Table 4 Outcomes of ANDAs that were submitted for P2 or P4 certifications
From: Characteristics and outcomes of the drug patent linkage system in China
2021 (Second half) | 2022 | 2023 (First half) | Total | |
|---|---|---|---|---|
Total number of P2 (N) | 36 | 149 | 125 | 310 |
Patent termination, no. (%) | 6(16.7) | 76(51) | 64(51.2) | 146(47.1) |
Patent invalidation, no. (%) | 25(69.4) | 62(41.6) | 57(45.6) | 144(46.4) |
Patent licensing, no. (%) | 0(0) | 3(2) | 4(3.2) | 7(2.3) |
Invalidation and licensing, no. (%) | 3(8.3) | 2(1.4) | 0(0) | 5(1.6) |
Termination and invalidation, no. (%) | 2(5.6) | 6(4) | 0(0) | 8(2.6) |
Only P2 (N) | 26 | 105 | 95 | 226 |
Patent termination, no. (%) | 3(11.5) | 40(38.1) | 41(43.2) | 84(37.2) |
Patent invalidation, no. (%) | 23(88.5) | 60(57.1) | 50(52.6) | 133(58.8) |
Patent licensing, no. (%) | 0(0) | 3(2.9) | 4(4.2) | 7(3.1) |
Invalidation and licensing, no. (%) | 0(0) | 2(1.9) | 0(0) | 2(0.9) |
P2 and P3 and/or P4 (N) | 10 | 44 | 30 | 84 |
Patent termination, no. (%) | 3(30) | 36(81.8) | 23(76.7) | 62(73.8) |
Patent invalidation, no. (%) | 2(20) | 2(4.6) | 7(23.3) | 11(13.1) |
Termination and invalidation, no. (%) | 2(20) | 6(13.6) | 0(0) | 8(9.5) |
Invalidation and licensing, no. (%) | 3(30) | 0(0) | 0(0) | 3(3.6) |
Total number of P4 (N) | 49 | 107 | 64 | 220 |
P4.1, no. (%) | 15(30.6) | 16(15) | 7(10.9) | 38(17.3) |
P4.2, no. (%) | 34(69.4) | 84(78.5) | 53(82.8) | 171(77.7) |
P4.1 and P4.2, no. (%) | 0(0) | 7(6.5) | 4(6.3) | 11(5) |