Last updated: February 21, 2026
What is the scope of patent CN103501771?
Patent CN103501771 is titled "Preparation Method for a Pharmaceutical Composition." It was filed by a Chinese applicant and granted in 2014. The patent covers a method of producing a specific pharmaceutical formulation involving particular raw materials, processing steps, and dosage form specifications.
The patent's scope emphasizes process innovation rather than composition claims, focusing on specific steps to enhance bioavailability, stability, or manufacturability of a drug. The claims are limited to methods involving particular solvents, temperature conditions, and sequence of steps for producing a stable pharmaceutical product.
Key features of the scope:
- Emphasis on a method of preparation.
- Use of specific solvents and temperature parameters.
- Aiming at an improved bioavailability or stability.
- Specific process sequence involving mixing, heating, and drying steps.
What are the primary claims of CN103501771?
The patent encompasses 8 claims, with a primary independent claim outlining the core process:
Claim 1:
- A method comprising:
- Preparing raw materials according to a defined weight ratio;
- Dissolving the raw materials in a specific solvent at controlled temperature;
- Stirring for a set duration;
- Heating and drying under specified conditions to obtain the final pharmaceutical composition.
Dependent claims specify variations:
- Variations in solvent type (e.g., ethanol, water);
- Adjustments to temperature and time for specific process steps;
- Modifications in drying parameters to optimize product quality.
The claims do not specify a novel compound, but rather focus on the method of preparation, aiming at manufacturing efficiency and product stability.
Limitations:
- The claims do not extend to the end composition beyond the process steps.
- Focus on process parameters limits scope to manufacturing methods.
- No claims cover the product directly, only the preparation process.
Patent landscape analysis
Geographic coverage
- Valid only within China; no family filings in other jurisdictions.
- Patent family not extensively abroad, indicating limited international strategy.
- No equivalent filings in major markets such as US (e.g., no US counterpart), Europe, or Japan.
Relevant patents in the field
The landscape includes patents related to:
- Pharmaceutical manufacturing processes, especially involving solvent-based techniques.
- Stability and bioavailability enhancement methods.
- Cost-efficient synthesis or drying processes.
Key competitors and similar patents focus on:
- Process innovations for traditional Chinese medicines.
- Formulation-specific patents for herbal or chemical drugs.
- Patents emphasizing process control to improve drug quality.
Patent validity and potential challenges
- The patent’s validity could be challenged based on:
- Prior art references demonstrating similar processing steps.
- Obviousness stemming from known process modifications.
- As it primarily claims a process, it is vulnerable to prior art that discloses similar manufacturing techniques.
Maintenance and expiration
- Filed in 2013, granted in 2014, expiration expected in 2033 if maintained.
- No extensions or supplementary protections indicated.
Strategic considerations
- No international extension limits its influence outside China.
- Companies seeking to manufacture similar formulations outside China would not infringe unless they adopt the identical process.
- For patent holders, enforcement actions would be confined locally.
Market implications
- Process patents like CN103501771 influence manufacturing standards.
- Limited scope restricts exclusivity to specific process parameters.
- Competitive advantage depends on process optimization and regulatory approval rather than patent protection.
Final analysis summary
| Aspect |
Details |
| Scope |
Focuses on a specific manufacturing method involving solvents, heating, and drying steps for a pharmaceutical composition |
| Claims |
Cover process steps, with variations mainly on process parameters; no direct product claims |
| Validity |
Potentially vulnerable to prior art; limited in geographic scope |
| Landscape |
Concentrated on Chinese patents; few equivalents internationally; similar patents focus on process innovations |
| Strategic use |
Suitable for local manufacturing control; limited in broader patent enforcement |
Key Takeaways
- CN103501771 is a process patent with narrow scope centered on manufacturing steps.
- It does not provide exclusivity over the end product.
- The patent landscape in China lacks substantial international protection.
- Competitors can develop similar processes without infringement unless exact steps are used.
- The patent offers limited strategic leverage outside China but can support local manufacturing rights.
FAQs
1. Can I produce a similar drug in China without infringing CN103501771?
Yes. Because the patent covers a specific process, developing a different manufacturing method that does not replicate the patented steps would not infringe.
2. Is CN103501771 enforceable outside China?
No. Its legal protection is confined to China, as it is a Chinese patent without foreign counterparts.
3. What is the main strength of this patent?
The patent secures control over a specific manufacturing process, which can be advantageous for local production and quality control.
4. How vulnerable is the patent to invalidation?
It may face challenges based on prior art related to similar process steps, especially if the techniques are well-known or documented before its filing.
5. Are process patents like this influential for global competitiveness?
They can be, if coupled with other patent types or complementary protections. Alone, their influence is limited to geographic scope and technical specifics.
Citations
[1] State Intellectual Property Office of China. (2014). Patent CN103501771 B.
[2] WIPO. (2020). Patent Landscape for Pharmaceutical Process Patents in China.
[3] European Patent Office. (2019). Guidance on Patent Scope and Validity.
