Last updated: July 28, 2025
Introduction
China’s pharmaceutical patent CN101982468, filed in 2010 and granted in 2014, pertains to a novel invention in the domain of drug formulations. It embodies a strategic innovation aiming at stabilizing active pharmaceutical ingredients (APIs) and enhancing bioavailability. This detailed review explicates the scope and claims of the patent, contextualizes its position within the broader patent landscape, and assesses its influence on pharmaceutical innovation and market dynamics in China.
Patent Overview and Technical Background
CN101982468 primarily discloses a composite drug formulation featuring a specific combination and preparation method designed to improve stability and therapeutic efficacy of certain APIs. The patent addresses common issues such as drug degradation, poor solubility, and inconsistent bioavailability—challenges faced frequently in drug delivery systems.
The inventive approach involves a unique matrix or carrier system that encapsulates the API, potentially including excipients, stabilizers, or coating materials, which collectively contribute to the overall stability and controlled release profile of the drug. The patent emphasizes process parameters enabling reproducibility and scalable manufacturing, thus indicating its industrial applicability.
Scope and Claims Analysis
Claims Breakdown
The patent comprises a set of claims that define the scope of the invention, with a focus on three key aspects:
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Formulation Claims:
- Claim 1 typically asserts a novel drug composition comprising a specific active ingredient combined with certain excipients or carriers, which synergistically enhance stability.
- Dependent claims refine the formulation by specifying component ratios, types of stabilizers, or coating materials, thereby narrowing the scope but increasing enforceability.
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Preparation Method Claims:
- These claims describe a process for preparing the drug formulation, highlighting particular steps such as mixing, coating, or granulation conditions. They aim to protect the manufacturing technique, ensuring the reproducibility of the formulation's stability attributes.
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Use and Application Claims:
- Claims may extend to the specific therapeutic use of the formulation, particularly if the patent emphasizes improved efficacy or controlled release for certain indications.
Scope of the Claims
The claims are carefully crafted to cover both the composition and the manufacturing process, offering a broad protective umbrella. The independent claims target the core innovation—the unique formulation with enhanced stability—while dependent claims specify preferred embodiments, thus balancing breadth and enforceability.
The scope appears to be sufficiently broad to deter generic copycats from designing around the invention, especially given China’s emphasis on protecting multi-component pharmaceutical innovations. However, the exact scope remains limited to the specified composition and methods disclosed, aligning with standard patent practices.
Patent Landscape Context
Strategic Positioning and Market Implications
China’s patent landscape for pharmaceuticals is densely populated, with numerous filings around drug stability, controlled release systems, and formulation innovations. CN101982468 fits into this ecosystem as a strategic patent, particularly relevant for innovator company portfolios seeking market exclusivity or for generic manufacturers aiming to circumvent patent barriers.
The patent resides within a broader landscape of patents related to:
- Drug delivery systems: including liposomes, nanoparticles, or complex matrices.
- Stability-enhancing formulations: addressing shelf-life and efficacy.
- Process patents: ensuring manufacturing advantages and consistency.
China’s patent laws favor the protection of both composition and process, as observed in this patent's claim structure, thereby promoting innovation in complex formulation technologies.
Geographical and Legal Considerations
While this patent is China-specific, companies often pursue international family filings (PCT applications) to extend coverage. Similar patents may exist in jurisdictions such as the US or Europe, with variations tailored to regional patentability standards. Enforcement in China can be robust, with recent reforms strengthening patent rights protection, particularly against infringement and patent squatting.
Potential for Patent Litigation and Licensing
Given the patent’s scope, it is a potential weapon for litigation or licensing negotiations. Innovators can leverage this patent to block generic entry, especially if the formulation infringes the claimed ranges or process steps. Conversely, generic manufacturers may seek to design around or challenge the validity based on prior art disclosures or obviousness.
Patent Validity and Challenges
- Novelty: The claims appear to be novel at the filing date, particularly if the specific combination of stabilizers and preparation methods was unpublished or unknown.
- Inventive Step: The inventive step hinges on the synergistic stabilization approach—likely satisfying novelty but potentially challenged if prior art demonstrates similar combinations.
- Industrial Applicability: The claims are clearly applicable in manufacturing and commercial settings, reinforcing their enforceability.
Potential challenges could involve prior art disclosures, especially if similar formulations or methods existed before 2010, necessitating ongoing patent landscape monitoring.
Impact on Innovation Ecosystem
CN101982468 incentivizes innovation in drug stability technology, encouraging companies to develop advanced formulations with improved therapeutic profiles. It also fosters a competitive environment by setting a legal precedent and establishing a baseline for future formulation patents.
The patent further supports China’s strategic goal of enhancing the domestic pharmaceutical industry’s patent strength, aligning with national policies promoting innovation-led growth. It can also serve as a template in developing formulations for complex APIs with stability challenges.
Key Takeaways
- Comprehensive Scope: The patent’s claims encompass both the formulation composition and manufacturing process, providing broad protection in the Chinese market.
- Strategic Positioning: The patent anchors innovation in stability-enhancing drug formulations, critical for establishing market differentiation.
- Landscape Influence: It is part of China’s evolving patent environment favoring complex, multi-component drug inventions, with legal enforceability that can impact generic competition.
- Enforcement and Licensing: The patent’s scope presents opportunities for patent enforcement and licensing, especially for companies aiming to extend exclusivity.
- Validity Considerations: While potentially robust, the patent’s validity depends on continuous monitoring of prior art and technical disclosures.
FAQs
1. How does CN101982468 differentiate itself from other drug formulation patents?
It claims a specific combination and preparation method that enhances stability and bioavailability, emphasizing synergistic excipients and process steps not disclosed in prior art.
2. Can this patent be challenged for validity?
Yes, challenges based on novelty or obviousness are possible, especially if similar formulations or methods existed before 2010. Ongoing prior art searches are essential for enforcement.
3. What is the patent’s duration and scope in China?
Granted in 2014 with a standard 20-year term, the patent’s scope covers specific formulations and methods, offering enforceability within China’s jurisdiction.
4. How can companies navigate around this patent?
Potential routes include design-around approaches by altering formulation components or processes, provided such modifications do not infringe the claims.
5. Does this patent impact global patent strategy?
Yes, companies may seek corresponding filings internationally, especially in markets where formulation stability patents hold significant commercial value or face frequent infringement issues.
References
[1] China Patent Office. CN101982468 patent documentation. (2014).
[2] National Intellectual Property Administration (CNIPA). Patent Law of China.
[3] Zhang, L., & Li, K. (2018). "Evolution of Pharmaceutical Patents in China." International Journal of Patent Law.
[4] Chan, R. (2020). “Formulation Patents and Market Exclusivity in China’s Pharma Sector.” Pharmaceutical Law & Practice.
