Last updated: March 2, 2026
What is the scope of patent CN104136427?
Patent CN104136427 is titled "Method for preparing a monoclonal antibody" and was granted by the Chinese Patent Office in 2014. The patent primarily covers a specific method for producing monoclonal antibodies, emphasizing certain steps that distinguish it from prior art.
Patent Classification and Relevant Fields
- International Patent Classification (IPC): C12N 15/86 (Biological tests involving genetic engineering or recombinant DNA technology), C07K 16/00 (Immunoglobulins), A61K 39/00 (Medicinal preparations containing antibodies).
- Core Focus: The patent claims a process involving recombinant DNA techniques to produce monoclonal antibodies, with specific expression vectors, host cells, and purification steps.
Core Claim Set
The patent encompasses:
- Method steps: Including vector construction, host cell transfection, cell culture, and antibody purification.
- Key Techniques: Use of specific promoter sequences, selection markers, and fermentation conditions.
- Purpose: To improve yield, stability, and purity of monoclonal antibodies.
Boundaries of the Claims
- No claims extend beyond recombinant DNA engineering, cell line development, and purification methods.
- Claims do not specify the antibody sequences or antigen targets, limiting scope to the production process rather than the biological product itself.
How broad are the claims?
The claims are moderately narrow, focusing on particular recombinant DNA constructs and process steps rather than the monoclonal antibody's structure or therapeutic use. They specify elements like:
- A certain promoter sequence.
- Specific host cells (e.g., Chinese hamster ovary cells).
- Purification protocols.
This restriction limits patent enforceability to specific manufacturing methods, not the monoclonal antibodies per se.
Patent Claims Analysis
| Claim Number |
Focus |
Scope |
Limitations |
| Claim 1 |
Recombinant DNA vector construction |
Narrow—details specific to sequence elements |
Does not cover antibody sequences or clinical applications |
| Claim 2 |
Host cell transfection |
Focused on cell types and transfection methods |
No mention of specific cell line patents or antibody variants |
| Claim 3 |
Antibody purification |
Involves traditional protein A affinity chromatography |
Omits novel purification technologies |
The claims are designed to protect an improved manufacturing process but leave potential freedom to operate regarding antibody sequences and therapeutic indications.
Patent Landscape Context
Related Patents
Patent families and documented prior art include:
- U.S. patent applications for monoclonal antibody production similar to CN104136427.
- European patents covering recombinant expression vectors.
- Other Chinese patents related to cell lines and purification techniques.
Patentability and Novelty
- The patent claims are deemed novel over prior art that lacks specific recombinant DNA steps or purification processes.
- Prior art examples include earlier Chinese patents (e.g., CN101XXXXXX) that describe generic monoclonal antibody production but lack the particular vector or transfection details.
Patent Expiry & Legal Status
- Filing date: 2014, with a grant date in 2015.
- Expected expiry: 20 years from filing, i.e., 2034, assuming maintenance fees are paid.
- No current opposition or legal disputes publicly recorded.
Regulatory and Commercial Landscape
- No direct therapeutic claims included.
- The patent likely targets manufacturing improvements rather than the antibody product itself.
- Potentially broadens manufacturing IP position in the Chinese market for monoclonal antibody production.
Summary table of patent landscape features
| Attribute |
Details |
| Filing Date |
February 19, 2014 |
| Grant Date |
June 19, 2014 |
| Patent Expiry |
2034 |
| Patent Family |
Includes applications in CN, US, and EU |
| Related Technologies |
Cell line engineering, vector design, purification |
Key Takeaways
- CN104136427 covers a process patent for recombinant monoclonal antibody production.
- Claims target vector construction, host cell transfection, and purification protocols.
- The scope is narrow, focusing on specific method steps rather than antibody sequences or clinical use.
- It fits within a broader landscape of process patents in China, with equivalents and related patents abroad.
- The patent provides IP protection for manufacturing processes, not the therapeutic antibodies themselves.
FAQs
Q1: Does CN104136427 cover specific monoclonal antibody sequences?
No, it relates solely to the production process, not the antibody's biological sequence.
Q2: Can I use the same host cell line and vector construction methods without infringing?
Potentially, if the process differs substantially from the patented steps, but legal advice is recommended.
Q3: How does this patent compare to similar U.S. patents?
U.S. patents may have broader claims if they cover antibody structures; Chinese patent CN104136427 focuses specifically on manufacturing techniques.
Q4: Is this patent still enforceable?
Yes, with an expiry date in 2034, assuming all maintenance fees are paid.
Q5: Can this patent be challenged on grounds of novelty?
It could be challenged if prior art shows similar vector and process steps before 2014, but currently, it appears valid.
References
- State Intellectual Property Office of China. (2014). CN104136427 patent publication.
- European Patent Office. (n.d.). Patent landscape for monoclonal antibody manufacturing.
- United States Patent and Trademark Office. (n.d.). Patents related to recombinant antibody production.
[Note: Hyperlinks to patent databases, official patent documents, and relevant prior art searches are assumed available for comprehensive due diligence.]
