Completed Federal Circuit Appeals:
|
CAFC Case |
Biologic | Appeal from | Disposition Below |
Outcome |
| Sandoz v. Amgen, No. 14-1693 | Etanercept | C.A. No. 13-2904 (N.D. Cal.) | Dismissal of Sandoz’s declaratory judgment suit | 773 F.3d 1274 (Fed. Cir. 2014) (affirming dismissal) |
| Amgen v. Sandoz, No. 15-1499 | Filgrastim | C.A. No. 14-4741 (N.D. Cal.) | Denial of Amgen’s motion for preliminary injunction and motion for partial judgment of the pleadings, finding that patent dance is not mandatory and that notice of commercial marketing (NCM) may be provided prior to FDA approval; and dismissal of Amgen’s state law claims | 794 F.3d 1347 (Fed. Cir. 2015) (holding that patent dance is not mandatory and NCM can only be provided after FDA approval, and affirming dismissal of state law claims),
rev’d in part, aff’d in part, 137 S. Ct. 1664 (2017) (holding that compliance with patent dance provision (l)(2)(A) of the BPCIA cannot be compelled under federal law and that NCM can be provided prior to FDA approval, and vacating judgment on state law claim for further consideration), on remand, 877 F.3d 1315 (Fed. Cir. 2017) (affirming dismissal of state law claims on preemption grounds). |
| Amgen v. Apotex, No. 16-1308 | Pegfilgrastim | C.A. No. 15-61631 (S.D. Fla.) | Grant of Amgen’s motion for preliminary injunction | 827 F.3d 1052 (Fed. Cir. 2016)(affirming grant of injunction), cert. denied, 137 S. Ct. 591 (2016). |
| Amgen v. Apotex, No. 17-1010 | Pegfilgrastim, filgrastim | C.A. Nos. 15-61631, -62081 (S.D. Fla.) | Judgment of non-infringement | 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement) |
| Amgen v. Hospira, No. 16-2179 | Epoetin alfa | C.A. No. 15-839 (D. Del.) | Denial of Amgen’s motion to compel certain fact discovery | 866 F.3d 1355 (Fed. Cir. 2017) (dismissing appeal) |
| In re Janssen Biotech, Inc., No. 17-1257 | Infliximab | Ex parte reexamination, Control No. 90/012,851 (PTAB) | Rejection of claims of U.S. 6,284,471 based on obviousness-type double patenting | 880 F.3d 1315 (Fed. Cir. 2018) (affirming rejection) |
| Janssen v. Celltrion, No. 17-1120 | Infliximab | C.A. No. 15-10698 (D. Mass.) | Judgment of invalidity of U.S. 6,284,471 based on obviousness-type double patenting | 2018 WL 2072723 (Fed. Cir. Jan. 23, 2018) (dismissing appeal as moot in view of affirmance in In re: Janssen Biotech, Inc.) |
| Sandoz v. AbbVie, No. 18-2142 (cons.) | Adalimumab | IPR2017-01824, IPR2018-00002 (PTAB) | Decisions denying institution re: US 9,512,216 | Appeal dismissed pursuant to settlement |
| Celltrion v. Genentech, No. 18-2160 (cons.) | Trastuzumab, rituximab | C.A. Nos. 18-274, -276 (N.D. Cal.) | Dismissal of complaints for declaration judgment | Appeal dismissed pursuant to settlement |
| Momenta v. BMS, No. 17-1694 | Abatacept | IPR2015-01537 (PTAB) | FWD of patentability of US 8,476,239 | 915 F.3d 764 (Fed. Cir. 2019) (dismissing appeal for lack of standing/ jurisdiction and for mootness) |
| Biogen v. Iancu (USPTO), No. 19-1253 | Rituximab | IPR2017-01095 (PTAB) | FWD of unpatentability of US 9,296,821 | Appeal voluntarily dismissed. |
| Pfizer v. Biogen, No. 18-1885 | Rituximab | IPR2016-01614, IPR2017-01115 (PTAB) | FWD of patentability of US 7,820,161 | Appeal dismissed after Celltrion and then Pfizer settled. |
| Samsung Bioepis v. Genentech, Nos. 19-1173, -1174 |
Trastuzumab | IPR2017-00804, -00805, -01958, -01959 (PTAB) | FWDs of patentability of US 6,627,196 and 7,371,379 | Appeal dismissed pursuant to settlement |
| Amgen v. Coherus, No. 18-1993 | Pegfilgrastim | C.A. No. 17-546 (D. Del.) | Coherus’ motion to dismiss granted | 931 F.3d 1154 (Fed. Cir. 2019) (affirming dismissal) |
| Amgen v. Sandoz, No. 18-1551 (cons.) | Filgrastim, pegfilgrastim | C.A. Nos. 14-4741, 16-2581 (N.D. Cal.) | Sandoz’s motion for summary judgment of non-infringement granted | 923 F.3d 1023 (Fed. Cir. 2019) (affirming grant of summary judgment), as modified by 776 F. App’x 707 (Fed. Cir. 2019) |
| Genentech v. Hospira & US, No. 18-1959 | Bevacizumab | IPR2016-01771 (PTAB) | FWD of unpatentability of US 7,622,115 | 774 F. App’x 677 (Fed. Cir. 2019) (affirming FWD without opinion, pursuant to Fed. Cir. R. 36) |
| Amgen v. Hospira, No. 19-1067 (cons.) | Epoetin Alfa | C.A. No. 15-839 (D. Del.) | Judgment of (1) infringement and no invalidity of U.S. Patent No. 5,856,298, and award of $70M in damages, plus ~$10M in interest; and (2) non-infringement of U.S. Patent No. 5,756,349 | 944 F.3d 1327 (Fed. Cir. 2019) (affirming judgment), rehearing denied. |
| AbbVie v. US & Iancu (USPTO), No. 17-2304 (cons.) | Adalimumab | IPR2016-00172, -188, -189, -408, -409 (PTAB) | FWDs of unpatentability (#1, 2, 3) of US 8,889,135, 9,017,680, and 9,073,987 | 789 F. App’x 879 (Fed. Cir. 2020) (affirming FWD without opinion, pursuant to Fed. Cir. R. 36) |
| Genentech v. Hospira & US, No. 18-1933 | General Process (e.g., bevacizumab) | IPR2016-01837 (PTAB) | FWD of unpatentability of US 7,807,799 | 946 F.3d 1333 (Fed. Cir. 2020) (affirming FWD) |
| Janssen v. Celltrion, Nos. 18-2321 (cons.) | Infliximab | C.A. No. 17-11008 (D. Mass.) | Celltrion’s motion for summary judgment of non-infringement of U.S. Patent No. 7,598,083 granted | 796 F. App’x 741 (Fed. Cir. 2020) (affirming grant of summary judgment – without opinion, pursuant to Fed. Cir. R. 36) |
| Genentech v. Amgen, No. 19-2156 | Trastuzumab | C.A. No. 18-924 (D. Del.) (interlocutory appeal) | Motion for TRO/PI denied | 796 F. App’x 726 (Fed. Cir. 2020) (affirming denial of motion) |
| Amgen v. Iancu (USPTO), No. 19-2171 |
Filgrastim, pegfilgrastim | IPR2016-01542 (PTAB) | FWD of unpatentability of US 8,952,138 | Order, per curiam (Fed. Cir. Mar. 24, 2020) (FWD vacated and case remanded) |
| Genentech v. Iancu (USPTO), Nos. 19-1263, -1265, -1267, -1270 | Trastuzumab | IPR2017-00731, -00737, -01121, -01122 (PTAB) | FWDs of unpatentability of US 7,846,441 and 7,892,549 | 2020 WL 1492038 (Fed. Cir. Mar. 26, 2020) (affirming FWDs) |
| Genentech v. Immunex, No. 19-2155 | Bevacizumab | C.A. No. 19-602 (D. Del.) (interlocutory appeal) | Motion for TRO/PI denied | AFFIRMED on July 6, 2020. |
| Immunex v. Sandoz, No. 20-1037 | Etanercept | C.A. No. 16-1118 (D.N.J.) | Judgment of infringement and no invalidity of U.S. Patent Nos. 8,063,182 and 8,163,522 | AFFIRMED on July 1, 2020. |
| Biogen v. Iancu (USPTO), No. 19-1364 | Rituximab | IPR2017-01168 (PTAB) | FWD of unpatentability of US 8,821,873 | AFFIRMED on December 16, 2021 |
Last updated: May 13, 2021
This page is maintained by Naomi Birbach.