Patent-based analysis of biosafety trends in synthetic biology

Synthetic biology, an interdisciplinary field integrating biology, engineering and computer science, creates new biological systems but simultaneously raises biosafety risks such as the leakage of biological materials, genetic contamination and malicious abuse. These risks threaten not only human health and ecosystems but also national security and social stability.

A new study published in the Journal of Biosafety and Biosecurity explored the biosafety trends in synthetic biology through patent analysis, aiming to identify potential hazards and provide actionable solutions for policymakers, scientists and practitioners. As an exploratory study, it also provides a conceptual framework for mapping biosafety themes in the patent literature, though the modest sample precludes statistical generalisation.

Using the Derwent Innovations Index, 90 relevant patents were retrieved (search date: March 2024) via Boolean combinations of "synthetic biology" and "biosafety" synonyms in titles, abstracts and claims. Through thematic term identification, data cleansing and manual classification, the patent landscape and technological advances at this intersection were assessed, and four biosafety classifications were proposed: operational biosafety, technical cell-culture limitations, pathogenic microorganism biosafety, and infrastructure and facility biosafety.

In particular, operational biosafety dominated the sample (≈80%, n=72), covering precautions and procedural standards for handling biological materials, with particular attention to protein manipulation (25%) and Escherichia coli handling (15%), such as screening marker genes in transgenic plants and food-grade expression systems.

Technical cell-culture limitations (≈33%, n=30) highlighted vector-construction risks, including the manipulation, diffusion and uncertainty of genetic information, with representative patents on artificial cells and nucleic acid constructs.

Pathogenic microorganism biosafety (≈17%, n=15) concerned bacterial genome modification, with recombination in 47% of such patents raising issues of gene stability and environmental release. Infrastructure and facility biosafety (≈14%, n=13) centred on physical safeguards such as biosafety cabinets (46%), air filtration and containment systems. Other categories included biosensors (11%), food biosafety (9%) and microbiology laboratory biosafety (8%).

Notably, a number of patents were published through the World Intellectual Property Organization and the European Patent Office to obtain international protection. Emerging domains such as cyber-biosecurity remain barely represented (1%), yet are expected to become future hotspots.

Quantitatively, over half of the patents were filed between 2017 and 2022, peaking in 2022. The top ten patent transferees accounted for 24% of the sample. Geographically, filings concentrated in China and the United States: US patents emphasised operational-level safety (89% of US applications), whereas Chinese patents stressed infrastructure innovation, including biosafety cabinets (30% of samples). These patterns reflect distinct national priorities in biosafety management.

These findings support anticipatory, evidence-based biosafety governance, consistent with scholarship by DiEuliis, Mendonca and Sun on early-stage biosecurity assessment and patent data as policy indicators.

The study concludes that biosafety management should integrate technical innovation monitoring, infrastructure investment and proactive risk assessment into national policy frameworks, ensuring that safety evolves alongside technological progress. The authors proposed that future research should integrate multi-language patent databases, extend temporal coverage and apply citation-network mapping and AI-assisted screening to build a comprehensive picture of biosafety governance and innovation dynamics in synthetic biology.

Contact the author: School of Humanities and Social Sciences, University of Science and Technology of China, Hefei, China. liuhuan520@ustc.edu.cn

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