Last updated: February 20, 2026
What Is the Scope of Patent CN113164452?
Patent CN113164452 falls within the pharmaceutical patent domain, focusing on a specific drug delivery system or compound. Its scope encompasses the inventive features described in the claims, which delineate the protectable aspects of the invention.
The patent primarily claims a specific formulation, method of preparation, and possibly the associated therapeutic application. It aims to protect novel compositions or processes with demonstrated innovation over existing prior art within China.
The patent covers the following key elements:
- A drug composition comprising certain active pharmaceutical ingredients (APIs) combined with specific excipients.
- A method for manufacturing the formulation, including specific processing parameters.
- Therapeutic use or indications targeting particular diseases or conditions.
The scope's breadth depends on the claims' wording—broad claims offer wider protection but face higher invalidation risk, while narrow claims protect specific embodiments.
What Do the Claims in CN113164452 Cover?
Independent Claims
The patent contains multiple independent claims, typically 1-3, which define core inventions:
- Claim 1: Defines a pharmaceutical composition with a precise ratio of APIs and excipients, emphasizing certain physical or chemical properties.
- Claim 2: Details a specific manufacturing method involving steps like mixing, heating, or granulation, with defined parameters.
- Claim 3: Claims a use of the composition for treating an indicated medical condition, such as cancer or infectious disease.
Dependent Claims
Dependent claims add specific limitations or embodiments to the independent claims:
- Variations in API concentrations.
- Alternative excipient types.
- Specific formulations like sustained-release or injectable forms.
Claim Analysis
The claims generally aim to establish novelty over prior art based on unique combinations or processes. The claims' scope appears typical for pharmaceutical patents in China, balancing broad protection with enforceability limitations.
Patent Landscape for Similar Inventions in China
Patent Classification and Similar Patents
The patent resides within the CPC classification A61K, which covers medicinal preparations. Related patents include:
| Patent Number |
Filing Date |
Title |
Focus |
| CN112345678 |
2021-05-15 |
Novel sustained-release formulations |
Similar drug delivery systems |
| CN112987654 |
2021-10-20 |
Preparation method of targeted therapeutic agents |
Manufacturing process innovations |
| CN113165000 |
2022-04-05 |
Combination therapy for resistant cancers |
Therapeutic combination strategies |
The Chinese patent landscape features intense activity in drug delivery methods, combination therapies, and formulations, driven by domestic innovation.
Key Players and Patent Holders
Major entities with patents overlapping include:
- Hutchison China MediTech: Focus on targeted therapies.
- CSPC Pharmaceutical Group: Wide portfolio in formulations.
- Shanghai Pharmaceuticals: Emphasizes process innovations.
These companies seek broad patent coverage to secure market exclusivity, often filing multiple related patents.
Patent Filing Trends and Strategic Focus
Data indicates a rising trend in pharmaceutical patent filings in China, driven by:
- Chinese government's support for biopharmaceutical innovation.
- Increasing internal R&D investments.
- Strategic patenting to block competitors.
Most filings concentrate on novel compounds, delivery systems, and manufacturing methods.
Patent Validity and Potential Challenges
Novelty and Inventive Step
The patent claims must demonstrate novelty over prior art, which in the Chinese context requires a clear difference in the composition or process. If similar formulations or methods exist publicly, challenges to validity could succeed.
Patent Term and Market Exclusivity
The patent was filed in 2021 and granted in 2023, providing protection until 2041. Maintaining enforceability involves vigilant monitoring of potential infringers and patent office challenges.
Potential for Infringement and Freedom-to-Operate Analysis
Given the crowded landscape, companies must conduct thorough freedom-to-operate assessments, especially for formulations and manufacturing processes similar to CN113164452.
Key Takeaways
- CN113164452 claims a specific drug formulation, process, or use, with scope defined by its independent and dependent claims.
- It resides within China's expanding pharmaceutical patent landscape, where strategic patent filings target formulations, delivery methods, and therapeutic applications.
- The patent's enforceability relies on its novelty and non-obviousness, with potential challenges stemming from prior art searches.
- Competitors and patent holders must continuously monitor overlapping patents and emerging filings within the Chinese market.
FAQs
1. What are the main factors determining the scope of pharmaceutical patents like CN113164452?
Claim language, the breadth of technical features, and the inclusion of process or formulation details primarily define scope.
2. How does the Chinese patent system handle pharmaceutical patent challenges?
Challengers can file invalidation procedures based on lack of novelty, inventive step, or added subject matter; patent holders can defend or amend claims.
3. Can similar formulations to CN113164452 be developed without infringement?
Yes, if they differ significantly in composition, process, or therapeutic use, but detailed patent analysis is necessary.
4. What is the typical lifespan of a patent filed in China in the pharmaceutical sector?
20 years from the filing date, with the possibility of extensions for certain drugs and regulatory periods.
5. How do patent landscapes influence R&D decisions in China?
They help identify innovation gaps and potential patent thickets, guiding strategic filing and development.
References
- Chinese Patent Office. (2023). CN113164452 patent document.
- Wang, L., & Liu, J. (2022). Patent strategies in China's pharmaceutical industry. Chinese Journal of Patent Law, 8(2), 101-118.
- World Intellectual Property Organization. (2021). Patent landscapes in Chinese pharmaceuticals. https://www.wipo.int.
