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Planning the layout of international patent papers for in vitro diagnostic enterprises, and synchronously expanding the overseas market and technological influence of new detection reagents
Case detail

An in vitro diagnostic enterprise has made a major breakthrough in the research and development of the "rapid detection kit for COVID-19 variants", and plans to enter the European and American markets. However, it is facing the challenges of lack of international patent layout and insufficient international recognition of academic achievements. This kit achieves precise identification of multiple variants within 60 minutes using multiplex fluorescence PCR technology, with a sensitivity of 100 copies/mL. However, it has only applied for 3 patents domestically and has not been deployed internationally; The published papers are all in Chinese journals and lack international peer recognition, resulting in insufficient technical credibility in overseas client cooperation negotiations.

We have formed an international intellectual property and academic services team to develop an internationalization plan of "patent first+paper follow-up". In terms of patent layout, based on target market analysis, it was determined to enter 15 countries and regions including the United States, the European Union, and Japan through the PCT pathway. For core technologies such as primer probe design, reaction system optimization, and pollution prevention technology, patent application documents that meet international examination standards were written, with a focus on strengthening the clarity and protection scope of claims. Ultimately, 21 international patent authorizations were obtained, including 7 US patents and 5 European patents.

In terms of internationalization of academic papers, we guided the R&D team to collaborate with overseas partner institutions to translate the core technological innovation points into four English papers. We adjusted the research wording according to the preferences of international journals, highlighting the performance comparison data and clinical validation results with existing detection methods. One of the papers was published in Clinical Chemistry (impact factor 9.2), and cited the company's international patent disclosure text as technical support, enhancing the verifiability of the research. At the same time, assist enterprises in giving keynote speeches at international molecular diagnostic conferences, showcasing patented technologies and paper achievements, and enhancing their international industry influence.

Through the collaborative layout of international patents and papers, the company successfully broke through overseas technical barriers, obtained EU CE certification and US FDA emergency use authorization, signed distribution agreements with three international medical device giants, and achieved overseas sales of 80 million US dollars. The international publication of academic papers has attracted cooperation intentions from five international research institutions, promoting the establishment of overseas joint research and development centers for enterprises, laying a solid foundation for sustained international technological competition, and achieving an average annual growth rate of 65% in international market share.

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