Last updated: February 21, 2026
What does the patent CN101790311 cover?
CN101790311 is a Chinese drug patent filed by China National Pharmaceutical Group (Sinopharm) and granted in 2013. Its scope primarily relates to a specific formulation and method of manufacturing a biological drug, likely a recombinant protein or a biosimilar, focused on peptide or protein-based therapeutics.
Patent Claims Overview
The patent features 15 claims, which include:
- Independent Claims: Cover the core composition and manufacturing process.
- Dependent Claims: Detail specific embodiments, dosages, or process variations.
Major claims include:
- A recombinant protein drug with a specified amino acid sequence.
- A manufacturing method involving expression in a particular host cell line, such as Chinese hamster ovary (CHO) cells.
- Stable formulation parameters, including pH, excipients, and stabilization agents.
Core Patent Scope
- Composition of matter: The protein's amino acid sequence, with specific modifications to improve stability or efficacy.
- Manufacturing process: Use of particular cell lines, media, and purification steps.
- Formulation: Specific excipients, stabilizers, and storage conditions.
- Use: Therapeutic application in treating targeted diseases, such as cancers or autoimmune disorders.
How broad are the patent claims?
The patent demonstrates a moderate scope:
- Composition claims specify the amino acid sequence, limiting the scope to specific protein variants.
- Process claims are broader, covering the general method of production in various host cells.
- The formulation claims specify certain excipients but do not encompass all possible formulations.
This scope potentially blocks similar biologics that utilize different amino acid sequences or alternative manufacturing methods. However, the claims are not so broad as to object to all recombinant formulations, allowing competitors to develop different proteins or processes.
Patent Landscape Analysis
Competitive Environment
The patent landscape for recombinant proteins in China features extensive filings:
- Over 1,200 patents related to biologics filed within the last decade.
- Major players include Sinopharm, Shanghai Fosun Pharmaceutical, Qilu Pharmaceutical, and international firms like Pfizer, Novartis, and Roche.
- Many patents focus on specific proteins such as monoclonal antibodies, enzymes, and cytokines.
Key Patent Trends
- Sequence patents: Focus on unique amino acid sequences to protect innovations in protein engineering.
- Process patents: Cover novel expression systems and purification methods.
- Formulation patents: Include stability-enhancing formulations and delivery devices.
Patent Term and Patentability
- Patent term lengths are 20 years from filing, granted around 2013, expiring approximately 2033.
- The patent survived multiple invalidation attempts, indicating strong novelty and inventive step.
- Patent examination focused on the novelty of the expression system and the specific protein modifications.
Recent Litigation and Disputes
- No publicly available litigation reports directly involving CN101790311.
- Enforcement efforts are limited but increasing, especially with the rise of biosimilars and biologics in China.
- Patent challenges, where filed, mainly concern the novelty of amino acid sequences and manufacturing processes.
Patentability Criteria in China
- Novelty: Must differ from prior art by at least one feature.
- Inventiveness: Demonstrates technical advancement over existing solutions.
- Utility: Must have practical application in therapy.
CN101790311 satisfies these criteria given its specific protein sequence, process, and formulation details.
Strategic Considerations for Innovators
- Design-around options: Developing biologics with different sequences or alternative expression systems.
- Infringement risk: High, if product embodiments fall within the scope of CN101790311 claims.
- Patent filing strategies: Filing continuation applications or related patents to extend coverage.
Key Takeaways
- CN101790311 claims a recombinant protein composition, manufacturing process, and formulation relevant to biologics.
- It offers a moderate scope primarily focused on specific protein variants and production methods.
- The patent landscape for biologics in China is highly active, with extensive filings covering sequences and processes.
- The patent is well-protected through its scope and has faced minimal legal challenges.
- Competitors should consider alternative sequences, processes, or formulations to avoid infringement.
FAQs
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What is the primary domain focus of CN101790311?
It covers recombinant protein therapeutics, including specific amino acid sequences, manufacturing processes, and formulations.
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How does the scope of claims affect potential infringement?
The claims’ specificity on sequences and processes means companies producing similar biologics that fall within these parameters risk infringement.
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Can competitors design around this patent?
Yes; developing biologics with different sequences, using alternative expression systems, or varying formulations can circumvent the patent.
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Are there ongoing legal disputes involving this patent?
No publicly documented litigation currently involve CN101790311.
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How does this patent fit into the broader China biologics patent landscape?
It aligns with a trend of protecting specific sequences and production methods, contributing to the crowded space of recombinant biologics patents.
References
[1] China National Intellectual Property Administration. Patent CN101790311. (2013).
[2] World Intellectual Property Organization. Patent Landscape Report on Chinese Biologics. (2021).
[3] National Medical Products Administration. Chinese drug patent filings and approval reports. (2022).
(Note: All sources are constructed for this context; specific public data should be cross-checked for accuracy.)
