没有免费上市:仿制药公司的风险进入

Keith M. Drake, Robert He, Thomas G. McGuire, Alice Ndikumana
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引用次数: 0

摘要

【摘要】在获得FDA批准后,仿制药制造商可以在专利侵权诉讼结束前“冒着风险”发起诉讼,但如果最终败诉,则有支付损害赔偿的风险。仿制药可以通过等到上诉程序完成后再上市来消除风险,但等待也有缺点。我们检查FDA批准的具有“第一申报者”地位的仿制药申请(这排除了其他仿制药事先进入),以检查有风险进入的经验模式。在我们的数据中,诉讼当事人通常在法律判决之前和解。对于其余的药物,在地方法院做出有利的判决之前获得FDA批准的药物总是有风险的。在获得有利的地区法院判决之前没有FDA批准的仿制药,除非批准与上诉决定及时接近,或者它已经丧失了第一申报者排他性(表明等待成本低)。
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No Free Launch: At-Risk Entry by Generic Drug Firms

Abstract

After receiving FDA approval, a generic drug manufacturer can launch ‘at risk’ before any patent infringement litigation concludes, but it risks paying damages if it ultimately loses the litigation. A generic can eliminate the risk by waiting to launch until after the appeals process is complete but waiting has downsides too. We examine FDA approvals of generic drug applications with ‘first-filer’ status (which precludes other generics from entering beforehand) to examine empirical patterns of at-risk entry. In our data, litigants usually settled prior to a legal decision. For the remainder, drugs that received FDA approval prior to a favorable district court decision were always launched at risk. Generics without FDA approval before a favorable district court decision launched upon approval unless the approval was close in time to the appeal decision, or it had forfeited the first-filer exclusivity (indicating a low cost of waiting).

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来源期刊
CiteScore
2.60
自引率
8.30%
发文量
9
期刊介绍: International Journal of the Economics of Business presents original, peer reviewed research in economics that is clearly applicable to business or related public policy problems or issues. The term "business" is used in its widest sense to encompass both public and private sector—governmental, private non-profit and cooperative organizations, as well as profit-seeking enterprises. International Journal of the Economics of Business carries papers relating to three main spheres: The organization—to analyse and aid decision making and the internal organization of the business; The industry—to analyse how businesses interact and evolve within and across industries.
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