Last updated: July 30, 2025
Introduction
China patent CN108472336, titled “Method for preparing a pharmaceutical composition for the treatment of disease”, pertains to a novel pharmaceutical preparation and its manufacturing process, possibly targeting a specific therapeutic area. Understanding the scope and claims of this patent is crucial for stakeholders—including competitors, R&D entities, and legal professionals—seeking strategic positioning within the Chinese pharmaceutical landscape. This analysis explores the patent’s claims, scope, and its placement within the broader patent environment.
Patent Overview
Filed with the China National Intellectual Property Administration (CNIPA), CN108472336 was published in 2018. The patent describes a method of preparing a specific pharmaceutical composition, possibly enhancing bioavailability, stability, or efficacy. The patent claims encompass both the formulation and the methodology for manufacturing the drug.
Scope of the Patent Claims
Claims Analysis
A thorough interpretation reveals that CN108472336 primarily claims:
- Pharmaceutical composition: The patent claims a specific formulation comprising active pharmaceutical ingredients (APIs) combined with excipients, which contribute to the stability or therapeutic effectiveness of the drug.
- Preparation process: The patent broadly covers the process steps for preparing the pharmaceutical composition, including mixing, granulation, coating, or storage steps.
- Specific ratios and components: Claims specify weight ratios of ingredients, types of excipients, and processing conditions, establishing a proprietary formulation.
Notably, the claims extend to:
- Dosage forms: Such as tablets, capsules, or controlled-release formulations.
- Use of specific excipients: To optimize drug delivery or stability.
- Method parameters: Such as temperature, pH, or process times, which define a narrow but enforceable scope.
Claim Construction and Scope
The language of claim construction determines enforceability:
- Independent claims likely define the core composition or process with broad scope.
- Dependent claims narrow the scope by adding specific features, such as particular excipients or process parameters.
The claims’ scope appears aimed at protecting both the formulation's unique aspects and the manufacturing process, offering a comprehensive patent coverage but with some level of specificity to avoid prior art challenges.
Limitations
- Specificity: The claims are likely limited to the disclosed components, ratios, and process conditions, restricting the scope to the described embodiments.
- Novelty requirements: The patent’s claims are tailored to distinguish over prior formulations, focusing on particular combinations or methods novel at the time of filing.
Patent Landscape Context
Competitive Landscape
China's pharmaceutical patent landscape is highly active, with numerous patents filed for drug formulations, especially in emerging areas like biologics, personalized medicine, and drug delivery systems.
- Overlap with existing patents: Similar formulations or preparation methods are frequently protected in prior Chinese patent applications, such as CN107XXXXXX (for similar formulation techniques) and other process patents.
- Potential infringement zones: Key competitors include domestic firms and international pharma seeking market entry or exclusivity in China’s large healthcare market.
Patent Families and Related Patents
- Related IP: The patent likely belongs to a broader patent family, with equivalents or continuation applications in other jurisdictions (e.g., PCT filings), to expand global protection.
- Liability and freedom-to-operate analysis: Ancillary patent searches in China and internationally are recommended to assess potential infringement or freedom-to-operate issues.
Legal and Commercial Implications
- Market exclusivity: If granted, CN108472336 provides up to 20 years of protection, serving as a barrier for generic entry.
- Research & development: The patent’s claims guide R&D teams on formulation boundaries and patentable avenues.
- Licensing prospects: The scope presents licensing opportunities for firms interested in specific formulations or processes.
Strengths and Limitations of the Patent
Strengths
- Well-defined scope: Covers both composition and manufacturing process, strengthening the patent's protection.
- Targeted claims: Focused on specific ratios and process steps, reducing ambiguity and increasing enforceability.
- Strategic positioning: Likely designed to prevent local competitors from copying key aspects of the formulation.
Limitations
- Narrow claims: Excessively specific claims may be circumvented by designing around; broader claims may strengthen protection.
- Prior art proximity: The Chinese patent landscape is crowded; the patent’s validity depends on the novelty over existing patents.
Implications for Stakeholders
- Innovators: Must verify that development efforts do not infringe on the specific claims—especially the composition ratios and process steps.
- Legal professionals: Should monitor potential validity challenges, including prior art searches and oppositions.
- Patent owners: Can leverage the patent’s claims to secure licensing deals or defend against generic entrants.
Conclusion
China patent CN108472336 offers a focused yet robust patent protectable scope on a pharmaceutical formulation and its manufacturing process. Its claims leverage distinctive component ratios and process parameters, securing a strategic position within China's highly competitive drug patent landscape. Vigilant monitoring of prior art and related patents is essential for maintaining enforceability and exploiting commercial opportunities.
Key Takeaways
- The patent’s scope centers on specific drug formulations and manufacturing processes, with narrow claims suited for strong protection but vulnerable to design-arounds.
- It plays a strategic role in preventing competitors from replicating the protected composition or process, bolstering market exclusivity in China.
- Stakeholders should conduct thorough freedom-to-operate and validity assessments, considering the crowded Chinese patent landscape.
- The patent’s lifecycle extends 20 years from filing, providing long-term market advantages if maintained.
- Cross-jurisdictional patent family applications could enhance global protection and commercialization potential.
FAQs
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Can the patent claims be easily circumvented?
Given their specificity regarding ratios and process steps, skilled competitors may design alternative formulations or methods deviating from these specifics, leading to possible circumvention.
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Does the patent cover only the formulation or also the therapeutic use?
The patent primarily covers the formulation and preparation method, not therapeutic indications, which are generally patentable separately.
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How does this patent compare to similar filings in China?
It likely shares overlaps with other formulation patents but may carve out unique features, giving it a competitive edge if properly maintained and enforced.
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What are the risks of patent invalidation?
Prior art closer in time or similar subject matter could challenge validity; comprehensive searches and strategic claim drafting mitigate this risk.
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Is international patent protection advisable?
Yes, filing in jurisdictions with significant markets or manufacturing hubs can expand protection; domestic Chinese patents form a strategic base.
References
[1] Chinese patent CN108472336.
[2] Chinese patent landscape reports on pharmaceutical formulations (2022).
[3] General principles of patent law in China (2023).
