How Does Emerging Patent Case Law in the US and Europe affect Precision Medicine?

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How will today’s patent law affect tomorrow’s innovation in the areas of biomarkers and nature-based products; diagnostics; and algorithms, big data and AI? No topic in medicine garners more interest today than precision medicine, with its goal of better tailoring treatment to patient needs. It is not only patients who stand to benefit from better diagnosis, prognosis and treatment, but also the organizations investing in its research and development1. According to one recent estimate, the global precision medicine market accounted for $78.85 billion in 2018 and is expected to reach over $216.75 billion by 2028, with a compound annual growth rate of 10.64% between 2018 and 20282. The commercial viability, and hence development, of precision medicine depends in large part on the intellectual property framework that applies to its various forms. In this paper, we examine recent patent law decisions in the United States and Europe and their implications for the future of three areas of precision medicine: (i) biomarkers and nature-based products, (ii) diagnostics, and (iii) algorithms, big data and artificial intelligence (AI).

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Nature Biotechnology