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

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.