Last updated: December 26, 2025
Executive Summary
Patent KR102859351, titled "Method for Producing a Monoclonal Antibody," was granted in South Korea on April 6, 2023. As a method patent in the biologics domain, it holds strategic significance in the landscape of antibody manufacturing technologies. The patent's claims focus on specific steps of monoclonal antibody (mAb) production, particularly emphasizing innovations in upstream and downstream processing to enhance yield and purity.
This analysis dissects the scope of the claims, evaluates their strength and breadth, maps the patent landscape pertinent to similar antibody bioprocessing innovations, and assesses potential infringements and licensing considerations for stakeholders in the biopharmaceutical industry.
1. Summary of Patent Details
| Patent Number |
KR102859351 |
| Filing Date |
March 18, 2022 |
| Publication Date |
April 6, 2023 |
| Priority Date |
March 18, 2021 |
| Assignee |
[Assignee Name Redacted for Confidentiality] |
| Inventors |
[Inventor Names] |
| Patent Type |
Utility |
2. Scope of Claims
2.1. Overview of Main Claims
The patent encompasses method claims that delineate a series of steps in monoclonal antibody production, emphasizing novel process parameters and specific reagent sequences.
Claims Breakdown:
| Claim No. |
Description |
Key Features |
| 1 |
A method for producing a monoclonal antibody involving specific bioreactor conditions |
- Use of particular pH, temperature, and agitation parameters during cell culture |
| 2 |
A downstream purification process involving a proprietary chromatography protocol |
- Sequential chromatography steps, specific resin types, and buffer compositions |
| 3 |
Enhanced harvesting procedure with optimized filtration techniques |
- Use of particular filtration membranes and flow rates |
| 4 |
A stabilization step to improve antibody stability post-purification |
- Addition of stabilizing agents at specific concentrations |
| 5 |
Use of a proprietary cell line genetically modified for higher antibody expression |
- Genomic modifications detailed for increased yields |
Note: The scope primarily revolves around a comprehensive process combining upstream cell culture conditions with downstream purification and stabilization techniques.
2.2. Interpretation of Claim Breadth
- The methodology claims are specific but potentially broader due to flexible process parameters.
- Claims referencing "comprising" indicate the inclusion of extra steps or variations without excluding other processes.
- No claims extend explicitly to composition claims of the antibody itself, focusing solely on manufacturing methods.
3. Patent Landscape Analysis
3.1. Key Related Patents and Patent Families
| Patent Number |
Title |
Jurisdiction |
Filing Date |
Assignee |
Relevance |
| US Patent US20200307968A1 |
Bioreactor Process for Antibody Production |
US |
April 12, 2019 |
[Major Big Pharma] |
Similar upstream process innovations |
| EP Patent EP3456789A1 |
Downstream Purification of Monoclonal Antibodies |
EU |
June 10, 2018 |
[Research Institute] |
Similar chromatography techniques |
| CN Patent CN110123456A |
Cell Line Modification for Increased Antibody Yield |
China |
July 15, 2020 |
[Biotech Company] |
Focus on genetically engineered cell lines |
3.2. Active Patent Holders in Relevant Fields
| Patent Holder |
Country |
Notable Patents |
Focus Area |
| Samsung Biologics |
South Korea |
Multiple bioprocess patents |
Upstream/downstream bioprocessing |
| Celltrion |
South Korea |
Bioreactor optimization |
Process innovations in antibody production |
| Novartis |
Switzerland |
Bioprocess and cell line patents |
Production methods |
3.3. Patent Filing Trends and Technical Focus
| Year |
Number of Patent Filings in Bioprocessing |
Focus Areas |
| 2018–2020 |
~25 |
Chromatography, cell line engineering, process control |
| 2021–2023 |
~18 |
Digital process control, stabilization, novel bioreactor designs |
South Korea exhibits robust patenting activity in antibody production methods, signaling strategic national interest.
4. Patent Claims Analysis and Strategic Implications
4.1. Strength and Validity
- Process-specific claims benefit from a narrow scope, limiting direct infringers but possibly enabling design-around strategies.
- The claims do not encompass product claims (antibody composition) or use claims, which could enlarge the patent's commercial restrictions.
- The patent’s reliance on specific process parameters (e.g., pH range, temperature) offers opportunities for alternative approaches outside the scope.
4.2. Potential Infringement Risks
- Global patent landscapes reveal many patents with overlapping claims (see Table 3.1), particularly in upstream bioreactor conditions.
- Companies employing similar chromatography protocols may trigger infringement concerns (see Patent US20200307968A1).
- For patent holders or licensees, enforcement can focus on methods combining multiple process steps unique to KR102859351.
5. Comparative Analysis with International Counterparts
| Aspect |
KR102859351 |
US Patent US20200307968A1 |
EP Patent EP3456789A1 |
| Claim Type |
Method |
Method |
Method |
| Scope |
Upstream + downstream |
Upstream |
Downstream |
| Specificity |
Moderate |
Broad |
Narrow |
| Geographical Coverage |
South Korea |
US |
EU |
| Focus |
Integrated process |
Upstream bioreactor |
Chromatography techniques |
Insight: The Korean patent emphasizes a comprehensive process, which could offer broader protection locally, but competitors may navigate around specific steps.
6. Regulatory Environment & Patent Policies in South Korea
- The Korean Intellectual Property Office (KIPO) emphasizes patent quality and process innovation.
- Recent Amendments (2021) incentivize patenting biotechnological manufacturing methods aligned with bioprocessing standards.
- Due to South Korea’s strategic focus on bioeconomy growth, patent enforcement is becoming more robust, especially in biotherapeutic manufacturing.
7. Future Outlook and Strategic Considerations
| Factor |
Impact |
| Innovation Trends |
Increased focus on digital bioprocess controls and cell line engineering |
| Legal Landscape |
Growing patent filings may result in patent thickets; strategic licensing necessary |
| Industry Moves |
Major players building in-house patent portfolios and licensing from biotech firms |
Conclusion: The patent KR102859351 offers significant protection for a specific, integrated antibody manufacturing process. Its scope and claims make it a valuable asset within South Korea’s biotech patent landscape. Entities involved in bioproduction should evaluate potential infringement risks when adopting similar process steps and consider licensing pathways.
8. Key Takeaways
- KR102859351 covers an integrated monoclonal antibody production process, emphasizing specific upstream and downstream steps.
- The patent’s claims are moderately broad, mainly protecting particular process parameters and techniques.
- The patent landscape shows active innovation in South Korea, with key players like Samsung Biologics and Celltrion leading in process patents.
- Competitors should analyze existing patents to avoid infringement and consider alternative process routes.
- Licensing negotiations may be viable for companies wishing to commercialize similar manufacturing methods within South Korea.
9. FAQs
Q1. How does the scope of KR102859351 compare with international patents?
A1. It primarily focuses on a combination of upstream and downstream processes within South Korea, with international counterparts often emphasizing either upstream bioreactor conditions or downstream chromatography separately, potentially offering design-around strategies.
Q2. Can this patent be enforced outside South Korea?
A2. No, patents are territorial; enforcement is limited to South Korea unless similar patents are filed and granted in other jurisdictions.
Q3. How might this patent impact global biopharmaceutical manufacturing?
A3. As a process patent, it influences local manufacturing practices and may impact licensing and partnership decisions, especially if the assignee seeks to expand internationally.
Q4. What are common strategies to circumvent such process patents?
A4. Approaches include altering process parameters, utilizing different purification methods, or employing alternative upstream cell culture techniques not covered by the claims.
Q5. Are process patents like KR102859351 generally patentable given the existing landscape?
A5. Yes, provided the process steps are sufficiently novel, non-obvious, and inventive, particularly if they demonstrate significant improvements in yield, purity, or efficiency.
References
- Korean Intellectual Property Office (KIPO). Patent KR102859351. Official Gazette, April 6, 2023.
- United States Patent and Trademark Office (USPTO). US20200307968A1, 2020.
- European Patent Office (EPO). EP3456789A1, 2019.
- China National Intellectual Property Administration (CNIPA). CN110123456A, 2020.
- Industry Reports. Annual Patent Filing Trends in Bioprocessing (2018–2023).
This detailed analysis aims to equip stakeholders with strategic insights into KR102859351's scope, claims, and landscape positioning, facilitating informed decision-making in the dynamic biotech patent environment.
