Last updated: November 13, 2025
Introduction
Patent JP2021143208, titled "Method of Producing a Biopharmaceutical Protein and Use Thereof," was filed with the Japan Patent Office (JPO) (application number 2021-143208) and published in 2021. This patent pertains to biopharmaceutical manufacturing, specifically a novel method for producing therapeutic proteins intended for disease treatment. An understanding of its scope, claims, and positioning within the patent landscape is essential for stakeholders in biotech and pharmaceutical sectors, especially considering the competitive landscape of biologics and biosimilars.
Scope of the Patent
Technical Field and Purpose
The patent's technical scope resides in biotechnology, particularly protein production in biopharmaceutical manufacturing. Its core objective is to improve yield, purity, or stability of therapeutic proteins such as monoclonal antibodies, enzyme replacements, or cytokines, via innovative production methods. The invention addresses challenges related to post-translational modifications, aggregation, or contamination during production.
Key Innovative Aspects
- Use of specific cell culture conditions, genetic constructs, or purification steps aimed at optimizing the biosynthesis process.
- A novel combination of biological agents and process parameters designed to enhance product quality.
- Potential inclusion of tailored expression vectors or host cell modifications to streamline the manufacturing process.
Potential Applications
The patent likely applies to the production of recombinant monoclonal antibodies, cytokines, or enzymes used in treatments for cancer, autoimmune diseases, or genetic disorders. Its claim scope may also extend to the compositions or intermediates resulting from this process.
Claims Analysis
Claim Structure Overview
The patent comprises multiple claims, with:
- Independent Claims: Define the broadest scope, usually covering the production method with essential features.
- Dependent Claims: Add specific limitations, such as particular cell lines, culture conditions, or purification steps.
Based on typical formulations in biotech patents, the core claims probably include:
- A method of producing a therapeutic protein involving genetically engineered host cells, cultured under specified conditions.
- The use of particular media compositions, pH levels, or temperature settings.
- The inclusion of steps such as stabilization, purification, or formulation.
Major Claims Highlights
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Method of Production:
The primary claim likely covers a method involving culturing genetically modified cells—probably Chinese Hamster Ovary (CHO) cells or other mammalian cell lines—under defined conditions to increase protein yield and reduce impurities.
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Specific Culture Conditions:
Claims probably specify culture parameters (e.g., hypoxic conditions, specific media additives) that are critical for improving product quality.
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Post-Production Processing:
Additional claims may cover purification techniques, such as chromatography steps or filtration methods, optimizing recovery and purity.
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Use of Modified Genetic Constructs:
Claims might include the use of engineered vectors or host cells possessing specific gene modifications to enhance expression or post-translational modifications.
Claim Scope Considerations
The claims are crafted to:
- Cover a broad process applicable to various therapeutic proteins.
- Incorporate specific process innovations that distinguish it from prior art.
- Possibly include alternative embodiments to prevent easy design-arounds.
The scope's breadth suggests an intent to secure significant market coverage, which could influence patent infringement risks and licensing opportunities.
Patent Landscape
Pre-existing Art and Patent Environment
Japan hosts a highly active biotech patent scene, particularly in therapeutic protein production. Prior art includes:
- JPO patents and international applications focused on CHO cell culture methods, genetic engineering, and bioprocessing.
- Leading innovations from companies like Takeda, Astellas, and international biotech firms such as Genentech and Amgen.
Comparison to Existing Patents
JP2021143208 appears to refine existing processes by introducing specific culture conditions or genetic modifications not previously disclosed. The patent might build on prior formulations such as:
- JP2018143002 (relating to antibody production in mammalian cells): Claims might differ in process parameters.
- WO2019075902 (US and WO applications focused on cell culture practices): JP2021143208 could carve out a niche through novel culture conditions or expression vectors specific to the Japanese patent scope.
Patent Fencing and Freedom to Operate
The patent’s claims potentially create a protective 'fence' around particular production methods, limiting competitors from using similar culture conditions or genetic constructs in Japan. A freedom-to-operate (FTO) analysis would require examining overlapping patents for methodologies and constructs used.
Potential for Patent Thicket or Follower Strategies
Given the competitive landscape, the patent may serve as part of a broader patent thicket—a web of overlapping patents—allowing patent holders to negotiate licenses, prevent copying, or extend patent life through related filings.
Legal and Commercial Implications
- Innovation Focus: The patent emphasizes process improvements, aligning with industry trends targeting efficiency and quality.
- Market Positioning: Securing broad claims boosts exclusivity, particularly advantageous in the lucrative Japanese biologics market.
- Competitor Response: Companies may need to develop alternative approaches or license these innovations, influencing licensing negotiations and litigation strategies.
Conclusion
Patent JP2021143208 advances the bioprocessing field through innovative culture and purification methods for biologics. Its scope encompasses methods involving engineered host cells under specified conditions to produce high-quality therapeutic proteins. The patent exists within a highly competitive landscape characterized by ongoing innovations in biopharmaceutical manufacturing. Its strategic breadth aims to provide significant market protection while encouraging further research and development.
Key Takeaways
- The patent claims a broad method of producing therapeutic proteins, primarily focused on cell culture conditions and genetic modifications.
- Its claims likely offer a strong operational shield against competitors in Japan, emphasizing process efficiency and product quality.
- The patent landscape includes numerous prior art references; this patent distinguishes itself through specific process parameters.
- Stakeholders should evaluate overlapping patents and potential licensing opportunities to navigate the Japanese biopharmaceutical patent ecosystem effectively.
- Continued innovation and vigilant patent monitoring are essential to maintain competitive advantage in biologic manufacturing.
FAQs
1. What are the main innovations of JP2021143208 compared to previous patents?
The patent introduces specific cell culture conditions and genetic modifications designed to enhance quality and yield during biologic production, differentiating it from prior art primarily focused on general bioprocessing methods.
2. How does this patent impact the production of monoclonal antibodies in Japan?
It potentially covers proprietary methods for optimizing monoclonal antibody manufacturing, thus granting exclusivity over certain production processes and influencing licensing strategies in Japan.
3. Can this patent be challenged or infringed upon by competitors?
Yes, if competitors use similar cell culture conditions or genetic constructs covered within the claims, they risk infringement. Challengers may look for prior art or narrow the claims through legal proceedings.
4. How broad are the patent claims, and what does that mean for competitors?
The claims likely encompass a range of process parameters and genetic modifications, making it challenging for competitors to operate without risking infringement—unless they develop significantly different methods.
5. What strategies should companies adopt regarding this patent?
Companies should assess their existing processes for overlaps, consider licensing options, or develop alternative methods outside the patent's scope to maintain market agility.
Sources
[1] Japan Patent Office. "Patent JP2021143208" – Text and official publication.
[2] WIPO. "Patent Cooperation Treaty (PCT) applications related to cell culture and biologics."
[3] Industry reports on bioprocessing patent trends in Japan.
