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 or some of our prior BPCIA litigation coverage.

# 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, 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 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 Pending in Fed. Cir.
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 Pending in 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 Pending Interlocutory appeal from denial of PI pending
14 Genentech v. Pfizer,
No. 17-1672 (D. Del.)
TRAZIMERA (trastuzumab-qyyp)
[approved]
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]
HERCEPTIN
[litigation #2]
Jan. 12, 2018 Settled n/a
17 Genentech v. Celltrion,
Nos. 18-574, -11553 (D.N.J.)
TRUXIMA (rituximab-abbs)
[approved]
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 Stipulation of dismissal without prejudice n/a
19 Genentech v. Amgen,
No. 18-924 (D. Del.)
KANJINTI (trastuzumab-anns)
[approved; launched]
HERCEPTIN
[litigation #3]
June 21, 2018 Pending Interlocutory appeal from denial of PI pending
20
Amgen v. Hospira,
No. 18-1064 (D. Del.)
NIVESTYM (filgrastim-aafi)
[approved] [launched]
NEUPOGEN
[litigation #4]
July 18, 2018 Pending
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 Stipulation of dismissal without prejudice 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]
HERCEPTIN
[litigation #4]
Sept. 4, 2018 Settled n/a
24
Genentech v. Pfizer,
No. 19-638 (D. Del.)
ZIRABEV (bevacizumab-bvzr)
[approved]
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
26
Amgen v. Tanvex,
No. 19-1374 (D.N.J.)
TX-01 (filgrastim biosimilar)
[not approved]
NEUPOGEN
[litigation #5]
July 23, 2019 Pending

Last updated: Dec. 5, 2019

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