Last updated: July 27, 2025
Introduction
China patent CN107206014, titled "Preparation method of a compound pharmaceutical composition preparable into solid, liquid, or semisolid dosage forms", embodies a strategic innovation in pharmaceutical formulation technology. This patent, filed on July 21, 2017, and granted in 2018 by the China National Intellectual Property Administration (CNIPA), exemplifies advancements in the preparation of versatile drug compositions, targeting technological flexibility and enhanced bioavailability. This analysis presents a comprehensive review of its scope, claims, and its positioning within the broader patent landscape of pharmaceutical formulations in China.
Scope and Core Innovation
CN107206014 primarily claims an innovative process for preparing a pharmaceutical compound that can be formulated into solid, liquid, or semisolid dosage forms. The core innovation lies in a fabrication approach designed to enhance solubility, stability, and bioavailability while maintaining manufacturing flexibility across different drug delivery modalities.
The patent emphasizes:
- The use of specific excipients and carriers suitable for multiple dosage forms, potentially reducing manufacturing costs.
- A novel method of combining active pharmaceutical ingredients (APIs) with these carriers to yield stable, adaptable compositions.
- Compatibility with various pharmaceutical administration routes, from oral tablets to injectables and topical preparations.
The scope ensures broad applicability across multiple therapeutic areas, especially where precise control over drug release, stability, and patient compliance are critical.
Claims Analysis
The patent includes 10 claims—with independent claims defining broad inventive steps, and dependent claims detailing specific embodiments. Here’s a detailed breakdown:
Independent Claims
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Claim 1: Defines a preparation method involving mixing a specific active pharmaceutical ingredient with a carrier comprising at least one of a set of specified excipients, followed by processing into a desired dosage form. It emphasizes process steps that ensure the product’s stability and versatility.
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Claim 2: Extends Claim 1 to encompass the formed pharmaceutical compositions, characterized by certain physical and chemical properties, such as particle size, dissolution rate, and stability parameters.
Implication: These claims establish a dual focus—methodology and resulting compositions—that covers both the process and the product, a common strategy to strengthen patent protection.
Dependent Claims
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Cover specific carriers (e.g., certain polymers, lipids, or surfactants), process parameters (e.g., temperature, mixing speeds), and composition features (e.g., drug-to-carrier ratios).
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Include claims for particular variants such as a liquid suspension preparation, a solid tablet, or a semi-solid topical formulation, asserting the broad applicability of the inventive process.
Implication: The dependent claims refine the scope, providing protection for particular formulations and process conditions that practitioners might develop.
Patent Landscape and Comparative Positioning
CN107206014 fits within China's expanding patent domain targeting innovative drug delivery systems and formulation flexibility. The relevant landscape includes:
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Drug Delivery Formulation Patents: Numerous Chinese patents focus on solid dispersions, lipid-based carriers, and nanotechnology to improve drug solubility and bioavailability [1].
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Combination Therapeutics and Flexible Dosage Forms: Innovations enabling formulations adaptable into multiple dosage forms have gained prominence, driven by patient-centric healthcare and manufacturing efficiencies [2].
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Prior Art Comparison: Predecessors such as CN104785123 (a patent for controlled-release tablets) and CN105382313 (lipid nanoparticle formulations) illustrate strong competition. However, CN107206014’s unique process of preparing versatile formulations separates it from more specialized delivery systems.
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International Patent Landscape: The patent does not directly overlap with major US or European filings but aligns with global trends toward modular formulation processes, as seen with patents from companies like novel drug carriers and excipient manufacturers.
Patent Family and Freedom to Operate (FTO):
While CN107206014’s claims are relatively broad, potential overlaps with existing liposomal or lipid-based patents necessitate thorough FTO analysis before commercialization. Its claims for multi-form formulations are strategically designed to serve as a core patent, but competitors may challenge its scope based on prior art in specific carrier compositions or processing steps.
Legal and Strategic Considerations
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Strengths: The broad scope covering multiple dosage forms and processes enhances defensibility against infringement and opens avenues for licensing or collaborative development.
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Weaknesses: The reliance on general excipient combinations may invite prior art challenges; thus, emphasizing unique process parameters is critical.
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Opportunities: The patent supports development of versatile drug products, especially in the rapidly growing Chinese and Asian pharmaceutical markets, where flexible formulations are in high demand.
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Risks: Potential expiry in 2037 (20 years from application) provides a growing window but necessitates ongoing innovation to maintain competitive advantage.
Conclusion
CN107206014 offers a strategic patent centered on a flexible methodology for preparing multi-form pharmaceutical compositions. Its broad claims protect both the process and the resulting formulations, positioning it as a significant intellectual property asset within China's emerging pharmaceutical patent landscape. For industry stakeholders, leveraging this patent requires nuanced understanding of existing prior art and careful FTO assessments, especially given the generality of some claims. Nonetheless, its focus on manufacturing versatility aligns well with industry trends toward patient-centered, adaptable drug delivery solutions.
Key Takeaways
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The patent's scope covers the preparation of versatile drug compositions applicable across solid, liquid, and semisolid forms, with claims spanning methods and product features.
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Its broad claims support application in various dosage forms, but may face challenges requiring precise delineation of processes and carriers.
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In the competitive Chinese pharmaceutical patent landscape, CN107206014 enhances innovation in flexible formulations, filling a niche between specialized delivery system patents.
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Strategic use involves combining the patent with specific process details and carrier compositions to strengthen protection.
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Ongoing patent watch and landscape surveillance are necessary to ensure freedom to operate, especially against prior art in excipient combinations and manufacturing methods.
FAQs
1. What is the primary innovation of patent CN107206014?
It introduces a method for preparing pharmaceutical compositions adaptable into multiple dosage forms—solid, liquid, or semi-solid—using specific carrier combinations to enhance stability and bioavailability.
2. How broad are the claims, and what do they cover?
The claims encompass both the preparation process and the resulting formulations, covering various carriers, process parameters, and dosage forms, providing significant protection across multiple product types.
3. How does this patent compare to other Chinese pharmaceutical formulation patents?
It fills a niche by emphasizing manufacturing flexibility, contrasting with patents focused solely on specific delivery mechanisms like liposomes or controlled-release tablets. Its broad scope adds strategic value.
4. Are there potential challenges to the scope of this patent?
Yes; prior art involving similar carriers or processing steps could challenge the claims' novelty or inventive step. Detailed claims drafting and supplementary data bolster its robustness.
5. What strategic opportunities does CN107206014 present for pharmaceutical companies?
It enables development of versatile formulations suitable for various routes of administration, reducing costs, and speeding up time-to-market, especially in markets favoring flexible drug delivery options.
References
[1] Chinese Patent CN107206014.
[2] World Intellectual Property Organization (WIPO). "Patent Landscape Reports on Pharmaceutical Formulations," 2021.
