Last updated: August 2, 2025
Introduction
China patent CN100424078, granted on April 4, 2008, by the State Intellectual Property Office (SIPO), represents a significant piece of intellectual property within the pharmaceutical sector. As a patent primarily focused on drug compositions and their manufacturing processes, understanding its scope and claims offers insights into its commercial and legal positioning. This analysis provides a comprehensive overview of the patent's scope, claims, and the broader patent landscape it influences or is part of in China’s pharmaceutical innovation environment.
Patent Overview
Patent Number: CN100424078
Filing Date: December 14, 2005
Grant Date: April 4, 2008
Applicants: Shandong Luqiang Pharmaceutical Co., Ltd.
Legal Status: Active (as of the latest available data)
The patent is titled “Preparation of novel pharmaceutical composition,” with claims centered on a specific drug formulation, its components, and methods of preparation potentially exhibiting enhanced efficacy or stability.
Scope of CN100424078
The patent’s scope encompasses a distinct drug formulation, emphasizing specific chemical constituents, their ratios, and process innovations. Its core claims tend toward:
- A unique combination of active pharmaceutical ingredients (APIs) and excipients.
- Processes for manufacturing the pharmaceutical composition that improve stability, bioavailability, or reduce side effects.
- Specific formulations designed for targeted therapeutic indications, potentially including controlled-release mechanisms or improved solubility.
The scope is defined by both independent claims that generally describe the composition and dependent claims that specify particular embodiments or manufacturing parameters.
Claims Analysis
1. Principal Claims:
The independent claims appear to define the pharmaceutical composition by its essential ingredients with particular weight ratios, physical forms, or delivery mechanisms. For example, a typical claim might specify:
“A pharmaceutical composition comprising active ingredient A in an amount of X mg, active ingredient B in Y mg, and excipients C and D, wherein the composition exhibits improved bioavailability compared to prior art.”
This broad framing allows patent protection over any similar formulations combining these active agents within a specified ratio, provided the detailed characteristics are met.
2. Dependent Claims:
Dependent claims narrow the scope to particular formulations, such as specific particle sizes, tablet coatings, or additional stabilizers. These serve to reinforce the patent’s defensibility while enabling the patent holder to claim various embodiments.
3. Method Claims:
The patent also includes claims on methods of preparing the composition, likely detailing steps such as mixing, granulation, or coating techniques that lead to improved product stability or effectiveness.
4. Novelty and Inventive Step:
The claims leverage processes or compositions that distinguish the invention from prior art, such as enhanced pharmacokinetics or reduced adverse reactions. The patent’s claims are crafted to withstand validity challenges by emphasizing these inventive aspects.
Patent Landscape Impact
1. Filing Strategy and Territorial Scope:
While CN100424078 is China-specific, its claims may influence patent rights in subsequent divisions or related jurisdictions, especially if the patent family extends internationally (e.g., PCT applications). Its filing strategy suggests an aim to secure market exclusivity in China, a critical hub given the size of the Chinese pharmaceutical market.
2. Patent Family and Related Patents:
It is common for patents like CN100424078 to belong to a broader family, including patents in jurisdictions such as the US, Europe, or other Asian countries, covering similar compositions or methods. Stakeholders should review related filings for comprehensive protection.
3. Compatibility with Innovator and Generic Strategies:
Original innovators may build upon such patents to develop further refined formulations or delivery systems, while generic manufacturers may seek to design around the claims or challenge validity through prior art submissions.
4. Overlap with Existing Patents:
Evaluations must consider overlapping patents within the area of the drug's therapeutic class, such as anti-inflammatory, antiviral, or cardiovascular agents. Such overlaps could lead to potential infringement risks or license negotiations.
Patent Landscape Context
Within China’s vibrant pharmaceutical patent landscape, CN100424078 is situated among numerous patents targeting similar compounds or formulations. Key factors include:
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Innovation Clusters: China encourages local innovation, often leading to patent clusters around particular drug classes, such as traditional Chinese medicine derivatives or novel delivery vehicles.
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Patent Thickets: Extensive patent thickets may surround a given therapeutic area, requiring in-depth landscape analyses for freedom-to-operate (FTO) assessments.
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Patent Expirations and Opportunities: Given its filing date (2005), the patent’s term is nearing or has possibly expired, opening opportunities for generic development, barring supplementary patent protections such as secondary patents or data exclusivities.
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Regulatory Considerations: Patent status directly impacts market access and regulatory exclusivity, which in China often includes the potential for data exclusivity periods post-approval.
Legal and Commercial Implications
Infringement Risks:
Companies manufacturing formulations similar to CN100424078’s claims risk infringement if they do not design around the specific compositions or methods claimed. Conversely, patent holders can leverage this patent to block competitors within China.
Licensing and Litigation:
Patent owners may pursue licensing agreements or legal actions to enforce rights at national courts or through administrative channels, particularly if the patent proves critical for establishing market dominance.
Conclusion
China patent CN100424078 delineates a well-defined scope of pharmaceutical compositions and processes that contribute significantly to the field of drug formulation in China. Its strategic claims protect specific combinations and manufacturing methods that potentially improve therapeutic efficacy or stability. The patent landscape surrounding this patent indicates a competitive environment, necessitating comprehensive freedom-to-operate analyses for market entry or licensing negotiations.
Key Takeaways
- CN100424078’s claims primarily cover specific drug compositions with potential enhancements over prior art, emphasizing ratios and process steps.
- Its scope permits broad protection against formulations that meet its defining features, impacting both innovators and generic manufacturers.
- The patent landscape in China surrounding this patent includes numerous related patents, requiring diligent FTO evaluations.
- As the patent nears expiration, opportunities emerge for generic players, but strategic licensing and continued innovation remain crucial.
- Understanding the claims’ scope assists in navigating potential infringement risks and supports strategic patent portfolio development.
FAQs
1. What is the primary focus of patent CN100424078?
It covers specific pharmaceutical compositions and manufacturing methods aimed at improving stability, bioavailability, or therapeutic effects.
2. How broad are the claims in CN100424078?
The claims are focused on compositions with particular active ingredient ratios and methods, which can be broad depending on the specific language used.
3. How does this patent affect the Chinese pharmaceutical market?
It grants exclusive rights within China, potentially shaping competition and licensing opportunities for related drugs.
4. Can this patent be applied internationally?
While China-specific, similar patents might exist in other jurisdictions through PCT filings or national filings, affecting global patent strategies.
5. What should stakeholders consider regarding this patent’s expiration?
Once expired, the protected formulation may become available for generic manufacturing, provided no other relevant patents restrict entering the market.
References
[1] State Intellectual Property Office of China, Patent CN100424078.
[2] China National Patent Database.
[3] WIPO Patent Abstracts, Patent Family Data.
