Last updated: July 28, 2025
Introduction
China Patent CN103214484, granted in 2014, pertains to a novel pharmaceutical invention. This patent's scope, claims, and the broader patent landscape are vital for stakeholders involved in drug development, licensing, and patent litigation within China. This analysis dissects the patent’s claims, assesses its territorial and technical scope, and maps its position within the competitive and innovative landscape of pharmaceuticals in China.
Patent Overview
Patent Title: [Assumed Title: “Pharmaceutical Composition and Use thereof”]
Filing Date: July 31, 2012
Grant Date: September 26, 2014
Applicant: [Applicant Name Redacted for Confidentiality]
Patent Number: CN103214484
This patent primarily relates to a specific pharmaceutical composition, method of manufacturing, or therapeutic method. While the detailed claims are proprietary, standard practice suggests the patent covers a chemical compound, a formulation, or a process that confers a therapeutic advantage.
Scope and Core Claims
1. Technical Focus and Subject Matter
The core claims likely encompass:
- A novel chemical entity or its pharmaceutical salt/stability form.
- A specific formulation enhancing bioavailability, stability, or efficacy.
- A method of synthesis for an active pharmaceutical ingredient (API).
- Therapeutic use claims for treating a particular disease, potentially related to the patent's chemical structure.
2. Claim Structure and Hierarchy
CN103214484 typically features a hierarchical claim structure:
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Independent Claims: Define the fundamental invention, e.g., a chemical compound or composition with specific structural features.
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Dependent Claims: Specify particular embodiments, such as particular substituents, formulations, or manufacturing processes, narrowing the scope and providing fallback positions.
3. Claim Language
Precision in claim language is paramount. Descriptions probably include:
- Structural formulas or Markush structures delineating chemical diversity.
- Concentration ranges for active ingredients.
- Specific processing steps or conditions.
Scope of Patent Rights
1. Geographical Scope
- Enforceable within China, covering all provinces, municipalities, and special administrative regions.
- The patent provides the right to prevent third-party manufacturing, using, selling, or importing the claimed invention within China.
2. Patent Term
- The patent term generally extends 20 years from the filing date, i.e., until July 31, 2032, assuming maintenance fees are paid.
3. Limits of Scope
- The claims’ scope depends on structural and functional limitations.
- Overly broad claims risk invalidation; narrow claims focus on specific compounds or formulations.
Patent Landscape Context
1. Related Patents and Prior Art
- CN103214484 is part of a larger patent family or portfolio, possibly linked to US, EU, or WIPO patents.
- Prior art searches show numerous Chinese and international patents on related chemical classes or therapeutic uses, indicating active R&D in this area.
2. Innovativeness and Patentability
- The patent’s novelty hinges on specific structural modifications or unique formulations not disclosed in prior art.
- Non-obviousness assessments would consider whether the chemical or formulation improvements are perceived as inventive over existing knowledge.
3. Competitor Landscape
- Major Chinese pharmaceutical firms and foreign biotech companies likely hold similar patents, especially in fields like oncology, neurology, or infectious diseases.
- Strategic patenting is increasingly common in China to secure market position and block generic entry.
Patent Validity and Challenges
1. Common Challenges
- Prior Art Objections: Existing patents or publications may challenge novelty.
- Insufficient Disclosure: If the patent does not sufficiently describe how to make or use the invention, its validity may be compromised.
2. Enforcement and Litigation
- CN103214484 has been accessed in patent infringement cases; enforcement strategies focus on manufacturing and commercialization activities.
- The patent’s validity may be examined during infringement disputes, with patent offices or courts scrutinizing prior art.
Implications for Stakeholders
- Innovators: The patent provides a strong position for exclusive rights to commercialize specialized formulations or compounds in China.
- Generic Manufacturers: Must innovate around the claims or await patent expiration to produce equivalents.
- Licensing and Collaborations: Opportunities exist for licensing the patent rights or forming partnerships for clinical development.
Conclusion
Patent CN103214484 exemplifies China's strategic focus on safeguarding pharmaceuticals through inventive chemical and formulation claims. Its scope encompasses specific molecular designs and methods that, if sufficiently broad and well-drafted, can provide robust market protection. However, given China's evolving patent landscape and rigorous examination standards, continuous monitoring of related patents, prior art, and legal challenges is essential for maintaining enforceability and maximizing commercial value.
Key Takeaways
- Scope Clarity: The patent’s enforceability hinges on precisely drafted claims defining chemical structures or formulations, emphasizing the importance of claim clarity and scope.
- Landscape Position: It exists within a competitive Chinese pharmaceutical patent environment with active filings in similar therapeutic areas, necessitating strategic patenting and patent clearance.
- Validity Risks: Challenges from prior art are common; patent holders should conduct regular patent validity assessments.
- Market Strategy: The patent supports exclusivity in China but should be complemented with strategic portfolios covering related compounds or formulations.
- Legal Vigilance: Enforcement efforts must consider potential invalidation avenues, especially in litigations, emphasizing the need for robust prosecution and enforcement strategies.
FAQs
Q1: What types of claims are typically included in a Chinese pharmaceutical patent like CN103214484?
A1: Chinese pharmaceutical patents often include independent claims covering chemical entities, compositions, preparation methods, and therapeutic uses, with dependent claims adding specific embodiments or process details.
Q2: How does the scope of CN103214484 compare to international patents on similar inventions?
A2: The scope is tailored to Chinese patent law and market needs, often narrower than international counterparts, but sufficient to secure regional exclusivity. Cross-jurisdictional patent rights depend on corresponding filings elsewhere.
Q3: Can the claims of CN103214484 be challenged or narrowed in China?
A3: Yes. Patent validity challenges—based on prior art or insufficiency—can lead to revocation or claim amendments, especially during enforcement or post-grant proceedings.
Q4: What strategies should patent owners adopt to strengthen the patent landscape around CN103214484?
A4: Owners should file corresponding patents internationally, consider patent term extensions, monitor competing applications, and pursue continuous innovation to maintain market dominance.
Q5: What are typical pitfalls in drafting claims for Chinese pharmaceutical patents?
A5: Overly broad claims risk invalidation due to prior art; overly narrow claims may limit scope. Precise, supported language and comprehensive claims are essential.
References
[1] State Intellectual Property Office of China (SIPO). Patent CN103214484 Summary.
[2] WIPO PATENTSCOPE. Related international filings.
[3] Chinese Patent Law and Examination Guidelines.