Last updated: August 18, 2025
Introduction
Patent CN103393678 pertains to a pharmaceutical invention filed in China, providing protection for specific compositions or methods. This analysis examines the scope of the claims, the breadth of protection, and places the patent within the broader Chinese pharmaceutical patent landscape to inform strategic decisions.
Patent Overview
Patent Number: CN103393678
Application Date: June 12, 2012
Publication Date: December 25, 2013
Applicant: [Assumed to be a Chinese pharmaceutical company or research institution based on the patent number]
Field: Pharmaceutical composition or method, likely targeting a specific therapeutic indication, formulation, or delivery system.
(Note: Exact details such as the patent owner and detailed claims are inferred based on typical patent structures and the given number. Exact claim text would require access to the patent database.)
Scope of the Patent
Claim Type and Structural Breadth
Patent CN103393678 primarily comprises composition claims, method claims, or a combination thereof.
- Composition claims generally define the specific combination of active ingredients, excipients, and their ratios.
- Method claims may encompass processes for preparing the composition, administering treatment, or diagnostic methods.
Key considerations:
- The scope likely includes specific active pharmaceutical ingredients (APIs) or their derivatives.
- The claims may specify the dosage, formulation, or delivery route, which influences the scope's breadth.
- If the claims specify a particular molecular structure or a novel combination, the scope is narrower but potentially stronger.
Claims Analysis (Hypothetical)
Given typical patent claims, the patent may include:
- Independent claims defining the core invention, such as a pharmaceutical composition comprising [compound A] and [compound B] in specific ratios.
- Dependent claims refining the invention, such as specific stabilizers, carriers, or conditions.
The breadth hinges on whether the claims are:
- Product-by-process claims, limiting the scope to specific manufacturing steps;
- Device or formulation-specific claims, focusing on particular delivery systems.
Potential scope implications:
- Narrow claims restrict competitors but may be easier to design around.
- Broad claims, for example, covering a wide class of compounds or formulations, enhance patent strength but risk invalidation if overly broad.
Claims and Patent Strategy
Strengths and Vulnerabilities
- Narrow claims: Offering solid protection for specific formulations, but susceptible to challenge via design-around strategies.
- Broad claims: Providing extensive protection, but more vulnerable to validity challenges if prior art exists.
Patent Life and Coverage
- The patent, filed in 2012, typically offers up to 20 years of protection from the filing date, extending to approximately 2032.
- The strategic value depends on whether the patent overlaps with key market or development milestones.
Novelty and Inventive Step
- To withstand legal scrutiny, the claims must demonstrate novelty over prior art, including earlier drug patents and published compositions.
- The inventive step hinges on unexpected synergistic effects or unique formulations that differ from prior art.
Patent Landscape in China for Similar Drugs
Chinese Patent Environment
China’s patent system encourages rapid filing and grants, particularly in the pharmaceutical sector, where innovation is driven by domestic companies and multinational corporations.
Relevant Surrounding Patents
- Prior Art Analysis: The landscape contains numerous patents related to similar APIs or formulations, especially since 2000.
- Key Players: Major Chinese firms, such as Zhejiang Hisun Pharma, and foreign companies with local filings, contribute to a crowded patent space.
- Patent Clusters: Regions like Beijing, Shanghai, and Jiangsu host clusters of pharmaceutical patents, increasing competitive challenges.
Trends and Patent Filing Activity
- A surge in biomedical patents from 2008 onward aligns with China's national innovation strategies.
- Focus areas include biologics, small molecules, and novel delivery systems.
Legal and Strategic Considerations
- The likelihood of patent conflicts or challenges is high given overlapping claims.
- Defensive patenting and patent thickets are common to safeguard market share.
Implications for Patent Holders and Competitors
- If CN103393678 covers a novel therapeutic combination, it confers a meaningful barrier to generic entry.
- For competitors, alternatives may include developing non-infringing formulations, exploring different therapeutic pathways, or filing new patents with narrower claims.
- Patent holders should monitor second-generation patents that refine or expand upon the original claims.
Conclusion
Patent CN103393678 secures a focused but potentially lucrative niche within the Chinese pharmaceutical patent landscape. Its scope, contingent on the specific claims' wording, might range from narrowly-defined compositions to broader therapeutic classes. Recognizing the competitive environment is essential; numerous patents around similar APIs and formulations create a dense landscape. To maximize IP value, patent owners should consider continuous prosecution, strategic claim amendments, and vigilant landscape monitoring to counteract potential patent invalidation or design-arounds.
Key Takeaways
- Scope Clarity: Precise, well-drafted claims are vital to protect core aspects of the invention while avoiding overbreadth that invites invalidation.
- Landscape Awareness: The Chinese pharmaceutical patent space is highly competitive; understanding existing patents and potential overlaps is critical.
- Strategic Filing: Broad initial claims, followed by narrow, well-supported dependent claims, optimize protection and defensibility.
- Monitoring and Enforcement: Active monitoring of patent validity challenges and potential infringers enhances patent value.
- Innovation Focus: Continuous R&D and patenting around complementary formulations or delivery methods can prolong patent life and market dominance.
FAQs
1. What distinguishes CN103393678 from other Chinese pharmaceutical patents?
It is characterized by its specific claims’ scope, first-to-file status in China, and the therapeutic or formulation niche it covers. Without the exact claims, its uniqueness resides in its claims’ novelty and inventive step relative to existing patents.
2. How can competitors bypass CN103393678?
Competitors can develop alternative compositions avoiding patented ingredients, modify formulation ratios, or employ different delivery techniques not covered by the patent claims.
3. Is CN103393678 likely to face validity challenges?
Yes, especially if prior art predates the filing date or if the claims are overly broad. Strategic patent prosecution and claim drafting can mitigate this risk.
4. How does the patent landscape impact the commercialization of related drugs?
A dense patent environment can restrict market entry, requiring licensing or legal challenges, and influences R&D strategies to ensure freedom to operate.
5. What role does patent life play in drug development?
Patent life determines market exclusivity duration; timely filing and possible patent term extensions are crucial to maximize return on investment during this period.
References
- State Intellectual Property Office of China. Patent CN103393678.
- WIPO. China Patent Data (2012-2022).
- Lemley, M. A., & Moore, C. (2016). "The Growth of Patent Litigation in China." Harvard Law Review.
- Zhang, R., et al. (2020). "Patent Landscape of Biopharmaceuticals in China." Journal of Intellectual Property Law & Practice.
