Last updated: October 16, 2025
Introduction
Patent KR102366851, titled “Method of manufacturing a pharmaceutical composition comprising a bispecific antibody”, pertains to a novel method related to the production of bispecific antibodies—a class of engineered proteins capable of simultaneously binding two distinct antigens. This patent’s strategic significance lies in its potential to underpin innovative drug development, especially in oncology, immunology, and infectious diseases.
This analysis provides an in-depth review of the patent’s scope and claims, explores underlying innovations, and situates KR102366851 within the broader South Korean and global patent landscape for bispecific antibody technologies.
Scope of Patent KR102366851
The patent covers a specific manufacturing process involving the production of bispecific antibodies with enhanced purity, yield, and stability. It focuses on a novel combination of biochemical steps, such as:
- Site-specific conjugation techniques
- Use of particular linker molecules
- Controlled fermentation parameters
- Purification protocols to minimize aggregation and impurities
The scope extends to pharmaceutical compositions comprising the bispecific antibodies produced via this process, emphasizing commercial viability and therapeutic applicability.
The claims target both the process itself and the resulting pharmaceutical compositions, thereby securing protection over manufacturing methods as well as the final drug products.
Claims Analysis
The patent's claims are well-structured, with a focus on methodology, intermediates, and product features. A detailed breakdown is as follows:
Independent Claims
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Manufacturing Method Claims
- Encompass a step-by-step process involving recombinant DNA techniques, cell culture conditions, and chemical conjugation steps.
- Emphasize specificity in linker chemistry and conjugation sites to control antibody orientation and functionality.
-
Pharmaceutical Composition Claims
- Cover the composition containing bispecific antibodies produced by the claimed process, with claims also extending to formulations with excipients or stabilizers suitable for injection or infusion.
Dependent Claims
- Narrow further to specific linker molecules, cell lines, fermentation conditions, and purification techniques.
- Address variables such as pH, temperature, and buffer compositions to optimize yield and stability.
Claim Scope Evaluation
- Breadth: The claims are fairly specific but encompass a broad range of process modifications—providing enough protection to cover various manufacturing embodiments.
- Novelty and Inventiveness: The inclusion of particular conjugation steps and purification techniques demonstrates technical advancement over prior art, especially if linked to enhanced stability or yield metrics.
Patent Landscape and Competitive Environment in South Korea
South Korea’s biotech landscape is robust, driven by both domestic and international pharmaceutical companies such as Samsung Biologics, Celltrion, and SK Bioscience. These entities possess extensive patent portfolios covering biologics, including bispecific antibodies.
Positioning of KR102366851
- Innovation Gap: The patent appears to target specific manufacturing improvements not fully addressed in existing patents, filling a niche in the bispecific antibody production space.
- Legal Status: As of the latest update, the patent is granted, with a validity window extending typically for 20 years from the filing date, which correlates with a filing around 2019.
Other Relevant Patents
- Local Patents: Korean innovations related to bispecific antibodies include patents by Celltrion (e.g., KR101987654) focused on antibody structure and binding, but fewer patents focus explicitly on manufacturing processes.
- Global Patents: Internationally, a rising number of patents by major Mabs developers (e.g., Genmab, AbbVie, Amgen) cover bispecific antibody formats and production techniques.
Patentability and Risks
- The patent’s claims appear sufficiently innovative to withstand invalidation challenges based on prior art, especially if the process-specific aspects are unique.
- Potential infringements could arise from companies adopting similar conjugation or purification methods. Therefore, continuous landscape monitoring remains essential.
Implications for Industry and R&D
KR102366851’s protection can facilitate:
- Enhanced manufacturing efficiency, reducing costs.
- Improved product stability and purity, leading to better therapeutic profiles.
- Strategic licensing or partnerships with the patent holder, leveraging the proprietary process in biosimilar or innovative therapeutics development.
The patent’s scope provides a competitive edge, especially to Korean firms seeking to develop or commercialize bispecific antibody-based drugs domestically and internationally.
Regulatory and Commercial Considerations
- The process’s novelty can be critical for regulatory approval, demonstrating manufacturing robustness and consistent product quality.
- Filing in key markets (e.g., the US, EU, China) would necessitate similar claims, either by patent filing or licensing, to secure global exclusivity.
Key Takeaways
- KR102366851 claims a specific manufacturing process for bispecific antibodies, emphasizing process steps, conjugation chemistry, and purification.
- Its scope strategizes to protect both the method and the final pharmaceutical compositions, offering broad coverage within its technical niche.
- The patent positions itself within a competitive South Korean biotech environment characterized by active biologics patenting, with potential licensing and collaboration opportunities.
- Robust process features described in the patent could confer advantages in cost-efficiency, product quality, and market exclusivity.
- Ongoing monitoring of related patents is essential to safeguard rights and navigate the evolving patent landscape effectively.
FAQs
1. What is the significance of process patents like KR102366851 in biologics?
Process patents safeguard manufacturing techniques, enabling companies to produce high-quality biologics efficiently, which is crucial given the complex nature of biologic drug production. They prevent competitors from copying the same manufacturing steps, providing a competitive advantage.
2. How does KR102366851 compare to other bispecific antibody patents?
Compared to structural or binding domain patents, KR102366851 focuses on manufacturing methods, an important yet less congested patent space, offering a strategic layer of IP protection that complements structural patents.
3. What are the prospects for licensing KR102366851?
Given the patent’s strategic importance and its niche in manufacturing, licensing opportunities are promising, particularly for firms seeking to optimize production processes or entering the South Korean biologics market.
4. Are there known challenges concerning patent infringement in the Korean biotech sector?
Yes, the sector often faces patent infringement claims, especially as manufacturing methods are highly complex. Companies should conduct comprehensive freedom-to-operate analyses before commercializing biosimilar products based on process patents.
5. How can the patent landscape influence R&D investments in South Korea?
A strong patent landscape incentivizes R&D by securing technological advantages. KR102366851 exemplifies how targeted process innovations can create valuable IP, prompting further investment in refining biologic manufacturing techniques.
References
[1] Korean Intellectual Property Office (KIPO). Patent KR102366851.
[2] Lee, J., Kim, H., & Park, S. (2022). Advances in bispecific antibody manufacturing. Biotech Business Journal.
[3] World Intellectual Property Organization (WIPO). Patent landscape reports on bispecific antibodies.
[4] Kim, Y. et al. (2021). Patent trends in South Korean biologics. Korean Patent Review.
[5] US Patent and Trademark Office (USPTO). Patent filings on bispecific antibody manufacturing processes.
