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专利期届满前的第 IV 段判决和仿制药进入对品牌制药公司的影响。

The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms.

机构信息

Department of Economics, Owen G Glenn Building, The University of Auckland, Auckland, New Zealand.

出版信息

J Health Econ. 2011 Jan;30(1):126-45. doi: 10.1016/j.jhealeco.2010.09.004. Epub 2010 Oct 8.

DOI:10.1016/j.jhealeco.2010.09.004
PMID:21074873
Abstract

This purpose of this paper is to investigate the impact of Paragraph IV patent infringement decisions on brand drug pharmaceutical firms. Paragraph IV decisions determine whether a generic firm can enter before the period of exclusivity ends. I construct a novel dataset of all Paragraph IV decisions and find that they disproportionately involve the highest revenue drugs, significant periods of patent protection, and a non-trivial portion of all brand drugs facing generic entry. I also estimate the impact of Paragraph IV decisions on brand firm profitability and find they have large value consequences.

摘要

本文旨在研究第四段专利侵权裁决对品牌药品制药公司的影响。第四段裁决决定仿制药公司是否可以在专有权期限结束前进入市场。我构建了一个全新的第四段裁决数据集,发现它们不成比例地涉及收入最高的药物、重要的专利保护期以及所有面临仿制药进入市场的品牌药物的相当一部分。我还估计了第四段裁决对品牌公司盈利能力的影响,发现它们具有重大的价值后果。

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