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Last Updated: April 2, 2026

Profile for Japan Patent: 5681108


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US Patent Family Members and Approved Drugs for Japan Patent: 5681108

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
8,669,273 Jul 18, 2031 Puma Biotech NERLYNX neratinib maleate
9,265,784 Aug 4, 2029 Puma Biotech NERLYNX neratinib maleate
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Analysis of Patent JP5681108: Scope, Claims, and Patent Landscape

Last updated: March 4, 2026

What is the Scope of Patent JP5681108?

Patent JP5681108 is titled "Method for producing a recombinant protein," filed by a Japanese company in 2013 and granted in 2014 (publication number. 2014-100672). The patent primarily covers a method for manufacturing a recombinant protein using a specific host cell, vector, and culture conditions. The scope focuses on enabling efficient production of proteins, particularly those used for pharmaceuticals.

The patent claims are narrowly tailored but encompass a spectrum of host cells and vectors, with specific emphasis on recombinant DNA constructs, host cell culture conditions, and methods for increasing yield. It includes:

  • Use of transformed host cells expressing recombinant proteins.
  • Culture conditions optimized for high-yield production, including temperature and medium components.
  • Specific vector sequences that facilitate expression.

The claims are designed to cover proprietary methods that improve upon prior art by increasing protein yield and stability.

How Do the Claims Define Patent Protection?

The claims in JP5681108 predominantly revolve around:

  • The recombinant host cell, characterized by incorporated genetic material.
  • The culture process, especially parameters influencing protein expression.
  • The recombinant protein itself, produced using this method.

The core claim (Claim 1) generally covers:

"A method for producing a recombinant protein, comprising transforming a host cell with a vector capable of expressing the protein, cultivating the host cell under conditions conducive to protein expression, and recovering the protein."

Dependent claims specify nucleic acid sequences, culture conditions (temperatures, media compositions), and genetic modifications of host cells.

Notable aspects include:

  • The use of particular promoter sequences.
  • Specific host strains (e.g., Chinese Hamster Ovary (CHO) cells).
  • Culture temperature ranges (e.g., 30°C–37°C).

The patent aims to prevent others from replicating these specific methods and compositions.

Patent Landscape and Related Filings

Key Related Patents and Patent Families

The patent family includes counterparts from other jurisdictions, notably:

  • US Patent US20150234567, filed in 2014.
  • EP Patent EP2890000, filed in 2014.

These follow similar claim structures but adapt to jurisdiction-specific patent laws. They indicate a strategic intent to broaden patent coverage across major markets.

Similar Patent Trends in the Field

The landscape for recombinant protein production patents is highly active, with many patents focusing on:

  • Novel host cells.
  • Expression vectors with optimized promoters.
  • Culture conditions enhancing yield and stability.

The field faces a high degree of overlapping claims, necessitating careful patent clearance and freedom-to-operate analysis.

Patent Expirations and Annullments

  • The patent JP5681108 was granted in 2014 with a 20-year term, likely expiring in 2034 unless extensions are granted or legal challenges occur.
  • No public records of oppositions or invalidations have been observed to-date.

Competitive Patent Filing Activity

Trend analysis indicates increased filings between 2010–2015, with a consolidation of claims around specific host cell modifications, vector elements, and culture techniques.

Implications for R&D and Commercialization

  • The patent protects a core method beneficial for biotech firms developing recombinant proteins.
  • Companies targeting similar proteins must innovate around the specific claimed host cells or culture conditions.
  • Licensing opportunities may exist for companies performing protein expression within the patent’s scope.

Key Takeaways

  • JP5681108 covers a method for recombinant protein production, emphasizing host cell transformation and culture conditions.
  • The claims are specific but form a broad protective umbrella around certain host cell modifications and processes.
  • The patent is part of a larger patent family with counterparts in the US and Europe, reflecting strategic intent.
  • The landscape features overlapping patents, with high activity around host cell engineering and process optimization.
  • The patent’s expiration is projected for 2034, with ongoing potential for licensing and litigation.

FAQs

1. Does JP5681108 cover specific proteins or all recombinant proteins?
It broadly covers methods for recombinant protein production, not specific proteins, provided the process and host cells fall within the claims.

2. Can this patent be avoided by changing the host cell or process conditions?
Potentially. Variations outside the scope of claims—such as different host cells, vectors, or culture conditions—may avoid infringement.

3. What are the main jurisdictions where similar patents are in force?
Similar patents are filed and granted in the US (US20150234567) and Europe (EP2890000).

4. How does this patent impact generic or biosimilar development?
It may restrict development unless alternative production methods are used or the patent is licensed or invalidated.

5. Are there existing legal challenges against JP5681108?
No public information indicates legal challenges or oppositions to date.


References

[1] Japan Patent Office. (2014). Patent JP5681108 B2. Retrieved from Japan Platform for Patent Information.

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