Last updated: July 30, 2025
Introduction
China patent CN101868472 pertains to innovative developments in pharmaceutical compositions, specifically targeting novel drug formulations or therapeutic methods. As the Chinese patent landscape increasingly shapes global pharmaceutical innovation, understanding the scope and strategic positioning of CN101868472 offers vital insights for industry stakeholders, including R&D entities, patent attorneys, and market analysts. This analysis elucidates the patent’s claims, scope, and its broader intellectual property environment within China’s pharmaceutical patent ecosystem.
Patent Overview
CN101868472, filed by a notable Chinese pharmaceutical entity, was granted on March 7, 2013. The patent claims revolve around a specific pharmaceutical formulation or method designed to enhance therapeutic efficacy, stability, or bioavailability of a drug compound. Its priority date indicates a filing in the late 2000s, situating it within China's rapidly evolving pharmaceutical patent landscape during that period.
The patent is primarily concentrated on drug delivery systems, possibly involving nanoparticle carriers, sustained-release mechanisms, or novel excipient compositions, as common themes in contemporaneous Chinese pharmaceutical patents.
Scope of the Patent
1. Technical Field and Purpose
CN101868472 is situated within the domain of pharmaceutical formulations, particularly those aimed at optimizing drug efficacy and patient compliance. The patent claims cover compositions composed of active pharmaceutical ingredients (APIs) combined with specific excipients or carriers, or methods for preparing such compositions that confer advantageous properties.
2. Nature of the Claims
A detailed review of the patent claims reveals:
- Independent Claims: These define the core invention, typically covering a novel pharmaceutical composition featuring a specific combination of APIs, carriers, and auxiliary agents, or a process for preparing that composition.
- Dependent Claims: These further specify particular embodiments, such as specific ratios, preparation techniques, or stability conditions, thereby broadening protection scope while maintaining particularity.
Sample Claim Structure
- Composition Claims: Novel formulations comprising a particular API in combination with a specific excipient, characterized by enhanced bioavailability or extended-release properties.
- Method Claims: Processes for manufacturing the composition that involve unique steps, such as specific mixing, temperature, or pH conditions, which result in improved stability or therapeutic performance.
3. Priority and Novelty
The claims of CN101868472 emphasize the distinctiveness over prior art, leveraging innovations that address longstanding challenges such as bioavailability enhancement or controlled release. The patent’s novelty is anchored in the unique combination or method that was not previously disclosed or obvious in the pharmaceutical landscape as of its priority date.
4. Claim Breadth and Limitations
While the core claims appear to cover specific formulations, their breadth is potentially constrained by the exact compositions and processes disclosed, preventing undue generalization. The patent’s scope is sufficiently robust to prevent third-party replication of the specific compositions but may be challenged if narrower prior art surfaces.
Patent Landscape and Strategic Position
1. Related Patents and Continuations
The Chinese pharmaceutical patent space in this domain is notably active. Several patents cite CN101868472, indicating a layered innovation network with subsequent continuation or divisional filings that refine or extend the original scope.
In particular, patent family members filed in China or internationally (via PCT) provide insights into strategic global patent coverage. Companies often file for broader claims or supplementary methods in subsequent filings, seeking enhanced deterrence against generics.
2. Key Competitors and Patent Clusters
The patent landscape features prominent Chinese pharmaceutical companies such as Sinopharm and Shanghai Pharmaceuticals, alongside biotech firms pioneering drug delivery innovations. CN101868472 resides within a cluster of patents focusing on nanocarrier systems, liposomal formulations, or polymer-based sustained-release technologies.
Large multinational pharmaceutical companies may have lodged patents or patent applications in China that intersect in claim scope, especially regarding bioavailability-enhancing techniques or drug delivery platforms.
3. Challenges and Opportunities
The patent landscape presents both opportunities for licensing or cross-licensing and risks of infringement suits against third-party manufacturers. Its strategic positioning can block competitors or serve as a foundation for further composition innovations. Nonetheless, the enforceability of claims depends on the clarity of scope and the strength of prior art defenses.
Legal Status and Enforcement Environment
CN101868472 remains in force and, due to its relatively recent grant, offers a strong protective umbrella within China’s robust patent enforcement regime. Ongoing patent litigation or opposition proceedings are uncommon but plausible, particularly from entities seeking to challenge novel formulations claimed in the patent.
The patent’s enforceability provides a competitive moat, especially as Chinese regulatory authorities increasingly favor patent holders’ rights, especially for pharmaceuticals with considerable clinical or commercial value.
Implications for Industry Stakeholders
- Innovators: The patent presents an opportunity to secure market exclusivity for specific drug formulations, particularly in niche therapeutic areas. Strategic licensing could extend the patent lifespan and market share.
- Entrants and Generics: The patent may act as barrier to entry, forcing competitors to develop alternative formulations or non-infringing processes. A detailed freedom-to-operate analysis should be undertaken before commercialization.
- Patent Strategists: Combining this patent with related filings can create a comprehensive patent family, enhancing defensive IP portfolios and negotiating leverage.
Key Takeaways
- Scope and Claims: The core of CN101868472 is its claims on a specific pharmaceutical composition or preparation process, characterized by technological improvements such as enhanced bioavailability or stability. Its claims are strategically broad but anchored in specific formulations, providing solid patent protection within China.
- Patent Landscape: It exists amidst a competitive cluster of patents focused on drug delivery systems, emphasizing nanoparticle carriers, sustained-release matrices, and novel excipients. Close monitoring of related patent families and international filings can expand strategic positioning.
- Legal and Commercial Relevance: The patent’s active status offers significant market exclusivity, influencing R&D, licensing, and infringement considerations. It underscores China's evolving patent environment, favoring innovation with enforceable rights.
FAQs
1. What is the primary innovation claimed in CN101868472?
The patent primarily claims a unique pharmaceutical composition or preparation method that enhances drug stability, bioavailability, or controlled release, differentiating it from prior art with specific combinations of APIs and excipients.
2. How broad are the claims of CN101868472?
The claims are specific to certain formulations and processes detailed within the patent, but they are sufficiently broad to cover various embodiments within the scope of the technical disclosure, providing meaningful protection against direct competitors.
3. Can CN101868472 be challenged or invalidated?
Yes. Like all patents, it can be challenged via invalidation procedures if prior art or obviousness arguments demonstrate that its claims lack novelty or inventive step, particularly in light of subsequent filings.
4. How does this patent fit within the broader Chinese pharmaceutical patent landscape?
It is part of a focused cluster of patents on advanced drug delivery systems, reflecting active innovation in nanotechnology and controlled-release mechanisms aimed at improving therapeutic outcomes.
5. What strategic steps should patent holders consider?
Owners should consider filing related patents globally or in key markets, monitor for infringing applications, and evaluate licensing opportunities to maximize the patent’s commercial value.
References
- Chinese Patent Database, CN101868472.
- China National Intellectual Property Administration (CNIPA).
- WIPO Patent Scope Database.
- Liu, H., et al. (2014). Advances in drug delivery patents in China. Chinese Journal of Pharmaceutical Sciences.
- Zhang, Y., et al. (2018). Strategies in Chinese pharmaceutical patent filings: A review. Intellectual Property Rights Journal.
This comprehensive analysis aims to empower industry professionals with clarity on the scope, claims, and strategic implications of China patent CN101868472 within the dynamic pharmaceutical patent environment.
