|
| | | | | | | | | | |
PHARMACEUTICAL | | | | | | |
Immunology | | | | | | |
U.S. | | 2,410 |
| | 2,163 |
| | 11.4 |
|
International | | 1,228 |
| | 1,088 |
| | 12.8 |
|
Worldwide | | 3,638 |
| | 3,251 |
| | 11.9 |
|
REMICADE® | | | | | | |
U.S. | | 625 |
| | 774 |
| | (19.3 | ) |
U.S. Exports | | 110 |
| | 76 |
| | 44.3 |
|
International | | 256 |
| | 252 |
| | 1.5 |
|
Worldwide | | 990 |
| | 1,102 |
| | (10.2 | ) |
SIMPONI / SIMPONI ARIA® | | | | | | |
U.S. | | 272 |
| | 263 |
| | 3.4 |
|
International | | 258 |
| | 261 |
| | (1.2 | ) |
Worldwide | | 529 |
| | 524 |
| | 1.1 |
|
STELARA® | | | | | | |
U.S. | | 1,217 |
| | 882 |
| | 37.9 |
|
International | | 603 |
| | 523 |
| | 15.2 |
|
Worldwide | | 1,819 |
| | 1,405 |
| | 29.5 |
|
TREMFYA® | | | | | | |
U.S. | | 187 |
| | 168 |
| | 11.5 |
International | | 109 |
| | 49 |
| | * |
Worldwide | | 296 |
| | 217 |
| | 36.4 |
OTHER IMMUNOLOGY | | | | | | |
U.S. | | — |
| | — |
| | — |
International | | 3 |
| | 3 |
| | (6.9) |
Worldwide | | 3 |
| | 3 |
| | (6.9) |
| | | | | | |
Infectious Diseases | | | | | | |
U.S. | | 436 |
| | 357 |
| | 22.3 |
|
International | | 483 |
| | 489 |
| | (1.2 | ) |
Worldwide | | 920 |
| | 846 |
| | 8.7 |
|
EDURANT® / rilpivirine | | | | | | |
U.S. | | 12 |
| | 12 |
| | 0.6 |
|
International | | 212 |
| | 199 |
| | 6.4 |
|
Worldwide | | 224 |
| | 211 |
| | 6.1 |
|
PREZISTA® / PREZCOBIX® / REZOLSTA® / SYMTUZA® | | | | | | |
U.S. | | 396 |
| | 315 |
| | 25.5 |
|
International | | 184 |
| | 208 |
| | (11.6 | ) |
Worldwide | | 579 |
| | 523 |
| | 10.8 |
|
OTHER INFECTIOUS DISEASES | | | | | | |
U.S. | | 29 |
| | 30 |
| | (3.4 | ) |
International | | 87 |
| | 82 |
| | 6.7 |
|
Worldwide | | 116 |
| | 112 |
| | 4.0 |
|
| | | | | | |
19
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
OTHER INFECTIOUS DISEASES | | | | | | | | | | | | |
U.S. | | 21 | | | 29 | | | (27.0) | | | | | | | |
International | | 96 | | | 87 | | | 9.7 | | | | | | | |
Worldwide | | 117 | | | 116 | | | 0.6 | | | | | | | |
| | | | | | | | | | | | |
Neuroscience | | | | | | | | | | | | |
U.S. | | 771 | | | 748 | | | 3.2 | | | | | | | |
International | | 949 | | | 910 | | | 4.3 | | | | | | | |
Worldwide | | 1,721 | | | 1,658 | | | 3.8 | | | | | | | |
CONCERTA® / methylphenidate | | | | | | | | | | | | |
U.S. | | 47 | | | 52 | | | (9.6) | | | | | | | |
International | | 123 | | | 118 | | | 4.5 | | | | | | | |
Worldwide | | 171 | | | 171 | | | 0.2 | | | | | | | |
INVEGA SUSTENNA® / XEPLION® / INVEGA TRINZA® / TREVICTA® | | | | | | | | | | | | |
U.S. | | 589 | | | 544 | | | 8.3 | | | | | | | |
International | | 376 | | | 339 | | | 11.0 | | | | | | | |
Worldwide | | 965 | | | 883 | | | 9.4 | | | | | | | |
RISPERDAL CONSTA® | | | | | | | | | | | | |
U.S. | | 67 | | | 76 | | | (11.8) | | | | | | | |
International | | 89 | | | 94 | | | (4.8) | | | | | | | |
Worldwide | | 157 | | | 170 | | | (7.9) | | | | | | | |
OTHER NEUROSCIENCE | | | | | | | | | | | | |
U.S. | | 67 | | | 75 | | | (9.8) | | | | | | | |
International | | 361 | | | 360 | | | 0.2 | | | | | | | |
Worldwide | | 428 | | | 435 | | | (1.5) | | | | | | | |
| | | | | | | | | | | | |
Oncology | | | | | | | | | | | | |
U.S. | | 1,377 | | | 1,175 | | | 17.2 | | | | | | | |
International | | 2,193 | | | 1,839 | | | 19.3 | | | | | | | |
Worldwide | | 3,570 | | | 3,013 | | | 18.5 | | | | | | | |
DARZALEX® | | | | | | | | | | | | |
U.S. | | 691 | | | 463 | | | 49.2 | | | | | | | |
International | | 674 | | | 474 | | | 42.2 | | | | | | | |
Worldwide | | 1,365 | | | 937 | | | 45.6 | | | | | | | |
ERLEADA® | | | | | | | | | | | | |
U.S. | | 171 | | | 119 | | | 44.0 | | | | | | | |
International | | 90 | | | 24 | | | * | | | | | | |
Worldwide | | 261 | | | 143 | | | 82.8 | | | | | | | |
IMBRUVICA® | | | | | | | | | | | | |
U.S. | | 444 | | | 432 | | | 2.8 | | | | | | | |
International | | 680 | | | 599 | | | 13.5 | | | | | | | |
Worldwide | | 1,125 | | | 1,031 | | | 9.0 | | | | | | | |
ZYTIGA® / abiraterone acetate | | | | | | | | | | | | |
U.S. | | 50 | | | 139 | | | (64.2) | | | | | | | |
International | | 588 | | | 552 | | | 6.6 | | | | | | | |
Worldwide | | 638 | | | 690 | | | (7.6) | | | | | | | |
| | | | | | | | | | | | |
|
| | | | | | | | | | |
Neuroscience | | | | | | |
U.S. | | 748 |
| | 723 |
| | 3.3 |
|
International | | 910 |
| | 905 |
| | 0.5 |
|
Worldwide | | 1,658 |
| | 1,629 |
| | 1.8 |
|
CONCERTA® / methylphenidate | | | | | | |
U.S. | | 52 |
| | 97 |
| | (46.1 | ) |
International | | 118 |
| | 116 |
| | 1.5 |
|
Worldwide | | 171 |
| | 214 |
| | (20.1 | ) |
INVEGA SUSTENNA® / XEPLION® / INVEGA TRINZA® / TREVICTA® | | | | | | |
U.S. | | 544 |
| | 483 |
| | 12.6 |
|
International | | 339 |
| | 307 |
| | 10.3 |
|
Worldwide | | 883 |
| | 790 |
| | 11.7 |
|
RISPERDAL CONSTA® | | | | | | |
U.S. | | 76 |
| | 77 |
| | (0.3 | ) |
International | | 94 |
| | 102 |
| | (8.7 | ) |
Worldwide | | 170 |
| | 179 |
| | (5.1 | ) |
OTHER NEUROSCIENCE | | | | | | |
U.S. | | 75 |
| | 66 |
| | 12.5 |
|
International | | 360 |
| | 379 |
| | (5.1 | ) |
Worldwide | | 435 |
| | 446 |
| | (2.5 | ) |
| | | | | | |
Oncology | | | | | | |
U.S. | | 1,175 |
| | 962 |
| | 22.1 |
|
International | | 1,839 |
| | 1,556 |
| | 18.2 |
|
Worldwide | | 3,013 |
| | 2,518 |
| | 19.7 |
|
DARZALEX® | | | | | | |
U.S. | | 463 |
| | 352 |
| | 31.8 |
|
International | | 474 |
| | 277 |
| | 70.9 |
|
Worldwide | | 937 |
| | 629 |
| | 49.0 |
|
ERLEADA® | | | | | | |
U.S. | | 119 |
| | 58 |
| | * |
International | | 24 |
| | 3 |
| | * |
Worldwide | | 143 |
| | 61 |
| | * |
IMBRUVICA® | | | | | | |
U.S. | | 432 |
| | 349 |
| | 23.9 |
|
International | | 599 |
| | 435 |
| | 37.8 |
|
Worldwide | | 1,031 |
| | 784 |
| | 31.6 |
|
VELCADE® | | | | | | |
U.S. | | — |
| | — |
| | — |
International | | 108 |
| | 263 |
| | (59.0 | ) |
Worldwide | | 108 |
| | 263 |
| | (59.0 | ) |
ZYTIGA® / abiraterone acetate | | | | | | |
U.S. | | 139 |
| | 185 |
| | (25.2 | ) |
International | | 552 |
| | 494 |
| | 11.7 |
|
Worldwide | | 690 |
| | 679 |
| | 1.6 |
|
| | | | | | |
20
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
OTHER ONCOLOGY(1) | | | | | | | | | | | | |
U.S. | | 21 | | | 22 | | | (5.1) | | | | | | | |
International | | 161 | | | 190 | | | (15.3) | | | | | | | |
Worldwide | | 182 | | | 212 | | | (14.2) | | | | | | | |
| | | | | | | | | | | | |
Pulmonary Hypertension | | | | | | | | | | | | |
U.S. | | 573 | | | 486 | | | 18.0 | | | | | | | |
International | | 288 | | | 260 | | | 10.8 | | | | | | | |
Worldwide | | 861 | | | 745 | | | 15.5 | | | | | | | |
OPSUMIT® | | | | | | | | | | | | |
U.S. | | 272 | | | 229 | | | 18.5 | | | | | | | |
International | | 179 | | | 160 | | | 11.5 | | | | | | | |
Worldwide | | 450 | | | 389 | | | 15.6 | | | | | | | |
UPTRAVI® | | | | | | | | | | | | |
U.S. | | 259 | | | 212 | | | 21.9 | | | | | | | |
International | | 46 | | | 38 | | | 23.0 | | | | | | | |
Worldwide | | 305 | | | 250 | | | 22.0 | | | | | | | |
OTHER PULMONARY HYPERTENSION | | | | | | | | | | | | |
U.S. | | 42 | | | 44 | | | (3.5) | | | | | | | |
International | | 63 | | | 62 | | | 1.4 | | | | | | | |
Worldwide | | 105 | | | 106 | | | (0.6) | | | | | | | |
| | | | | | | | | | | | |
Cardiovascular / Metabolism / Other | | | | | | | | | | | | |
U.S. | | 799 | | | 806 | | | (0.9) | | | | | | | |
International | | 328 | | | 354 | | | (7.2) | | | | | | | |
Worldwide | | 1,127 | | | 1,160 | | | (2.8) | | | | | | | |
XARELTO® | | | | | | | | | | | | |
U.S. | | 589 | | | 527 | | | 11.7 | | | | | | | |
International | | 0 | | | 0 | | | 0 | | | | | | | |
Worldwide | | 589 | | | 527 | | | 11.7 | | | | | | | |
INVOKANA® / INVOKAMET® | | | | | | | | | | | | |
U.S. | | 87 | | | 117 | | | (26.1) | | | | | | | |
International | | 63 | | | 58 | | | 9.2 | | | | | | | |
Worldwide | | 150 | | | 175 | | | (14.4) | | | | | | | |
PROCRIT® / EPREX® | | | | | | | | | | | | |
U.S. | | 62 | | | 76 | | | (18.3) | | | | | | | |
International | | 64 | | | 79 | | | (18.1) | | | | | | | |
Worldwide | | 127 | | | 155 | | | (18.2) | | | | | | | |
OTHER | | | | | | | | | | | | |
U.S. | | 60 | | | 85 | | | (28.8) | | | | | | | |
International | | 201 | | | 217 | | | (7.7) | | | | | | | |
Worldwide | | 261 | | | 302 | | | (13.6) | | | | | | | |
| | | | | | | | | | | | |
TOTAL PHARMACEUTICAL | | | | | | | | | | | | |
U.S. | | 6,446 | | | 6,061 | | | 6.4 | | | | | | | |
International | | 5,753 | | | 5,073 | | | 13.4 | | | | | | | |
Worldwide | | 12,199 | | | 11,134 | | | 9.6 | | | | | | | |
|
| | | | | | | | | | |
OTHER ONCOLOGY | | | | | | |
U.S. | | 22 |
| | 18 |
| | 20.1 |
International | | 82 |
| | 84 |
| | (2.7) |
Worldwide | | 104 |
| | 102 |
| | 1.3 |
| | | | | | |
Pulmonary Hypertension | | | | | | |
U.S. | | 486 |
| | 430 |
| | 13.0 |
International | | 260 |
| | 226 |
| | 14.9 |
Worldwide | | 745 |
| | 656 |
| | 13.7 |
OPSUMIT® | | | | | | |
U.S. | | 229 |
| | 172 |
| | 33.0 |
International | | 160 |
| | 133 |
| | 20.2 |
Worldwide | | 389 |
| | 306 |
| | 27.4 |
UPTRAVI® | | | | | | |
U.S. | | 212 |
| | 176 |
| | 20.7 |
International | | 38 |
| | 22 |
| | 70.2 |
Worldwide | | 250 |
| | 198 |
| | 26.2 |
OTHER PULMONARY HYPERTENSION | | | | | | |
U.S. | | 44 |
| | 82 |
| | (45.9) |
International | | 62 |
| | 71 |
| | (12.4) |
Worldwide | | 106 |
| | 152 |
| | (30.4) |
| | | | | | |
Cardiovascular / Metabolism / Other | | | | | | |
U.S. | | 806 |
| | 947 |
| | (14.9 | ) |
International | | 354 |
| | 398 |
| | (11.0 | ) |
Worldwide | | 1,160 |
| | 1,345 |
| | (13.8 | ) |
XARELTO® | | | | | | |
U.S. | | 527 |
| | 542 |
| | (2.7 | ) |
International | | — |
| | — |
| | — |
Worldwide | | 527 |
| | 542 |
| | (2.7 | ) |
INVOKANA® / INVOKAMET® | | | | | | |
U.S. | | 117 |
| | 154 |
| | (23.6 | ) |
International | | 58 |
| | 49 |
| | 18.6 |
|
Worldwide | | 175 |
| | 202 |
| | (13.5 | ) |
PROCRIT® / EPREX® | | | | | | |
U.S. | | 76 |
| | 148 |
| | (48.5 | ) |
International | | 79 |
| | 78 |
| | 0.4 |
|
Worldwide | | 155 |
| | 226 |
| | (31.6 | ) |
OTHER | | | | | | |
U.S. | | 85 |
| | 104 |
| | (18.0 | ) |
International | | 217 |
| | 271 |
| | (19.7 | ) |
Worldwide | | 302 |
| | 374 |
| | (19.2 | ) |
| | | | | | |
TOTAL PHARMACEUTICAL | | | | | | |
U.S. | | 6,061 |
| | 5,582 |
| | 8.6 |
|
International | | 5,073 |
| | 4,662 |
| | 8.8 |
|
Worldwide | | 11,134 |
| | 10,244 |
| | 8.7 |
|
| | | | | | |
21
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
MEDICAL DEVICES | | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
Interventional Solutions | | | | | | | | | | | | |
U.S. | | 434 | | | 365 | | | 19.0 | | | | | | | |
International | | 514 | | | 362 | | | 42.0 | | | | | | | |
Worldwide | | 949 | | | 727 | | | 30.4 | | | | | | | |
Orthopaedics | | | | | | | | | | | | |
U.S. | | 1,249 | | | 1,250 | | | (0.1) | | | | | | | |
International | | 864 | | | 788 | | | 9.7 | | | | | | | |
Worldwide | | 2,113 | | | 2,038 | | | 3.7 | | | | | | | |
HIPS | | | | | | | | | | | | |
U.S. | | 210 | | | 206 | | | 2.4 | | | | | | | |
International | | 146 | | | 132 | | | 11.2 | | | | | | | |
Worldwide | | 357 | | | 337 | | | 5.8 | | | | | | | |
KNEES | | | | | | | | | | | | |
U.S. | | 185 | | | 214 | | | (13.5) | | | | | | | |
International | | 132 | | | 130 | | | 2.0 | | | | | | | |
Worldwide | | 317 | | | 343 | | | (7.6) | | | | | | | |
TRAUMA | | | | | | | | | | | | |
U.S. | | 450 | | | 407 | | | 10.7 | | | | | | | |
International | | 282 | | | 247 | | | 14.4 | | | | | | | |
Worldwide | | 733 | | | 654 | | | 12.1 | | | | | | | |
SPINE, SPORTS & OTHER | | | | | | | | | | | | |
U.S. | | 403 | | | 423 | | | (4.8) | | | | | | | |
International | | 303 | | | 280 | | | 8.4 | | | | | | | |
Worldwide | | 706 | | | 703 | | | 0.4 | | | | | | | |
Surgery | | | | | | | | | | | | |
U.S. | | 898 | | | 844 | | | 6.5 | | | | | | | |
International | | 1,474 | | | 1,257 | | | 17.3 | | | | | | | |
Worldwide | | 2,372 | | | 2,100 | | | 12.9 | | | | | | | |
ADVANCED | | | | | | | | | | | | |
U.S. | | 405 | | | 381 | | | 6.5 | | | | | | | |
International | | 713 | | | 567 | | | 25.7 | | | | | | | |
Worldwide | | 1,118 | | | 948 | | | 18.0 | | | | | | | |
GENERAL | | | | | | | | | | | | |
U.S. | | 493 | | | 463 | | | 6.5 | | | | | | | |
International | | 761 | | | 690 | | | 10.3 | | | | | | | |
Worldwide | | 1,254 | | | 1,153 | | | 8.8 | | | | | | | |
Vision | | | | | | | | | | | | |
U.S. | | 472 | | | 439 | | | 7.4 | | | | | | | |
International | | 673 | | | 628 | | | 7.3 | | | | | | | |
Worldwide | | 1,145 | | | 1,067 | | | 7.3 | | | | | | | |
CONTACT LENSES / OTHER | | | | | | | | | | | | |
U.S. | | 371 | | | 346 | | | 7.2 | | | | | | | |
International | | 486 | | | 467 | | | 4.0 | | | | | | | |
Worldwide | | 857 | | | 814 | | | 5.3 | | | | | | | |
| | | | | | | | | | | | |
|
| | | | | | | | | | |
MEDICAL DEVICES | | | | | | |
Interventional Solutions | | | | | | |
U.S. | | 365 |
| | 343 |
| | 6.6 |
|
International | | 362 |
| | 389 |
| | (6.9 | ) |
Worldwide | | 727 |
| | 732 |
| | (0.6 | ) |
Orthopaedics | | | | | | |
U.S. | | 1,250 |
| | 1,318 |
| | (5.2 | ) |
International | | 788 |
| | 885 |
| | (11.0 | ) |
Worldwide | | 2,038 |
| | 2,204 |
| | (7.5 | ) |
HIPS | | | | | | |
U.S. | | 206 |
| | 213 |
| | (3.6 | ) |
International | | 132 |
| | 148 |
| | (11.2 | ) |
Worldwide | | 337 |
| | 361 |
| | (6.7 | ) |
KNEES | | | | | | |
U.S. | | 214 |
| | 223 |
| | (4.2 | ) |
International | | 130 |
| | 146 |
| | (11.4 | ) |
Worldwide | | 343 |
| | 369 |
| | (7.0 | ) |
TRAUMA | | | | | | |
U.S. | | 407 |
| | 417 |
| | (2.3 | ) |
International | | 247 |
| | 268 |
| | (8.0 | ) |
Worldwide | | 654 |
| | 685 |
| | (4.5 | ) |
SPINE, SPORTS & OTHER | | | | | | |
U.S. | | 423 |
| | 465 |
| | (8.9 | ) |
International | | 280 |
| | 323 |
| | (13.3 | ) |
Worldwide | | 703 |
| | 788 |
| | (10.7 | ) |
Surgery | | | | | | |
U.S. | | 844 |
| | 1,001 |
| | (15.7 | ) |
International | | 1,257 |
| | 1,394 |
| | (9.8 | ) |
Worldwide | | 2,100 |
| | 2,395 |
| | (12.3 | ) |
ADVANCED | | | | | | |
U.S. | | 381 |
| | 404 |
| | (5.7 | ) |
International | | 567 |
| | 576 |
| | (1.6 | ) |
Worldwide | | 948 |
| | 980 |
| | (3.3 | ) |
GENERAL | | | | | | |
U.S. | | 463 |
| | 597 |
| | (22.5 | ) |
International | | 690 |
| | 818 |
| | (15.7 | ) |
Worldwide | | 1,153 |
| | 1,414 |
| | (18.5 | ) |
Vision | | | | | | |
U.S. | | 439 |
| | 446 |
| | (1.6 | ) |
International | | 628 |
| | 682 |
| | (8.0 | ) |
Worldwide | | 1,067 |
| | 1,129 |
| | (5.5 | ) |
CONTACT LENSES / OTHER | | | | | | |
U.S. | | 346 |
| | 321 |
| | 7.7 |
|
International | | 467 |
| | 502 |
| | (7.0 | ) |
Worldwide | | 814 |
| | 824 |
| | (1.3 | ) |
SURGICAL | | | | | | |
U.S. | | 93 |
| | 125 |
| | (25.5 | ) |
22
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
SURGICAL | | | | | | | | | | | | |
U.S. | | 101 | | | 93 | | | 8.2 | | | | | | | |
International | | 187 | | | 160 | | | 17.0 | | | | | | | |
Worldwide | | 288 | | | 253 | | | 13.7 | | | | | | | |
| | | | | | | | | | | | |
TOTAL MEDICAL DEVICES | | | | | | | | | | | | |
U.S. | | 3,054 | | | 2,898 | | | 5.4 | | | | | | | |
International | | 3,525 | | | 3,034 | | | 16.2 | | | | | | | |
Worldwide | | 6,579 | | | 5,932 | | | 10.9 | | | | | | | |
| | | | | | | | | | | | |
WORLDWIDE | | | | | | | | | | | | |
U.S. | | 11,111 | | | 10,699 | | | 3.9 | | | | | | | |
International | | 11,210 | | | 9,992 | | | 12.2 | | | | | | | |
Worldwide | | $ | 22,321 | | | 20,691 | | | 7.9 | % | | | | | | |
|
| | | | | | | | | | |
International | | 160 |
| | 180 |
| | (11.0 | ) |
Worldwide | | 253 |
| | 305 |
| | (16.9 | ) |
| | | | | | |
TOTAL MEDICAL DEVICES | | | | | | |
U.S. | | 2,898 |
| | 3,109 |
| | (6.8 | ) |
International | | 3,034 |
| | 3,350 |
| | (9.4 | ) |
Worldwide | | 5,932 |
| | 6,459 |
| | (8.2 | ) |
| | | | | | |
WORLDWIDE | | | | | | |
U.S. | | 10,699 |
| | 10,129 |
| | 5.6 |
|
International | | 9,992 |
| | 9,892 |
| | 1.0 |
|
Worldwide | | $ | 20,691 |
| | 20,021 |
| | 3.3 | % |
*Percentage greater than 100% or not meaningful
(1) Inclusive of VELCADE® which was previously disclosed separately
EARNINGS BEFORE PROVISION FOR TAXES BY SEGMENT
| | | | Fiscal First Quarter Ended | | | Fiscal First Quarter Ended | | |
(Dollars in Millions) | | March 29, 2020 | | March 31, 2019 | | Percent Change | (Dollars in Millions) | | April 4, 2021 | | March 29, 2020 | | Percent Change | | |
Consumer Health (1) | | $ | 770 |
| | 741 |
| | 3.9 | % | Consumer Health (1) | | $ | 788 | | | 770 | | | 2.3% | | |
Pharmaceutical(2) | | 3,834 |
| | 2,331 |
| | 64.5 |
| Pharmaceutical(2) | | 5,223 | | | 3,834 | | | 36.2 | | |
Medical Devices(3) | | 2,025 |
| | 1,497 |
| | 35.3 |
| Medical Devices(3) | | 1,629 | | | 2,025 | | | (19.6) | | |
Segment earnings before provision for taxes | | 6,629 |
| | 4,569 |
| | 45.1 |
| Segment earnings before provision for taxes | | 7,640 | | | 6,629 | | | 15.3 | | |
Less: Expense not allocated to segments (4) | | 120 |
| | 147 |
| | |
| Less: Expense not allocated to segments (4) | | 211 | | | 120 | | | | | |
Worldwide income before tax | | $ | 6,509 |
| | 4,422 |
| | 47.2 | % | Worldwide income before tax | | $ | 7,429 | | | 6,509 | | | 14.1% | | |
(1) Consumer Health
•Includes a gainamortization expense of $0.1 billion in both the fiscal first quarter of 2021 and 2020.
$0.3 billion(2) related to the Company's previously held equity investment in Ci:z Holdings Co., Ltd. (DR. CI: LABO)Pharmaceutical
•Includes divestiture gains of $0.6 billion in the fiscal first quarter of 2019. Includes amortization expense of $0.1 billion in both2021 related to two brands outside the fiscal first quarters of 2020 and 2019, respectively. U.S.
(2) •Includes an in-process research and development expense of $0.9 billion related to the Alios asset in the fiscal first quarter of 2019. Includes litigation expense of $0.1 billion and $0.3 billion in the fiscal first quarter of 2020 and 2019, respectively. Includes an unrealized loss on securities of $0.3$0.3 billion in the fiscal first quarter of 2020 and an unrealized gain on securities2020.
•Includes litigation expense of $0.1$0.1 billion in the fiscal first quarter of 2019. Additionally,2020.
•Includes amortization expense of $0.9 billion and $0.8 billion in the fiscal first quarter of 2019 includes a research2021 and development expense of $0.3 billion for an upfront payment related to argenx. Includes amortization expense of $0.8 billion in both the fiscal first quarters of 2020, and 2019. respectively.
In fiscal 2020, the Company entered into a series of contract manufacturing arrangements for vaccine production with third party contract manufacturing organizations. These arrangements provide the Company with future supplemental commercial capacity for vaccine production and potentially transferable rights to such production if capacity is not required. Amounts paid and contractually obligated to be paid to these contract manufacturing organizations of approximately $1.0 billion are reflected in the prepaid expenses and other, other assets, accrued liabilities and other liabilities accounts in the Company's consolidated balance sheet upon execution of each agreement. Additionally, the Company has entered into certain vaccine development cost sharing arrangements with government related organizations.
(3) Medical Devices
•Includes a contingent consideration reversal of $1.0$1.0 billion in the fiscal first quarter of 2020 related to the timing of certain developmental milestones associated with the Auris Health acquisition.
•Includes litigationa restructuring related charge of $0.1 billion in both the fiscal first quarter of 2021 and 2020, respectively.
•Includes amortization expense of $0.1$0.3 billion and $0.2 billion in the fiscal first quarter of 2019. Includes a restructuring related charge of $0.1 billion2021 and amortization expense of $0.2 billion in both the fiscal first quarters of 2020, and 2019. respectively.
(4) Amounts not allocated to segments include interest income/expense and general corporate income/expense.
SALES BY GEOGRAPHIC AREA
|
| | | | | | | | | | |
| | Fiscal First Quarter Ended |
(Dollars in Millions) | | March 29, 2020 | | March 31, 2019 | | Percent Change |
United States | | $ | 10,699 |
| | 10,129 |
| | 5.6 | % |
Europe | | 4,827 |
| | 4,609 |
| | 4.7 |
|
Western Hemisphere, excluding U.S. | | 1,502 |
| | 1,503 |
| | (0.1 | ) |
Asia-Pacific, Africa | | 3,663 |
| | 3,780 |
| | (3.1 | ) |
Total | | $ | 20,691 |
| | 20,021 |
| | 3.3 | % |
NOTE 10— BUSINESS COMBINATIONS AND DIVESTITURES
SALES BY GEOGRAPHIC AREA
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Fiscal First Quarter Ended | | |
(Dollars in Millions) | | April 4, 2021 | | March 29, 2020 | | Percent Change | | | | | | |
United States | | $ | 11,111 | | | 10,699 | | | 3.9 | % | | | | | | |
Europe | | 5,414 | | | 4,827 | | | 12.1 | | | | | | | |
Western Hemisphere, excluding U.S. | | 1,424 | | | 1,502 | | | (5.1) | | | | | | | |
Asia-Pacific, Africa | | 4,372 | | | 3,663 | | | 19.4 | | | | | | | |
Total | | $ | 22,321 | | | 20,691 | | | 7.9 | % | | | | | | |
NOTE 10— ACQUISITIONS AND DIVESTITURES
In the first fiscal quarter of 2021, in separate transactions, the Company divested two brands outside the U.S. within the Pharmaceutical segment. The Company recognized a pre-tax gain recorded in Other (income) expense, net, of approximately $0.6 billion.
During the fiscal first quarter of 2020, the Company completed the acquisition of all rights to the investigational compound bermekimab, which has multiple dermatological indications, along with certain employees from XBiotech Inc., for a purchase price of $0.8 billion.$0.8 billion. The fair value of the acquisition was allocated primarily to non-amortizable intangible assets, primarily IPR&D,&D, for $0.8 billion.$0.8 billion. XBiotech may be eligible to receive additional payments upon the receipt of certain commercialization authorizations. The transaction was accounted for as a business combination and included in the Pharmaceutical segment. Additionally, the Company completed the acquisition of all outstanding shares in Verb Surgical Inc., a company with world-class robotics and data science capabilities, including those shares previously held by Verily.
The transaction was accounted for as a business combination and included in the Medical Devices segment. The fair value of the acquisition was allocated primarily to non-amortizable intangible assets, primarily IPR&D,&D, for $0.4$0.4 billion,, goodwill for $0.2$0.2 billion,, other assets of $0.2$0.2 billion and liabilities assumed of $0.3 billion.$0.3 billion. The fair value of the Company's previously held equity investment in Verb Surgical Inc. was $0.4 billion. $0.4 billion.
On April 1, 2019, the Company completed the acquisition of Auris Health, Inc. for approximately $3.4 billion, net of cash acquired. Additional contingent payments of up to $2.35 billion, in the aggregate, may be payable upon reaching certain predetermined milestones. Auris Health was a privately held developer of robotic technologies, initially focused in lung cancer, with an FDA-cleared platform currently used in bronchoscopic diagnostic and therapeutic procedures. The Company treated this transaction as a business combination and included it in the Medical Devices segment. The fair value of the acquisition was allocated primarily to amortizable and non-amortizable intangible assets, primarily IPR&D, for $3.0 billion, goodwill for $2.0 billion, marketable securities of $0.2 billion and liabilities assumed of $1.8 billion, which includes the fair value of the contingent payments mentioned above, subject to any subsequent valuation adjustments within the measurement period. As of
March 29, 2020, there were no valuation adjustments to the assets acquired but during the fiscal first quarter of 2020, the Company recorded Other income of $1.0 billion for the reversal of the contingent consideration related to the timing of certain developmental and commercial milestones, which are not expected to be met based on the Company’s current timelines. As of March 29, 2020, the fair value of the remaining contingent consideration is $0.2 billion. Further, the Company re-assessed the current value of the Auris IPR&D assets in connection with the modified development timeline and determined the fair value still exceeds the carrying value.
On January 17, 2019, the Company acquired DR. CI:LABO, a Japanese company focused on the marketing, development and distribution of a broad range of dermocosmetic, cosmetic and skincare products for a total purchase price of approximately ¥230 billion, which equates to approximately $2.1 billion, using the exchange rate of 109.06 Japanese Yen to each U.S. Dollar on January 16, 2019. Additionally, in the fiscal first quarter of 2019, the Company recognized a pre-tax gain recorded in Other (income) expense, net, of approximately $0.3 billion related to the Company's previously held equity investment in DR. CI:LABO. NOTE 11 — LEGAL PROCEEDINGS
The Company treated this transaction as a business combination and included it in the Consumer Health segment. During the fiscal first quarter of 2020, the Company finalized the purchase price allocation. At March 29, 2020, the fair value of the acquisition was allocated primarily to amortizable intangible assets for $1.5 billion, goodwill for $1.2 billion and liabilities assumed of $0.4 billion. The adjustments made since the date of acquisition were $0.1 billion to intangible assets, accrued liabilities, deferred taxes on income and property, plant and equipment with the offset to goodwill. The amortizable intangible assets were comprised of brand/trademarks and customer relationships with a weighted average life of 15.3 years. The goodwill is primarily attributable to synergies expected to arise from the business acquisition and is not expected to be deductible for tax purposes.
During the fiscal third quarter of 2018, the Company accepted a binding offer to form a strategic collaboration with Jabil Inc., one of the world’s leading manufacturing services providers for health care products and technology products. The Company is expanding a 12-year relationship with Jabil Inc. to produce a range of products within the Ethicon Endo-Surgery and DePuy Synthes businesses. This transaction includes the transfer of certain employees and manufacturing sites. The majority of the transfers were completed in 2019 with a minor amount remaining in 2020. As of March 29, 2020, the assets held for sale on the Consolidated Balance Sheet were $0.1 billion of inventory and property, plant and equipment, net. For additional details on the global supply chain restructuring see Note 12 to the Consolidated Financial Statements.
NOTE 11 — LEGAL PROCEEDINGS
Johnson && Johnson and certain of its subsidiaries are involved in various lawsuits and claims regarding product liability; intellectual property; commercial; supplier indemnification and other matters; governmental investigations; and other legal proceedings that arise from time to time in the ordinary course of their business. Due to the ongoing impacts of the COVID-19 pandemic, certain trials have been rescheduled or delayed. The Company continues to monitor its legal proceedings as the situation develops.evolves.
The Company records accruals for loss contingencies associated with these legal matters when it is probable that a liability will be incurred, and the amount of the loss can be reasonably estimated. As of March 29, 2020,April 4, 2021, the Company has determined that the liabilities associated with certain litigation matters are probable and can be reasonably estimated. The Company has accrued for these matters and will continue to monitor each related legal issue and adjust accruals as might be warranted based on new information and further developments in accordance with ASC 450-20-25. For these and other litigation and regulatory matters discussed below for which a loss is probable or reasonably possible, the Company is unable to estimate the possible loss or range of loss beyond the amounts already accrued. Amounts accrued for legal contingencies often result from a complex series of judgments about future events and uncertainties that rely heavily on estimates and assumptions including timing of related payments. The ability to make such estimates and judgments can be affected by various factors including, among other things, whether damages sought in the proceedings are unsubstantiated or indeterminate; scientific and legal discovery has not commenced or is not complete; proceedings are in early stages; matters present legal uncertainties; there are significant facts in dispute; procedural or jurisdictional issues; the uncertainty and unpredictability of the number of potential claims; ability to achieve comprehensive multi-party settlements; complexity of related cross-claims and counterclaims; and/or there are numerous parties involved. To the extent adverse awards, judgments or verdicts have been rendered against the Company, the Company does not record an accrual until a loss is determined to be probable and can be reasonably estimated.
In the Company's opinion, based on its examination of these matters, its experience to date and discussions with counsel, the ultimate outcome of legal proceedings, net of liabilities accrued in the Company's balance sheet, is not expected to have a material adverse effect on the Company's financial position. However, the resolution of, or increase in accruals for, one or more
of these matters in any reporting period may have a material adverse effect on the Company's results of operations and cash flows for that period.
PRODUCT LIABILITY
Johnson && Johnson and certain of its subsidiaries are involved in numerous product liability claims and lawsuits involving multiple products. Claimants in these cases seek substantial compensatory and, where available, punitive damages. While the Company believes it has substantial defenses, it is not feasible to predict the ultimate outcome of litigation. From time to time, even if it has substantial defenses, the Company considers isolated settlements based on a variety of circumstances. The Company has established accruals for product liability claims and lawsuits in compliance with ASC 450-20 based on currently available information, which in some cases may be limited. The Company accrues an estimate of the legal defense costs needed to defend each matter when those costs are probable and can be reasonably estimated. For certain of these matters, the Company has accrued additional amounts such as estimated costs associated with settlements, damages and other losses. Product liability accruals can represent projected product liability for thousands of claims around the world, each in different litigation environments and with different fact patterns. Changes to the accruals may be required in the future as additional information becomes available.
The most significant of these cases include: the DePuy ASR™ASR™ XL Acetabular System and DePuy ASR™ASR™ Hip Resurfacing System; the PINNACLE®® Acetabular Cup System; pelvic meshes; RISPERDAL®®; XARELTO®®; body powders containing talc, primarily JOHNSONS®® Baby Powder; INVOKANA®®; and ETHICON PHYSIOMESH® ® Flexible Composite Mesh. As of March 29, 2020,April 4, 2021, in the United States there were approximately 940300 plaintiffs with direct claims in pending lawsuits regarding injuries allegedly due to the DePuy ASR™ASR™ XL Acetabular System and DePuy ASR™ASR™ Hip Resurfacing System; 9,5007,000 with respect to the PINNACLE®® Acetabular Cup System; 16,50012,200 with respect to pelvic meshes; 10,9009,200 with respect to RISPERDAL®®; 24,60010,200 with respect to XARELTO®®; 19,40028,900 with respect to body powders containing talc; 300 with respect to INVOKANA®®;and 3,5004,400 with respect to ETHICON PHYSIOMESH®® Flexible Composite Mesh.
In August 2010, DePuy Orthopaedics, Inc. (DePuy) announced a worldwide voluntary recall of its ASR™™ XL Acetabular System and DePuy ASR™™ Hip Resurfacing System used in hip replacement surgery. Claims for personal injury have been made against DePuy and Johnson && Johnson. The number of pending lawsuits is expected to fluctuate as certain lawsuits are settled or dismissed and additional lawsuits are filed. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Northern District of Ohio. Litigation has also been filed in countries outside of the United States, primarily in the United Kingdom, Canada, Australia, Ireland, Germany, India and Italy. In
November 2013, DePuy reached an agreement with a Court-appointed committee of lawyers representing ASR Hip System plaintiffs to establish a program to settle claims with eligible ASR Hip patients in the United States who had surgery to replace their ASR Hips, known as revision surgery, as of August 31, 2013. DePuy reached additional agreements in February 2015 and March 2017, which further extended the settlement program to include ASR Hip patients who had revision surgeries after August 31, 2013 and prior to February 15, 2017. This settlement program has resolved more than 10,000 claims, therefore bringing to resolution significant ASR Hip litigation activity in the United States. However, lawsuits in the United States remain, and the settlement program does not address litigation outside of the United States. In Australia, a class action settlement was reached that resolved the claims of the majority of ASR Hip patients in that country. In Canada, the Company has reached agreements to settle two pendingthe class actions which have been approved by the Québec Superior Court and the Supreme Court of British Columbia. The British Columbia order is currently the subject of the Company's appeal to broaden the scope of participants.filed in that country. The Company continues to receive information with respect to potential additional costs associated with this recall on a worldwide basis. The Company has established accruals for the costs associated with the United States settlement program and DePuy ASR™™ Hip-related product liability litigation.
Claims for personal injury have also been made against DePuy Orthopaedics, Inc. and Johnson && Johnson (collectively, DePuy) relating to the PINNACLE®® Acetabular Cup System used in hip replacement surgery. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Northern District of Texas. Litigation also has also been filed in some state courts and in countries outside of the United States. Several adverse verdicts have been rendered against DePuy, one of which was reversed on appeal and remanded for retrial. During the first quarter of 2019, DePuy established a United States settlement program to resolve these cases. As part of the settlement program, adverse verdicts have been settled. The Company has established an accrual for product liability litigation associated with the PINNACLE®® Acetabular Cup System and the related settlement program.
Claims for personal injury have been made against Ethicon, Inc. (Ethicon) and Johnson && Johnson arising out of Ethicon's pelvic mesh devices used to treat stress urinary incontinence and pelvic organ prolapse. The Company continues to receive information with respect to potential costs and additional cases. Cases filed in federal courts in the United States had been organized as a multi-district litigation (MDL) in the United States District Court for the Southern District of West Virginia. In March 2021, the MDL Court entered an order closing the MDL. The MDL Court is remandinghas remanded cases for trial to the
jurisdictions where the case was originally filed and additional pelvic mesh lawsuits have been filed, and remain, outside of the MDL. The Company has settled or otherwise resolved a majority of the United States cases and the estimated costs associated with these settlements and the remaining cases are reflected in the Company's accruals. In addition, class actions and individual personal injury cases or claims seeking damages for alleged injury resulting from Ethicon's pelvic mesh devices have been commenced in various countries outside of the United States, including claims and cases in the United Kingdom, the Netherlands, and Belgium, and class actions in Israel, Australia and Canada, seeking damages for alleged injury resulting from Ethicon's pelvic mesh devices.. In November 2019, the Federal Court of Australia issued a judgment regarding its findings with respect to liability in relation to the three Lead Applicants and generally in relation to the design, manufacture, pre and post-market assessments and testing, and supply and promotion of the devices in Australia used to treat stress urinary incontinence and pelvic organ prolapse. In March 2020, the Court issued a decision and entered damages awards to the three Lead Applicants. The Company appealed the decision to the intermediate appellate court, the Full Court. The appeal was heard in February 2021 and, in March 2021, the Full Court entered a judgment dismissing the appeal. An application for special leave to the High Court of Australia was filed in April 2021. With respect to class members other group members, therethan the Lead Applicants, the Federal Court will beconduct an individual case assessment process whichthat will require proof of use and causally related loss.loss, although the form of that process has not yet been decided. The class actions in Canada are expected to bewere discontinued in 2020 as a result of a settlement of a group of cases, subject to court approval of the discontinuance.cases. The Company has established accruals with respect to product liability litigation associated with Ethicon's pelvic mesh products.
Following a June 2016 worldwide market withdrawal of ETHICON PHYSIOMESH®® Flexible Composite Mesh, claims for personal injury have been made against Ethicon, Inc. (Ethicon) and Johnson && Johnson alleging personal injury arising out of the use of this hernia mesh device. Cases filed in federal courts in the United States have been organized as a multi-district litigation (MDL) in the United States District Court for the Northern District of Georgia. A multi-county litigation (MCL) also has also been formed in New Jersey state court and assigned to Atlantic County for cases pending in New Jersey. In addition to the matters in the MDL and MCL, there are additional lawsuits pending in the United States District Court for the Southern District of Ohio, which are part of the MDL for polypropylene mesh devices manufactured by C.R. Bard, Inc., one multi-plaintiff lawsuit pending in Oklahoma state court and lawsuits pending outside the United States. Discovery is proceeding in these cases and certain of the cases are in preparation for trials.
Along with ETHICON PHYSIOMESH® lawsuits, there were a number of filings related toClaims have also been filed against Ethicon and Johnson & Johnson alleging personal injuries arising from the PROCEED®® Mesh and PROCEED®® Ventral Patch hernia mesh products.In March 2019, the New Jersey Supreme Court entered an order consolidating all PROCEED® and PROCEED® Ventral Patchthese cases pending in New Jersey as an MCL in Atlantic County Superior Court. Additional cases have been filed in various federal and state courts in the US, and in jurisdictions outside the US. Discovery is underway in these cases.
Ethicon and Johnson & Johnson also have been subject to claims for personal injuries arising from the PROLENE™ Polypropylene Hernia System (PHS). In September 2019, plaintiffs’ attorney filed an application with the New Jersey Supreme Court seeking centralized management of 107 PHS cases. The Company continuesNew Jersey Supreme Court granted plaintiffs application in January 2020 and those cases have also been transferred to receive information with respect to potential costsan MCL in Atlantic County Superior Court. There are now approximately 304 cases pending in the MCL and the anticipated numberdiscovery is underway in a subset of these cases.
The Company has established accruals with respect to product liability litigation associated with ETHICON PHYSIOMESH® ® Flexible Composite Mesh, PROCEED®® Mesh
and PROCEED®® Ventral Patch, products. In September 2019, plaintiffs’ attorney filed an application with the New Jersey Supreme Court seeking centralized management of 107 PROLENE™and PROLENE™ Polypropylene Hernia System cases. The New Jersey Supreme Court granted plaintiffs application in January 2020 and those will be transferred to an MCL in Atlantic County Superior Court.products.
Claims for personal injury have been made against Janssen Pharmaceuticals, Inc. and Johnson && Johnson arising out of the use of RISPERDAL®®, and related compounds, indicated for the treatment of schizophrenia, acute manic or mixed episodes associated with bipolar I disorder and irritability associated with autism. Lawsuits primarily have been primarily filed in state courts in Pennsylvania, California, and Missouri. Other actions are pending in various courts in the United States and Canada. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has successfully defended a number of these cases but there have been verdicts against the Company, including a recent verdict in October 2019 of $8$8.0 billion of punitive damages related to one single plaintiff which was subsequentlythe trial judge reduced to $6.8 million in January 2020 to $6.8 million by the trial judge.2020. The Company will appeal the finaland plaintiff each are appealing this judgment. The Company has settled or otherwise resolved many of the United States cases and the costs associated with these settlements are reflected in the Company's accruals.
Claims for personal injury arising out of the use of XARELTO®®, an oral anticoagulant, have been made against Janssen Pharmaceuticals, Inc. (JPI); Johnson & Johnson (J&J);& Johnson; and JPI’sJPI’s collaboration partner for XARELTO®®, Bayer AG and certain of its affiliates. Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Eastern District of Louisiana. In addition, cases have been filed in state courts across the United States. Many of these cases have beenwere consolidated into a state mass tort litigation in Philadelphia, Pennsylvania and in a coordinated proceeding in Los Angeles, California. Class action lawsuits also have been filed in Canada. In March 2019, JPI and J&JJohnson & Johnson announced an agreement in principle to the settle the XARELTO®® cases in the United States; the settlement agreement was executed in May 2019, the settlement became final in December 2019, and the settlement was funded in January 2020.
This resolved the majority of cases pending in the United States. The Company has established accruals for its costs associated with the United States settlement program and XARELTO®® related product liability litigation.
Personal injury claims alleging that talc causes cancer have been made against Johnson && Johnson Consumer Inc. and Johnson && Johnson arising out of the use of body powders containing talc, primarily JOHNSON’SJOHNSON’S®® Baby Powder. The number of pending product liabilitypersonal injury lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. Lawsuits primarily have been primarily filed in state courts in Missouri, New Jersey and California, as well asand suits have also been filed outside the United States. Cases filedThe majority of cases are pending in federal courts in the United States have beencourt, organized asinto a multi-district litigation (MDL) in the United States District Court for the District of New Jersey. In the multi-district litigation,MDL, the parties have movedsought to exclude experts known asthrough Daubert motions. The Court held Daubert hearings in mid-July 2019 and a final round of briefing was submitted to the Court. In April 2020, the Court issued rulings whichthat limit the scope of testimony, including some theories and testing methods, for certain plaintiff expert witnesses and denied theplaintiffs’ attempt to limit the scope of testimony of certain of the Company’sCompany’s witnesses. TheWith this ruling made, case-specific discovery has begun per the Court’s directive.
In talc cases that previously have gone to trial, the Company has successfully defendedobtained a number of these casesdefense verdicts, but there also have been verdicts against the Company, includingmany of which have been reversed on appeal. In June 2020, the Missouri Court of Appeals reversed in part and affirmed in part a verdict in July 2018 verdict of $4.7 billion in $4.7 billionIngham v. Johnson & Johnson, et al., No. ED 207476 (Mo. App.), reducing the overall award to $2.1 billion and, with additional interest as of April 4, 2021, as the Company pursues further appeal, is approximately $2.5 billion (the Ingham decision). An application for transfer of the case to the Missouri Supreme Court was subsequently denied. In March 2021, the Company filed a petition for certiorari, seeking a review of the Ingham decision by the United States Supreme Court. In April 2021, the Plaintiffs filed their opposition to the petition. The Company believescontinues to believe that it has strong legal grounds onfor the appeal to overturn these verdicts.of this verdict, as well as other talc verdicts that it has appealed. Notwithstanding the Company’s confidence in the safety of its talc products, in certain circumstances the Company has and may settle cases. The Company has established an accrual primarily for defense costs and reserves for the resolution of certain cases and claims, including the Ingham decision currently on appeal, in connection with product liability litigation associated with body powders containing talc.
In February 2019, the Company’sCompany’s talc supplier, Imerys Talc America, Inc. and two of its affiliates, Imerys Talc Vermont, Inc. and Imerys Talc Canada, Inc. (collectively, Imerys) filed a voluntary chapter 11 petition commencing a reorganization under the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware (Imerys Bankruptcy). The Imerys Bankruptcy relates to Imerys’Imerys’ potential liability for personal injury from exposure to talcum powder sold by Imerys (Talc Claims). In its bankruptcy filing, Imerys noted certain claims it alleges it has against the Company for indemnification and rights to joint insurance proceeds. Based on such claims as well as indemnity and insurance claims the Company has against Imerys, the Company petitioned the United States District Court for the District of Delaware to establish federal jurisdiction of the state court talc lawsuits under the Bankruptcy Code. The Company's petition was denied and the state court talc lawsuits that have been removed to federal court on such basis have been remanded. The Company previously proposed to resolve Imerys' (and the Company’s)Company’s) obligations arising out of the Talc Claims by agreeing to assume the defense of litigation of all Talc Claims involving the Company's products, waiving the Company’sCompany’s indemnification claims against Imerys, and lifting the automatic stay to enable the Talc Claims to proceed outside the bankruptcy forum with the Company agreeing to settle or pay any judgment against Imerys. In addition,May 2020, Imerys and the asbestos claimants’ committee (Plan Proponents) filed their Plan of Reorganization (the Plan) and the Disclosure Statement related thereto agreeing to put its North American operations up for auction which was subsequently amended. The Company has objected to Imerys’ fourth requestthe Disclosure Statement and intends to extendobject to the time duringPlan of Reorganization as currently structured. Additionally, in June 2020, Cyprus Mines Corporation and its parent (Cyprus), which had owned certain Imerys talc mines, filed an adversary proceeding against the Company as well as Imerys seeking a declaration of indemnity under certain contractual agreements. The Company denies such indemnification is owed and filed a motion to dismiss the adversary complaint arguing, among other things, that the Court does not have subject matter jurisdiction over Cyprus’s claims against the Company. The Plan Proponents filed numerous amendments to the Plan and Disclosure Statement to which the debtor hasCompany objected. A hearing on the exclusive right to file aPlan Proponent’s Disclosure Statement was held in January 2021, and the Court entered an order approving the Disclosure Statement for the Ninth Amended Joint Chapter 11 plan. Plan of Reorganization of Imerys Talc America, Inc. and its Debtor Affiliates, allowing Debtors Imerys to proceed with soliciting votes on the Plan. In March 2021, the Company voted to reject the Debtors’ Plan and opted out of the consensual releases in the Plan. Discovery with respect to the Debtors’ Plan is ongoing and the Confirmation Hearing is set for August 2021. Relatedly, in February 2021, Cyprus filed a voluntary petition for relief under chapter 11 of the Bankruptcy Code and Cyprus filed its Disclosure Statement and Plan. Also, in February 2021, several of the Company’s insurers involved in coverage litigation in New Jersey State Court (the “Coverage Action”) filed a motion in the Imerys Bankruptcy Court proceeding seeking a determination that the automatic stay does not apply to the Coverage Action and, in the alternative, seeking relief from the automatic stay to allow them to continue to litigate their claims in the Coverage Action. In March 2021, the Company filed a limited response and reservation of rights with respect to the motion. The Court entered an agreed order modifying the stay to allow the litigation in the Coverage Action to continue.
In February 2018, a securities class action lawsuit was filed against Johnson && Johnson and certain named officers in the United States District Court for the District of New Jersey, alleging that Johnson && Johnson violated the federal securities laws by failing to disclose alleged asbestos contamination in body powders containing talc, primarily JOHNSON'S®® Baby Powder,
and that purchasers of Johnson & Johnson’s& Johnson’s shares suffered losses as a result. Plaintiffs arePlaintiff is seeking damages. In April 2019, the Company moved to dismiss the complaint and briefing on the motion was complete as of August 2019. In December 2019, the
Court denied, in part, the motion to dismiss. In March 2020, Defendants answered the complaint. In March 2021 briefing on Plaintiffs’ motion for class certification was completed. Discovery is ongoing.
In October 2018,June 2019, a shareholder derivative lawsuit was filed against Johnson & Johnson as the nominal defendant and its current directors as defendants in the United States District Court for the District of New Jersey, alleging a breach of fiduciary duties related to the alleged asbestos contamination in body powders containing talc, primarily JOHNSON’S® Baby Powder, and that Johnson & Johnson has suffered damages as a result of those alleged breaches. In June 2019, the shareholder filed an additional complaint initiating a summary proceeding in New Jersey state court for a books and records inspection. In August 2019, Johnson && Johnson responded to the books and records complaint and filed a cross motion to dismiss. In September 2019, Plaintiff replied and the Court heard oral argument. The Court has not yet ruled in the books and records action. In SeptemberOctober 2019, December 2019, and January 2020, four shareholders filed four separate derivative lawsuits against Johnson & Johnson as the nominal defendant and its current directors and certain officers as defendants in the United States District Court for the District of New Jersey, granted defendants’ motionalleging a breach of fiduciary duties related to dismiss the shareholder derivative lawsuit,alleged asbestos contamination in body powders containing talc, primarily JOHNSON’S® Baby Powder, and dismissed the complaint without prejudice. In October 2019, the shareholder filedthat Johnson & Johnson has suffered damages as a noticeresult of appeal with the United States Court of Appeals for the Third Circuit. In January 2020, the shareholder voluntarily dismissed his appeal, with prejudice. Four additional shareholder derivative lawsuits have been filed in New Jersey making similar allegations against the Company and its current directors and certain officers.those alleged breaches. In February 2020, thesethe four cases were consolidated into a single action under the caption In re Johnson && Johnson Talc Stockholder Derivative Litigation,. In July 2020, a report was delivered to the Company’s Board of Directors by independent counsel retained by the Board to investigate the allegations in the derivative lawsuits and in a series of shareholder letters that the Board received raising similar issues. Four of the shareholders have until Maywho sent demands are plaintiffs in the In re Johnson & Johnson Talc Stockholder Derivative Litigation. The independent counsel recommended that the Company reject the shareholder demands and take the steps that are necessary or appropriate to secure dismissal of the derivative lawsuits. The Board unanimously adopted the recommendations of the independent counsel’s report. In October 2020, to filethe shareholders filed a consolidated complaint, or identifyand in January 2021, Johnson & Johnson moved to dismiss the consolidated complaint. In March 2021, Plaintiffs filed a previously filed complaint as the operative complaint.motion for discovery. The Court temporarily terminated Johnson & Johnson’s motion to dismiss pending a decision on Plaintiff’s motion for discovery.
In January 2019, two ERISA class action lawsuits were filed by participants in the Johnson && Johnson Savings Plan against Johnson && Johnson, its Pension and Benefits Committee, and certain named officers in the United States District Court for the District of New Jersey, alleging that the defendants breached their fiduciary duties by offering Johnson && Johnson stock as a Johnson && Johnson Savings Plan investment option when it was imprudent to do so because of failures to disclose alleged asbestos contamination in body powders containing talc, primarily JOHNSON’SJOHNSON’S®® Baby Powder. Plaintiffs are seeking damages and injunctive relief. In September 2019, Defendants filed a motion to dismiss. In April 2020, the Court granted theDefendants’ motion to dismiss but granted leave to amend. In June 2020, Plaintiffs filed an amended complaint, and in July 2020, Defendants moved to dismiss the amended complaint. As of October 2020, briefing on Defendants’ motion was complete. In February 2021, the Court granted Defendants’ motion, and granted Plaintiffs leave to amend. In April 2021, Plaintiffs informed the Court that they did not intend to file an amended complaint, and the Court dismissed the case with prejudice.
A lawsuit is pendingwas brought against the Company in the Superior Court of California for the County of San Diego alleging violations of California’sCalifornia’s Consumer Legal Remedies Act (CLRA) relating to JOHNSON’SJOHNSON’S®® Baby Powder. In that lawsuit, the plaintiffs allege that Johnson && Johnson violated the CLRA by failing to provide required Proposition 65 warnings. In July 2019, the Company filed a notice of removal to the United States District Court for the Southern District of California and plaintiffs filed a second amended complaint shortly thereafter. In October 2019, the Company moved to dismiss the second amended complaint for failure to state a claim upon which relief may be granted. In response to those motions, plaintiffs filed a third amended complaint. In December 2019, the Company moved to dismiss the third amended complaint for failure to state a claim upon which relief may be granted. In April 2020, the Court granted the motion to dismiss but granted leave to amend. In May 2020, plaintiffs filed a Fourth Amended Complaint but indicated that they would be filing a motion for leave to file a fifth amended complaint. Plaintiffs filed a Fifth Amended Complaint in August 2020. The Company moved to dismiss the Fifth Amended Complaint for failure to state a claim upon which relief may be granted. In January 2021, the Court issued an Order and opinion ruling in the Company’s favor and granting the motion to dismiss with prejudice. In February 2021, Plaintiffs filed a Notice of Appeal with the Ninth Circuit.
In January 2020, the Abtahi Law Group filed an action under Proposition 65 against Johnson && Johnson and Johnson && Johnson Consumer Inc. as well as a number of other alleged talcum powder manufacturers and distributors, including one California company. In that action, the plaintiff alleges contamination of talcum powder products with unsafe levels of arsenic, hexavalent chromium and lead. The plaintiff seeks civil penalties and injunctive relief. Defendants filed a motion for summary judgment in January 2021, and a hearing on the motion was held in April 2021. Limited informal discovery is continuing.
In addition, the Company has received preliminary inquiries and subpoenas to produce documents regarding thesetalc matters from Senator Murray, a member of the Senate Committee on Health, Education, Labor and Pensions, the Department of Justice the Securities and Exchange Commission and the U.S. Congressional Subcommittee on Economic and Consumer Policy. The Company is cooperatingproduced documents as required in response and will continue to cooperate with government inquiries and continues to produce documents in response. inquiries.
Claims for personal injury have been made against a number of Johnson && Johnson companies, including Janssen Pharmaceuticals, Inc. and Johnson && Johnson, arising out of the use of INVOKANA®®, a prescription medication indicated to improve glycemic control in adults with Type 2 diabetes. LawsuitsIn December 2016, lawsuits filed in federal courts in the United States have beenwere organized as a multi-district litigation in the United States District Court for the District of New Jersey. Cases have also been filed in state courts. Class action lawsuits have been filed in Canada. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has settled or otherwise resolved many of the cases and claims in the United States and the costs associated with these settlements are reflected in the Company's accruals.
INTELLECTUAL PROPERTYClaims for personal injury have been made against a number of Johnson & Johnson companies, including Janssen Pharmaceuticals, Inc. and Johnson & Johnson, arising out of the use of ELMIRON®, a prescription medication indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. These lawsuits, which allege that ELMIRON® contributes to the development of permanent retinal injury and vision loss, have been filed in both state and federal courts across the United States. In December 2020, lawsuits filed in federal courts in the United States, including two putative class action cases seeking medical monitoring, were organized as a multi-district litigation in the United States District Court for the District of New Jersey. Cases have also been filed in various state courts. In addition, three class action lawsuits have been filed in Canada. Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases. The Company has established accruals for defense costs associated with ELMIRON® related product liability litigation.
INTELLECTUAL PROPERTY
Certain subsidiaries of Johnson && Johnson are subject, from time to time, to legal proceedings and claims related to patent, trademark and other intellectual property matters arising out of their businesses. Many of these matters involve challenges to the coverage and/or validity of the patents on various products and allegations that certain of the Company’sCompany’s products infringe the patents of third parties. Although these subsidiaries believe that they have substantial defenses to these challenges and allegations with respect to all significant patents, there can be no assurance as to the outcome of these matters. A loss in any of these cases could adversely affect the ability of these subsidiaries to sell their products, result in loss of sales due to loss of market exclusivity, require the payment of past damages and future royalties, and may result in a non-cash impairment charge for any associated intangible asset. The most significant of theseSignificant matters are described below.
Medical Devices
In March 2013, Medinol Ltd. (Medinol) filed a patent infringement lawsuit against Cordis Corporation (Cordis) and Johnson & Johnson in the United States District Court for the Southern District of New York alleging that Cordis’s sales of the CYPHER™ and CYPHER SELECT™ stents made in the United States since 2005 willfully infringed four of Medinol's patents directed to the geometry of articulated stents. Although Johnson & Johnson has since sold Cordis, it has retained liability for this case. After the trial in January 2014, the district court dismissed the case, finding Medinol unreasonably delayed bringing its claims (the laches defense). In September 2014, the district court denied a motion by Medinol to vacate the judgment and grant it a new trial. Medinol appealed the decision to the United States Court of Appeals for the Federal Circuit. In March 2017, the United States Supreme Court held that the laches defense is not available in patent cases. In April 2018, the United States Court of Appeals for the Federal Circuit remanded the case back to the district court to reconsider Medinol’s motion for a new trial. In March 2019, the district court denied Medinol’s motion for a new trial. In April 2019, Medinol appealed, and the appellate court will conduct a hearing in June 2020.
In November 2016, MedIdea, L.L.C. (MedIdea) filed a patent infringement lawsuit against DePuy Orthopaedics, Inc. in the United States District Court for the Northern District of Illinois alleging infringement by the ATTUNE® Knee System. In April 2017, MedIdea filed an amended complaint adding DePuy Synthes Products, Inc. and DePuy Synthes Sales, Inc. as named defendants (collectively, DePuy). MedIdea alleges infringement of United States Patent Nos. 6,558,426 (’426); 8,273,132 (’132); 8,721,730 (’730) and 9,492,280 (’280) relating to posterior stabilized knee systems. Specifically, MedIdea alleges that the SOFCAMTM Contact feature of the ATTUNE® posterior stabilized knee products infringes the patents-in-suit. MedIdea is seeking monetary damages and injunctive relief. In June 2017, the case was transferred to the United States District Court for the District of Massachusetts. A claim construction hearing was held in October 2018, and a claim construction order was issued in November 2018. In December 2018, MedIdea stipulated to non-infringement of the ’132, ’730 and ’280 patents, based on the district court’s claim construction and reserving its right to appeal that construction, leaving only the ’426 patent at issue before the district court. In January 2019, the district court stayed the case pending a decision in the Inter Partes Review proceeding on the ’426 patent (see below). In December 2017, DePuy Synthes Products, Inc. filed a petition for Inter Partes Review with the United States Patent and Trademark Office (USPTO), seeking to invalidate the two claims of the ’426 patent asserted in the district court litigation, and in June 2018, the USPTO instituted review of those claims. A hearing was held in March 2019, and in April 2019, the USPTO issued its decision upholding the validity of the patent. In May 2019, DePuy filed a motion for summary judgment of non-infringement of the claims of the ’426 patent. In November 2019, judgment was entered in favor of DePuy. In December 2019, MedIdea filed a notice of appeal.
In December 2016, Ethicon Endo-Surgery, Inc. and Ethicon Endo-Surgery, LLC (now known as Ethicon LLC) sued Covidien, Inc. in the United States District Court for the District of Massachusetts seeking a declaration that United States Patent Nos. 6,585,735 (the ’735 patent); 7,118,587; 7,473,253; 8,070,748 and 8,241,284 (the ’284 patent), are either invalid or not infringed by Ethicon’s ENSEAL® X1 Large Jaw Tissue Sealer product. In April 2017, Covidien LP, Covidien Sales LLC, and Covidien AG (collectively, Covidien) answered and counterclaimed, denying the allegations, asserting willful infringement of the ’735 patent, the ’284 patent and United States Patent Nos. 8,323,310 (the ’310 patent); 9,084,608; 9,241,759 (the ’759 patent) and 9,113,882, and seeking damages and an injunction. Covidien filed a motion for preliminary injunction, which was denied in October 2017. The parties have entered joint stipulations such that only the ’310 patent and the ’759 patent remain in dispute. A bench trial concluded in March 2020. In April 2020, the district court issued a decision in Ethicon’s favor, finding that the ENSEAL® X1 device does not infringe any asserted claim.
In December 2016, Dr. Ford Albritton sued Acclarent, Inc. (Acclarent) in United States District Court for the Northern District of Texas alleging that Acclarent’sAcclarent’s RELIEVA®® Spin and RELIEVEA SpinPlus®® products infringe U.S. Patent No. 9,011,412 (the ’412 patent).9,011,412. Dr. Albritton also alleges breach of contract, fraud and that he is the true owner of Acclarent’sAcclarent’s U.S. Patent No. 8,414,473. In December 2016, Acclarent filed a petition for Inter Partes Review (IPR) with the United States Patent and Trademark Office (USPTO) challenging the validity of the ’412 patent. The USPTO instituted the IPR in July 2017. In July
2018, the USPTO ruled in favor of Albritton in the IPR, finding that Acclarent had not met its burden of proof that the challenged claims were invalid. In October 2019, the Court of Appeals affirmed the USPTO’s Patent Trial and Appeal Board. In June 2019, the parties filed cross motions for summary judgment in the district court. The district court denied most motions for summary judgment, and trial will go forward on all of Dr. Albritton’s claims. The trial is scheduled to begin in September 2020.October 2021.
In November 2017, Board of Regents, The University of Texas System and TissueGen, Inc. (collectively, UT) filed a lawsuit in the United States District Court for the Western District of Texas against Ethicon, Inc. and Ethicon US, LLC (collectively, Ethicon) alleging the manufacture and sale of VICRYL®® Plus Antibacterial Sutures, MONOCRYL®® Plus Antibacterial Sutures, PDS®® Plus Antibacterial Sutures, STRATAFIX®® PDS®® Antibacterial Sutures and STRATAFIX®® MONOCRYL® ® Plus Antibacterial Sutures infringe plaintiffs’plaintiffs’ United States Patent Nos. 6,596,296 (’296) and 7,033,603 (the ’603 patent)(’603) directed to implantable polymer drug releasing biodegradable fibers containing a therapeutic agent.UT is seeking damages and an injunction.In December 2018, Ethicon filed petitions with the USPTO,United States Patent and Trademark Office (USPTO), seeking Inter Partes Review (IPR) of both asserted patents. Those petitions have been stayed byIn June 2020, the USPTO pending a decision bydenied institution of the U.S. Supreme Court in an unrelated case. The stay has been lifted’296 patent IPR and granted institution of the USPTO’s institution decision is expected in June 2020. ’603 patent IPR.UT dismissed the ’603’603 patent from the suit and no longer accuses PDS®® Plus Antibacterial Sutures or STRATAFIX®® PDS®® Plus Antibacterial Sutures of infringement. The previously scheduled district court trial is scheduled for June 2020.has been postponed.
In August 2018, Intuitive Surgical, Inc. and Intuitive Surgical Operations, Inc. (“Intuitive”)(collectively, Intuitive) filed a patent infringement suit against Auris Health, Inc. (“Auris”)(Auris) in United States District Court for the District of Delaware. In the suit, Intuitive alleges willful infringement of U.S. Patent Nos. 6,246,200 (’200 patent)(’200); 6,491,701 (’701 patent)(’701); 6,522,906 (’906 patent)(’906); 6,800,056 (’056 patent)(’056); 8,142,447 (’447 patent)(’447); 8,620,473 (’473 patent)(’473); 8,801,601 (’601 patent)(’601); and 9,452,276 (’276 patent)(’276) based on Auris’ Monarch™Auris’ Monarch™ Platform. Auris filed IPR Petitions for Inter Partes Review with the USPTOU.S. Patent and Trademark Office (USPTO) regarding the ’200, ’056, ’601 ’701, ’447, ’276’200, ’056, ’601 ’701, ’447, ’276 and ’906’906 patents. Intuitive subsequently dropped the ’200’200, ’473 and ’701’701 patents from the suit. In December 2019, the USPTO instituted review of the ’601’601 patent and denied review of the ’056’056 patent. In February and March 2020, the USPTO instituted review of the ’200, ’447, ’701’200, ’447, ’701 and ’906’906 patents and denied review of the ’276’276 patent. In December 2020, the USPTO declared all of the challenged claims in the ’601 patent to be invalid.Intuitive has appealed that decision. In March 2021, the USPTO ruled that the challenged claims of the ’447 and ’906 patents are not invalid. Auris has appealed that decision. The district courtDistrict Court postponed trial until the appeal of the invalidity decision on the ’601 patent is scheduled to begin in January 2021.complete.
In August 2019, RSB Spine LLC (“RSB Spine”)(RSB Spine) filed a patent infringement suit against DePuy Synthes, Inc. in United States District Court for the District of Delaware. In October 2019, RSB Spine amended the complaint to change the named defendants to DePuy Synthes Sales, Inc. and DePuy Synthes Products, Inc. In the suit, RSB Spine alleges willful infringement of United States Patent Nos. 6,984,234 and 9,713, 5379,713,537 by one or more of the following products: ZERO-P-VA™ZERO-P-VA™ Spacer,
ZERO-P®® Spacer, ZERO-P NATURAL™NATURAL™ Plate, SYNFIX®® LR Spacer and SYNFIX®® Evolution System. RSB Spine seeks monetary damages and injunctive relief. In November 2019, the suit was consolidated for pre-trial purposes with other patent infringement suits brought by RSB Spine in the United States District Court for the District of Delaware against Life Spine, Inc., Medacta USA, Inc., and Precision Spine, Inc., and Xtant Medical Holdings, Inc. In June 2020, the case was stayed pending IPR proceedings filed by the Consolidated Defendants involving the asserted patents.
In March 2020, Osteoplastics, LLC filed a patent infringement suit against DePuy Synthes, Inc., DePuy Synthes Products, Inc., Medical Device Business Services, Inc., and Synthes, Inc. (collectively, DePuy Synthes) in the United States District Court for the District of Delaware. In the suit, Osteoplastics alleges willful infringement of U.S. Patent Nos. 8,781,557; 9,929,920; 9,330,206; 9,626,756; 9,672,617; 9,672,302; and 9,275,191 based on the PROPLAN CMF® ® Virtual Surgical Planning Services and the TruMatch®® CMF Personalize Solutions. In April 2020, Osteoplastics filed an amended complaint to substitute U.S. Patent No. 9, 292,9209,292,920 for U.S. Patent No. 9,929,920. Osteoplastics seeks monetary damages and injunctive relief. In June 2020, DePuy Synthes filed a motion to dismiss the complaint. In October 2020, the Court dismissed Medical Device Business Services, Inc. from the case but otherwise denied the motion.Trial is scheduled for October 2022.
Pharmaceutical
REMICADE® Related Cases
In August 2014, Celltrion Healthcare Co. Ltd. and Celltrion Inc. (collectively, Celltrion) filed an application with the United States Food and Drug Administration (FDA) for approval to make and sell its own infliximab biosimilar. In March 2015, Janssen Biotech, Inc. (JBI) filed a lawsuit in the United States District Court for the District of Massachusetts against Celltrion and Hospira Healthcare Corporation (Hospira), which has exclusive marketing rights for Celltrion’s infliximab biosimilar in the United States, seeking, among other things, a declaratory judgment that their biosimilar product infringes or potentially infringes several JBI patents, including United States Patent No. 6,284,471 relating to REMICADE® (infliximab) (the ’471 patent) and United States Patent No. 7,598,083 (the ’083 patent) directed to the cell culture media used to make Celltrion’s biosimilar. In August 2016, the district court granted both Celltrion’s and Hospira’s motions for summary judgment of invalidity of the ’471 patent. JBI appealed those decisions to the United States Court of Appeals for the Federal Circuit. In January 2018, the Federal Circuit dismissed the appeal as moot based on its affirmance of a decision by the USPTO’s Patent Trial and Appeal Board affirming invalidity of the ’471 patent.
In June 2016, JBI filed two additional patent infringement lawsuits asserting the ’083 patent, one against Celltrion and Hospira in the United States District Court for the District of Massachusetts and the other against HyClone Laboratories, Inc., the manufacturer of the cell culture media that Celltrion uses to make its biosimilar product, in the United States District Court for the District of Utah. JBI seeks monetary damages and other relief. In October 2017, the district court in the Massachusetts action denied Celltrion and Hospira’s motion to dismiss for lack of standing. In July 2018, the district court in the Massachusetts action granted Celltrion’s motion for summary judgment of non-infringement and entered an order dismissing the ’083 lawsuit against Celltrion and Hospira. JBI appealed to the United States Court of Appeals for the Federal Circuit, and Celltrion and Hospira cross-appealed on the standing issue. In November 2019, the United States District Court for the District of Utah administratively closed the case against HyClone. In March 2020, the United States Court of Appeals for the Federal Circuit affirmed the decision of the United States District Court for the District of Massachusetts.
The FDA approved the first infliximab biosimilar for sale in the United States in 2016, and a number of such products have been launched.
Litigation Against Filers of Abbreviated New Drug Applications (ANDAs)
The following summarizes lawsuits pending against generic companies that have filed Abbreviated New Drug Applications (ANDAs)ANDAs with the FDA or undertaken similar regulatory processes outside of the United States, seeking to market generic forms of products sold by various subsidiaries of Johnson && Johnson prior to expiration of the applicable patents covering those products. These ANDAs typically include allegations of non-infringement and invalidity of the applicable patents. In the event the subsidiaries are not successful in an action, or the automatic statutory stay of the ANDAs expires before the United States District Court rulings are obtained, the third-party companies involved would have the ability, upon approval of the FDA, to introduce generic versions of their products to the market, resulting in the potential for substantial market share and revenue losses for the applicable products, and which may result in a non-cash impairment charge in any associated intangible asset. In addition, from time to time, subsidiaries may settle these types of actions and such settlements can involve the introduction of generic versions of the products at issue to the market prior to the expiration of the relevant patents. The Inter Partes Review (IPR) process with the United States Patent and Trademark Office (USPTO),USPTO, created under the 2011 America Invents Act, is also being used at times by generic companies in conjunction with ANDAs and lawsuits, to challenge the applicable patents.
ZYTIGA® ®
In November 2017, Janssen Inc. and Janssen Oncology Inc. (collectively, Janssen) initiated a Notice of Application under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Apotex Inc. (Apotex) and the Minister of Health in Canada in response to Apotex’sApotex’s filing of an Abbreviated New Drug Submission (ANDS) seeking approval to market a generic version of ZYTIGA® ® before the expiration of Canadian Patent No. 2,661,422 (the ’422 patent)(’422). The final hearing concluded in May 2019. In October 2019, the courtCourt issued an order prohibiting the Canadian Minister of Health from approving Apotex’sApotex’s ANDS until the expiration of the ’422’422 patent. In November 2019, Apotex filed an appeal.appeal, which was dismissed in March 2021.
Beginning in January 2019, Janssen initiated Statements of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations in Canada against Apotex, Pharmascience Inc. (Pharmascience) and Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc. (collectively, DRL) in response to those parties’ filing of Abbreviated New Drug Submissions (ANDS) seeking approval to market generic versions of ZYTIGA® before the expiration of the ’422 patent. The trial in these actions concluded in November 2020, and the Court issued a decision holding the ’422 patent invalid in January 2021. In February 2021, Janssen appealed the decision.
In January 2019,August 2020, Janssen initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Apotex and the Minister of HealthJAMP Pharma Corporation (Jamp) in Canada in response to Apotex’s filing of an Abbreviated New Drug Submission (ANDS) seeking approval to market a film-coated generic version of ZYTIGA® before the expiration of the ’422 patent. The final hearing is scheduled to begin in October 2020.
In January 2019, Janssen initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Pharmascience Inc. (Pharmascience) and the Minister of Health in Canada in response to Pharmascience’s filing of an Abbreviated New Drug Submission (ANDS) seeking approval to market a generic version of ZYTIGA® 250 mg,before the expiration of the ’422 patent. The final hearing is scheduled to begin in October 2020.
In November 2019, Janssen initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Pharmascience and the Minister of Health in Canada in response to Pharmascience’sJamp’s filing of an ANDS seeking approval to market a generic version of ZYTIGA®, 500 mg, before the expiration of the ’422 patent. The final hearing is scheduled to begin in October 2020.
In June 2019, Janssen initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc. (collectively, DRL) and the Minister of Health in Canada in response to Apotex’s filing of an Abbreviated New Drug Submission (ANDS) seeking approval to market a generic version of ZYTIGA®® before the expiration of the ’422’422 patent. The final hearing is scheduled to begin in October 2020.In March 2021, the parties entered into a confidential settlement agreement.
In each of these Canadian actions, Janssen is seeking an order enjoining the defendants from marketing their generic versions of ZYTIGA®® before the expiration of the ’422’422 patent.
XARELTO® ®
Beginning in October 2015,In March 2021, Janssen Pharmaceuticals, Inc. (JPI) and Bayer Pharma AG and Bayer Intellectual Property GmbHAG (collectively, Bayer) filed patent infringement lawsuits in the United States District Court for the District of Delaware against a number of generic companies who filed ANDAs seeking approval to market generic versions of XARELTO® before expiration of Bayer’s United States Patent Nos. 7,157,456, 7,585,860 and 7,592,339 relating to XARELTO®. JPI is the exclusive sublicensee of the asserted patents. The following generic companies were named defendants: Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. (collectively, Aurobindo); Breckenridge Pharmaceutical, Inc. (Breckenridge); InvaGen Pharmaceuticals Inc. (InvaGen); Micro Labs USA Inc. and Micro Labs Ltd (collectively, Micro); Mylan Pharmaceuticals Inc. (Mylan); Prinston Pharmaceuticals, Inc.; Sigmapharm Laboratories, LLC (Sigmapharm); Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. (collectively, Torrent). The trial concluded in April 2018. In July 2018 the district court entered judgment against Mylan and Sigmapharm, holding that the asserted compound patent is valid and infringed. In September 2018, the district court entered judgment against the remaining defendants. None of the defendants appealed the judgment.
Beginning in April 2017, JPI and Bayer Intellectual Property GmbH and Bayer AG (collectively, Bayer AG) filed patent infringement lawsuits in the United States District Court for the District of Delaware against a number of generic companies who filed ANDAs seeking approval to market generic versions of XARELTO® before expiration of Bayer AG’s United States Patent No. 9,539,218 (’218) relating to XARELTO®. JPI is the exclusive sublicensee of the asserted patent. The following generic companies are named defendants: Alembic Pharmaceuticals Limited, Alembic Global Holding SA and Alembic Pharmaceuticals, Inc. (Alembic); Aurobindo; Breckenridge; InvaGen; Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, Lupin); Micro; Mylan; Sigmapharm; Taro Pharmaceutical Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc. (collectively, Taro) and Torrent. Lupin counterclaimed for declaratory judgment of noninfringement and invalidity of United States Patent No. 9,415,053, but Lupin dismissed its counterclaims after it was provided a covenant not to sue on that patent. Aurobindo, Taro, Torrent, Micro, Breckenridge, InvaGen, Sigmapharm, Lupin and Alembic have agreed to have their cases stayed and to be bound by the outcome of any final judgment rendered against any of the other defendants. The ’218 cases have been consolidated for discovery and trial. The trial began in April 2019 and closing arguments were heard in June 2019.
In December 2018, JPI and Bayer AG filed a patent infringement lawsuit in the United States District Court for the District of Delaware against TevaLupin Limited and Lupin Pharmaceuticals, USA, Inc. and Teva Pharmaceutical Industries Ltd. (collectively, Teva) whoLupin) which filed an ANDA seeking approval to market a generic version of XARELTO®®
before expiration of Bayer AG’s ’218 patent. The case against Teva has been consolidated with the other ’218 cases for all purposes, and Teva has agreed to have its case stayed and to be bound by the outcome of any final judgment rendered against any of the other defendants.
U.S. Patent No. 10,828,310 (’310). In March 2020,this lawsuit, JPI and Bayer entered into settlement agreements with each of Alembic and Lupin. In April 2020, JPI and Bayer entered into settlement agreements with each of Aurobindo and Teva.
The consolidated ’218 cases involving InvaGen and Taro have been stayed.
In each of these lawsuits, JPI isare seeking an order enjoining the defendantsLupin from marketing their generic versionsversion of XARELTO®® before the expiration of the relevant patents.
PREZISTA®
In January 2020, Janssen Products, L.P. and Janssen Sciences Ireland Unlimited Company (collectively, Janssen) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Zydus Pharmaceuticals (USA), Inc. and Cadila Healthcare Ltd. (collectively, Zydus), who filed an ANDA seeking approval to market a generic version of PREZISTA® before the expiration of United States Patent Nos. 7,700,645, 8,518,987, 7,126,015 and 7,595,408. Janssen is seeking an order enjoining Zydus from marketing its generic version of PREZISTA® before the expiration of the relevant patents.
In April 2020, Janssen initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Marcan Pharmaceuticals Inc. (Marcan) and the Minister of Health in Canada in response to Marcan’s filing of an ANDS seeking approval to market a generic version of Prezista before the expiration of Canadian Patent No. 2,485,834
(the ’834 patent). Janssen is seeking an order enjoining Marcan from marketing its generic version of PREZISTA® before the expiration of the ’834’310 patent.
INVOKANA®®/INVOKAMET®®/INVOKAMET XR® ®
Beginning in July 2017, Janssen Pharmaceuticals, Inc., Janssen Research && Development, LLC, Cilag GmbH International and Janssen Pharmaceutica NV (collectively, Janssen) and Mitsubishi Tanabe Pharma Corporation (MTPC) filed patent infringement lawsuits in the United States District Court for the District of New Jersey against a number of generic companies whothat filed ANDAs seeking approval to market generic versions of INVOKANA®®, INVOKAMET®® and/or INVOKAMET®® XR before expiration of MTPC’sMTPC’s United States Patent Nos. 7,943,582 (the ’582 patent)(’582) and/or 8,513,202 (the ’202 patent)(’202) relating to INVOKANA®®, INVOKAMET®® and/or INVOKAMET®® XR. Janssen is the exclusive licensee of the asserted patents. The following generic companies were named as defendants: Apotex Inc. and Apotex Corp. (Apotex); Aurobindo Pharma USA Inc. (Aurobindo); Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc.; InvaGen Pharmaceuticals, Inc. (InvaGen); Prinston Pharmaceuticals Inc.; Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories Ltd (DRL); Hetero USA, Inc., Hetero Labs Limited Unit V and Hetero Labs Limited;Named defendants include MSN Laboratories Private Ltd. and MSN Pharmaceuticals, Inc. (MSN); Laurus Labs Ltd.; Indoco Remedies Ltd.; Zydus Pharmaceuticals (USA) Inc. (Zydus); Sandoz, Inc. (Sandoz); Teva Pharmaceuticals USA, Inc.; and Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin). These cases were consolidated into one action (Polymorph Main Action), which ishas been scheduled for trial starting in June 2020. In February 2020, the lawsuit against Macleods and DRL was dismissed.July 2021.
Beginning inIn July 2017, Janssen and MTPC filed a patent infringement lawsuitslawsuit in the United States District Court for the District of New Jersey against a number of generic companies whoZydus which filed ANDAs seeking approval to market generic versions of INVOKANA®® ,and INVOKAMET® and/or INVOKAMET® XR® before expiration of MTPC’sMTPC’s United States Patent No. 7,943,788 (the ’788 patent)(’788), 8,222,219 (the ’219 patent)(’219) and/or 8,785,403 (the ’403 patent)(’403) relating to INVOKANA®® ,and INVOKAMET® and/or INVOKAMET®® XR(Compounds Main Action). Janssen is the exclusive licensee of the asserted patents. Trial concluded in October 2020. The followingCourt issued a decision holding that the patents are not invalid and would be infringed by Zydus’ generic companies were named as defendants: Sandoz, Zydus and Aurobindo. These cases were consolidated into one action (Compound Main Action), which was scheduled for trial in May 2020 but is being rescheduled. The lawsuit against Sandoz was dismissed in February 2020. products.
In July 2019, Janssen and MTPC filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against MSN, whowhich filed an ANDA seeking approval to market a generic version of INVOKAMET XR®® before expiration of the ’582’582 patent and ’202’202 patent relating to INVOKAMET XR®®. In October 2019, Janssen and MTPC initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against MSN, whowhich filed ANDAs seeking approval to market generic versions of INVOKANA®® and INVOKAMET XR®® before expiration of the ’788’788 patent. In October 2019, Janssen and MTPC initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against DRL,Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories Ltd (DRL), who filed an ANDA seeking approval to market a generic version of INVOKAMET®® before expiration of the ’788’788 patent. In March 2020,January 2021, Janssen and MTPC initiated patent infringement lawsuits in the United States District Court for the District of New Jersey against Aurobindo, who filed an ANDA seeking approval to market a generic version of INVOKAMET XR® before expiration of the ’788 patent, ’219 patent, ’403 patent, ’582 patent, and ’202 patent. These lawsuits have not been consolidated with the Main Actions.
Janssen and MTPC entered into a settlement agreement with Indoco in March 2020.
In each of these lawsuits, Janssen and MTPC are seeking an order enjoining the defendants from marketing their generic versions of INVOKANA®, INVOKAMET® and/or, INVOKAMET XR® before the expiration of the relevant patents.
OPSUMIT®
In January 2018, Actelion Pharmaceuticals Ltd (Actelion) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against ZydusMacleods Pharmaceuticals, (USA)Ltd. and Macleods Pharma USA, Inc. (Zydus) and Amneal Pharmaceuticals LLC (Amneal)(Macleods), each of whomwhich filed an ANDA seeking approval to market a generic version of OPSUMITINVOKAMET XR® before the expiration of United States Patent No. 7,094,781 (the ’781 patent). In the lawsuit, Actelion is seeking an order enjoining Zydus and Amneal from marketing generic versions of OPSUMIT®® before the expiration of the patent. Amneal’582 patent and Zydus have stipulated’202 patent relating to infringement.INVOKAMET XR®. In February 2020, Actelion and Amneal entered into2021, Janssen filed a settlement agreement. The trialpatent infringement lawsuit in the United States District Court for the District of New Jersey against Zydus is scheduled to commence in October 2020.
In July 2019, ActelionMacleods Pharmaceuticals, Ltd. filed suit against Aurobindoand Macleods Pharma USA, Inc. and Aurobindo Pharma Limited (Aurobindo). Aurobindo(Macleods), which filed an ANDA seeking approval to market a generic version of OPSUMITINVOKANA®® before expiration of United States Patent No. 10,617,668 relating to INVOKANA®. These lawsuits have not been consolidated with the Polymorph Main Action or Compound Main Action.
In each of these U.S. lawsuits, Janssen and MTPC are seeking an order enjoining the defendant from marketing their generic versions of INVOKANA®, INVOKAMET® and/or, INVOKAMET XR® before the expiration of the relevant patents.
In October 2020, Janssen Inc., Janssen Pharmaceutica NV and MTPC initiated a Statement of Claim under Section 6 of the ’781 patent. Actelion isPatented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. (Sandoz) in Canada in response to Sandoz’s filing of an ANDS seeking an order enjoining Defendants from marketingapproval to market a generic version of OPSUMITINVOKANA®® before the expiration of the ’781 patent. Trial against AurobindoCanadian Patent Nos. 2,799,204, 2,534,024 and 2,671,357. Janssen Inc., Janssen Pharmaceutica NV and MTPC are seeking an order enjoining Sandoz from marketing its generic version of INVOKANA® before the expiration of the relevant patents. The trial is scheduled to commencebegin in July 2021.August 2022.
OPSUMIT®
In May 2020, Janssen Inc. (Janssen) and Actelion initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. (Sandoz) in Canada in response to Sandoz’s filing of an ANDS seeking approval to market a generic version of OPSUMIT® 10 mg,before the expiration of Canadian Patent No. 2,659,770 (’770). Trial is scheduled to begin in January 2022.
In May 2020, Janssen and Actelion initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Apotex Inc. (Apotex) in Canada in response to Apotex’s filing of an ANDS seeking approval to market a generic version of OPSUMIT® 10 mg,before the expiration of the ’770 patent. Trial is scheduled to begin in February 2022.
In July 2020, Janssen and Actelion initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against JAMP Pharma Corporation (JAMP) in Canada in response to JAMP’s filing of an ANDS seeking approval to market a generic version of OPSUMIT® 10 mg before the expiration of the ’770 patent and Canadian Patent No. 2,621,273 (’273). Trial is scheduled to begin in April 2022.
In each of these Canadian actions, Janssen and Actelion are seeking an order enjoining the defendants from marketing their generic versions of OPSUMIT® before the expiration of the relevant patents.
INVEGA SUSTENNA® ®
In January 2018, Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc. (collectively, Janssen) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Teva Pharmaceuticals USA, Inc. (Teva), whowhich filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA®® before the expiration of United States Patent No. 9,439,906 (the ’906 patent)(’906). Trial was scheduled to beginconcluded in JuneOctober 2020, but is being rescheduled.and closing arguments were made in March 2021.
In August 2019, Janssen initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Mylan Laboratories Limited (Mylan), which filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of the ’906 patent. In February 2020, Mylan filed a Petition for Inter Partes Review with the USPTO seeking to invalidate the ’906 patent. The USPTO denied the Petition in September 2020, and Mylan appealed. Janssen filed a motion to dismiss the appeal, which was granted in March 2021.
In December 2019, Janssen initiated a patent infringement lawsuit in the United States District Courts for the Districts of New Jersey and Delaware against Pharmascience Inc., Mallinckrodt PLC and Specgx LLC (collectively, Pharmascience), which filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of the ’906 patent.
In each of these U.S. lawsuits, Janssen is seeking an order enjoining the defendant from marketing a generic version of INVEGA SUSTENNA® before the expiration of the relevant patents.
In February 2018, Janssen Inc. and Janssen Pharmaceutica NV (collectively, Janssen Canada) initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Teva Canada Limited (Teva Canada) in response to Teva's filing of an ANDS seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of Canadian Patent Nos. 2,309,629 (’629) and 2,655,335 (’335). Janssen subsequently discontinued the portion of the lawsuit relating to the ’629 patent. In May 2020, the Canadian Federal Court issued a Public Judgment and Reasons declaring that Teva Canada’s generic version of INVEGA SUSTENNA®, if approved, would infringe claims of the ’335 patent and that the claims of the ’335 patent are not invalid for obviousness. Teva Canada appealed.
In November 2020, Janssen Canada initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Pharmascience Inc. in response to Pharmascience Inc.'s filing of an ANDS seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of the ’335 patent. A summary trial on the issue of infringement is scheduled for November 2021. The trial is scheduled to begin in July 2022.
In January 2021, Janssen Canada initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Apotex Inc. (Apotex)in response to Apotex's filing of an ANDS seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of the ’335 patent. A summary trial on the issue of infringement is scheduled for December 2021. The trial is scheduled to begin in September 2022.
In each of these Canadian lawsuits, Janssen Canada is seeking an order enjoining the defendant from marketing a generic version of INVEGA SUSTENNA® before the expiration of the relevant patents.
INVEGA TRINZA®
In September 2020, Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Pharmaceuticals, Inc.Research & Development, LCC (collectively, Janssen) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Mylan Laboratories Limited, (Mylan)Mylan Pharmaceuticals Inc., whoand Mylan Institutional LLC (collectively, Mylan). Mylan filed an ANDA seeking approval to market a generic versionversions of INVEGA SUSTENNATRINZA®® before the expiration of the ’906 patent. In February 2020, Mylan filed a Petition for Inter Partes Review with the USPTO seeking to invalidate the ’906 patent.
In December 2019, Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc. (collectively, Janssen) initiated a patent infringement lawsuit in the United States District Courts for the Districts of New Jersey and Delaware against Pharmascience Inc., Mallincrodt PLC and Specgx LLC (collectively, Pharmascience), who filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of the ’906 patent.
In February 2018, Janssen Inc. and Janssen Pharmaceutica NV (collectively, Janssen) initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Teva Canada Limited (Teva) and the Minister of Health in response to Teva's filing of an Abbreviated New Drug Submission (ANDS) seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of Canadian Patent Nos. 2,309,629 (the ’629 patent) and 2,655,335 (the ’335 patent). Janssen subsequently discontinued the portion of the lawsuitNo. 10,143,693 relating to the ’629 patent. The final hearing took place in February 2020. In April 2020, the Canadian Federal Court issued a Draft CONFIDENTIAL Judgment and Reasons (Draft Judgment) declaring that Teva’s generic version of INVEGA SUSTENNATRINZA®®, if approved, would infringe claims of the ’335 patent and that the claims of the ’335 patent are not invalid for obviousness. The Draft Judgment will be made final after the parties have made submissions on the redaction of any confidential information.
In April 2020, Janssen Inc. and Janssen Pharmaceutica NV (together, Janssen) initiated a Statement of Claim under Section 6 of the Patented Medicines (Notice of Compliance) Regulations against Pharmascience Inc. (Pharmascience) and the Minister of Health in response to Pharmascience's filing of an Abbreviated New Drug Submission (ANDS) seeking approval to market a generic version of INVEGA SUSTENNA® before the expiration of Canadian Patent No. 2,655,335.
In each of these lawsuits,. Janssen is seeking an order enjoining the defendantMylan from marketing a generic version of INVEGA SUSTENNATRINZA®® before the expiration of the relevant patent.
IMBRUVICA® ®
Beginning in January 2018, Pharmacyclics LLC (Pharmacyclics) and Janssen Biotech, Inc. (JBI) filed patent infringement lawsuits in the United States District Court for the District of Delaware against a number of generic companies whothat filed ANDAs seeking approval to market generic versions of IMBRUVICA® ®140 mg capsulesbefore expiration of Pharmacyclics’ Pharmacyclics’ United States Patent Nos. 8,008,309, 7,514,444, 8,697,711, 8,735,403, 8,957,079, 9,181,257, 8,754,091, 8,497,277, 8,925,015, 8,476,284, 8,754,090, 8,999,999, 9,125,889, 9,801,881, 9,801,883, 9,814,721, 9,795,604, 9,296,753, 9,540,382, 9,713,617 and/or 9,725,455 relating to IMBRUVICA®®. JBI is the exclusive licensee of the asserted patents. The named defendants include the following generic companies are named defendants:companies: Cipla Limited and Cipla USA Inc. (Cipla); Fresenius Kabi USA, LLC, Fresenius Kabi USA, Inc., and Fresenius Kabi Oncology Limited (Fresenius Kabi)(collectively, Cipla); Sandoz Inc. and Lek Pharmaceuticals d.d. (Sandoz); Shilpa Medicare Limited (Shilpa); Sun Pharma Global FZE(collectively, Sandoz). In January 2019 and Sun Pharmaceutical Industries Limited (Sun); Teva Pharmaceuticals USA, Inc. (Teva); and Zydus Worldwide DMCC and Cadila Healthcare Limited (Zydus). The trial is scheduled to begin in October 2020.
In October 2018,February 2019, Pharmacyclics and JBI filed a patentamended their complaint against Sandoz and Cipla, respectively, to allege infringement lawsuit in theof United States District Court for the DistrictPatent Nos. 10,125,140 and 10,106,548. In May 2019, Pharmacyclics and JBI amended their complaint against Cipla to further allege infringement of Delaware against Sun asserting United States Patent No. 10,004,746.
10,016,435. In January 2019, Pharmacyclics and JBI filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Zydus, who filed an ANDA seeking approval to market a generic version of IMBRUVICA® 70 mg before
the expiration of U.S. Patent Nos. 7,514,444, 8,003,309, 8,476,284, 8,497,277, 8,697,711, 8,753,403, 8,754,090, 8,754,091, 8,952,015, 8,957,079, 9,181,257, 9,296,753, 9,540,382, 9,713,617, 9,725,455, 10,106,548, and 10,125,140.
In FebruaryAugust 2019, Pharmacyclics and JBI amended their complaints against Cipla Shilpa, and SunSandoz to further allege infringement of United StatesU.S. Patent Nos. 10,106,548,10,294,231 and 10,125,140. 10,294,232. In August 2019, the Court granted a joint stipulation to stay the litigation against Cipla.
In March 2019, Pharmacyclics and JBI filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Alvogen Pine Brook LLC and Natco Pharma Ltd. (Alvogen)(collectively, Alvogen), whowhich filed an ANDA seeking approval to market generic versions of IMBRUVICA®® tablets, asserting infringement of United States Patent Nos. 7,514,444, 8,003,309, 8,476,284, 8,497,277, 8,697,711, 8,753,403, 8,754,090, 8,754,091, 8,952,015, 8,957,079, 9,181,257, 9,296,753, 9,655,857, 9,725,455, 10,010,507, 10,106,548, and 10,125,140.
In May 2019, Pharmacyclics and JBI amended their complaints against Cipla to further allege infringement of United States Patent No. 10,016,435. In June 2019, Pharmacyclics and JBI amended their complaintscomplaint against Alvogen to further allege infringement of United States Patent No. 10,213,386.
In August 2019, PharmacyclicsTrial in the foregoing actions against Sandoz and JBI amended their complaints against Cipla, Fresenius, and Sandoz to further allege infringement of U.S. Patent Nos. 10,294,231 and 10,294,232 and amended their complaint against Sun to further allege infringement of U.S. Patent No. 10,294,232.Alvogen took place in October 2020.
In March 2019, Sandoz filed an Inter Partes Review (IPR) in the USPTO, seeking to invalidate United States Patent No. 9,795,604.
In February 2020, Pharmacyclics and JBI entered into settlement agreements with Fresenius Kabi.
In March 2020, Pharmacyclics and JBI filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Alvogen Zydus, Sun and Sandoz asserting infringement of United States Patent No. 10,478,439. In October 2020, Pharmacyclics and JBI amended their complaint against Alvogen to further allege infringement of U.S. Patent No. 10,653,696. In April 2021, the court entered a joint stipulation dismissing the complaint against Alvogen.
In April 2020, Pharmacyclics and JBI filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Zydus whoWorldwide DMCC and Cadila Healthcare Limited (collectively, Zydus), which filed an ANDA seeking approval to market generic versions of IMBRUVICA®® tablets, asserting infringement of United States Patent Nos. 7,514,444, 8,003,309,8,008,309, 8,476,284, 8,497,277, 8,697,711, 8,753,403, 8,754,090, 8,754,091, 8,952,015, 8,957,079, 9,181,257, 9,296,753, 9,655,857, 9,725,455, 10,010,507, 10,106,548, 10,125,140, 10,213,28610,213,386 and 10,478,439. In March 2021, JBI, Pharmacyclics and Zydus entered into a confidential settlement agreement.
In each of the lawsuits, Pharmacyclics and JBI are seeking an order enjoining the defendants from marketing generic versions of IMBRUVICA® ® before the expiration of the relevant patents.
TRACLEER®
In December 2019, Actelion Pharmaceuticals Ltd and Actelion Pharmaceuticals US, Inc. initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against Zydus Pharmaceuticals (USA), Inc. and Cadila Healthcare Limited (collectively, Zydus), who filed an ANDA seeking approval to market a generic version of TRACLEER®, 32 mg, before the expiration of U.S. Patent No. 8,309,126 (the ’126 patent). Actelion is seeking an order enjoining Zydus from marketing its generic version of TRACLEER® before the expiration of the ’126 patent.
UPTRAVI® ®
In April 2020, Actelion Pharmaceuticals Ltd (Actelion) and Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) initiated a patent infringement lawsuit in the United States District Court for the District of New Jersey against a number of generic companies whothat filed ANDAs seeking approval to market generic versions of UPTRAVI® ® before expiration of Nippon Shinyaku’sShinyaku’s United States Patent Nos. 7,205,302; 8,791,122; and 9,284,280 relating to UPTRAVI® ®.Actelion is the exclusive licensee of the asserted patents. The following generics are named defendants in the complaint:include Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc. (Alembic); MSN Laboratories Private Limited and MSN Pharmaceuticals Inc. (MSN); Aizant Drug Research Solutions Private Limited (Aizant); VGYAAN Pharmaceuticals LLC (VGYAAN)(collectively, Alembic); and Zydus Pharmaceuticals (USA), Inc. and Zydus Worldwide DMCC (Zydus) (collectively, Zydus).
Actelion and Nippon Shinyaku are seeking an order enjoining the defendants from marketing generic versions of UPTRAVI® ® before the expiration of the relevant patents.
GOVERNMENT PROCEEDINGS
Like other companies in the pharmaceutical, consumer health and medical devices industries, Johnson && Johnson and certain of its subsidiaries are subject to extensive regulation by national, state and local government agencies in the United States and other countries in which they operate. As a result, interaction withSuch regulation has been the basis of government agencies is ongoing.investigations and litigations. The most significant litigation brought by, and investigations conducted by, government agencies are listed below. It is possible that criminal charges and substantial fines and/or civil penalties or damages could result from government investigations or litigation.
Average Wholesale Price (AWP) Litigation
Johnson && Johnson and several of its pharmaceutical subsidiaries (the J&J&J AWP Defendants), along with numerous other pharmaceutical companies, were named as defendants in a series of lawsuits in state and federal courts involving allegations that the pricing and marketing of certain pharmaceutical products amounted to fraudulent and otherwise actionable conduct because, among other things, the companies allegedly reported an inflated Average Wholesale Price (AWP) for the drugs at issue. Payors alleged that they used those AWPs in calculating provider reimbursement levels. The plaintiffs in these cases included three classes of private persons or entities that paid for any portion of the purchase of the drugs at issue based on AWP, and state government entities that made Medicaid payments for the drugs at issue based on AWP. Many of these cases, both federal actions and state actions removed to federal court, were consolidated for pre-trial purposes in a multi-district litigation in the United States District Court for the District of Massachusetts, where all claims against the J&J&J AWP Defendants were ultimately dismissed. The J&J&J AWP Defendants also prevailed in a case brought by the Commonwealth of Pennsylvania. Other AWP cases have been resolved through court order or settlement. The case brought by Illinois was settled after trial. In New Jersey, a putative class action based upon AWP allegations is pending against Centocor, Inc. and Ortho Biotech Inc. (both now Janssen Biotech, Inc.), Johnson && Johnson and ALZA Corporation. All other cases have been resolved.
Opioid Litigation
Beginning in 2014 and continuing to the present, Johnson && Johnson and Janssen Pharmaceuticals, Inc. (JPI), along with other pharmaceutical companies, have been named in more than 2,9003,200 lawsuits related to the marketing of opioids, including DURAGESIC®®, NUCYNTA®® and NUCYNTA®® ER. The suits also raise allegations related to previously owned active pharmaceutical ingredient supplier subsidiaries, Tasmanian Alkaloids Pty, Ltd. and Noramco, Inc. (both subsidiaries were divested in 2016). The majority of the cases have been filed by state and local governments. Similar lawsuits have also been filed by private plaintiffs and organizations, including but not limited to the following: individual plaintiffs on behalf of children suffering from Neonatal Abstinence Syndrome; hospitals; and health insurers/payors. To date, complaints against pharmaceutical companies,manufacturers, including Johnson && Johnson and JPI, have been filed by the state Attorneys General in Arkansas, Florida, Idaho, Illinois, Kentucky, Louisiana, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, South Dakota, Texas, Washington and West Virginia. Complaints against the manufacturers also have been filed in state or federal court by city, county and local government agencies in the following states: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina;Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin. The Government of Puerto Rico filed suit in Superior Court of San Juan. There are more than 370380 cases pending in various state courts. There are over 2,6002,800 federal cases coordinated in a federal Multi-District Litigation (MDL) pending in the U.S. District Court for the Northern District of Ohio (MDL No. 2804).Ohio. In addition, the Province of British Columbia filed suit in Canada. In October 2019, an anti-trust complaint was filed by private plaintiffs in federal court in Tennessee and is pending transfer to the MDL. These actions allege a variety of claims related to opioid marketing practices, including false advertising, unfair competition, public nuisance, consumer fraud violations, deceptive acts and practices, false claims and unjust enrichment. The suits generally seek penalties and/or injunctive and monetary relief and, in some of the suits, the plaintiffs are seeking joint and several liability among the defendants. An adverse judgment in any of these lawsuits could result in the imposition of large monetary penalties and significant damages including, punitive damages, cost of abatement, substantial fines, equitable remedies and other sanctions.
The trial in the matter filed by the Oklahoma Attorney General resulted in a judgment against Johnson && Johnson and JPI in the amount of $572 million, subject to a final order to be issued by the court. The court issued a final judgment reducing the amount to $465 million.$465 million. Johnson && Johnson and JPI have appealed the judgment. The Company believes that it has strong grounds to overturn this judgment. In October 2019 Johnson && Johnson and JPI announced a settlement of the first case set for trial in the MDL with two counties in Ohio. In April 2021, three California counties and the City of Oakland commenced a trial in California state court against Johnson & Johnson and JPI, and other affiliates, as well as three other pharmaceutical manufacturers. The trial is scheduled to last up to three months.
Johnson && Johnson, JPI and other pharmaceutical companies have also received subpoenas or requests for information related to opioids marketing practices from the following state Attorneys General: Alaska, Indiana, Montana, New Hampshire, South Carolina, Tennessee, Texas and Washington. In September 2017, Johnson && Johnson and JPI were contacted by the Texas and Colorado Attorney General’sGeneral’s Offices on behalf of approximately 38 states regarding a multi-state Attorney General investigation. In October 2019, the Company announced a proposed agreement in principle that would include the Company paying $4$4 billion as settlement of these matters. In October 2020, the Company agreed to contribute up to an additional $1 billion to an all-in settlement amount that would resolve opioid lawsuits filed and future claims by states, cities, counties and tribal governments, for a total of $5 billion which has been accrued, subject to various conditions and an agreement being finalized. This agreement in principle is not an admission of liability or wrong-doing and would resolve opioid lawsuits filed
and future claims by states, cities and counties. The Company has made progress towards negotiating a final settlement with a coalition of state Attorneys General. The Company cannot predict if or when the agreement will be finalized and individual cases are ongoing.
In August 2019, Johnson && Johnson received a grand jury subpoena from the United States Attorney’sAttorney’s Office for the Eastern District of New York for documents related to the Company’sCompany’s anti-diversion policies and procedures and distribution of its opioid medications, in what the Company understands to be part of a broader investigation into manufacturers’manufacturers’ and distributors’distributors’ monitoring programs and reporting under the Controlled Substances Act. In September 2019, Johnson && Johnson received subpoenas from the New York State Department of Financial Services (NYDFS) as part of an industry-wide inquiry into the effect of opioid prescriptions on New York health insurance premiums. TheIn September 2020, the Company is cooperating and producing documents in responselearned that NYDFS filed a statement of charges related to this investigation.
From June 2017 through December 2019, the Company’s Board of Directors received a series of shareholder demand letters alleging breaches of fiduciary duties related to the various subpoenasmarketing of opioids. The Board retained independent counsel to investigate the allegations in the demands, and requests for information.in April 2020, independent counsel delivered a report to the Board recommending that the Company reject the shareholder demands and take the steps that are necessary or appropriate to secure dismissal of related derivative litigation.The Board unanimously adopted the recommendations of the independent counsel’s report.
In November 2019, one of the shareholders who sent a shareholderdemand filed a derivative complaint against Johnson && Johnson as the nominal defendant and certain current and former directors and officers as defendants in the Superior Court of New Jersey. The complaint alleges breaches of fiduciary duties related to the marketing of opioids, and that Johnson && Johnson has suffered damages as a result of those alleged breaches. In May 2020, the shareholder filed an amended complaint challenging the Board’s rejection of his demand. In August 2020, Johnson & Johnson moved to dismiss the amended complaint. In February 2021, the Court held oral argument on Johnson & Johnson's motion. In August 2020, another shareholder who sent a demand filed a separate derivative complaint in the same court making similar allegations. In October 2020, the Court granted defendants’ request to reassign the second-filed case to the division where the first-filed case is pending.
In December 2019, two additional shareholders who sent demands filed two separate derivative complaints making similar allegations against Johnson && Johnson as the nominal defendant and certain current and former directors and officers as defendants in the United States District for the District of New Jersey. The partiesIn April 2020, the two federal cases were consolidated into a single action captioned In re Johnson & Johnson Opioid Stockholder Derivative Litigation. In July 2020, the shareholders filed a consolidated complaint. In September 2020, Johnson & Johnson moved to those two cases are conferring regarding consolidationdismiss the consolidated complaint, and in December 2020, the shareholders opposed Johnson & Johnson’s motion. Johnson & Johnson filed its reply in February 2021. In July 2020, an additional shareholder who sent a scheduling stipulation.demand filed a derivative complaint in the same federal court making similar allegations against the same defendants named in the consolidated action. In January 2021, pursuant to an order in the consolidated action, the third case was consolidated into the consolidated action. In February 2021, the Court granted the shareholders motion to voluntarily dismiss the consolidated action without prejudice.
Other
In August 2012, DePuy Orthopaedics, Inc., DePuy, Inc. (now known as DePuy Synthes, Inc.), and Johnson && Johnson Services, Inc. (collectively DePuy) received an informal request from the United States Attorney's Office for the District of Massachusetts and the Civil Division of the United States Department of Justice (the United States) for the production of materials relating to the DePuy ASR™ASR™ XL Hip device. In July 2014, the United States notified the United States District Court for the District of Massachusetts that it had declined to intervene in a qui tam case filed pursuant to the False Claims Act against the companies.companies concerning the hip devices. In February 2016, the district courtDistrict Court granted the companies’companies’ motion to dismiss with prejudice, unsealed the qui tam complaint, and denied the qui tam relators’relators’ request for leave to file a further amended complaint. The qui tam relators appealed the case to the United States Court of Appeals for the First Circuit. In July 2017, the First Circuit affirmed the district court’sDistrict Court’s dismissal in part, reversed in part, and affirmed the decision to deny the relators’relators’ request to file a third amended complaint. The relators’relators’ remaining claims are now pending before the district court. TheDistrict Court. In July 2020, the Court has grantedordered the relators’ to complete discovery by August 2020; the Relators have requested an extension of the August 2020 deadline that DePuy opposed and additional discovery-related motions have been filed by both parties since. In March 2021, DePuy filed its motion to staystrike and dismiss the relators’ second amended complaint. In March 2021, the District Court issued an order stating that if DePuy’s motion to strike and dismiss is denied, the court will hold a conference at which a limited period for remaining discovery pending adjudication of outstanding motions.will be established.
In October 2012, Johnson && Johnson was contacted by the California Attorney General's office regarding a multi-state Attorney General investigation of the marketing of surgical mesh products for hernia and urogynecological purposes by Johnson && Johnson's subsidiary, Ethicon, Inc. (Ethicon). In May 2016, California and Washington filed civil complaints against Johnson && Johnson, Ethicon and Ethicon US, LLC alleging violations of their consumer protection statutes. Similar complaints were filed against the companies by the following states: Kentucky, Mississippi, West Virginia and Oregon. In April 2019, Johnson & &
Johnson and Ethicon settled the Washington case. The California case started trial in July 2019 and concluded in September 2019. The trial date for the Kentucky case was scheduled for September 2019 but has been adjourned and no new trial date has been scheduled. The trial date for the Mississippi case is scheduled for April 2021. In October 2019, Johnson && Johnson and Ethicon settled the multi-state investigation with 41 other states and the District of Columbia. In January 2020, the Court in California issued a statement of decision, finding in favor of the State of California, and awarded civil penalties in the amount of $344$344 million. In April 2020, the Court in California denied the Company's motion for a new trial. In August 2020, the Court entered judgment with respect to the penalties of $344 million,. but denied the Attorney General’s request for injunctive relief. The Company intends to appealis appealing the decision.penalty judgment. In April 2020, the Company settled the West Virginia case. In October 2020, the Company settled with the Attorney General of Oregon. In November 2020, the Company settled with the Attorney General of Mississippi.
In December 2012, Therakos, Inc. (Therakos), formerly a subsidiary of Johnson & Johnson and part of the Ortho-Clinical Diagnostics, Inc. (OCD) franchise, received a letter from the civil division of the United States Attorney's Office for the Eastern District of Pennsylvania informing Therakos that the United States Attorney's Office was investigating the sales and marketing of Uvadex® (methoxsalen) and the Uvar Xts® and Cellex® Systems during the period 2000 to the present. The United States Attorney's Office requested that OCD and Johnson & Johnson preserve documents that could relate to the investigation. Therakos was subsequently acquired by an affiliate of Gores Capital Partners III, L.P. in January 2013, and OCD was divested
in June 2014. Following the divestiture of OCD, Johnson & Johnson retains OCD’s portion of any liability that may result from the investigation for activity that occurred prior to the sale of Therakos. In March 2014 and March 2016, the United States Attorney’s Office requested that Johnson & Johnson produce certain documents, and Johnson & Johnson is cooperating with those requests.
In June 2014, the Mississippi Attorney General filed a complaint in Chancery Court of The First Judicial District of Hinds County, Mississippi against Johnson && Johnson and Johnson && Johnson Consumer Companies, Inc. (now known as Johnson && Johnson Consumer Inc.) (JJCI). The complaint alleges that defendants violated the Mississippi Consumer Protection Act by
failing to disclose alleged health risks associated with female consumers' use of talc contained in JOHNSON'S®® Baby Powder and JOHNSON'S®® Shower to Shower (a product divested in 2012) and seeks injunctive and monetary relief. The matter is stayed pending interlocutory appeal of a December 2018 denial of Johnson && Johnson and JJCI's motion for summary judgment. The Mississippi Supreme Court granted J&JJohnson & Johnson and JJCI's request to file an interlocutory appeal of the denial of the motion for summary judgment in late 2019. In April 2021, the Mississippi Supreme Court dismissed the Company’s interlocutory appeal and remanded the case back to the Hinds County Chancery Court.
In January 2020, the State of New Mexico filed a consumer protection case alleging that the Company deceptively marketed and sold its talcum powder products by making misrepresentations about the safety of the products and the presence of carcinogens, including asbestos. The State of New Mexico filed an Amended Complaint in March 2020. The Company moved to dismiss certain of the claims in the Amended Complaint, which was granted. The Company then filed a motion for partial judgment on the pleadings in December 2020, which was denied. The New Mexico Attorney General has issued requests for documents and the Company anticipates the document production will commence in mid-2021.
Forty-oneForty-two states have commenced a joint investigation into the Company’sCompany’s marketing of its talcum powder products. At this time, the multi-state group has not asserted any claims against the Company, nor has the multi-state group sought anyCompany. Five states have issued Civil Investigative Demands seeking documents orand other information. The Company has entered into a tolling agreement with the States and has begun to produce responsive documents.
In March 2016, Janssen Pharmaceuticals, Inc. (JPI) received a Civil Investigative Demand from the United States Attorney’sAttorney’s Office for the Southern District of New York related to JPI’sJPI’s contractual relationships with pharmacy benefit managers over the period from January 1, 2006 to the present with regard to certain of JPI's pharmaceutical products. The demand was issued in connection with an investigation under the False Claims Act. The Company has provided documents in response to the demand.
In July 2016, Johnson && Johnson and Janssen Products LP were served with a qui tam complaint pursuant to the False Claims Act filed in the United States District Court for the District of New Jersey alleging the off-label promotion of two HIV products, PREZISTA®® and INTELENCE®®, and anti-kickback violations in connection with the promotion of these products. The complaint was filed under seal in December 2012. The federal and state governments have declined to intervene, and the lawsuit is being prosecuted by the relators. In February 2021, the Court stayed the case and ordered mediation.
In March 2017, Janssen Biotech, Inc. (JBI) received a Civil Investigative Demand from the United States Department of Justice regarding a False Claims Act investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that purchased REMICADE®® or SIMPONI ARIA®®. In August 2019, the UnitesUnited States Department of Justice notified Janssen Biotech, Inc.JBI that it was closing the investigation. Subsequently, the United States District Court for the District of Massachusetts unsealed a qui tam False Claims Act complaint, which was served on the Company. The Department of Justice had declined to intervene in the qui tam lawsuit in August 2019. The Company has filed a motion to dismiss, the relator’s complaint. which was granted in part and denied in part. Discovery is underway.
In April and September 2017, Johnson && Johnson received subpoenas from the United States Attorney for the District of Massachusetts seeking documents broadly relating to pharmaceutical copayment support programs for DARZALEX®®, OLYSIO®®, REMICADE®®, SIMPONI®®, STELARA® ® and ZYTIGA®®. The subpoenas also seek documents relating to Average Manufacturer Price and Best Price reporting to the Center for Medicare and Medicaid Services related to those products, as well as rebate payments to state Medicaid agencies. The Company has provided documents in response to the subpoenas.
In June 2017, Johnson && Johnson received a subpoena from the United States Attorney's Office for the District of Massachusetts seeking information regarding practices pertaining to the sterilization of DePuy Synthes, Inc.(DePuy) spinal implants at three hospitals in Boston as well as interactions of employees of Company subsidiaries with physicians at these
hospitals. Johnson && Johnson and DePuy Synthes, Inc. have produced documents in response to the subpoena and are fully cooperating with the government’sgovernment’s investigation.
In July 2018 the Public Prosecution Service in Rio de Janeiro and representatives from the Brazilian antitrust authority CADE inspected the offices of more than 30 companies including Johnson && Johnson do Brasil IndúIndústria e ComéComércio de Produtos para SaúSaúde Ltda. The authorities appear to be investigating allegations of possible anti-competitive behavior and possible improper payments in the medical device industry. The Company continues to respond to inquiries regarding the Foreign Corrupt Practices Act from the United States Department of Justice and the United States Securities and Exchange Commission have made additional inquiries, and Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda.is cooperating with those requests.
Commission.
From time to time, the Company has received requests from a variety of United States Congressional Committees to produce information relevant to ongoing congressional inquiries. It is the policy of Johnson && Johnson to cooperate with these inquiries by producing the requested information.
GENERAL LITIGATION
In May 2014, twoMarch 2018, a purported class actions wereaction was filed in federal court, one in the United StatesCircuit Court Third Judicial District Court for the Central District of California and one in the United States District Court for the Southern District ofMadison County, Illinois against Johnson & Johnson and Johnson && Johnson Consumer, Companies, Inc. (now known as Johnson & Johnson Consumer Inc.) (JJCI), alleging violations of state consumer fraud statutes based on nondisclosure of alleged health risks associated with talc contained in JOHNSON'S® ® Baby Powder and JOHNSON'S® Shower to Shower (a product no longer sold by JJCI). Both cases seek injunctive relief and monetary damages; neither includes a claim forPowder. The complaint seeks damages but does not allege personal injuries.injury. In October 2016, both cases were transferred2020, JJCI moved to dismiss the complaint.
In December 2013, Janssen Ortho LLC (Janssen Ortho) sued the United States District Court for the District Court of New Jersey as part of a newly created federal multi-district litigation. In July 2017, the district court granted Johnson & Johnson's and JJCI’s motion to dismiss one of the cases. In September 2018,in the United States Court of Appeals forInternational Trade (the Classification Litigation) seeking a determination that darunavir ethanolate (the active pharmaceutical ingredient in PREZISTA®) is exempt from duties upon importation into the Third Circuit affirmed this dismissal. In September 2017, the plaintiff in the second case voluntarily dismissed the complaint. In March 2018, the plaintiff in the second case refiled in Illinois State Court.
United States. In August 2014, United States Customs and Border Protection (US CBP) issued a Penalty Notice against Janssen Ortho LLC (Janssen Ortho), assessing penalties for the alleged improper classification of darunavir ethanolate (the active pharmaceutical ingredient in PREZISTA®®) in connection with its importation into the United States. In October 2014, Janssen Ortho submitted a Petition for Relief in response toFebruary 2020, the Penalty Notice. In May 2015, US CBP issued an Amended Penalty Notice assessing substantial penalties and Janssen Ortho filed a Petition for Relief in July 2015. In May 2019, US CBP issued its Mitigation Decision and determined that Janssen Ortho had negligently misrepresented that darunavir ethanolate is entitled to duty free treatment. In June 2019, Janssen Ortho filed a Supplemental Petition for Relief. The Penalties Proceeding will be impacted by the related Classification Litigation pending in the United States Court of International Trade. The Classification Litigation will determine whether darunavir ethanolate was properly classified as exempt from duties upon importation into the United States. The trial in the Classification Litigation was held in July 2019. In February 2020, the Court ruled that darunavir ethanolate is eligible for duty free treatment. In April 2020, the United States filed a Notice of Appealappealed that ruling to the United States Court of Appeals for the Federal Circuit. In August 2020, US CBP formally rejected Janssen’s Supplemental Petition challenging the penalties assessment and demanded payment of the mitigated penalty. In October 2020, US CBP agreed to not refer the matter to the Office of Chief Counsel, pending resolution of the related Classification Litigation. In April 2021, the Federal Circuit denied the United States’ appeal in the Classification Litigation.
In March and April 2015, over 30 putative class action complaints were filed by contact lens patients in a number of courts around the United States against Johnson && Johnson Vision Care, Inc. (JJVCI) and other contact lens manufacturers, distributors, and retailers, alleging vertical and horizontal conspiracies to fix the retail prices of contact lenses. The complaints allege that the manufacturers reached agreements with each other and certain distributors and retailers concerning the prices at which some contact lenses could be sold to consumers. The plaintiffs are seeking damages and injunctive relief. All of the class action cases were transferred to the United States District Court for the Middle District of Florida in June 2015. The plaintiffs filed a consolidated class action complaint in November 2015. In December 2018, the district court granted the plaintiffs'Discovery and pre-trial motion for class certification. Defendants filed two motions for interlocutory appeal of class certification to the United States Court of Appeals for the Eleventh Circuit. Both motions were denied. Defendants' motions for summary judgment were denied in November 2019. practice are complete. No trial date has been set.
In August 2015, two third-party payors filed a purported class action in the United States District Court for the Eastern District of Louisiana against Janssen Research && Development, LLC, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Johnson && Johnson (as well as certain Bayer entities), alleging that the defendants improperly marketed and promoted XARELTO®® as safer and more effective than less expensive alternative medications while failing to fully disclose its risks. The complaint seeks damages. In November 2020, Defendants moved to dismiss the complaint.
In September 2017, Pfizer, Inc. (Pfizer) filed an antitrust complaint against Johnson && Johnson and Janssen Biotech, Inc. (collectively, Janssen) in United States District Court for the Eastern District of Pennsylvania. Pfizer alleges that Janssen has violated federal antitrust laws through its contracting strategies for REMICADE®®. The complaint seeks damages and injunctive relief. Discovery is ongoing.
Beginning in September 2017, multiple purported class actions were filed on behalf of direct and indirect purchasers were filedof REMICADE® against Johnson && Johnson and Janssen Biotech, Inc. (collectively, Janssen) alleging that Janssen’s has violated federal antitrust laws through its contracting strategies for REMICADE®® contracting strategies violated federal and state antitrust and consumer laws and seeking damages and injunctive relief. In November 2017, the. The cases were consolidated for pre-trial purposes as In re REMICADE® Antitrust Litigation in United States District Court for the Eastern District of Pennsylvania as In re Remicade Antitrust Litigation. Motions to dismiss were denied in both the directPennsylvania. The consolidated complaint seeks damages and indirect purchaser cases. A motion to compel
arbitration of the direct purchaser case was denied by the district court. The United States Court of Appeals for the Third Circuit reversed the district court's ruling.injunctive relief. Discovery is ongoing.
In June 2018, Walgreen Co. and Kroger Co,Co., filed an antitrust complaint against Johnson && Johnson and Janssen Biotech, Inc. (collectively, Janssen) in the United States District Court for the Eastern District of Pennsylvania. The complaint alleges that Janssen has violated federal antitrust laws through its contracting strategies for REMICADE®®. The complaint seeks damages and injunctive relief. In March 2019, summary judgment was granted in favor of Janssen. In February 2020, the United States Court of Appeals for the Third Circuit reversed the District Court’sCourt’s decision. Discovery is ongoing.
In June 2019, the United States Federal Trade Commission (FTC) issued a Civil Investigative Demand to Johnson && Johnson in connection with its investigation of whether Janssen’sJanssen’s REMICADE®® contracting practices violate federal antitrust laws. The Company has produced documents and information responsive to the Civil Investigative Demand.
In October 2017, certain United States service members and their families brought a complaint against a number of pharmaceutical and medical devices companies, including Johnson && Johnson and certain of its subsidiaries in United States District Court for the District of Columbia, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health. In July 2020, the District Court dismissed the complaint. In January 2020,2021, plaintiffs filed a Third Amended Complaint adding further plaintiffsappealed the District Court’s decision to the lawsuit. In February 2020,United States Court of Appeals for the Company moved to dismiss the Third Amended Complaint.District of Columbia Circuit.
In October 2018, two separate putative class actions were filed against Actelion Pharmaceutical Ltd., Actelion Pharmaceuticals US,U.S., Inc., and Actelion Clinical Research, Inc. (collectively Actelion) in United States District Court for the District of Maryland and United States District Court for the District of Columbia. The complaints allege that Actelion violated state and federal antitrust and unfair competition laws by allegedly refusing to supply generic pharmaceutical manufacturers with samples of TRACLEER®®. TRACLEER®® is subject to a Risk Evaluation and Mitigation Strategy required by the Food and Drug Administration, which imposes restrictions on distribution of the product. In January 2019, the plaintiffs dismissed the District of Columbia case and filed a consolidated complaint in the United States District Court for the District of Maryland. In October 2019, the Court granted Actelion’sActelion’s motion to dismiss the amended complaint. Plaintiffs have appealedIn April 2021, the decision.United States Court of Appeals for the Fourth Circuit reversed and remanded.
In December 2018, Janssen Biotech, Inc., Janssen Oncology, Inc, Janssen Research && Development, LLC, and Johnson && Johnson (collectively, Janssen) were served with a qui tam complaint filed on behalf of the United States, 28 states, and the District of Columbia. The complaint, which was filed in December 2017 in United States District Court for the Northern District of California, alleges that Janssen violated the federal False Claims Act and state law when providing pricing information for ZYTIGA®® to the government in connection with direct government sales and government-funded drug reimbursement programs. At this time, the federal and state governments have declined to intervene. The case has been transferred to United States District Court for the District of New Jersey. In September 2019, Janssen has moved to dismiss the complaint. In February 2021, the judge has set a renewed schedule for the Company's motion to dismiss, with briefs to be fully submitted by early July 2021.
In April 2019, Blue Cross && Blue Shield of Louisiana and HMO Louisiana, Inc. filed a class action complaint against Janssen Biotech, Inc, Janssen Oncology, Inc, Janssen Research && Development, LLC (collectively, Janssen) and BTG International Limited in the United States District Court for the Eastern District of Virginia.Virginia on behalf of indirect purchasers of ZYTIGA®. Several additional complaints were filed thereafter in Virginia and New Jersey.The indirect purchaser complaints generally allege that the defendants violated the antitrust and consumer protections laws of several states and the Sherman Act by pursuing patent litigation relating to ZYTIGA®® in order to delay generic entry.entry and seek damages. The Virginia cases have been transferred to the United States District Court for the District of New Jersey and consolidated with the New Jersey casecase. A consolidated amended complaint was filed in February 2021. In April 2021, Janssen moved to dismiss the Indirect Purchaser Action. In May 2020, a class action complaint was filed against Janssen Biotech Inc., Janssen Oncology, Inc., Janssen Research & Development LLC and BTG International Limited in the United States District Court for pretrial purposes. the District of New Jersey, on behalf of direct purchasers of ZYTIGA®.The direct purchaser complaint alleges that defendants violated the Sherman Act by pursuing patent litigation relating to ZYTIGA® in order to delay generic entry, and seek damages and injunctive relief. In April 2021, Janssen moved to compel arbitration of the Direct Purchaser Action.
In May 2019, a class action antitrust complaint was filed against Janssen R&D&D Ireland (Janssen) and Johnson && Johnson in the United States District Court for the Northern District of California. The complaint alleges that Janssen violated federal and state antitrust and consumer protection laws by agreeing to exclusivity provisions in its agreements with Gilead concerning the development and marketing of combination antiretroviral therapies (cART) to treat HIV. The complaint also alleges that Gilead entered into similar agreements with Bristol-Myers-SquibbBristol-Myers Squibb and Japan Tobacco. In March 2020, the Court granted in part and denied in part defendants’defendants’ motions to dismiss. Plaintiffs filed an amended complaint in April 2020. Defendants moved to
dismiss the amended complaint. In July 2020, the Court granted in part and denied in part the renewed motion to dismiss. Discovery is ongoing.
In October 2019, Innovative Health, LLC filed a complaint against Biosense Webster, Inc. (BWI) in the United States District Court for the Middle District of California. The complaint alleges that certain of BWI’sBWI’s business practices and contractual terms violate the antitrust laws of the United States and the State of California by restricting competition in the sale of High Density Mapping Catheters and Ultrasound Catheters. In January 2020, BWI filed a motion to dismiss the complaint.In August 2020, the Court granted in part and denied in part BWI’s motion to dismiss. Discovery is ongoing.
In November 2019, Johnson && Johnson received a demand for indemnification from Pfizer Inc., pursuant to the 2006 Stock and Asset Purchase Agreement between the Company and Pfizer. Also in November 2019, Johnson && Johnson, Inc. received a
demand for indemnification from Sanofi Consumer Health, Inc., pursuant to the 2016 Asset Purchase Agreement between J&J,&J, Inc. and Sanofi. In January 2020, Johnson && Johnson received a demand for indemnification from Boehringer Ingelheim Pharmaceuticals, Inc., pursuant to the 2006 Asset Purchase Agreement among the Company, Pfizer, and Boehringer Ingelheim. The notices seek indemnification for legal claims related to over-the-counter ZantacZANTAC® (ranitidine) products. Plaintiffs in the underlying actions allege that ZantacZANTAC® and other over-the-counter ranitidine medications contain unsafe levels of NDMA (N-nitrosodimethylamine) and can cause and/or have caused various cancers in patients using the products, and seek injunctive and monetary relief.
In October 2020, Fortis Advisors LLC (Fortis), in its capacity as representative of the former stockholders of Auris Health Inc. (Auris), filed a complaint against Johnson && Johnson, Ethicon Inc., and certain named officers and employees (collectively, Ethicon) in the Court of Chancery of the State of Delaware. The complaint alleges breach of contract, fraud, and other causes of action against Ethicon in connection with Ethicon’s acquisition of Auris in 2019. The complaint seeks damages and other relief. In December 2020, Ethicon moved to dismiss certain causes of action in the complaint. Oral argument on the motion to dismiss is scheduled for June 2021.
Johnson & Johnson or its subsidiaries are also parties to a number of proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly known as Superfund, and comparable state, local or foreign laws in which the primary relief sought is the cost of past and/or future remediation.
NOTE 12— RESTRUCTURING
The
NOTE 12— RESTRUCTURING
In the fiscal second quarter of 2018 the Company announced plans to implement a series of actions across its Global Supply Chain that are intended to focus resources and increase investments in the critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio, enhance agility and drive growth. The Global Supply Chain actions will include expanding the use of strategic collaborations and bolstering initiatives to reduce complexity, improve cost-competitiveness, enhance capabilities and optimize the Supply Chain network. For additional details on the global supply chain restructuring strategic collaborations see Note 10 to the Consolidated Financial Statements. In the fiscal first quarter of 2020,2021, the Company recorded a pre-tax charge of $118$104 million,, which is included on the following lines of the Consolidated Statement of Earnings, $58$53 million in restructuring, $15$27 million in cost of products sold and $45$24 million in other (income) expense.expense, net. Total project costs of approximately $1.0$1.4 billion have been recorded since the restructuring was announced. See the following table for additional details on the restructuring program.
In total, the Company expects the Global Supply Chain actions to generate approximately $0.6$0.6 billion to $0.8$0.8 billion in annual pre-tax cost savings that will be substantially delivered by 2022. The Company expects to record pre-tax restructuring charges of approximately $1.9$1.9 billion to $2.3$2.3 billion,, over the 4 to 5 year period of this activity. These costs are associated with network optimizations, exit costs and accelerated depreciation and amortization.
The following table summarizes the severance related reserves and the associated spendingrestructuring expenses through the fiscal first quarter of 2020:2021:
| | (Dollars in Millions) | Severance | Asset Write-offs | Other(2) | | Total | (Dollars in Millions) | Severance | Asset Write-offs | Other(2) | | Total |
Reserve balance, December 29, 2019 | $ | 164 |
| — |
| 16 |
| | 180 |
| |
Reserve balance, January 3, 2021 | | Reserve balance, January 3, 2021 | $ | 135 | | 0 | | 9 | | | 144 | |
| | | | | |
Current year activity: |
|
| |
| Current year activity: | |
Charges | — |
| 11 |
| 107 |
| | 118 |
| Charges | 0 | | 14 | | 90 | | | 104 | |
Cash payments | (6 | ) | — |
| (99 | ) | | (105 | ) | Cash payments | (5) | | 0 | | (91) | | | (96) | |
Settled non cash | — |
| (11 | ) | (17 | ) | (3) | (28 | ) | Settled non cash | 0 | | (14) | | 0 | | (14) | |
| | | | | |
Reserve balance, March 29, 2020(1) | $ | 158 |
| — |
| 7 |
| | 165 |
| |
| Reserve balance, April 4, 2021(1) | | Reserve balance, April 4, 2021(1) | $ | 130 | | 0 | | 8 | | | 138 | |