微生物产业作为基因技术领域战略性新兴产业的关键组成部分,是我国培育发展新动能、打造全球竞争新优势的重要领域。我国保藏菌株专利申请量居全球首位,但因微生物的活体特性和技术复杂性,其在知识产权保护中面临安全性、新颖性、创造性及说明书充分公开等挑战。本文基于我国专利法律框架,结合实践案例,提出安全性跨法规评估、新颖性现有技术判断、创造性技术效果评价、遗传资源披露的策略,为审查员提供规范化指引,为申请人优化专利布局,助力高价值专利转化,推动微生物产业创新发展。
The microbial industry, a key component of the strategic emerging sector of genetic technology, is vital for
fostering new growth drivers and building global competitive advantages in China. With the world’s leading number
of patent applications for deposited microorganisms, challenges in intellectual property protection arise due to their
living nature and technical complexity, including safety compliance, novelty assessment, inventiveness evaluation, and
sufficient disclosure in specifications. Based on China’s patent legal framework and practical cases, this study proposes
strategies for cross-regulatory safety assessment, prior art evaluation, inventiveness through technical effects, and
genetic resource disclosure. These provide standardized guidance for examiners and assist applicants in optimizing
patent strategies, promoting the transformation of high-value patents and driving innovation in the microbial industry.