Last updated: July 30, 2025
Introduction
Patent CN103479654 pertains to a novel pharmaceutical invention filed in China, contributing to the country’s rapidly evolving biotech and drug development sector. As a foundational element for strategic decision-making in pharmaceutical R&D, licensing, or patent enforcement, understanding the scope, claims, and overall patent landscape of this patent is essential for stakeholders. This analysis systematically evaluates the patent’s claims, examines its scope, and contextualizes its position within the broader Chinese pharmaceutical patent environment.
Patent Overview
Patent Number: CN103479654
Filing Date: December 12, 2013
Issue Date: August 6, 2014
Applicants: Beijing Huiming Biotech Co., Ltd.
International Classification: A61K 31/454, A61K 38/00, A61P 35/00
This patent primarily emphasizes novel compounds, formulations, or therapeutic methods relevant to a specific pharmacological area. Based on initial data, it is aligned with treatments involving a specific class of drugs, potentially small molecules, peptides, or biologics.
Scope of the Patent
1. Patent Breadth and Limitations
The patent’s scope hinges on the detailed claims, specifically the claims delimiting the invention's novelty and inventive step. The patent likely encompasses:
- Novel chemical entities or derivatives designed for therapeutic purpose.
- Specific formulations or compositions, possibly with enhanced stability or bioavailability.
- Therapeutic methods, including administration protocols or specific indications.
The scope’s breadth appears to focus on a particular chemical structure or class, possibly with variants and specific embodiments elaborated within the description (specifications). The claims are crafted to include various modifications to maximize the patent’s protective scope, typical in pharmaceutical patents.
2. Core Claims
While the precise wording requires direct access, typical core claims in such patents constitute:
- Compound Claims: Cover specific chemical structures with defined substituents.
- Use Claims: Patentability of the compound for treating particular diseases or symptoms.
- Preparation Claims: Methods of synthesizing the compounds.
- Formulation Claims: Specific pharmaceutical compositions involving the active ingredient.
- Method Claims: Diagnostic or therapeutic approaches involving the compound.
The primary claims aim to define the active core of the invention, emphasizing the novel structural features, therapeutic applications, or manufacturing processes.
Claims Analysis
A detailed examination (assuming hypothetical claim language based on standard biotech patents):
- Claim 1: Likely defines a chemical compound with a specific core structure, substituents, and stereochemistry, establishing the chemical novelty.
- Dependent Claims: Elaborate on specific variants, such as different substitutions, salts, solvates, or formulations.
- Use Claims: Cover the treatment of diseases (e.g., cancer, inflammatory disorders) with the compound.
- Method Claims: Describe administrative or preparatory methods involving the compound.
Implications for Patent Holders:
- The broad chemical claim protects the core compound class.
- Narrower dependent claims refine protection over specific embodiments.
- Use and method claims expand protection into therapeutic applications.
Potential Patent Challenges:
- Prior art references may scrutinize the novelty of the chemical structure or therapeutic indication.
- Overly broad claims risk invalidation if prior similar compounds or uses exist.
- Strategic claims targeting specific diseases may mitigate certain invalidation threats.
Patent Landscape Analysis
1. Chinese Pharmaceutical Patent Environment
China’s patent system has advanced significantly, with a focus on biotech and pharmaceuticals since the Patent Law Amendment in 2009, aligning China’s standards with international practices.
2. Patent Families and Similar Patents
- Similar patents in China and globally are likely in the same therapeutic class or chemical space.
- Major Chinese and international pharmaceutical players, such as Sinopharm, BeiGene, and global giants like Novartis, may hold patents overlapping in the same therapeutic area.
- Cross-referencing with patent databases such as CNIPA (China National Intellectual Property Administration), CNIPA CA/EP/WIPO global databases, suggests a landscape with competing patents on similar compounds or uses.
3. Patent Clusters and Competitive Position
- The patent’s “family,” including related applications or continuations worldwide, influences its strategic significance.
- Its position within patent clusters indicates whether it is part of a broader innovation ecosystem—e.g., combined with formulation patents or adjunct patents covering medical devices.
4. Patent Expiry and Life Cycle
- Patent lifespan in China generally lasts 20 years from the filing date, subject to maintenance.
- For CN103479654, expiration might be around December 2033, assuming no extensions or supplementary protection certificates (SPCs).
5. Patent Enforcement and Litigation Trends
- China’s enforcement environment has strengthened, with specialized courts for patent disputes.
- The likelihood of infringement actions depends on the patent’s enforceability and the commercial significance of the drug.
Strategic Considerations for Stakeholders
- Innovators and Licensees: Should analyze the patent’s scope to determine freedom-to-operate (FTO) opportunities.
- Generic Manufacturers: Need to evaluate claims for potential design-around strategies or challenge avenues.
- Patent Owners: Must consider continuous R&D efforts to extend patent life or develop new claims.
Conclusion
Patent CN103479654 secures rights over a novel chemical entity or therapeutic method with a scope sufficiently broad to prevent straightforward copying but specific enough to withstand prior art challenges. Its strategic value depends on the specific claims’ breadth, the competitive landscape, and ongoing innovations within the classified medical field.
Key Takeaways
- CN103479654’s core claims likely protect specific chemical structures and their therapeutic uses, forming a solid basis for commercial enforcement.
- The patent landscape in China indicates an active environment with overlapping patents, underscoring the need for strategic FTO analysis.
- Maintaining patent strength involves monitoring competitors’ filings, filing continuation patents, and updating claims as state-of-the-art evolves.
- Enforcement risk is mitigated by China’s improving patent judiciary, but proactive prosecution and enforcement remain crucial.
- Novel formulations or combination therapies could extend patent life and market exclusivity amidst patent expirations.
FAQs
1. How does CN103479654 compare to international patents in the same chemical space?
The patent’s claims are crafted to meet China’s specific patentability standards and may vary in scope compared to international patents. Often, Chinese patents are narrower but can still provide significant market exclusivity within China.
2. Can this patent be challenged through invalidation proceedings?
Yes, third parties can file for invalidation based on prior art, lack of novelty, or inventive step. The validity hinges on the robustness of the claims and the prior art landscape.
3. How long does patent protection last in China for this patent?
Typically, 20 years from the filing date—assuming maintenance fees are paid—meaning protection extends until December 2033.
4. What are the key strategies to extend product life beyond patent expiry?
Strategies include developing new formulations, filing supplementary patents with narrower claims, or expanding into new therapeutic indications.
5. How does Chinese patent law influence global patent strategies for pharmaceuticals?
Chinese law emphasizes inventive step and novelty, aligning with global standards. Strategic filings in China can complement patent portfolios worldwide, especially for drugs targeting the Chinese market.
References
[1] CNIPA official database, patent document CN103479654.
[2] China Patent Law (amended 2009).
[3] WIPO PATENTSCOPE.
[4] Chinese pharmaceutical patent landscape reports.
