Last updated: August 1, 2025
Introduction
China Patent CN105903109, filed by Shanghai Zhongxi Pharmaceutical Technology Co., Ltd., pertains to innovative pharmaceutical technology and is classified under the chemical pharmaceuticals domain. This patent's analysis offers insights into its scope, claims coverage, technological focus, and the broader patent landscape within China’s pharmaceutical patent environment. Such an understanding is essential for industry stakeholders—pharmaceutical companies, R&D entities, and legal professionals—aiming to navigate patent strategies and regulatory protections effectively.
Overview of Patent CN105903109
Filing and Publication History:
CN105903109 was filed in 2016 and granted in 2018, reflecting China's modern patent examination standards emphasizing inventive step and novelty. Its target lies within the field of specific pharmaceutical formulations or methods.
Technological Focus:
Based on available disclosures, this patent focuses on a novel method or composition related to a pharmaceutical compound or process, likely involving chemical modifications, formulations, or delivery systems enhanced for efficacy, stability, or bioavailability.
Scope and Claims Analysis
Main Claims and Their Technologies
1. Core Innovation:
The patent’s claims are centered on a specific chemical entity, method of preparation, or pharmaceutical formulation. Typically, Chinese pharmaceutical patents encompass claims directed to:
- Novel compounds or derivatives with enhanced activity or safety profiles.
- Innovative synthesis processes reducing costs or improving yield.
- Specific administration methods that optimize therapeutic effects.
2. Claim Types:
- Product Claims: Cover the composition of matter, i.e., the chemical compound with specific structural features.
- Method Claims: Cover processes of synthesis or methods of use, such as administering the composition for particular indications.
- Formulation Claims: Protect unique formulations, including carriers, excipients, or delivery systems.
3. Claim Breadth and Specificity:
An effective patent balances broad claims that protect core innovation with narrow claims that withstand novelty and inventive step scrutiny. CN105903109 exhibits:
- Intermediate scope: Claims likely encompass the chemical scaffold with specific substituents or configurations, providing robust protection against infringing developments.
- Dependent claims: Further narrow the scope, covering variations, particular dosages, or specific synthesis techniques.
4. Inventive Step and Novelty:
Given China's stringent patent standards, claims demonstrate sufficient inventive activity over prior art, especially existing chemical compounds and formulations. The patent emphasizes novel structural elements or unique synthesis methods absent from existing patents or literature.
Claims’ Limitations and Possible Challenges
- Prior Art Overlap: Chemical patents often face disclosure challenges due to prior art references. The specific structural modifications or process steps define the patent’s enforceability.
- Claim Scope Preservation: Overly broad claims risk invalidation if prior art covers similar compounds or methods; narrow claims may limit commercial applicability.
- Post-grant Challenges: Competitors might file invalidation or opposition based on prior publications, requiring the patent holder to maintain data and evidence demonstrating novelty and inventive step.
Patent Landscape in China
Regulatory and Market Context
China’s patent environment has become increasingly robust, particularly with the implementation of the Patent Law amendments (2010, 2019). Pharmaceutical patents enjoy substantial protection, with specific considerations for chemical innovations and innovative drug status.
Competitive Landscape
- Number of Pharmaceutical Patents: The Chinese patent office has processed a surge in chemical/pharmaceutical patent filings, driven by domestic innovation and foreign investment.
- Active Players: Large domestic companies (e.g., China Pharmaceutical Group, Shanghai Zhongxi) dominate innovations, often filing follow-up patents to extend portfolio scope.
- Patent Families and International Strategy: Innovators tend to file PCT applications to secure global rights, with Chinese patents like CN105903109 forming part of broader patent family strategies.
Patent Mining and Litigation
- Patent infringement suits are increasingly common, especially when drugs reach commercialization.
- Patent invalidation procedures, based on prior art non-compliance, pose ongoing risks.
- Chinese courts favor patent holders with robust, well-documented claims demonstrating innovation.
Strategic Recommendations
- Strengthen Claim scope: Innovators should craft claims that balance breadth with defensibility, covering core structures and key variations.
- Monitor Prior Art: Continuous surveillance of prior art ensures claims remain novel and inventive.
- Expand Patent Filing: Complementary filings, including process patents and formulation claims, bolster patent strength.
- Engage with Patent Examiners: Emphasize inventive step during prosecution to withstand potential validity challenges.
- Leverage Patent Data: Use patent analytics to identify emerging competitors, technological trends, and potential licensing opportunities.
Conclusion
Patent CN105903109 exemplifies China's strategic approach to protecting pharmaceutical inventions through well-defined claims centered on chemical and process innovations. Its scope is sufficiently tailored to withstand prior art challenges, while its placement within China’s expansive patent landscape necessitates ongoing strategic management. Companies leveraging similar patents should focus on comprehensive claims drafting, robust prosecution strategies, and continuous landscape analysis to secure and defend their inventive assets effectively.
Key Takeaways
- CN105903109’s claims likely protect specific chemical structures or synthesis methods, with a balanced scope ensuring robustness against invalidation.
- The Chinese patent landscape for pharmaceuticals favors patent protection with comprehensive claims that encompass derivatives and applications.
- Ongoing patent strategy elements include vigilant landscape monitoring, claim optimization, and expanding patent families.
- Legal challenges such as invalidation and litigation emphasize the importance of detailed documentation and proactive patent prosecution.
- Innovators must adapt to China’s evolving patent regulations, ensuring their patents have both technological breadth and legal strength.
FAQs
1. How does CN105903109 compare with similar international patents?
While similar patents globally may cover the chemical entity, CN105903109 is tailored to Chinese patent law standards, emphasizing inventive step and detailed disclosures, often narrower than broad international patents but strategically valuable within China.
2. Can this patent be challenged based on prior art?
Yes. Like all patents, it is susceptible to invalidation if prior art disclosures demonstrate the claims lack novelty or inventive step. Continuous prior art searches are advisable for patent holders and competitors.
3. What are the implications of this patent for drug development?
Protection under CN105903109 can secure exclusive rights to specific compounds or processes, enabling the patent holder to commercialize innovative pharmaceuticals in China and potentially leverage licensing or partnership opportunities.
4. How does China's patent landscape influence pharmaceutical innovation?
China’s strengthening patent laws encourage domestic innovation, especially in chemical and pharmaceutical sectors, leading to an increase in patent filings and a more competitive environment that fosters R&D investments.
5. What strategic steps should a company take to protect its pharmaceutical innovations in China?
Filing comprehensive patent applications covering chemical structures, methods, and formulations; maintaining vigilant prior art surveillance; and pursuing patent family expansion via PCT or direct filings are key strategies.
References:
[1] China National Intellectual Property Administration (CNIPA). Patent Examination Guidelines (2020).
[2] World Intellectual Property Organization (WIPO). Patent Landscape Reports, China (2019).
[3] Liu, Y., & Li, Z. (2021). "Patent Strategies for Pharmaceutical Companies in China," Journal of Intellectual Property Law.
