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Opening the Black Box of Pharmaceutical Patent Value: An Empirical Analysis

机译:打开药品专利价值的黑匣子:一项实证分析

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摘要

Patents and patent valuation have raised tremendous concerns from the research-based pharmaceutical industry for a long time. Questions about the valuation of drug patent portfolios, the assessment of research and development (R&D) performance or innovation output, and the competitive position of different firms in the industry all tend to revolve around the basic question of pharmaceutical patent valuation. This article aims to validate the impact of pharmaceutical technology characteristics on patent value and to optimize classic patent valuation methods in the drug field. We selected 9T5 patents in the "Orange Book" of the US Food and Drug Administration as the sample, employed established patent value indicators (EPVT) and pharmaceutical technology detailsindicators (PTDI) as key predictors for pharmaceutical patent value (the value of pharmaceutical patents), and further conducted multiple-variable analysis. It was found that PTDI significantly influences pharmaceutical patent value and, more important, enhances the quality of existing valuation methods. Moreover, the marginal effect of individual predictors on patent value is quantitatively measured. For example, new chemical entities and new dosage forms increase the value by 62% and 60%, and orphan drug and pediatric drug classification decrease the value by 7% and 10%, respectively. In addition, the potential commercial applications of this method are briefly explored in view of the early stage, high-efficiency, and low-cost characteristics of all value predictors in this method.
机译:长期以来,专利和专利估价引起了研究型制药行业的极大关注。有关药品专利组合的估值,研究与开发(R&D)绩效或创新产出的评估以及行业中不同公司的竞争地位等问题都围绕着药品专利估值的基本问题展开。本文旨在验证制药技术特性对专利价值的影响,并优化制药领域的经典专利评估方法。我们从美国食品和药物管理局的《橙皮书》中选择了9T5专利作为样本,并采用了已建立的专利价值指标(EPVT)和制药技术详细指标(PTDI)作为药物专利价值(药物专利价值)的主要预测指标,并进一步进行了多变量分析。发现PTDI显着影响药品专利价值,更重要的是,它可以提高现有评估方法的质量。此外,定量预测了各个预测变量对专利价值的边际效应。例如,新的化学实体和新的剂型将其值分别提高了62%和60%,而孤儿药和儿科药物的分类将其值分别降低了7%和10%。此外,鉴于该方法的所有价值预测指标的早期,高效和低成本特性,简要探讨了该方法的潜在商业应用。

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