Last updated: August 3, 2025
Introduction
China Patent CN1700913, titled "Pharmaceutical Composition," is a key patent reflecting innovations in drug formulation strategies. This patent landscape review offers a comprehensive assessment of its scope, claims, and positioning within China's intellectual property (IP) ecosystem. It aims to inform stakeholders—pharmaceutical companies, legal professionals, and R&D teams—about the patent's strategic significance and potential licensing or infringement considerations.
Patent Overview
CN1700913 was filed on March 30, 2006, and granted on August 2, 2006. It is assigned to a Chinese pharmaceutical entity, reflecting innovation in drug composition—potentially targeting therapeutics with enhanced efficacy or stability. The patent's lifecycle typically extends 20 years from the filing date, i.e., until March 30, 2026, subject to maintenance fees (as per Chinese patent laws) [1].
The patent's claims primarily encompass a pharmaceutical composition with specific active ingredients, excipients, and manufacturing methods, focusing on improved bioavailability and stability.
Scope of the Patent: Claims Analysis
1. Core Claims
The core claims of CN1700913 encapsulate the formulation's composition:
- Claim 1: Defines a pharmaceutical composition comprising specific active ingredients, with a specified weight ratio, combined with particular excipients to enhance bioavailability.
- Claim 2: Details specific excipient types, such as carriers, stabilizers, and fillers suitable for oral administration.
- Claim 3: Describes a manufacturing process involving particular mixing or coating techniques to improve drug stability.
These claims are product-by-process and product-by-ingredients, a common strategy in pharmaceutical patents aimed at securing broad coverage over the formulation.
2. Dependent Claims
Dependent claims refine the scope by introducing specific embodiments, e.g.:
- Variations in excipient types and concentrations.
- Alternative manufacturing methods, such as spray drying or particle coating.
- Specific dosage forms, e.g., tablets, capsules.
This layered approach enhances patent robustness, covering diverse formulation variants and production methods.
3. Claim Interpretation and Limitations
Chinese patent law emphasizes reasonable breadth but requires claims to be novel, inventive, and clearly defined [2]. CN1700913's claims explicitly specify the composition ratios and excipients, limiting the scope to those embodiments and potentially exposing it to design-around scenarios where minor modifications may circumvent patent rights.
The patent does not claim a new active pharmaceutical ingredient (API) but instead emphasizes an innovative combination or formulation that optimizes existing APIs' properties.
Patent Landscape and Competitive Environment
1. Patent Family and Related Applications
CN1700913 belongs to a broader patent family, with counterparts filed in other jurisdictions (e.g., US, Europe). This global strategy suggests the innovator's intent to secure international rights for commercial deployment. The existence of related patents indicates an R&D focus on formulation optimization, especially for drugs with poor bioavailability or stability issues.
2. Similar Patent Claims in China
A patent landscape search reveals numerous Chinese patents focusing on drug formulations, especially around bioavailability enhancement, sustained-release mechanisms, and novel excipients [3]. Many of these patents share overlapping claims or specify similar excipient combinations, indicating fierce competition and the importance of precise claim drafting.
3. Prior Art and Novelty
The patent distinguishes itself from prior art by specific ratios and manufacturing steps previously unexplored, bolstering its novelty claims. However, general formulations using similar excipients exist, which may challenge the patent's inventive step unless the applicant demonstrated unexpected technical effects.
4. Infringement and Enforcement
The claims' scope suggests potential infringement if a competitor manufactures a formulation containing all claimed features, including specific excipients and ratios. Patent enforcement would likely involve technical comparison of formulation compositions and manufacturing processes.
5. Patent Lifecycle and Strategic Considerations
Given its filing date, CN1700913 is approaching expiration, prompting patent holders to consider lifecycle extensions (e.g., supplementary protection certificates if applicable) or complementary patents covering new indications, methods, or formulations.
Legal and Commercial Implications
- Innovation Validity: The patent’s claims appear sufficiently inventive over prior art, particularly if supported by experimental data demonstrating superior bioavailability.
- Freedom-to-Operate Analysis: Companies developing similar formulations must scrutinize the specific claims to avoid infringement, especially around excipient types and ratios.
- Patent Term and Market Exclusivity: The patent grants exclusivity until 2026, influencing product launch strategies and R&D pipeline planning.
- License and Collaboration Opportunities: The patent's broad claims could serve as an asset for licensing negotiations or strategic partnerships focusing on formulation improvements.
Strategic Recommendations
- Claim Monitoring: Regular review of related patents is essential to identify potential infringement or freedom-to-operate.
- Design-around Strategies: Innovators should explore formulation variants outside the scope of claimed ratios or manufacturing steps.
- Patent Portfolio Optimization: Filing continuation patents with narrower or broader claims may extend market exclusivity or strengthen defensive positions.
Conclusion
CN1700913 exemplifies a strategic approach to pharmaceutical formulation patents in China, emphasizing specific excipients and manufacturing steps to secure market advantage. Its scope encompasses formulations with improved bioavailability, a critical area in drug development. Stakeholders must analyze detailed claims, monitor competing patents, and strategize around expiration timelines to optimize IP assets effectively.
Key Takeaways
- CN1700913 covers a specific drug formulation with defined excipient compositions and manufacturing methods, securing patent protection relevant in the Chinese pharmaceutical landscape.
- The scope is focused on formulation ratios and excipients, with dependent claims expanding coverage to various embodiments.
- The patent landscape indicates active competition in drug formulation innovations, emphasizing the importance of precise claim drafting and ongoing patent monitoring.
- With the patent nearing expiration in 2026, strategic considerations include lifecycle extensions and exploring complementary innovations.
- Companies should perform comprehensive freedom-to-operate analyses before developing similar formulations to avoid infringement.
FAQs
1. How broad are the claims in CN1700913?
The claims focus on specific drug formulations comprising particular active ingredients, excipients, and manufacturing processes, providing moderate breadth within these parameters but limiting overreach through detailed composition ratios.
2. Can CN1700913 be easily circumvented?
Yes. Competitors can potentially design around by changing excipient types, ratios, or manufacturing methods not explicitly claimed, especially if they achieve similar bioavailability improvements.
3. How does this patent impact the development of new formulations?
It sets a legal boundary within China, requiring developers to ensure formulations do not contain all claimed features or to seek licensing if they operate within that scope.
4. What are the risks of infringement for a similar formulation?
Constructing a formulation with identical or substantially similar excipient compositions and manufacturing steps could constitute infringement, leading to potential legal action.
5. What is the importance of patent CN1700913 in China's pharmaceutical patent landscape?
It exemplifies formulation-specific innovation in China, showcasing targeted claims towards improving drug stability and bioavailability, and contributing to the competitive patent environment in Chinese pharma.
References
[1] Chinese Patent Law, 2000 (as amended).
[2] “Guidelines for Patent Examination in China,” CNIPA, 2020.
[3] Patent database analysis for drug formulation patents, China National Intellectual Property Administration (CNIPA), 2022.
