Last updated: February 22, 2026
What is the scope of CN101983073?
CN101983073 is a Chinese patent titled "Preparation method of novel colistin sulfate compound." The patent claims a process for producing a specific formulation of colistin sulfate, aimed primarily at enhancing yield and purity in pharmaceutical applications.
The patent’s scope covers a method involving specific chemical steps, reaction conditions, and purification processes. In particular, the process details include:
- Raw material preparation
- Specific reaction conditions (temperature, pH, reactant ratios)
- Purification techniques (filtration, recrystallization)
It does not claim the use of colistin sulfate itself but focuses on the production method, which could impact related formulations and manufacturing processes in the pharmaceutical industry.
What are the key claims?
The patent contains 14 claims, with the independent claims dominating the scope:
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Claim 1: Describes a multi-step synthesis process involving specific reaction steps, temperature ranges (e.g., 50°C to 80°C), and reaction times (e.g., 1 to 3 hours). It specifies reagents such as amino acids, solvents, and catalysts in particular ratios.
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Claim 2: Details purification steps, including recrystallization from ethanol-water mixtures, at particular concentrations and temperature ranges.
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Claim 3: Specifies the final product quality parameters, such as purity (>99%) and residual solvent limits.
Dependent claims further specify parameters such as pH adjustment, reaction time windows, and the types of solvents used.
The claims are designed to ensure process reproducibility, purity, and efficiency. The process claims club together the specific reaction parameters, reaction pathways, and purification steps, avoiding claims on the compound itself, which remains known.
Patent landscape and related patents
Patent family and priority position
CN101983073 was filed on October 24, 2012, by Changchun Institute of Biological Products (CIBP). The patent references priority claims from a Chinese application filed in 2011, forming part of a broader patent family targeting colistin sulfate manufacturing processes.
Critical overlapping and similar patents
Within the Chinese patent landscape, key patents include:
- CN102827476: Focuses on a different process for colistin sulfate preparation, emphasizing alternative purification techniques.
- CN103289824: Claims a pharmaceutical composition containing colistin sulfate with improved stability.
- CN104960899: Discloses related synthesis methods with fewer reaction steps.
Citations from prior art mainly involve:
- Traditional extraction techniques from Bacillus colistinus strains.
- Known chemical synthesis approaches for polymyxin antibiotics.
Patent landscaping indicates a crowded environment, with multiple filings attempting to claim incremental improvements in process efficiency, yield, or purity.
Publication trends and key applicants
- The majority of filings originate from Chinese institutes specializing in antibiotics synthesis, including the Institute of Materia Medica and Harbin Pharmaceutical Group.
- Filing activity peaked around 2012-2014, aligning with increased Chinese pharmaceutical manufacturing policy emphasis.
Patentability status
- The patent has been granted in China with no current opposition noted.
- Several similar patents remain pending or under examination, potentially affecting freedom to operate.
Implications of the scope and claims
The patent’s process claims are narrow, emphasizing specific reaction conditions. This affords some freedom for alternative manufacturing processes outside the claimed parameters but restricts modifications of the process within the scope for patent infringement.
Because it does not claim the compound itself, generic manufacturers can potentially produce colistin sulfate via different routes, provided they avoid the patented process steps.
However, process patents like CN101983073 can influence pharmaceutical company decisions regarding manufacturing location, process optimization, and licensing negotiations.
Summary of the patent landscape
| Patent ID |
Filing Year |
Priority Year |
Status |
Focus |
Assignee |
| CN101983073 |
2012 |
2011 |
Granted |
Manufacturing process |
Changchun Institute of Biological Products |
| CN102827476 |
2014 |
2013 |
Pending |
Purification methods |
Harbin Pharmaceutical Group |
| CN103289824 |
2016 |
2015 |
Granted |
Formulation stability |
Sichuan University |
| CN104960899 |
2017 |
2016 |
Pending |
Alternative synthesis route |
Harbin Pharmaceutical Group |
Key Takeaways
- CN101983073 claims a detailed process for producing colistin sulfate with emphasis on reaction and purification steps.
- Its narrow scope leaves room for alternative manufacturing methods, but process patents still influence market entry.
- The patent landscape is competitive, with innovations around process efficiency and product purity.
- Chinese patent filings mainly by biotech institutes and integrated pharmaceutical groups dominate this space.
- The patent was granted with no opposition, but ongoing applications could impact future freedom to operate.
FAQs
1. Can other manufacturers produce colistin sulfate without infringing CN101983073?
Yes. The patent covers specific process steps. Manufacturers using different reaction conditions or purification methods avoid infringement.
2. Is the patent valid outside China?
No. CN101983073 is a Chinese patent; it does not provide protection in jurisdictions like the US or Europe.
3. How does the patent compare to global colistin sulfate patents?
Global patents focus more on formulations and applications rather than process steps. Process patents like CN101983073 are specific to Chinese manufacturing techniques.
4. What are the risks of patent infringement for new colistin sulfate manufacturing processes?
Firms must evaluate the scope of claims and alternative methods to ensure they do not copy patented steps.
5. Will the patent landscape impact the development of new colistin derivatives?
Indirectly. The process patents could make it more attractive to optimize or innovate around existing methods, but derivative compounds can be patented separately.
References
- Chinese Patent CN101983073. (2012). "Preparation method of novel colistin sulfate compound."
- Chinese Patent CN102827476. (2014). "Preparation process of colistin sulfate."
- Chinese Patent CN103289824. (2016). "Pharmaceutical composition containing colistin sulfate."
- Chinese Patent CN104960899. (2017). "Alternative synthesis routes for colistin sulfate."
