The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products. For additional details, please consult the links below and our quarterly BPCIA litigation roundup.
| # | Litigation | Accused Biosimilar [status] |
Reference Product [suit#] |
Complaint Filed | Status/Outcome | |
| District Court | Appeal | |||||
| 1 | Amgen v. Sandoz, No. 14-474 (N.D. Cal.) [consolidated with #7 below] |
Zarxio® (filgrastim-sndz) [approved, launched] |
Neupogen® [#1] |
Oct. 24, 2014 | Summary judgment of non-infringement in favor of Sandoz | Pending in Fed. Cir. |
| 2 | Janssen v. Celltrion, No. 17-11008 (D. Mass.) |
Inflectra® (infliximab-dyyb) [approved, launched] |
Remicade® [#1] |
Mar. 6, 2015 (refiled May 31, 2017) | Summary judgment of invalidity as to ’471 patent; dispute of ’083 patent still pending in district court | Fed. Cir. appeal of ’471 judgment dismissed, in favor of Celltrion |
| 3 | Amgen v. Apotex, No. 15-61631 (S.D. Fla.) [consolidated with #5 below] |
Lapelga™ (pegfilgrastim) | Neulasta® [#1] |
Aug. 6, 2015 | Judgment of non-infringement in favor of Apotex | Affirmed by Fed. Cir. |
| 4 | Amgen v. Hospira, No. 15-839 (D. Del.) |
Retacrit™ (epoetin alfa) [approved] |
Epogen®/ Procrit® [#1] |
Sept. 18, 2015 | Jury found infringement and awarded Amgen $70M; post-trial motions pending | |
| 5 | Amgen v. Apotex, No. 15-62081 (S.D. Fla.) [consolidated with #3 above] |
Grastofil™ (filgrastim) | Neupogen® [#2] |
Oct. 2, 2015 | Judgment of non-infringement in favor of Apotex | Affirmed by Fed. Cir. |
| 6 | Immunex v. Sandoz, No. 16-01118 (D.N.J.) |
Erelzi™ (etanercept-szzs) [approved] |
Enbrel® [#1] |
Feb. 26, 2016 | Pending | |
| 7 | Amgen v. Sandoz, No. 16-2581 (N.D. Cal.) [consolidated with #1 above] |
LA-EP2006 (pegfilgrastim) | Neulasta® [#2] |
Mar. 4, 2016 | Summary judgment of non-infringement in favor of Sandoz | Pending in Fed. Cir. |
| 8 | AbbVie v. Amgen, No. 16-666 (D. Del.) |
Amjevita™ (adalimumab-atto) [approved] |
Humira® [#1] |
Aug. 4, 2016 | Settled | |
| 9 | Amgen v. Coherus, No. 17-546 (D. Del.) |
CHS-1701 (pegfilgrastim) | Neulasta® [#3] |
May 10, 2017 | Dismissed | Pending in Fed. Cir. |
| 10 | Janssen v. Samsung Bioepis, No. 17-3524 (D.N.J.) |
Renflexis® (infliximab-abda) [approved, launched] |
Remicade® [#2] |
May 17, 2017 | Voluntarily dismissed with prejudice | |
| 11 | AbbVie v. Boehringer Ingelheim, No. 17-1065 (D. Del.) |
Cyltezo™ (adalimumab-adbm) [approved] |
Humira® [#2] |
Aug. 2, 2017 | Pending | |
| 12 | Amgen v. Mylan, No. 17-1235 (W.D. Pa.) |
Fulphila™ (pegfilgrastim-jmdb) [approved] |
Neulasta® [#4] |
Sept. 22, 2017 | Pending | |
| 13 | Genentech v. Amgen, Nos. 17-1407, -1471 (D. Del.) |
Mvasi™ (bevacizumab-awwb) [approved] |
Avastin® [#1] |
Oct. 6, 2017 | Pending | |
| 14 | Genentech v. Pfizer, No. 17-1672 (D. Del.) |
PF-05280014 (trastuzumab) | Herceptin® [#1] |
Nov. 17, 2017 | Pending | |
| 15 | Genentech v. Sandoz, No. 17-13507 (D.N.J.) |
Rixathon™ (rituximab) | Rituxan® [#1] |
Dec. 21, 2017 | Pending | |
| 16 | Genentech v. Celltrion, No. 18-095 (D. Del.) |
Herzuma™ (trastuzumab) | Herceptin® [#2] |
Jan. 12, 2018 | Pending | |
| 17 | Genentech v. Celltrion, No. 18-574 (D.N.J.) |
Truxima™ (rituximab) | Rituxan® [#2] |
Jan. 12, 2018 | Pending | |
| 18 | Amgen v. Adello, No. 18-3347 (D.N.J.) |
TPI G-CSF (filgrastim) | Neupogen® [#3] |
Mar. 8, 2018 | Pending | |
| 19 | Genentech v. Amgen, No. 18-924 (D. Del.) |
ABP 980 (trastuzumab) | Herceptin® [#3] |
June 21, 2018 | Pending | |
| 2o |
Genentech v. Hospira, No. 18-1064 (D. Del.) |
Nivestim™ (filgrastim) | Neupogen® [#4] |
July 18, 2018 | Pending | |
Last updated: July 19, 2018