Last updated: August 8, 2025
Introduction
South Korea’s patent KR101683318, titled "Method for Producing an Adenovirus Vector and an Adenovirus Vector," was granted to Samsung Biologics Co., Ltd. The patent was issued on November 13, 2017. Its strategic relevance extends across the biopharmaceutical and gene therapy markets, particularly in the production of adenoviral vectors for vaccines and gene therapies. This analysis explores the scope of the claims, the specific technical features covered, and the patent landscape context, providing insights essential for stakeholders involved in vaccine development, gene therapy, and biomanufacturing.
Scope of Patent KR101683318
Technical Field
The patent pertains to biotechnological processes, specifically the bio-manufacturing of recombinant adenoviruses used as vectors for vaccine delivery and gene therapy. The invention aims to optimize the production process of adenoviral vectors, ensuring higher efficiency, purity, and yield.
Main Objective
The core objective is to provide a method that simplifies adenovirus vector production, reduces contaminants, and enhances process reproducibility. These advancements support scalable, cost-effective manufacturing critical for commercial vaccine production.
Legal Scope and Enforceability
The patent’s enforceable scope is primarily defined by its claims, which delineate the boundaries of protection. The claims encompass specific steps in the production process, properties of the produced vectors, and certain compositions—strategically drafted to cover both the process and the final product.
Claims Analysis
Claim Structure Overview
The patent contains multiple claims, with independent and dependent claims structured as follows:
- Independent Claims: These broadly define the process of producing an adenovirus vector, focusing on key steps like cell culture conditions, vector purification, and specific genetic modifications.
- Dependent Claims: These further specify process parameters, such as culture media composition, timing of steps, and purification methods, thus narrowing scope but adding clarity and legal robustness.
Key Elements of the Claims
1. Production Process
- Cell Line: The claims specify the use of human embryonic kidney (HEK) 293 cells or other specific cell lines suitable for adenovirus propagation.
- Culture Conditions: Parameters include culture media supplemented with particular nutrients, agitation conditions, and incubation temperatures optimized to maximize viral replication.
- Genetic Modifications: Claims address introduction of foreign DNA into the adenoviral genome, with particular focus on insertion sites or promoters to enhance expression profiles.
- Harvesting and Purification: The method covers steps such as cell lysis, virus clarification, chromatography, and filtration, emphasizing reduction of host cell proteins and DNA contaminants.
2. Viral Vector Composition
- Genetic Content: The claims specify vectors carrying therapeutic genes and vectors with specific deletions or modifications to improve safety and efficacy.
- Purity and Quality: The process aims for vectors with low endotoxin levels and high infectivity, ensuring suitability for clinical applications.
3. Product Claims
- While primarily process-oriented, some claims extend to the adenovirus vectors produced, especially those with defined genetic features or purity levels. This dual focus protects both the method and the resulting vectors.
Scope Limitations
- The claims are specific to adenoviruses produced via the disclosed method under certain cell culture conditions. Variations outside these parameters may not be covered, rendering alternative production methods susceptible to design-around strategies.
Patent Landscape Context
Comparative Overview
- KR101683318 is situated in a patent landscape that includes global patents on adenoviral vector manufacturing, such as US patents on vector design and European filings on downstream purification (e.g., EP patents).
- Similar patents often focus on genetic modifications (e.g., E1 gene deletions), manufacturing steps, or vector purity.
- South Korea’s patent system generally grants broad process claims, but as seen in this patent, claims are often limited to specific cell lines, process parameters, or genetic constructs.
Positioning and Differentiation
- Compared to prior art, KR101683318 emphasizes process efficiency and vector purity, aligning with demands for scalable manufacturing.
- Samsung Biologics’ patent portfolio leverages its core expertise in biomanufacturing, which may serve as a barrier to entry for competitors relying on different production technologies.
Freedom to Operate
- Companies seeking to develop adenovirus-based vaccines or gene therapies in South Korea must assess the scope of KR101683318 relative to their processes, especially if employing similar cell lines, culture conditions, or purification techniques.
- The patent’s claims are sufficiently specific to allow alternative methods, especially those deploying different cell lines, genetic modifications, or downstream processing methods, to avoid infringement.
International Considerations
- While this patent is South Korea-specific, it has potential counterparts or family patents filed under PCT, US, or EP routes, creating a broader landscape that firms must navigate for global development strategies.
- Samsung’s strategy indicates a focus on protecting core process innovations in key markets, potentially influencing licensing negotiations or patent enforcement tactics.
Implications for Industry Stakeholders
For Biotech and Pharma Companies
- The patent underscores the importance of process innovations in adenoviral vector manufacturing.
- It warns of potential IP barriers when adopting similar cell lines, culture parameters, or purification steps.
- Seeking alternative production methods or designing around the specific claims could mitigate patent risks.
For Patent Strategists
- Monitoring KR101683318’s claims provides insights into Samsung’s strategic focus, emphasizing process efficiency and vector quality.
- Patents with layered dependent claims serve to strengthen enforcement, prompting competitors to innovate around specific process parameters rather than rely on broad techniques.
For Licensing and Business Development
- The patent presents opportunities for licensing negotiations, especially for firms seeking to leverage Samsung Biologics’ manufacturing expertise.
- Licensing can facilitate enter into markets with existing patent enforcement measures, especially for adenoviral vectors in vaccines targeting COVID-19 or other infectious diseases.
Key Takeaways
- KR101683318 covers a specific process for adenoviral vector production, emphasizing cell culture conditions, genetic modifications, and purification steps.
- Its claims are narrowly tailored, primarily protecting the process steps and certain vector characteristics, allowing room for alternative methods.
- The patent landscape shows a mix of process and product patents; companies should evaluate their processes against both process-specific claims and vector design restrictions.
- Samsung’s patent strategy highlights a focus on scalable, high-quality vector manufacturing, aligning with global demand for COVID-19 vaccines and gene therapies.
- Entities developing adenovirus vectors must conduct comprehensive freedom-to-operate analyses, considering both South Korean patents and international family applications.
FAQs
Q1: What is the primary innovation claimed in KR101683318?
A1: The primary innovation lies in the process of producing recombinant adenoviruses with optimized cell culture and purification steps that enhance yield and purity, facilitating scalable manufacturing for vaccines and gene therapies.
Q2: Can companies develop adenoviral vectors using alternative cell lines to avoid infringement?
A2: Yes. The claims are specific to certain cell lines like HEK 293; using different host cells or markedly different production processes can help avoid infringement, assuming they do not infringe other aspects of the patent.
Q3: How does this patent influence global adenovirus vector production?
A3: While specific to South Korea, the patent reflects strategic innovations that could influence global manufacturing, especially if licensed or if similar patent applications are filed internationally, affecting companies’ development plans.
Q4: Are the claims in KR101683318 applicable to vectors used in COVID-19 vaccines?
A4: Potentially, if the vectors are produced using the claimed methods and genetic modifications. Companies must analyze claim language carefully to assess infringement risk.
Q5: What strategies can competitors adopt to circumvent this patent?
A5: Competitive firms can modify process parameters, utilize different cell lines, or employ alternative downstream purification steps outside the scope of the patent claims to develop non-infringing methods.
References
- Korean Intellectual Property Office (KIPO). Patent KR101683318.
- World Intellectual Property Organization (WIPO). Patent family files related to adenoviral vectors and manufacturing methods.
- Scientific literature on adenovirus vector manufacturing. (e.g., "Manufacturing of Adenoviral Vectors," Human Gene Therapy. 2019.)
- Industry reports on biopharmaceutical patent landscapes. (e.g., "Patent Strategies for Viral Vector Manufacturing," Deloitte, 2021.)
