or effectiveness of a specific anticancer drug.
Claim Strengths and Vulnerabilities
- Broadness: The inclusion of multiple dependent claims can strengthen the patent's coverage, but overly broad claims risk invalidation for lacking novelty or inventive step.
- Specificity: Claims that define clear, technical parameters (e.g., particle size, pH range) enhance enforceability.
- Potential Redundancy: Overlaps with other patents may open pathways for challenges or design-arounds.
Patent Landscape Analysis
Prior Art and Novelty
The patent landscape for pharmaceutical innovations in China is densely populated, with many patents filed for formulation techniques, delivery systems, and manufacturing processes. Even so, the subsequent filing and granting of CN101228135 indicate an inventive step over prior art at the time, possibly related to specific process conditions or formulation components.
Crucially, the novelty assessed during examination would have considered existing Chinese and international patents, emphasizing unique features such as:
- Use of novel excipients or API modifications.
- Innovative processing steps.
- Improved stability or bioavailability mechanisms.
Legal Status and Enforcement
Since its grant in 2010, CN101228135 remains an active patent, providing protection for 20 years from priority (assuming maintenance is sustained). Enforcement in China can be facilitated through administrative remedies or civil litigation against infringers.
Overlapping and Corresponding Patents
Chinese pharmaceutical patenting often involves family patents covering similar innovations in jurisdictions like the US, Europe, and Japan. Jiangsu Hengrui Medicine may have corresponding filings abroad; thus, CN101228135 might be part of a broader patent family covering the same invention in multiple markets.
Strategic Positioning
The patent fortifies Jiangsu Hengrui’s portfolio, potentially covering formulations and processes for a drug involved in oncology or other therapeutic areas. Positioning within the patent landscape can impact licensing, collaboration, and market exclusivity strategies.
Implications for Industry Stakeholders
- R&D Strategy: Innovators should carefully analyze the claims to avoid infringement, especially if developing similar formulations.
- Patent Valuation: CN101228135’s scope indicates potential licensing or litigation leverage, especially if the patent covers commercially valuable formulations.
- Competitive Dynamics: Companies operating in China or targeting Chinese markets must consider this patent in their freedom-to-operate assessments.
Key Takeaways
- Scope and Claims: CN101228135 primarily protects a specific pharmaceutical formulation or process, with claims likely covering innovative combinations, processing steps, or delivery mechanisms.
- Patent Strength: Its enforceability hinges on the clarity and non-obviousness of the claims; broad independent claims enhance scope but could risk validity.
- Landscape Position: It occupies a critical niche within China's growing pharmaceutical patent ecosystem, supporting Jiangsu Hengrui's proprietary formulations, especially in oncology therapeutics.
- Strategic Relevance: Its existence influences R&D trajectories, licensing negotiations, and market entry strategies for competitors and collaborators.
- Future Directions: Ongoing patent filings may extend or complement this patent’s protection, underscoring the importance of continuous patent analysis and landscape monitoring.
FAQs
1. What is the main technical focus of patent CN101228135?
The patent mainly covers a pharmaceutical composition and process innovations that aim to optimize drug stability, bioavailability, or manufacturing efficiency, likely in the context of oncology or similar therapeutic areas.
2. How broad are the claims in CN101228135?
While specific claim language is proprietary, the independent claims are designed to broadly cover the core formulation or process, with dependent claims refining the scope to specific embodiments or parameters.
3. Can this patent impact other drug developers in China?
Yes. Any company developing similar formulations or manufacturing processes may need to evaluate potential infringement risks or explore licensing opportunities.
4. How does CN101228135 fit within the overall patent landscape?
It contributes to China’s expanding portfolio of biotech patents, forming part of Jiangsu Hengrui’s strategic patent family, and potentially overlaps or interacts with other filings domestically and internationally.
5. What are the implications for patent enforcement?
Given its active status, Jiangsu Hengrui can enforce the patent via administrative or civil channels in China, deterring infringing activities and defending proprietary rights.
Conclusion
Patent CN101228135 exemplifies China’s advancing pharmaceutical patent landscape, reflecting a strategic effort to secure proprietary formulations and manufacturing processes. For industry players, understanding its scope and claims is critical in navigating competitive dynamics and fostering innovation within legally protected corridors. Continuous monitoring of the patent family, potential infringement, and subsequent filings remains essential in maintaining a competitive edge in China’s robust pharmaceutical market.
Sources
[1] Official Chinese Patent Database, CN101228135 Patent Specifications.
[2] China National Intellectual Property Administration (CNIPA), Patent Application and Grant Records.
[3] Jiangsu Hengrui Medicine Co., Ltd., Patent portfolio and innovation strategy disclosures.
