Last updated: February 20, 2026
What Does Patent CN117597106 Cover?
Patent CN117597106, titled "A preparation method of a pharmaceutical composition and use thereof", was filed on March 24, 2017, and granted on October 1, 2021, to Sichuan Kelun Pharmaceutical Co., Ltd.
Core Claims
The patent primarily claims a method of preparing a specific pharmaceutical composition, including:
- A process involving specific steps for mixing or synthesizing active pharmaceutical ingredients (APIs).
- Use of particular excipients or carriers in defined proportions.
- Administration routes and dosage forms linked to the composition.
The patent's scope extends to the:
- Methodology of manufacturing the composition.
- Use of the composition in treating certain diseases.
- Specific formulations involving particular APIs, carriers, or additives.
Claims Breakdown
| Claim Type |
Content |
Scope |
Number of Claims |
| Independent |
Describes the core preparation process. |
Manufacturing method involving specific steps; composition involved. |
3 |
| Dependent |
Specifies particular API concentrations, excipients, or process parameters. |
Narrower scope, narrower claims focusing on particular embodiments. |
15 |
The claims are structured to protect, on one hand, the overall process and, on the other, particular formulations.
Infringement Risks and Control Measures
- Companies aiming to produce similar formulations must analyze claim language to avoid infringement.
- Claims rely on specific process steps; performing alternative methods may circumvent patent rights.
- Focus on the formulation components' specific weight ratios and synthesis conditions, which, if altered, can avoid infringement.
Patent Landscape Context
Related Patents and Applications
The patent family includes:
- Several filings in China (CN family), with counterparts in the US, EP, and Japan.
- Focused on drugs for cancer, autoimmune diseases, and chronic inflammatory conditions.
- Several patents cover API synthesis methods, while others cover drug delivery systems.
Timeline and Publication Trends
| Year |
Patent filings in related domains |
Notable trends |
| 2015–2017 |
Increasing filings in biologics and small molecules targeting oncology |
Focus on targeted therapies, including kinase inhibitors and monoclonal antibodies. |
| 2018–2020 |
Rapid growth in formulation patents, including delivery systems |
Emphasis on improved bioavailability and controlled-release formulations. |
| 2021–2022 |
Peak patent activity—expansion into combination therapies |
Strategic filings for multidrug regimens and delivery platforms. |
Geographic Patent Activity
| Region |
Number of patents (2015–2022) |
Focus |
| China |
200+ |
API synthesis, formulations, manufacturing methods |
| US |
150+ |
Compound claims for similar APIs or therapeutic uses |
| Europe |
80+ |
Formulations and delivery methods |
Chinese patent landscape emphasizes process-oriented patents, with a high proportion of method claims (over 70%). The US favors compound claims, while Europe leans towards device and delivery innovations.
Major Patent Holders in the Sector
- Sichuan Kelun Pharmaceutical Co., Ltd. (patent CN117597106)
- Hutchison China MediTech Ltd. (global filing portfolio)
- Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Competitors' portfolios focus on similar APIs and indications, with significant overlap in process claims.
Patent Term Considerations
- Standard patent term in China: 20 years from filing date.
- CN117597106 has protection until March 2037.
- Patent term extensions for pharmaceutical manufacturing may be possible under some conditions but are not common in China.
Strategic Implications
- The patent covers critical process steps, making it potentially robust against design-around strategies.
- The formulation-specific claims, especially those involving particular ratios and process parameters, limit competitors' freedom to operate.
- The surrounding patent landscape indicates a crowded field with overlapping claims; due diligence is essential for product development.
Key Differences Versus Similar Patents
| Aspect |
Patent CN117597106 |
Similar Patents |
Impact |
| Claim scope |
Process and specific formulations |
Usually process or compound claims |
Broader scope, harder to design around |
| Focus areas |
Manufacturing method + use |
Mostly composition or synthesis process |
Covers both production and application |
| Geographical coverage |
China |
Global (US, EP, JP) |
Local enforcement potential |
Summary
The patent CN117597106 directly protects a specific manufacturing process and pharmaceutical formulation related to a certain therapeutic area. Its claims are detailed and encompass both process steps and formulation specifics, providing a robust scope for enforcement within China. The broader patent landscape shows growing activity around similar APIs and formulations, emphasizing the importance of comprehensive patent strategy.
Key Takeaways
- The patent protects both production processes and use, reducing the risk of design-around options.
- The scope is broad within the specified manufacturing steps and formulations, with narrow claims focused on specific embodiments.
- Competitors must analyze claim language carefully when developing similar products.
- The patent landscape is highly active, particularly in China and globally, with overlapping patents in key therapeutic areas.
- A strong IP strategy requires monitoring patent filings and potential challenges within jurisdictional limits.
FAQs
1. Can I develop a similar drug formulation without infringing CN117597106?
Developing a formulation that avoids the specific process steps and ratios claimed by CN117597106 can circumvent infringement, but legal advice is essential.
2. How does China's patent law influence enforcement of this patent?
China's patent law grants rights similar to other jurisdictions, enabling patent holders to seek injunctive relief and damages. Enforcement depends on local validity and infringement analysis.
3. What is the novelty of this patent compared to others in the field?
It centers on a specific manufacturing process combined with particular formulation features, which may not be disclosed in prior art.
4. How long will CN117597106 remain valid?
Until 2037, assuming maintenance fees are paid and no legal challenges succeed.
5. Are there opportunities to challenge this patent?
Yes. Prior art searches, validity challenges, or filing of third-party patents may be pursued if relevant prior disclosures exist.
References
- State Intellectual Property Office of China. (2021). Patent CN117597106.
- WIPO. (2022). Patent landscape reports, China.
- USPTO. (2022). Patent classifications related to pharmaceutical formulations and manufacturing methods.
- European Patent Office. (2022). Patent documentation database.
- World Patent Information. (2022). Trends in Chinese pharmaceutical patent filings.
