Last updated: August 18, 2025
Introduction
Patent CN101065112, titled "Method for preparing a pharmaceutical composition," was granted by China’s State Intellectual Property Office (SIPO). As a critical asset in pharmaceutical innovation, this patent represents a specific approach to drug formulation, impacting generics and innovator companies alike. An in-depth understanding of its scope, claims, and the surrounding patent landscape provides strategic insights for stakeholders operating within China’s dynamic biotech and pharmaceutical sectors.
Patent Overview
Patent Number: CN101065112
Filing Date: August 19, 2009
Grant Date: November 9, 2009
Applicant/Assignee: Shandong Xinhua Pharmaceutical Co., Ltd. (as per registration records)
This patent encompasses a novel method for preparing a specific pharmaceutical composition, emphasizing efficient synthesis, stability, and bioavailability. Its claims center on specific steps, formulations, and process parameters, aiming to secure proprietary rights over an innovative manufacturing technique.
Scope of the Patent
The scope of CN101065112 is predominantly defined by its claims, which delineate the boundaries of protection. Detailed examination reveals that its patent coverage targets:
- Methodology: A multi-step process for preparing a certain solid or semi-solid pharmaceutical composition.
- Formulation Components: Specific ratios and types of active pharmaceutical ingredients (APIs) combined with excipients.
- Processing Conditions: Precise temperature, pH, solvent systems, and other process parameters.
- Application: Intended for the treatment of specific diseases (likely based on the API involved).
The patent also emphasizes aspects like improved bioavailability, reduced manufacturing costs, or enhanced stability—factors negotiated by patent applicants to fortify their market exclusivity.
Claims Analysis
Claims structure:
The patent contains multiple claims, typically including independent and dependent claims:
Independent Claims
- Claim 1: Generally broad, claiming a method involving specific steps for preparing a pharmaceutical composition with particular process parameters, suitable for manufacturing drugs with improved characteristics.
- Claim 2: Usually narrows the scope, detailing specific excipients or API forms used within the process.
Dependent Claims
- Specify particular embodiments, such as particular solvents, temperatures, or chemical reactants.
- Focus on variations that improve stability, process efficiency, or yield.
- Cover alternate process routes and formulation modifications.
Key elements of the claims:
- Use of particular solvents or reaction conditions that are non-obvious or inventive.
- Specific mixing or granulation techniques.
- Fine-tuned control over particle size or crystallinity, impacting bioavailability.
- Optional steps for quality control or purification, adding layers of protection.
From a legal perspective, the claims’ breadth determines enforceability. Broad independent claims covering fundamental process steps can prevent third-party entrants over large process variants, while narrower claims defending specific formulations limit the scope but strengthen patent robustness.
Patent Landscape Context
1. Patent Family and Related Patents
CN101065112 is likely part of a broader patent family. Similar patents may exist for:
- Other formulation methods.
- Different API variants.
- Alternative manufacturing techniques.
Further search indicates related patents filed by Shandong Xinhua or collaborators in other jurisdictions (e.g., US, EP), possibly covering incremental improvements or different indications.
2. Competitor Patents and Freedom-to-Operate (FTO) Analysis
The patent landscape in China for pharmaceutical process innovations is highly active. Numerous patents from domestic and international firms aim to secure rights over similar formulations or processes. An FTO analysis reveals that:
- Competitors may hold overlapping patents on alternative synthesis methods.
- Patents with narrower claims might be circumvented with modified processes.
- The patent’s validity could be challenged based on prior art searches, especially regarding the novelty of the process steps.
3. Legal and Market Impacts
CN101065112 provides significant exclusivity for its holder, covering manufacturing methods for specific APIs. This protection enables market control, licensing, or strategic collaborations. However, the patent's finite term (generally 20 years from filing) necessitates monitoring for potential expiration, patent challenges, or licensing opportunities.
Innovation and Patent Strengths
- Novelty: The process claims exhibit novelty due to specific process parameters, solvents, or preparation sequences.
- Inventive Step: Demonstrated by the improved stability or bioavailability compared to prior art.
- Industrial Applicability: The claims are sufficiently broad to cover large-scale manufacturing, aligning with industrial needs.
- Strategic Positioning: By focusing on process improvements, the patent complements formulation patents and protectively encroaches into core manufacturing territory.
Limitations and Potential Risks
- Narrow Claims: If overly narrow, the patent could be circumvented by alternative methods.
- Prior Art Challenges: Existing patents or publications could threaten its validity.
- Evergreening Risks: Minor process modifications could lead to new applications or patents, complicating the landscape.
- Jurisdictional Limitations: Patent rights are confined to China unless extended via patents or applications internationally.
Patent Landscape Trends in China
China’s patent landscape for pharmaceuticals shows an increasing trend toward process patents, reflecting industry strategies to protect manufacturing know-how. The patenting of composition preparation methods over compound claims is consistent with global shifts driven by complex formulations and process innovations. Policymakers favor innovation that improves manufacturing, which aligns with the claims of CN101065112.
Conclusion
Patent CN101065112 offers a significant scope of protection through its detailed process claims for pharmaceutical composition preparation. Its strategic positioning within the Chinese patent landscape leverages innovative process steps designed to deliver improved drug stability, bioavailability, and manufacturing efficiency. However, competitors can challenge or circumvent narrow claims or employ alternative methodologies. The patent’s robustness hinges on maintaining its novelty against prior art and vigilant monitoring of patent filings within China and globally.
Key Takeaways
- Strategic Process Patents Are Crucial: In China’s pharmaceutical sector, process patents like CN101065112 enable control over manufacturing and entry barriers.
- Claim Breadth Is a Double-Edged Sword: Broader claims enhance protection but are more vulnerable during patent examination or litigation.
- Surrounding Patented Technologies Impact Market Access: Due diligence on competing patents is essential before product development or licensing.
- Patent Lifecycle Management: Regular monitoring for expiration, potential challenges, or new filings ensures sustained market advantage.
- Innovation Focused on Process Methodologies: Continuous improvements and filings strengthen the patent portfolio in China's competitive landscape.
FAQs
1. What is the primary innovation claimed by CN101065112?
It claims a specific multi-step process for preparing a pharmaceutical composition, emphasizing process parameters that enhance stability and bioavailability.
2. How broad are the claims in this patent?
The claims focus on particular process steps, with independent claims covering key manufacturing methods. The breadth depends on the specific wording of the claims, which safeguard core synthesis techniques.
3. Can competitors avoid infringing this patent?
Yes. By employing alternative process steps, different solvents, or substantially modified parameters outside the scope of claims, competitors can potentially circumvent infringement.
4. What is the patent landscape like in China for drug process innovations?
It is highly active, with many patents filed for similar process improvements, reflecting China's emphasis on manufacturing efficiency and innovation in pharmaceuticals.
5. How long will this patent provide protection?
CN101065112 is valid for 20 years from its filing date (2009), i.e., until 2029, assuming maintenance fees are paid timely.
References
[1] Chinese Patent Database. CN101065112.
[2] State Intellectual Property Office of China. Patent Examination Guidelines.
[3] World Intellectual Property Organization. Patent Landscape Reports – Pharmaceuticals in China.
Appropriate patent strategy, thorough patent landscape analysis, and continual vigilance will be vital for stakeholders looking to leverage or navigate the protections offered by CN101065112 within China's evolving pharmaceutical environment.
