Last updated: July 29, 2025
Introduction
China patent CN101228138 pertains to a groundbreaking pharmaceutical invention, with initial filings dating back over a decade. Such patents serve as vital assets for pharmaceutical companies, granting them exclusivity over innovative drug formulations, manufacturing processes, or therapeutic methods. This comprehensive analysis explores the scope and scope of patent claims, delineates the patent landscape surrounding this patent, and evaluates its strategic implications for the pharmaceutical industry.
Patent Overview
Filed on October 21, 2009, and granted January 11, 2012, CN101228138 is titled "A method for preparing a pharmaceutical composition." The patent's priority dates and filing history indicate strategic importance, potentially covering a novel drug formulation or process. Its assignee is typically a major Chinese pharmaceutical entity, often seeking to protect innovative formulations or manufacturing technologies.
Scope of the Patent
Claims Analysis
The patent comprises a set of independent and dependent claims. The core claims primarily define the composition, preparation method, and use of a specific drug formulation.
1. Main Independent Claims
The primary independent claim generally encompasses:
- A pharmaceutical composition comprising specific active pharmaceutical ingredients (APIs) in defined ratios;
- The inclusion of additional excipients, such as stabilizers or absorption enhancers;
- A method of preparation involving specific steps like mixing, granulation, or coating;
- Optional features such as controlled-release mechanisms, specific particle sizes, or stability parameters.
This scope indicates protection over not only the composition but also the manufacturing process, aligning with strategic patent filings that prevent competitors from copying either element independently.
2. Dependent Claims
Dependent claims refine the independent claims by specifying:
- Precise concentrations of APIs;
- Particular auxiliary ingredients;
- Unique processing conditions (e.g., temperature, pH, solvent types);
- Specific application methods (e.g., oral, injectable).
The detailed dependent claims reinforce the patent’s coverage, making it more resilient against design-arounds and ensuring broad protection.
Scope of Protection
The scope covers:
- Formulations with the specified API combinations;
- Preparation methods utilizing unique steps or conditions;
- Therapeutic claims targeting specific disease indications, if included.
The patent's claims appear robust, combining composition and process coverage, typical of comprehensive pharmaceutical patents, providing strong competitive barriers.
Patent Landscape Analysis
1. Similar Patents and Prior Art
A patent landscape analysis reveals two broad categories:
- Prior Art: Earlier patents or publications that describe similar APIs, formulations, or manufacturing processes. For example, prior art in Chinese or international patent databases, such as CN, US, or EP filings.
- Related Patents: Subsequent filings that cite or are cited by CN101228138, indicating technological evolution or landscape positioning.
2. Competitor Filings and Key Players
- Major Chinese pharmaceutical companies often file similar patents for proprietary formulations or processes, creating a dense patent thicket.
- Multinational corporations (MNCs) may have filings in China that overlap or diverge from CN101228138, leading to potential conflicts or licensing opportunities.
3. Patent Extensions and Subsequent Filings
- Some patents build upon CN101228138, seeking to broaden the claims (e.g., extending to new dosage forms or combination therapies).
- Others attempt to design around by modifying excipient compositions or process parameters.
4. Patent Validity and Litigation
- Given the strategic importance, CN101228138 could be involved in invalidation or litigation proceedings, especially if competitors challenge its novelty or inventive step.
- The Chinese patent examination process emphasizes inventive step and novelty, but existing prior art can impact patent enforceability.
5. Geographic and Industry Context
- Although China’s patent landscape is mature, global patent families often include counterparts in the US, Europe, and Japan. Cross-jurisdictional enforcement depends on corresponding filings and patent family strategies.
Strategic Implications
- Patent Strength: The combination of composition and process claims enhances enforceability.
- Market Exclusivity: The patent potentially extends exclusivity into key Chinese markets, especially if licensing is negotiated or infringement is litigated.
- Innovation Positioning: The patent reflects technological innovation, likely supporting lifecycle management strategies.
Regulatory and Commercial Considerations
- The patent’s scope influences regulatory approvals, particularly in establishing proprietary formulations or manufacturing processes.
- Commercial success depends on how the patent aligns with clinical development stages and market needs.
Key Legal and Strategic Recommendations
- Monitor for potential litigation or patent challenges originating from competitors.
- Explore licensing agreements with patent holders for access to proprietary formulations.
- Track subsequent filings to ensure freedom-to-operate and identify emerging patent thickets.
- For generic manufacturers, identify design-around opportunities that avoid infringement.
Key Takeaways
- CN101228138 offers comprehensive protection covering specific drug formulations and their preparation methods, serving as a robust barrier against generic equivalents.
- Its broad claims could lead to enforcement advantages but may also face challenges if prior art is leveraged successfully.
- The patent landscape surrounding CN101228138 is dense, with multiple filings from industry players seeking either to expand upon or circumvent its scope.
- Strategic positioning should involve continuous monitoring for legal challenges and emerging patents, ensuring sustained market exclusivity.
- Cross-jurisdictional patent strategies are critical, especially considering international patent families and drug market plan considerations.
FAQs
1. What is the primary innovation protected by CN101228138?
It covers a specific pharmaceutical composition and its preparation method, including unique formulations and manufacturing processes designed to enhance drug stability, efficacy, or bioavailability.
2. How does CN101228138 compare with international patents in the same field?
While primarily a Chinese patent, similar functionalities may be protected internationally via patent families; the scope may differ based on local patent laws, but the strategic protections are often aligned with global patent portfolio strategies.
3. Can competitors develop similar drugs without infringing this patent?
Yes, if they modify the formulation or process sufficiently to avoid infringement, such as altering excipient ratios, applying different manufacturing steps, or developing alternative therapeutic methods.
4. What are the risks of patent invalidation for CN101228138?
Major risks include prior art showing lack of novelty or inventive step, or procedural issues during examination. Litigation or patent invalidation actions could challenge its enforceability.
5. How should patent holders maximize the commercial value of CN101228138?
By actively enforcing rights, licensing to strategic partners, pursuing extensions or supplementary patents, and integrating the patent into comprehensive market entry and lifecycle management strategies.
References:
[1] Chinese Patent CN101228138, "A method for preparing a pharmaceutical composition."
[2] Patent landscape analyses, Chinese Patent Office reports, and relevant sector publications.
