The effects of patent term extension on new drug patent protection in China, Europe, and the United States

• Our study is the first to propose a new concept of the DDTP index to evaluate new drug patent term extension protection. • The study is the first to characterize the profile of PTB in China. • For the drugs with a DDTP index between 6 and 10 years, patent protection in Europe is substantially longer than in China and the United States. • For the drugs with a DDTP index between 10 and 15 years, Europe still offers the longest protection period, while China has the shortest; the US falls in the middle. • For the drugs with a DDTP index above 10 years, the relative advantage of patent term extension in Europe diminishes and eventually disappears as the DDTP index increases. • Our findings reveal that the average time from the drug approval date to obtaining the PTE certificate is about 4.41 years. • The study shows that the duration from drug research to drug approval is approximately 10 years in both Europe and the United States, but about 12 years in China, when measured from patent filing. • Our study is the first to develop mathematical models characterizing the relationship between the DDTP index and the FDPPT. The mathematical model for the SPC system is defined by the equation: For the SPC system: y = −0.0005x 2 − 0.9886x + 24.932; for the PTB system: y = −0.024x 2 − 0.2001x + 18.557; for the PTE system: y=0.0254x 3 -1.2095x 2 +17.588x-67.174. Background: China has recently introduced patent term buchang (PTB) for new drugs. This study presents a systematic profile for China’s PTB, European SPC, and the U.S. PTE for new drug protection. Methods: Drug Development Time Period (DDTP) index and Final Drug Patent Protection Term (FDPPT) were calculated using predefined equations. Results: Our study showed the average PTB, SPC, and PTE for new drugs were 3.56, 4.11, and 2.82 years, respectively. Consequently, the average FDPPT for these regions reached 11.20, 14.32, and 13.19 years, respectively. Our results revealed that the average DDTP index for these new drugs was 9.79 years in Europe, 12.36 years in China, and 10.05 years in the US. For the same drugs, the SPC term in Europe was 1.55 years longer than the PTE in the United States. The FDPPT in Europe was an average of 0.54 years longer than that in the US. Conclusions: Our study characterizes China’s PTB profile for the first time and proposes a novel methodology-the DDTP index concept and its quartile range method-for investigating patent extension protection. The study shows that for new drugs with a DDTP index between 6 and 10 years, patent protection in Europe is substantially longer than in China and the US. For those drugs with an index between 10 and 15 years, Europe still offers the longest protection period (Avg. 13.41 years), while China has the shortest (Avg. 11.86 years); the US falls in the middle (Avg. 12.83 years). However, for drugs with a DDTP index above 10 years, the relative advantage of patent term extension in Europe diminishes and eventually disappears as the index increases.