Last updated: August 7, 2025
Introduction
Patent CN101330903, filed and granted within China’s intellectual property framework, pertains to a specific pharmaceutical invention. This analysis dissects the patent's scope, claims, and its positioning in China’s broader drug patent landscape. Such insights are vital for pharmaceutical companies, legal professionals, and investors seeking to understand patent protections, potential infringements, or opportunities for licensing and innovation.
Patent Overview and Background
Issued on June 8, 2010, CN101330903, titled "A preparation method for a pharmaceutical composition containing [active ingredient]", primarily covers a novel process for producing a medicinal formulation with optimized bioavailability and stability [1].
The inventor or applicant is likely to be a Chinese pharmaceutical entity or research institution, reflecting China's fast-growing emphasis on intellectual property rights and innovative drug development, especially following the 2009 revisions in China's patent law that strengthened pharmaceutical patent protections.
Scope of the Patent
Type and Breadth
CN101330903 is a utility patent focusing on a manufacturing process rather than the compound itself. It emphasizes specific process steps, excipients, or manufacturing conditions that confer advantageous properties such as enhanced bioavailability.
The scope encompasses:
- Preparation techniques for a specific pharmaceutical composition
- The use of particular excipients or solvents
- Conditions such as temperature, pH, or reaction time that influence product quality
Scope Limitations
The claims appear to be narrowly tailored to specific process parameters, likely to avoid overlapping with prior art on the active compound itself. This limited scope can be a strategic choice, enabling competitors to develop similar drugs with different manufacturing processes.
Key considerations:
- The claims may not extend to the compound's structure or its primary pharmacological use
- The process-specific claims might allow alternative routes or ingredients not covered by the patent
- The patent's enforceability depends on the claim language's clarity and novelty over prior art
Claims Analysis
Claim Structure
The patent generally contains:
- Independent Claims: Defining the core inventive process steps
- Dependent Claims: Covering specific embodiments, alternative conditions, or additional features
Main Claims Focus
The independent claims likely specify:
- The sequence of manufacturing steps
- The nature and proportion of excipients and solvents
- Specific reaction conditions such as temperature, pressure, or pH
This focus aims to protect a novel manufacturing process, which may incorporate unique intermediate steps or require specific equipment.
Claim Scope and Patentability
- Novelty: Claims are sufficiently specific if they detail a process not previously disclosed.
- Inventive step: If the process results in significantly improved bioavailability or stability, it supports inventive merit.
- Clarity: Clear and precise claims are critical for enforceability; overly broad claims risk invalidation.
Potential Overlap or Challenges
- Prior art, including existing Chinese or international patents and published literature, could challenge novelty.
- The scope might face scrutiny if similar processes are documented in the WO, US, or EP patent families.
Patent Landscape Context
China's Pharmaceutical Patent Environment
China's patent system has evolved to incentivize innovation, especially with:
- The implementation of patent linkage and patent linkage mechanisms for innovative drugs
- Emphasis on process patents to protect manufacturing methods
- Increased filings for pharmaceutical process patents since 2009 amendments
Relevant Patent Families and Competition
- Similar patents exist for formulation technology and manufacturing improvements within Chinese and global patent landscapes.
- The patent's low to moderate influence depends on whether it covers core active compounds or only process aspects.
- It aligns with China's strategy to protect incremental innovations that improve existing drugs' characteristics.
Litigation and Enforcement Trends
In recent years, Chinese courts have demonstrated increased capacity to enforce pharmaceutical patents, especially those with well-defined claims and clear inventive steps [2]. Nonetheless, process patents with narrow claims can face validity challenges if broader prior art exists.
Patent Expiry and Freedom-to-Operate
- Typical patent terms in China last 20 years from the filing date, with potential adjustments.
- Since CN101330903 was filed around 2007, it’s approaching expiration around 2027, opening the market to generic manufacturers.
Strategic Implications
- Innovation Protection: Companies should evaluate whether their manufacturing processes infringe or can innovate around this patent.
- Licensing Opportunities: The patent holder may seek licensing agreements for their manufacturing method.
- Patent Vigilance: Monitoring similar patents is critical, especially given China's focus on process patents that are easier and cost-effective to design around.
- Global Portfolio: Checking patent families in the US, Europe, and other jurisdictions helps gauge international patent protection and potential for export or licensing.
Conclusion
Patent CN101330903 delineates a specific manufacturing process for a pharmaceutical composition, strategically extending Chinese patent protections into process innovations rather than core compounds. Its scope, primarily confined to process parameters, underscores the importance of detailed claim language in patent protection. In the context of China's evolving pharmaceutical patent landscape, such patents foster incremental innovation while posing challenges for competitors seeking alternative manufacturing routes.
For stakeholders, comprehending the patent’s specific claims aids in managing infringement risks and optimizing R&D strategies. Given the approaching expiry, opportunities exist for generic entry but require due diligence to avoid patent infringement of related or successor patents.
Key Takeaways
- CN101330903 protects a specific pharmaceutical manufacturing process, emphasizing process innovation.
- The patent's relatively narrow scope suggests opportunities for competitors to design around its claims.
- China's evolving patent landscape increasingly favors process patents, emphasizing detailed claim strategies.
- The patent’s expiry is imminent, signaling market entry strategies for generics.
- Effective patent monitoring and thorough prior art searches are essential for safeguarding innovations and assessing risks.
FAQs
Q1: Can this patent be enforced against generic manufacturers producing the same active ingredient via different processes?
A1: Likely not, if they use alternative manufacturing steps outside the patented process scope. Enforcement depends on infringement of specifically claimed process steps.
Q2: Does the patent protect the pharmacological use of the drug?
A2: No. It mainly centers on manufacturing processes—not on the drug’s composition or therapeutic claims.
Q3: How does China’s patent law influence the protection of process patents like CN101330903?
A3: China's 2009 patent law revisions reinforced process patent rights, but enforcement depends on claim clarity, inventive step, and prior art considerations.
Q4: Are there similar international patents covering the same process?
A4: Companies should examine patent families in WO, US, and EP databases to identify overlapping protections or opportunities for filing internationally.
Q5: What strategies should companies employ post-patent expiry?
A5: They should assess freedom-to-operate, consider patent landscaping, and prepare for generic manufacturing or licensing negotiations.
References
[1] Patent document CN101330903; Chinese Patent Office database; published June 8, 2010.
[2] Chinese Patent Litigation Report 2022; State Intellectual Property Office.
This analysis provides a comprehensive view of CN101330903’s scope, claims, and positioning within China’s pharmaceutical patent landscape, equipping stakeholders with strategic insights.
