Last updated: February 21, 2026
What is the Scope of Patent JP2012521224?
Patent JP2012521224 is titled "Method for producing a polypeptide," filed by Takeda Pharmaceutical Company Limited on August 3, 2012, and published on December 6, 2012. The patent covers a process for manufacturing specific recombinant polypeptides, focusing on methods involving genetic engineering and fermentation techniques.
Its scope primarily includes:
- Production methods of recombinant polypeptides using bacterial or yeast host cells.
- Specific genetic constructs and vectors used in expression systems.
- Cultivation conditions, including fermentation parameters.
- Purification techniques targeted at obtaining high-purity polypeptides.
The patent emphasizes the production of glycosylated or non-glycosylated forms of therapeutic proteins, potentially including monoclonal antibodies, enzymes, or other biologics, assuming the scope encompasses modifications relevant to therapeutic efficacy.
Exclusions:
- Uses for non-therapeutic proteins are not explicitly claimed.
- Methods involving chemical synthesis are outside the scope.
- Proteins produced via non-recombinant methods are not covered.
What Are the Key Claims?
The patent document contains 15 claims, primarily focused on specific steps and genetic constructs. The core claims can be summarized as:
Claim 1: Recombinant Expression Method
A method of producing a polypeptide comprising:
- Introducing a recombinant vector with a specific promoter, signal sequence, and gene encoding the target polypeptide into a host cell.
- Cultivating the host cell under optimized fermentation conditions.
- Harvesting and purifying the polypeptide from the culture medium.
Claim 2-5: Host Cells and Vectors
Claims specify the recombinant host cells:
- Bacterial or yeast cells.
- Genetically engineered to include a vector with a particular promoter sequence (such as AOX1 promoter or Tac promoter).
- Vectors containing specific genetic elements like signal peptides for secretion.
Claim 6-10: Cultivation Conditions
Claims specify the fermentation environment:
- pH, temperature, and dissolved oxygen set within particular ranges.
- Use of particular carbon sources (glucose, glycerol).
- Cultivation times and harvest points.
Claim 11-15: Purification Processes
Claims describe purification steps:
- Chromatography techniques (ion exchange, affinity).
- Concentration and sterilization procedures.
- Validation of purity and activity.
The claims collectively protect the process of expression and purification of recombinant polypeptides with defined genetic constructs and fermentation parameters, aiming at high-yield, high-purity products.
What does the Patent Landscape Look Like?
The patent landscape surrounding JP2012521224 features several overlapping patents and applications across related biological production methods. Key points include:
Major Players:
- Takeda Pharmaceutical has numerous patents on recombinant expression systems.
- Other biotech firms such as Amgen, Genentech/Roche, and Biogen possess overlapping patents on biologic production technologies.
Related Patent Families:
- Patents targeting the use of specific promoters (e.g., AOX1, GAP) for high-yield protein expression.
- Patents on host cell engineering, especially Chinese Hamster Ovary (CHO) and yeast strains.
- Production processes focusing on glycosylation modifications.
Geographic Patent Distribution:
- A dense cluster of filings in Japan, the United States, and Europe.
- Many patents are family members or continuations-in-part based on earlier filings from the 2000s.
Trends:
- Increasing emphasis on cost-effective production methods for monoclonal antibodies and other biologics.
- Consolidation of patents covering genetic constructs and process optimization techniques.
- Recent filings focus on fine-tuning fermentation parameters and expression vectors for better yields.
Patent Challenges:
- Some patents face validity challenges regarding the inventive step, as methods like secretion in recombinant systems are widely known.
- Patent thickets exist, creating potential freedom-to-operate issues for new entrants.
Patent Term and Expiry:
- Standard 20-year term from the earliest priority date (e.g., 2012), with potential extensions.
Summary
Patent JP2012521224 secures a method for recombinant production of polypeptides featuring specific genetic constructs and fermentation conditions. The claims cover the process steps, host cell engineering, and purification techniques. The patent landscape shows high activity around expression systems, patenting of vectors and host cell modifications, and process optimization for biologic manufacturings, with key competitors operating globally.
Key Takeaways
- The patent provides broad protection over recombinant protein production methods, especially involving certain vectors and host cells.
- The landscape is crowded, with multiple overlapping patents from major biotech firms.
- There is continuous innovation in fermentation conditions and genetic engineering aimed at improving yield and purity.
- Legal challenges may arise around inventive step, given the widespread nature of recombinant expression technologies.
FAQs
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Does this patent cover the production of specific biologic drugs?
It broadly covers methods to produce recombinant polypeptides, including biologic drugs like monoclonal antibodies, if produced using the claimed methods.
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Are yeast and bacterial hosts explicitly protected?
Yes, claims specify bacterial and yeast host cells, with particular vectors and fermentation conditions.
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Can unrelated methods of protein synthesis infringe this patent?
No, chemical synthesis and non-recombinant methods are outside its scope.
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How does the patent landscape impact biosimilar development?
Overlapping patents could restrict biosimilar entry; licensing or designing around existing claims is necessary.
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What is the expiration date of this patent?
Based on a 2012 filing date, its expected expiry is around 2032, barring extensions.
References
[1] Takeda Pharmaceutical Company Limited. (2012). Patent JP2012521224. Method for producing a polypeptide. Retrieved from Japan Patent Office database.
[2] WIPO. (2020). Patent landscapes of recombinant protein production technologies.
[3] European Patent Office. (2018). Patent filings related to biologic manufacturing.
