Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination

• 成果类型: Article
• 署名作者: Frakes, Michael D.; Wasserman, Melissa F.
• 署名单位: Duke University; University of Texas System; University of Texas Austin
• 刊物名称: AMERICAN ECONOMIC JOURNAL-ECONOMIC POLICY
• ISSN/ISSBN: 1945-7731
• DOI: 10.1257/pol.20200703
• 发表日期: 2023
• 页码: 151-183
• 关键词: market-size; INNOVATION; CHALLENGES; entry; PRODUCTIVITY; COMPETITION; LITIGATION; liability; IGNORANCE; ECONOMICS

摘要

We explore how the U.S. Patent and Trademark Office may improve the quality of issued patents on secondary drug features by giving examiners more time to review drug patent applications. Our findings suggest that current time allocations are causing examiners to issue low-quality secondary patents on the margin. To assess the merits of expanding ex ante scrutiny of drug patent applications at the agency, we set forth estimates of the various gains and losses associated with giving examiners more time, including reduced downstream litigation costs and added personnel expenses, along with both the static gains and dynamic innovation losses associated with earlier generic entry. (JEL K11, L65, O31, O34, O38)