可专利性因素及其对药品专利权利要求保护和起诉时间的影响分析

IF 2.2 Q2 INFORMATION SCIENCE & LIBRARY SCIENCE

World Patent Information Pub Date : 2025-01-22 DOI:10.1016/j.wpi.2025.102334

Jyosna Devi Ravula , Ramakrishna Nirogi , Manthan D. Janodia

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引用次数: 0

摘要

由于专利涵盖的创新范围广泛，制药行业在专利申请方面面临着独特的挑战。由于各种因素，包括其固有的复杂性和可专利性被拒绝的可能性，专利申请过程是艰巨的。该研究开发了一个新的数据集，其中包含橙皮书中列出的基于USFDA 2020日历年批准的专利。该研究旨在分析专利审查过程，特别是通过专利驳回严重程度量表检查专利局诉讼驳回的严重程度及其对审查时间表的影响。在437项专利中，322项（65项主要专利和257项次要专利）的权利要求范围在起诉期间发生了重大变化。结果表明，二级专利的明显拒绝率为72.76%(187/257)，高于一级专利的33.85%（22/65）。进一步分析显示，二级专利的驳回程度与驳回次数（p值为0.0036）和起诉时间（p值为0.0008）之间存在很强的相关性。该研究还强调了实施各种战略和使用实验数据以减轻可专利性拒绝和避免起诉延误的必要性。这些信息可以为专利从业者处理拒绝提供实用的见解。

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Analysis of patentability factors and its impact on claim protection and prosecution timelines for pharmaceutical patents

The pharmaceutical industry faces unique challenges in patent prosecution due to the broad scope of innovations that patents cover. Navigating the patent prosecution process is arduous due to various factors, including its inherent complexity and the potential for patentability rejections. The study developed a new dataset containing the Orange Book listed patents based on USFDA calendar year 2020 approvals. It aimed to analyze the patent prosecution process, specifically examining the severity of office action rejections through the patent rejection severity scale and their impact on prosecution timelines. Out of 437 patents, the claim scope significantly changed for 322 (65 primary and 257 secondary) during prosecution. The results indicated that the obviousness rejections occurred more frequently for secondary patents, with a rate of 72.76 % (187/257), compared to primary patents with 33.85 % (22/65). Further analysis revealed a strong association between the severity of office action rejections and the number of office actions (p-value of 0.0036) and prosecution time (p-value of 0.0008) for secondary patents. The study also emphasized the necessity of implementing various strategies and the use of experimental data to mitigate patentability rejections and circumvent prosecution delays. This information could provide practical insights to patent practitioners dealing with rejections.

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来源期刊

World Patent Information INFORMATION SCIENCE & LIBRARY SCIENCE-

CiteScore

3.50

自引率

18.50%

发文量

期刊介绍： The aim of World Patent Information is to provide a worldwide forum for the exchange of information between people working professionally in the field of Industrial Property information and documentation and to promote the widest possible use of the associated literature. Regular features include: papers concerned with all aspects of Industrial Property information and documentation; new regulations pertinent to Industrial Property information and documentation; short reports on relevant meetings and conferences; bibliographies, together with book and literature reviews.