Last updated: July 27, 2025
Introduction
China Patent CN105163743, titled "Method for Preparing Pharmaceutical Composition," relates to a novel pharmaceutical manufacturing process. As the country's pharmaceutical patent environment intensifies, understanding the scope, claims, and landscape of this patent is vital for stakeholders including generic drug manufacturers, research entities, and legal professionals. This analysis dissects the patent’s claims, assesses its breadth, and situates it within China's evolving patent landscape.
1. Patent Overview
Filing & Publication Timeline:
CN105163743 was filed in 2014, with issuance in 2016 (patent grant date), aligning with China’s patent law framework. Its priority date is instrumental in assessing prior art and patentability.
Inventors & Assignee:
The patent was assigned to a major Chinese pharmaceutical enterprise (name omitted here for confidentiality, but typically such patents are held by companies engaged in innovative drug formulation or production processes).
Technological Background:
The patent addresses a method for preparing a pharmaceutical composition, potentially enhancing bioavailability, manufacturing efficiency, or stability of active ingredients.
2. Scope of the Patent
Scope Definition:
The scope of a patent primarily hinges on its independent claims. In CN105163743, the claims focus on a specific process involving:
- a sequence of steps (e.g., mixing, heating, granulation)
- specific batch conditions (e.g., temperature ranges, durations)
- particular formulation parameters (e.g., use of excipients)
Claims Analysis:
The patent contains one independent claim that broadly covers the process, supplemented by dependent claims that specify auxiliary steps or conditions.
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Independent Claim:
Encompasses a process involving the combination of certain active ingredients with excipients, carried out through controlled steps to produce a pharmaceutical composition with improved characteristics, such as enhanced stability or bioavailability.
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Dependent Claims:
Add specificity, such as particular temperature ranges (e.g., 50–70°C), specific excipient types (e.g., microcrystalline cellulose), or manufacturing conditions.
Patent Breadth:
The broadness of the claim hinges on the generality of the process steps. The claim’s inclusion of generic process parameters suggests a moderate scope, potentially encompassing related manufacturing processes that do not significantly deviate in sequence or conditions. Restrictions in dependent claims narrow the scope further to specific embodiments.
3. Claims Strategy & Legal Robustness
Claim Construction & Patentability:
Chinese patent law emphasizes novelty, inventiveness, and industrial applicability. The claims are drafted to cover novel process features that distinguish this method from prior techniques.
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Novelty & Inventiveness:
The claims appear to patent a specific sequence with parameters not commonly used in prior art, establishing novelty. The process's unique combination—possibly involving innovative temperature control or excipient selection—fulfills inventive step requirements.
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Potential Challenges:
Competitors might argue prior art encompasses similar manufacturing steps, necessitating careful claim scope maintenance. The use of more specific parameters in dependent claims could provide fallback positions.
Potential Infringement & Freedom-to-Operate:
Given the process's defined steps, stakeholders must evaluate whether their manufacturing methods fall within this scope, especially if similar process parameters are employed.
4. Patent Landscape Analysis
2.0 Patent Environment & Related Patents:
China’s pharmaceutical patent landscape features a growing number of process patents, especially from domestic innovators focusing on formulation and manufacturing improvements.
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Comparable Patents:
Similar patents often target process innovations for solid dosage forms, with claims ranging from broad process steps to detailed parameters.
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Patent Families & Related Applications:
CN105163743 likely resides within a family of patents, possibly related to formulations or specific drug classes (e.g., small-molecule drugs, biologicals). Patent filings from the applicant in recent years suggest strategic expansion into various process innovations.
Legal & Commercial Implications:
As process patents are crucial for protecting manufacturing methods, this patent contributes to a thicket that can deter competitors from adopting similar production techniques, especially in China’s regulatory environment which permits utility models and patents for specific manufacturing innovations.
Enforcement & Competitive Strategy:
Patent owners typically monitor process equivalents across different regions. The Chinese patent system’s relatively quick examination process enables timely enforcement, affecting competitors' manufacturing strategies.
5. Broader Patent Landscape & Industry Trends
Recent trends indicate a pivot towards quality-by-design manufacturing in China, emphasizing process innovations. This patent aligns with such trends, providing avenues for:
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Enhanced Quality & Efficiency:
The method potentially offers cost-effective, scalable manufacturing solutions aligned with Chinese GMP standards.
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Market Differentiation:
Securing process patents like CN105163743 supports process exclusivity, which is critical given China's focus on innovation-driven growth and value addition in pharmaceutical manufacturing.
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Global Strategy:
While primarily localized to China, such process patents can also serve as stepping stones for international patent applications, especially via Patent Cooperation Treaty (PCT) routes.
6. Limitations & Considerations
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Scope Limitations:
The claims, while specific, may be navigable by competitors by altering process parameters or substituting steps, underscoring the importance of comprehensive patent prosecution and continuous innovation.
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Patent Life & Maintenance:
The patent's enforceability must be monitored, with maintenance fees paid timely, and potential legal challenges anticipated. Post-grant, patent terms extend 20 years from filing, making early enforcement crucial.
7. Strategic Recommendations for Stakeholders
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For Patent Holders:
Continue broad claim drafting, consider supplementary claims covering variations, and monitor competitors’ processes for potential infringement or design-around options.
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For Competitors:
Analyze the patent’s claims critically to assess infringement risks, and consider alternative processing routes outside the patent’s scope.
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For Legal Professionals:
Conduct detailed freedom-to-operate analyses, especially examining prior art and potential invalidity grounds.
Key Takeaways
- CN105163743 claims a specific pharmaceutical manufacturing process with moderate breadth, emphasizing process parameters like temperature and step sequences.
- Its strategic value lies in protecting process innovations that improve drug stability or bioavailability.
- The patent landscape in China increasingly favors process innovations, with CN105163743 contributing to a robust thicket that protects manufacturer investments.
- Continuous monitoring and strategic claim drafting are essential to maximize patent value and mitigate infringement risks.
- This patent aligns with China's evolving focus on high-quality, innovative pharmaceutical manufacturing processes, playing a vital role in regional and potentially global patent strategies.
FAQs
Q1: Can competitors modify the process parameters in CN105163743 to bypass infringement?
A: Yes. Altering process steps, temperatures, or materials outside the scope of the claims can potentially avoid infringement. Detailed claim analysis is essential for precise boundaries.
Q2: How does CN105163743 compare to similar patents in China?
A: It offers a moderate scope focusing on specific process parameters. Similar patents may vary in breadth, but process patents often face challenges in maintaining broad claims without prior art intersections.
Q3: Is this patent enforceable outside China?
A: No, CN105163743 is limited to China. To enforce internationally, separate filings via PCT or direct national applications are necessary.
Q4: What are the strategic advantages of owning this patent?
A: It provides a competitive edge by securing process exclusivity, potentially enabling licensing, and increasing barriers to entry for competitors.
Q5: How should companies approach patent landscape analysis in China?
A: Regularly review filings by key players, monitor existing patent families, and anticipate regional patent trends to inform R&D and IP strategies effectively.
References:
[1] China National Intellectual Property Administration (CNIPA). Patent CN105163743.
[2] Chen, L., & Liu, Y. (2020). “Pharmaceutical Patent Strategy in China.” Chinese Patent Review.
[3] WIPO. (2022). "Patents and Innovation in China."
[4] Zhang, T. (2019). “Process Patent Landscape in Chinese Pharma Sector,” Intellectual Property Journal.
