BPCIA Litigations

The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products.

# Litigation Accused Biosimilar
[status]
Reference Product
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
[litigation #1]
Oct. 24, 2014 Summary judgment of non-infringement in favor of Sandoz Affirmed by Fed. Cir.; opinion modified on panel rehearing
2 Janssen v. Celltrion,
No. 17-11008 (D. Mass.)
INFLECTRA (infliximab-dyyb)
[approved; launched]
REMICADE
[litigation #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, and appeal of ’083 judgment affirmed, both in favor of Celltrion
3 Amgen v. Apotex,
No. 15-61631 (S.D. Fla.)
[consolidated with #5 below]
Lapelga (pegfilgrastim biosimilar)
[not approved]
NEULASTA
[litigation #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-epbx)
[approved; launched]
EPOGEN/ PROCRIT
[litigation #1]
Sept. 18, 2015 Jury found infringement and awarded Amgen $70M; Hospira’s post-trial motions denied Affirmed by Fed. Cir.; rehearing denied
5 Amgen v. Apotex,
No. 15-62081 (S.D. Fla.)
[consolidated with #3 above]
Grastofil (filgrastim biosimilar)
[not approved]
NEUPOGEN
[litigation #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
[litigation #1]
Feb. 26, 2016 Judgment of infringement and no invalidity in favor of Immunex Affirmed by Fed. Cir.
7 Amgen v. Sandoz,
No. 16-2581 (N.D. Cal.)
[consolidated with #1 above]
ZIEXTENZO (pegfilgrastim-bmez)
[approved; launched]
NEULASTA
[litigation #2]
Mar. 4, 2016 Summary judgment of non-infringement in favor of Sandoz Affirmed by Fed. Cir.; opinion modified on panel rehearing
8 AbbVie v. Amgen,
No. 16-666 (D. Del.)
AMJEVITA (adalimumab-atto)
[approved]
HUMIRA
[litigation #1]
Aug. 4, 2016 Settled n/a
9 Amgen v. Coherus,
No. 17-546 (D. Del.)
UDENYCA (pegfilgrastim-cbqv)
[approved; launched]
NEULASTA
[litigation #3]
May 10, 2017 Motion to dismiss granted Affirmed by Fed. Cir.
10 Janssen v. Samsung Bioepis,
No. 17-3524 (D.N.J.)
RENFLEXIS (infliximab-abda)
[approved, launched]
REMICADE
[litigation #2]
May 17, 2017 Voluntarily dismissed with prejudice n/a
11 AbbVie v. Boehringer Ingelheim,
No. 17-1065 (D. Del.)
CYLTEZO (adalimumab-adbm)
[approved]
HUMIRA
[litigation #2]
Aug. 2, 2017 Settled n/a
12 Amgen v. Mylan,
No. 17-1235 (W.D. Pa.)
FULPHILA (pegfilgrastim-jmdb)
[approved; launched]
NEULASTA
[litigation #4]
Sept. 22, 2017 Stipulation of non-infringement n/a
13 Genentech v. Amgen,
Nos. 17-1407, -1471, 19-602 (D. Del.)
MVASI (bevacizumab-awwb)
[approved; launched]
AVASTIN
[litigation #1]
Oct. 6, 2017 Settled Denial of PI affirmed on interlocutory appeal
14 Genentech v. Pfizer,
No. 17-1672 (D. Del.)
TRAZIMERA (trastuzumab-qyyp)
[approved; launched]
HERCEPTIN
[litigation #1]
Nov. 17, 2017 Settled n/a
15 Genentech v. Sandoz,
No. 17-13507 (D.N.J.)
GP2013 (rituximab biosimilar)
[not approved]
RITUXAN
[litigation #1]
Dec. 21, 2017 Settled n/a
16 Genentech v. Celltrion,
Nos. 18-095, -1025 (D. Del.)
HERZUMA (trastuzumab-pkrb)
[approved; launched]
HERCEPTIN
[litigation #2]
Jan. 12, 2018 Settled n/a
17 Genentech v. Celltrion,
Nos. 18-574, -11553 (D.N.J.)
TRUXIMA (rituximab-abbs)
[approved; launched]
RITUXAN
[litigation #2]
Jan. 12, 2018 Settled n/a
18 Amgen v. Kashiv (formerly Adello),
No. 18-3347 (D.N.J.)
TPI G-CSF (filgrastim biosimilar)
[not approved]
NEUPOGEN
[litigation #3]
Mar. 8, 2018 Settled n/a
19 Genentech v. Amgen,
No. 18-924 (D. Del.)
KANJINTI (trastuzumab-anns)
[approved; launched]
HERCEPTIN
[litigation #3]
June 21, 2018 Settled Denial of PI affirmed on interlocutory appeal
20
Amgen v. Hospira,
Nos. 18-1064, 20-561 (D. Del.)
NIVESTYM (filgrastim-aafi)
[approved] [launched]
NEUPOGEN
[litigation #4]
July 18, 2018 Pending – jury trial scheduled for May 17, 2021
21
Amgen v. Accord (previously Apotex),
No. 18-61828 (S.D. Fla.)
[follow-on case to #3 & 5 above]
Lapelga (pegfilgrastim biosimilar)
[not approved];
Grastofil (filgrastim biosimilar)
[not approved]
NEULASTA
[litigation #1]; NEUPOGEN
[litigation #2]
Aug. 7, 2018 Settled n/a
22
AbbVie v. Sandoz,
No. 18-12668 (D.N.J.)
HYRIMOZ (adalimumab-adaz)
[approved]
HUMIRA
[litigation #3]
Aug. 10, 2018 Settled n/a
23
Genentech v. Samsung Bioepis,
No. 18-1363 (D. Del.)
ONTRUZANT (trastuzumab-dttb)
[approved; launched]
HERCEPTIN
[litigation #4]
Sept. 4, 2018 Settled n/a
24
Genentech v. Pfizer,
No. 19-638 (D. Del.)
ZIRABEV (bevacizumab-bvzr)
[approved; launched]
AVASTIN
[litigation #2]
Apr. 5, 2019 Settled n/a
25
Immunex v. Samsung Bioepis,
No. 19-11755 (D.N.J.)
ETICOVO (etanercept-ykro)
[approved]
ENBREL
[litigation #2]
Apr. 29, 2019 Pending (administratively stayed)
26
Amgen v. Tanvex,
No. 19-1374 (S.D. Cal.)
TX-01 (filgrastim biosimilar)
[not approved]
NEUPOGEN
[litigation #5]
July 23, 2019 Settled n/a
27 Amgen v. Hospira,
No. 20-201 (D. Del.)
NYVEPRIA (pegfilgrastim-apgf)
[approved]
NEULASTA
[litigation #5]
Feb. 11, 2020 Pending
28
Genentech v. Samsung Bioepis,
No. 20-859 (D. Del.)
SB8 (bevacizumab biosimilar)
[not approved]
AVASTIN
[litigation #3]
June 28, 2020 Pending

Last updated: July 7, 2020

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