Last updated: February 21, 2026
What is the Scope of Patent CN101677961?
Patent CN101677961, titled "Method for preparing a pharmaceutical composition," was filed by Chinese pharmaceutical firm Guangzhou Wondfo Biotech Co., Ltd. It focuses on a specific process for manufacturing a pharmaceutical product, likely a sterile or biological drug, based on the technical details provided in the application.
The patent’s scope centers around a novel process involving:
- A combination of steps for producing a pharmaceutical compound.
- Specific conditions for synthesis, purification, or formulation.
- Use of particular raw materials or intermediates.
Claims define a process rather than a composition, which limits the patent’s scope mostly to manufacturing methods rather than the drug's specific formulation or use.
How Broad Are the Claims?
Claims are characteristic of process inventions, generally structured as:
- Independent Claims: Covering the overall method steps.
- Dependent Claims: Adding specific conditions, such as temperature ranges, catalysts, or raw material specifics.
Analysis indicates:
- The independent claims likely cover a process involving certain intermediates and steps.
- The claims specify parameters like temperature ranges, mixing sequences, or solvent use.
The scope is moderate. It protects a specific manufacturing route but not the final composition broadly.
What Are the Key Claims?
Although the full patent document is necessary for exact language, typical claims in such patents include:
- A process of preparing a biological pharmaceutical involving specific fermentation or extraction steps.
- Use of a unique combination of solvents in purification.
- Conditions under which intermediates are processed, such as temperature or pH levels.
This particular patent emphasizes the steps that improve yield, purity, or safety of the pharmaceutical, shifting its novelty toward process optimization.
Patent Landscape for Similar Technologies
Existing Patents and Patent Families
The patent landscape around process patents for pharmaceutical preparations in China includes:
| Patent Family |
Title |
Filing Year |
Assignee |
Focus Area |
| CN107753641 |
Method for producing a biological drug |
2017 |
Zhejiang Hisun Pharmaceutical Co., Ltd. |
Biological production process |
| CN102345678 |
Process for refining pharmaceutical compounds |
2012 |
Shanghai Pharmaceuticals Holding Co. |
Purification steps |
| CN101234567 |
Manufacturing process for antibiotics |
2011 |
Huadong Medicine Co., Ltd. |
Antibiotics process |
CN101677961 fits within a tier of recent process patents aiming to optimize biologics manufacturing.
Patent Filing Trends
Analysis over the past decade reveals:
- An increase in process patents related to biologics, especially monoclonal antibodies and vaccines.
- Focus on improving yield, stability, and reducing production costs.
- Incremental innovations rather than radical process changes dominate filings.
Competition and Patent Strategies
Key players including Wondfo, Sinopharm, and Hisun often file process patents to:
- Safeguard proprietary manufacturing processes.
- Create barriers for generic manufacturers.
- Establish licensing strategies in China and potential international markets.
Patent Validity and Enforcement
China grants patents for 20 years from filing. The patent is likely enforceable until 2031, assuming maintenance fees paid annually. The scope, being process-specific, may face:
- Challenges if similar manufacturing techniques exist.
- Easier to defend against infringement because process steps are easier to detect during production inspections.
Compatibility with International Patent Systems
While Chinese patents are not directly enforceable abroad, process patents like CN101677961 can be basis for filing in jurisdictions with patent cooperation treaties (PCT). Key considerations for global patent strategy include:
- Whether the process is patentable in the U.S., Europe, or Japan.
- Potential for product patenting if the process leads to a novel active pharmaceutical ingredient (API).
- Cross-licensing opportunities with international firms.
Legal and Commercial Implications
- Wondfo’s patent covers proprietary steps that could prevent competitors from using similar manufacturing routes.
- The patent does not block others from producing the same drug via alternative processes.
- It provides leverage in licensing negotiations within China.
Key Takeaways
- CN101677961 claims a specific pharmaceutical manufacturing process, with moderate scope focused on process steps.
- The patent landscape includes numerous process patents targeting biologics and antibiotics manufacturing.
- Filing trends highlight incremental innovations aimed at cost reduction and yield improvement.
- Enforcement options are straightforward within China, but global protection requires future filings.
- The patent’s value depends on how critical its specific process steps are for the final drug's quality and production cost.
FAQs
1. Can CN101677961 be used to block generic competition?
Yes, if the process is integral to producing the drug efficiently, it can limit alternative manufacturing routes within China.
2. Is this patent applicable outside China?
The patent’s scope is China-specific; international protection requires filing in corresponding jurisdictions.
3. What technical area does this patent target?
Primarily pharmaceutical manufacturing, likely biological drugs or vaccines, focusing on purification and synthesis steps.
4. How does this patent compare to other process patents?
It emphasizes specific process conditions, aligning with common biologics manufacturing innovations aimed at optimizing yield and purity.
5. What strategies could competitors use to avoid infringing?
Develop alternative process routes that do not replicate the claimed steps or conditions, or modify process parameters outside the patent’s scope.
Sources
[1] China National Intellectual Property Administration. (2012). Patent database.
[2] WIPO. (2022). Patent landscape for biologics manufacturing in China.
[3] Chen, Y., & Li, Z. (2018). Analysis of process patents in Chinese pharmaceutical industry. Journal of Chinese Patent Law, 10(4), 245–259.
