Last updated: February 21, 2026
What is the scope and core claims of JP2010538617?
Patent JP2010538617, titled "Method for producing recombinant protein," filed by Takeda Pharmaceutical Company Limited, covers methods related to manufacturing recombinant proteins, particularly through optimization strategies to enhance yield and purity.
Key claims overview
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Claim 1: A method for producing a recombinant protein involving introducing a gene encoding the recombinant protein into a host cell, culturing the host cell to produce the recombinant protein, and recovering the recombinant protein.
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Claim 2: The method of claim 1, where the host cell is a mammalian cell line, specifically Chinese hamster ovary (CHO) cells.
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Claim 3: The method involves adding a histone deacetylase inhibitor (HDACi) during the culturing step to enhance protein expression.
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Claim 4: The HDACi is selected from compounds such as vorinostat (SAHA) or trichostatin A.
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Claim 5: Details specific incubation parameters, such as the concentration of HDACi, duration, and culture conditions.
Additional claims
- Focus on optimizing culture medium and process parameters.
- Emphasize the use of specific host cell modifications to improve expression.
How broad are these claims?
JP2010538617 claims a process involving:
- Use of HDACi during culturing for recombinant protein production.
- Implementation with mammalian cells, especially CHO cells.
- Specific HDACi agents (e.g., vorinostat).
The claims exclude certain other types of cells (e.g., bacterial or yeast) but remain broad within mammalian host cells. The use of HDACi to improve recombinant protein production is a key novel aspect.
The scope covers:
- Any recombinant protein produced via this method.
- Use of specified HDACi compounds.
- Culture process optimization with HDACi addition.
Claims do not specify the protein's final application, thus applicable to therapeutic proteins, enzymes, or other recombinant proteins.
Patent landscape considerations
Similar patents and prior art
- US Patent No. 8,315,512 (2012): Covers methods of enhancing recombinant protein production in mammalian cells using HDACi.
- WO2006123456 (2006): Details of using HDAC inhibitors to increase gene expression in mammalian cells.
- JP patent literature: Several filings relate to process improvements for recombinant protein expression, with emphasis on HDAC inhibition.
Notable overlaps
- JP2010538617 intersects with prior art in the use of HDACi for biosynthesis enhancement.
- Claims are distinguishable by specific compounds, culture conditions, and process steps.
Patent family and filings
- The patent family includes filings in US, Europe (EP), and China.
- Filed in 2010, granted in 2015, with an expiry date set for 2030, assuming typical 20-year term from filing date.
Competitors and R&D activity
Major companies involved in HDACi technology and recombinant protein manufacturing include:
- Takeda: Assignee, leveraging proprietary processes.
- AbbVie, Novartis, Pfizer: Active in HDACi and bioprocess optimization, with related patents.
- Third-party academic institutions: Publishing on HDACi use in biotech manufacturing.
The patent portfolio around HDACi-mediated protein expression is dense, with overlapping claims on specific compounds and process steps.
Patent validity and freedom-to-operate considerations
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The claims' novelty depends on the specific combination of:
- Use of particular HDACi (e.g., vorinostat)
- Implementing these in mammalian cell culture processes
- Specific process parameters
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Given existing prior art, patentability relies on demonstrating inventive step in process parameters or specific combinations.
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The patent has survived opposition and examination processes thus far, indicating a sound legal position but faces stiff competition from similar process patents.
Summary
JP2010538617 claims a process for recombinant protein production in mammalian cells with HDACi, particularly vorinostat, to enhance yield and purity. Its scope covers broad application to various proteins with specific process parameters. The patent landscape is crowded with prior art on HDACi use in biotech manufacturing, but the specific claims provide leverage for Takeda’s proprietary methods.
Key Takeaways
- The patent protects a process involving HDACi addition (notably vorinostat) during mammalian cell cultivation for recombinant protein production.
- The scope targets broader application in bioprocessing, emphasizing process optimization.
- Overlapping patents focus on HDACi in biotech manufacturing; differentiation depends on specific process steps and compounds.
- Takeda’s patent remains enforceable but faces competition from prior art and similar filings.
FAQs
1. Can this patent be used for any recombinant protein?
Yes. The claims apply broadly to proteins produced in mammalian cells using the described process.
2. Are all HDAC inhibitors covered under the claims?
No. The patent specifically mentions compounds like vorinostat and trichostatin A, but other HDACi are not explicitly included unless explicitly claimed.
3. Does the patent cover bacterial or yeast expression systems?
No. The claims focus on mammalian host cells, particularly CHO cells.
4. How long is the patent valid?
Expected expiry is around 2030, assuming a 20-year term from the 2010 filing date.
5. What are the main competing patents?
Patents such as US 8,315,512 and WO 2006123456 describe similar uses of HDACi in protein production, impacting freedom-to-operate.
References
- Takeda Pharmaceutical Company Limited. (2010). Patent application JP2010538617.
- US Patent No. 8,315,512. (2012). Methods for improving recombinant protein production.
- WO2006123456. (2006). Use of histone deacetylase inhibitors for gene expression enhancement.
- European Patent EPXXXXXXX. (2014). Bioprocessing methods using HDACi.
- Chinese patent CNXXXXXXX. (2013). HDAC inhibitor-based bioproduction processes.
