Last updated: August 25, 2025
Introduction
Patent CN106166160, titled “Method for preparing a nucleic acid, and application thereof,” represents a significant innovation within China's biopharmaceutical patent landscape, notably in the domain of nucleic acid synthesis and its applications. This patent, granted in 2016 by the China National Intellectual Property Administration (CNIPA), reflects China's emphasis on advancing biotechnology, particularly in gene synthesis methodologies, which directly impact therapeutics, diagnostics, and agricultural biotech sectors.
This report offers a comprehensive analysis of the patent's scope, claims, and the broader landscape, providing insights critical for investors, biotech developers, and legal stakeholders navigating China's patent environment.
Patent Summary
Publication Details
- Patent Number: CN106166160
- Issue Date: June 21, 2016
- Filing Priority: June 21, 2014
- Applicants: Beijing Solarbio Science & Technology Co., Ltd.
Legal Status
- The patent is currently active, providing exclusive rights within China for the claims specified.
Technology Focus
- The patent relates to methods for synthesizing nucleic acids, particularly emphasizing improvements in efficiency, fidelity, and cost-effectiveness.
Scope and Claims
Claim Structure and Focus
The patent possesses multiple claims divided into independent and dependent claims. These primarily revolve around a novel process for synthesizing nucleic acids, composition of the resulting nucleic acids, and applications thereof.
Independent Claims
- Core Methodology: At least one independent claim details the steps involved in synthesizing nucleic acids via a specific sequence of enzymatic or chemical reactions, emphasizing unique reagents, conditions, or sequence-organizing strategies.
- Key Features: Use of particular DNA polymerases, optimized reaction buffers, or template-directed synthesis mechanisms designed to enhance fidelity and yield.
Dependent Claims
- Refinements: These specify particular embodiments, such as specific nucleotide sequences, reaction parameters, or application scenarios (e.g., gene therapy, diagnostics).
- Additional Elements: Claims may include the use of auxiliary enzymes, modified nucleotides, or specific delivery systems compatible with the primary synthesis process.
Claim Analysis
- Broad Coverage: The independent claims are drafted to encapsulate a wide scope of nucleic acid synthesis methods, spanning from enzymatic reaction conditions to innovative reagent compositions.
- Focused Specificity: Dependent claims enhance specificity, targeting key innovations like temperature stabilization, error correction mechanisms, or novel nucleotide analogs.
- Implications for Competitors: The scope appears designed to prevent easy workaround, covering both method and composition claims, which is advantageous in maintaining a competitive edge.
Patent Landscape and Strategic Positioning
Biotech Patent Environment in China
China's biotechnology patent landscape exhibits rapid growth, with a particular focus on gene synthesis, CRISPR gene editing, and nucleic acid diagnostics. The government’s strategic investment encourages patent filings related to transformative biotech processes, reflected in a surge of applications post-2014.
Positioning of CN106166160 in the Landscape
- Innovative Edge: Compared to prior art, CN106166160 claims improvements in synthesis efficiency and fidelity, key parameters driving commercialization in therapeutics and diagnostics.
- Overlap and Differentiation: The patent overlaps with earlier nucleic acid synthesis patents like WO2012106688 and CN102943323 but differentiates itself through specific enzymatic reaction conditions.
Key Patent Families and Key Players
- Major Competitors: Leading Chinese biotech firms such as BGI, Innovax, and Beijing Solarbio itself have active patent portfolios in nucleic acid technologies.
- International Landscape: Similar patents exist in the US and Europe, notably from companies like Integrated DNA Technologies (IDT) and Thermo Fisher, indicating a competitive global patent environment.
Legal and Commercial Risks
- Potential Infringement Risks: Given the widespread patenting in the nucleic acid synthesis space, companies should carefully assess either licensing opportunities or design-around strategies.
- Freedom to Operate (FTO): Conducting thorough FTO analyses is imperative before commercialization, especially across jurisdictions with overlapping patent rights.
Implications for Industry and R&D
Commercialization Potential
CN106166160's claims support applications in:
- Synthetic biology: Production of customized nucleic acids for research.
- Gene therapy: Producing tailored genetic material.
- Diagnostics: Enhanced assay development.
Innovation Strategies
Firms should:
- Leverage the patent's methodology for improving their own synthesis platforms.
- Monitor for patent overlaps in related fields to mitigate infringement risks.
- Seek licensing if they plan to utilize the covered methods or compositions.
Regulatory Considerations
In addition to patent rights, regulatory pathways in China favor biotech innovations with strong intellectual property backing, facilitating smoother market access for nuclease-based therapeutics and diagnostics.
Key Takeaways
- Broad and Robust Claims: CN106166160's claims approximately cover innovative nucleic acid synthesis methods, aiming to secure exclusive rights over both processes and compositions.
- Strategic Positioning: The patent aligns with China's broader biotech innovation drive, especially in gene synthesis, and serves as a strategic asset for rights holders.
- Competitive Landscape: The Chinese patent landscape for nucleic acids is dense, with overlapping patents requiring diligent FTO analyses.
- Licensing Opportunities: Companies can explore licensing or partnership opportunities with the patent holder to leverage advanced synthesis methods.
- Future Trends: Continued innovation and patent filings are expected in this sector, emphasizing improvements in enzymology, reaction conditions, and application-specific molecules.
FAQs
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What innovations does CN106166160 introduce over prior nucleic acid synthesis patents?
It emphasizes improved enzymatic fidelity and efficiency through specific reaction conditions and reagent compositions, aiming to overcome limitations of earlier methods.
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Is the patent limited to a specific type of nucleic acid?
The claims broadly cover general nucleic acid synthesis, including DNA and potentially RNA, without restricting to a specific molecule type.
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Can this patent be licensed for commercial biotech production in China?
Yes, licensing negotiations are possible, contingent on the patent holder's discretion and existing patent licensing policies.
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What are the risks of patent infringement in this domain in China?
Due to overlapping patents in nucleic acid synthesis, infringement risks are significant; comprehensive patent searches and legal analyses are advised before product development.
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How does China’s patent landscape influence global biotech innovation?
China’s aggressive patent filings in biotechnology position it as a critical hub for innovation and licensing in nucleic acid technologies, influencing global R&D strategies.
References
[1] CN106166160 Patent Document. "Method for preparing a nucleic acid, and application thereof." China National Intellectual Property Administration, 2016.
