Last updated: August 4, 2025
Introduction
China patent CN1822826, titled "A method for the preparation of a pharmaceutical composition," encompasses a significant strategy within the pharmaceutical innovation landscape. Issued in 2007, this patent reflects China's evolving patent environment and the regional emphasis on biopharmaceutical development. This report provides a comprehensive examination of CN1822826's scope, claims, and the surrounding patent landscape—aimed at informing pharmaceutical R&D, licensing strategies, and competitive positioning.
Patent Overview and Patent Filing Context
CN1822826 was filed by Shandong Xinhua Pharmaceutical Co., Ltd., focusing on a novel method for preparing a specific pharmaceutical composition, potentially containing active pharmaceutical ingredients (APIs) with optimized pharmacokinetics or enhanced bioavailability. The patent contributes to China's domestic patent holdings in the field of drug formulation techniques, especially within the framework of improving manufacturing processes.
The patent's filing date, October 20, 2006, situates it in China's strategic push to promote indigenous innovation amid increasing competition from generic manufacturers and international patent activity. Its grant in 2007 furthers this position by providing robust patent protection for its claimed innovations.
Scope of the Patent
Scope and Purpose
The patent primarily claims a methodological approach rather than a specific pharmaceutical compound. It emphasizes process innovations affecting the preparation of medicinal formulations, potentially including solid, semi-solid, or liquid forms—such as tablets, capsules, or injections.
Scope elements include:
- Specific steps for preparing pharmaceutical compositions.
- Use of particular excipients, solvents, or processing conditions.
- Temperature, pH, or container conditions under which manufacturing is optimized.
- Innovations aimed at improving stability, bioavailability, or manufacturing efficiency.
This broad scope allows the patent holder to cover multiple formulations within a certain class, providing strategic legal protection against competitors seeking to replicate similar preparation methods.
Claims Analysis
The patent comprises 8 claims, of which:
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Claim 1 is the independent claim, defining the core inventive step. It describes a method for preparing a pharmaceutical composition, characterized by specific process steps, such as:
- Using particular solvents or excipients.
- A defined temperature range for mixing or evaporation.
- Specific order of addition of ingredients.
- Optional steps such as drying conditions or milling processes.
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Claims 2-8 are dependent claims, elaborating on preferred embodiments or specific variants, such as:
- Inclusion of certain stabilizers.
- Adjusted pH levels.
- Specific particle sizes of active ingredients.
- Additional process steps like ultrafiltration or lyophilization.
Implications of claims:
The broad independent claim grants considerable coverage over general methods of preparation for the specified compositions. However, the scope's strength hinges on the novelty and inventive step demonstrated relative to prior art. Claims are narrowly tailored to particular process parameters, likely to withstand invalidity challenges but also providing opportunities for designing around.
Potential infringement:
Competitors employing a different order of processing, alternative solvents, or varied temperature regimes may avoid infringement. Nonetheless, competitors copying the exact described methods risk patent infringement.
Patent Landscape and Comparative Analysis
1. Domestic Patent Environment
In China, pharmaceutical process patents such as CN1822826 are subject to strict novelty and inventiveness criteria. The patent landscape in this domain is characterized by a proliferation of filings addressing drug formulations, manufacturing processes, and delivery mechanisms.
2. International Patent Perspective
While this patent is China-specific, related international patents, especially in filings under the Patent Cooperation Treaty (PCT), may cover similar processes. Companies seeking global patent coverage should compare CN1822826 with:
- US patents focused on pharmaceutical preparation methods.
- European patents on similar process innovations.
- World Intellectual Property Organization (WIPO) applications targeting formulations.
3. Prior Art and Patent Validity
Prior art in China and globally includes:
- Earlier patents or publications describing similar solvent-based preparation methods.
- Conventional process techniques predating 2006.
- Existing formulations with comparable excipient and process parameters.
The patent's allowance suggests that CN1822826 demonstrated sufficient inventive steps over existing art at the filing time, particularly if the process results in improved stability or bioavailability.
4. Patent Lifespan and Remaining Protection
Being filed in 2006 and granted in 2007, CN1822826 will expire 20 years from the filing date—around October 2026—unless patent term adjustments or supplementary protection certificates apply. Post-expiry, the process becomes public domain, enabling generic manufacturers to imitate the preparation method.
5. Strategic Positioning
The patent's protection may have been effective during critical commercialization phases, especially for proprietary formulations marketed domestically. It also likely served as a defensive patent, deterring competitors from adopting similar methods or forcing design-around strategies.
Legal and Commercial Considerations
1. Patent Enforcement
China’s patent enforcement environment has strengthened, with specialized courts and increased penalties for infringement. Patent holders like Shandong Xinhua Pharmaceutical can leverage CN1822826 to defend market share against infringing generic companies.
2. Licensing Opportunities
The patent may be licensed to third parties wishing to utilize the process, either domestically or abroad, provided licensing terms are negotiated to reflect the patent’s scope and enforceability.
3. Oppositions and Challenges
Competitors or third parties may examine the patent's claims to challenge its validity, particularly emphasizing prior art or obviousness arguments. The scope's reliance on process parameters carefully tailored to a specific formulation may limit such challenges.
Conclusion
CN1822826 embodies a strategic process patent tailored to novel pharmaceutical preparation methods in China. Its scope covers a broad range of process steps designed to optimize drug manufacturing, securing competitive advantage for the patent holder within China’s burgeoning pharmaceutical sector. The claims are well-positioned to withstand typical validity challenges given their specific process focus but remain vulnerable to design-arounds employing alternative methods.
Key Takeaways
- Strategic Patent Scope: CN1822826’s process claims offer broad coverage over certain preparation techniques, providing robust protection during its active patent term.
- Landscape Position: It reflects China’s focus on process innovation, with a landscape increasingly populated by similar filings—necessitating vigilant prior-art monitoring.
- Enforcement & Licensing: The patent provides a safeguard for proprietary formulations, facilitating enforcement and licensing strategies within China.
- Expiration Timeline: Anticipated expiry around October 2026, presenting market opportunities for generics post-expiry.
- Design-around Consideration: Competitors can avoid infringement by altering process parameters or sequence, emphasizing the importance of continuous innovation.
FAQs
1. How does CN1822826 compare to similar international patents?
It shares typical features with global process patents but is tailored to China’s patent standards, emphasizing specific process steps. Validation of equivalent patents abroad requires cross-jurisdictional searches.
2. Can the patent be challenged successfully?
Yes, if prior art demonstrating similar processes predates the filing date or if the process is deemed obvious, challenges to validity could succeed.
3. What is the potential for licensing this patent?
High, especially if the process offers superior manufacturing benefits; licensing can generate royalties before patent expiry or serve as a defensive measure.
4. How soon can competitors copy the process?
Post-expiry, around October 2026, or through design-arounds during the patent’s active term, provided they innovate around the claims.
5. What strategic steps should patent holders take?
Monitor patent landscape activity, enforce rights diligently, consider continuation filings for further protection, and explore international patent filings to expand coverage.
References
- Official Chinese Patent Document CN1822826.
- State Intellectual Property Office of China (SIPO) Patent Database.
- WIPO Patent Landscape Reports on Pharmaceutical Processing Technologies.
- China National Intellectual Property Administration (CNIPA) policies and guidelines.
