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

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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Abstract

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.