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Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination.

ABSTRACT: We explore how the Patent 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.

SUBMITTER: Frakes MD

PROVIDER: S-EPMC10783444 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination.

Frakes Michael D MD Wasserman Melissa F MF

American economic journal. Economic policy 20230801 3

We explore how the Patent 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 ...[more]

PMID: 38213756

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Project description:China National Health Commission issued an implementation plan for budget performance management in health projects in April 2021, which emphasizes all health projects must be evaluated in advance prior to implementation. The study aims to develop an ex-ante performance evaluation framework for health projects and formulate a self-assessment report template. The study also attempts to gain insights into the ex-ante performance of health projects in China, identify issues and explore the factors that influence the ex-ante performance of health projects and make suggestions about improvement strategies. The framework was established by using a framework development methodology. To develop the framework, the findings from existing research were pooled and organized to create indicators and key points. The preliminary ex-ante performance evaluation framework was refined, validated and tested by the experts. Weight analysis was conducted by using the Analytic Hierarchy Process. Then the indicator system has been transformed into a project ex-ante performance self-assessment report template. Samples of 698 municipal health projects in China from 2021 to 2022 were analyzed. We invited experts to complete the scoring task by using our ex-ante performance evaluation framework. The ex-ante performance evaluation framework primarily examines five aspects, the necessity of the project, economy of input, rationality of performance indicators, feasibility of implementation plans, and compliance of financing. The overall ex-ante performance evaluation score for the sample projects was (91.19 ± 8.02). The sub-scores for necessity of project were (14.74 ± 1.85), economy of input was (34.45 ± 2.43), reasonableness of performance indicators was (8.27 ± 2.28), feasibility of implementation plan was (23.99 ± 3.84), and compliance of financing was (9.75 ± 1.47). Factors such as whether it was an epidemic prevention and control project, the project budget, project content, project objective, and project implementation organization were all influencing the ex-ante performance of health projects (P < 0.05). We have developed a ex-ante performance evaluation framework for health projects and established a project ex-ante performance self-assessment report template. They can offer a sufficient reference for project process management. Project implementation organization should elevate the awareness and proficiency of project managers regarding budget performance management. Government should improve the ability of ex-ante performance evaluation, and eliminate ineffective projects through ex-ante performance evaluation.

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Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination.

Publications

Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination.

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