BPCIA Litigations

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; summary judgment of non-infringement as to ’083 patent, subject to any appeal Fed. Cir. appeal of ’471 judgment dismissed, in favor of Celltrion; appeal of ’083 judgment pending
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; Hospira’s post-trial motions denied
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
20
Amgen v. Hospira,
No. 18-1064 (D. Del.)
Nivestim™ (filgrastim) Neupogen®
[#4]
July 18, 2018 Pending
21
Amgen v. Apotex,
No. 18-61828 (S.D. Fla.)
[follow-on case to #3 & 5 above]
Lapelga™ (pegfilgrastim); Grastofil™ (filgrastim) Neulasta®
[#1]; Neupogen®
[#2]
Aug. 7, 2018 Pending
22
AbbVie v. Sandoz,
No. 18-12668 (D.N.J.)
GP2017 (adalimumab) Humira®
[#3]
Aug. 10, 2018 Pending
23
Genentech v. Samsung Bioepis,
No. 18-1363 (D. Del.)
SB3 (trastuzumab) Herceptin®
[#4]
Sept. 4, 2018 Pending

Last updated: September 5, 2018