Test 2 – Appeals

Completed Federal Circuit Appeals:

Etanercept+

Sandoz v. Amgen, No. 14-1693

  • Biologic: Etanercept
  • Appeal from: C.A. No. 13-2904 (N.D. Cal.)
  • Disposition: Dismissal of Sandoz’s declaratory judgment suit
  • Outcome: 773 F.3d 1274 (Fed. Cir. 2014) (affirming dismissal)

Immunex v. Sandoz, No. 20-1037

  • Biologic: Etanercept
  • Appeal from: C.A. No. 16-1118 (D.N.J.)
  • Disposition: Judgment of infringement and no invalidity of U.S. Patent Nos. 8,063,182 and 8,163,522
  • Outcome: AFFIRMED on July 1, 2020.

Filgrastim+

Amgen v. Sandoz, No. 15-1499

  • Biologic: Filgrastim
  • Appeal from: C.A. No. 14-4741 (N.D. Cal.)
  • Disposition: 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
  • Outcome: 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. 17-1010

  • Biologic: Pegfilgrastim, Filgrastim
  • Appeal from: C.A. Nos. 15-61631, -62081 (S.D. Fla.)
  • Disposition: Judgment of non-infringement
  • Outcome: 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement)

Amgen v. SandozNo. 18-1551 (cons.)

  • Biologic: Filgrastim, Pegfilgrastim
  • Appeal from: C.A. Nos. 14-4741, 16-2581 (N.D. Cal.)
  • Disposition: Sandoz’s motion for summary judgment of non-infringement granted
  • Outcome: 923 F.3d 1023 (Fed. Cir. 2019) (affirming grant of summary judgment), as modified by 776 F. App’x 707 (Fed. Cir. 2019)

Amgen v. Iancu (USPTO), No. 19-2171

  • Biologic: Filgrastim, Pegfilgrastim
  • Appeal from: IPR2016-01542 (PTAB)
  • Disposition: FWD of unpatentability of US 8,952,138
  • Outcome: Order, per curiam (Fed. Cir. Mar. 24, 2020) (FWD vacated and case remanded)

Pegfilgrastim+

Amgen v. Apotex, No. 16-1308

  • Biologic: Pegfilgrastim
  • Appeal from: C.A. No. 15-61631 (S.D. Fla.)
  • Disposition: Grant of Amgen’s motion for preliminary injunction
  • Outcome: 827 F.3d 1052 (Fed. Cir. 2016)(affirming grant of injunction), cert. denied, 137 S. Ct. 591 (2016).

Amgen v. Apotex, No. 17-1010

  • Biologic: Pegfilgrastim, Filgrastim
  • Appeal from: C.A. Nos. 15-61631, -62081 (S.D. Fla.)
  • Disposition: Judgment of non-infringement
  • Outcome: 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement)

Amgen v. CoherusNo. 18-1993

  • Biologic: Pegfilgrastim
  • Appeal from: C.A. No. 17-546 (D. Del.)
  • Disposition: Coherus’ motion to dismiss granted
  • Outcome: 931 F.3d 1154 (Fed. Cir. 2019) (affirming dismissal)

Amgen v. SandozNo. 18-1551 (cons.)

  • Biologic: Filgrastim, Pegfilgrastim
  • Appeal from: C.A. Nos. 14-4741, 16-2581 (N.D. Cal.)
  • Disposition: Sandoz’s motion for summary judgment of non-infringement granted
  • Outcome: 923 F.3d 1023 (Fed. Cir. 2019) (affirming grant of summary judgment), as modified by 776 F. App’x 707 (Fed. Cir. 2019)

Amgen v. Iancu (USPTO), No. 19-2171

  • Biologic: Filgrastim, Pegfilgrastim
  • Appeal from: IPR2016-01542 (PTAB)
  • Disposition: FWD of unpatentability of US 8,952,138
  • Outcome: Order, per curiam (Fed. Cir. Mar. 24, 2020) (FWD vacated and case remanded)

Epoetin Alfa+

Amgen v. Hospira, No. 16-2179

  • Biologic: Epoetin Alfa
  • Appeal from: C.A. No. 15-839 (D. Del.)
  • Disposition: Denial of Amgen’s motion to compel certain fact discovery
  • Outcome: 866 F.3d 1355 (Fed. Cir. 2017) (dismissing appeal)

Amgen v. Hospira, No. 19-1067 (cons.)

  • Biologic: Epoetin Alfa
  • Appeal from: C.A. No. 15-839 (D. Del.)
  • Disposition: 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
  • Outcome: 944 F.3d 1327 (Fed. Cir. 2019) (affirming judgment), rehearing denied.

Infliximab+

In re Janssen Biotech, Inc., No. 17-1257

  • Biologic: Infliximab
  • Appeal from: Ex parte reexamination, Control No. 90/012,851 (PTAB)
  • Disposition: Rejection of claims of U.S. 6,284,471 based on obviousness-type double patenting
  • Outcome: 880 F.3d 1315 (Fed. Cir. 2018) (affirming rejection)

Janssen v. Celltrion, No. 17-1120

  • Biologic: Infliximab
  • Appeal from: C.A. No. 15-10698 (D. Mass.)
  • Disposition: Judgment of invalidity of U.S. 6,284,471 based on obviousness-type double patenting
  • Outcome: 2018 WL 2072723 (Fed. Cir. Jan. 23, 2018) (dismissing appeal as moot in view of affirmance in In re: Janssen Biotech, Inc.)

Janssen v. Celltrion, Nos.  18-2321 (cons.)

  • Biologic: Infliximab
  • Appeal from: C.A. No. 17-11008 (D. Mass.)
  • Disposition: Celltrion’s motion for summary judgment of non-infringement of U.S. Patent No. 7,598,083 granted
  • Outcome: 796 F. App’x 741 (Fed. Cir. 2020) (affirming grant of summary judgment – without opinion, pursuant to Fed. Cir. R. 36)

Adalimumab+

Sandoz v. AbbVie, No. 18-2142 (cons.)

AbbVie v. US & Iancu (USPTO), No. 17-2304 (cons.)

  • Biologic: Adalimumab
  • Appeal from: IPR2016-00172, -188, -189, -408, -409 (PTAB)
  • Disposition: FWDs of unpatentability (#123) of US 8,889,135, 9,017,680, and 9,073,987
  • Outcome: 789 F. App’x 879 (Fed. Cir. 2020) (affirming FWD without opinion, pursuant to Fed. Cir. R. 36)

Trastuzumab+

Celltrion v. Genentech, No. 18-2160 (cons.)

  • Biologic: Trastuzumab, Rituximab
  • Appeal from: C.A. Nos. 18-274, -276 (N.D. Cal.)
  • Disposition: Dismissal of complaints for declaration judgment
  • Outcome: Appeal dismissed pursuant to settlement

Samsung Bioepis v. Genentech, Nos. 19-1173, -1174

  • Biologic: Trastuzumab
  • Appeal from: IPR2017-00804, -00805, -01958, -01959 (PTAB)
  • Disposition: FWDs of patentability of US 6,627,196 and 7,371,379
  • Outcome: Appeal dismissed pursuant to settlement

Genentech v. AmgenNo. 19-2156

  • Biologic: Trastuzumab
  • Appeal from: C.A. No. 18-924 (D. Del.) (interlocutory appeal)
  • Disposition: Motion for TRO/PI denied
  • Outcome: 796 F. App’x 726 (Fed. Cir.  2020) (affirming denial of motion)

Genentech v. Iancu (USPTO), Nos. 19-1263, -1265, -1267, -1270

  • Biologic: Trastuzumab
  • Appeal from: IPR2017-00731, -00737, -01121, -01122 (PTAB)
  • Disposition: FWDs of unpatentability of US 7,846,441 and 7,892,549
  • Outcome: 2020 WL 1492038 (Fed. Cir. Mar. 26, 2020) (affirming FWDs)

Abatacept+

Momenta v. BMS, No. 17-1694

  • Biologic: Abatacept
  • Appeal from: IPR2015-01537 (PTAB)
  • Disposition: FWD of patentability of US 8,476,239
  • Outcome: 915 F.3d 764 (Fed. Cir. 2019) (dismissing appeal for lack of standing/ jurisdiction and for mootness)

Rituximab+

Biogen v. Iancu (USPTO), No. 19-1253

  • Biologic: Rituximab
  • Appeal from: IPR2017-01095 (PTAB)
  • Disposition: FWD of unpatentability of US 9,296,821
  • Outcome: Appeal voluntarily dismissed.

Celltrion v. Genentech, No. 18-2160 (cons.)

  • Biologic: Trastuzumab, Rituximab
  • Appeal from: C.A. Nos. 18-274, -276 (N.D. Cal.)
  • Disposition: Dismissal of complaints for declaration judgment
  • Outcome: Appeal dismissed pursuant to settlement

Pfizer v. Biogen, No. 18-1885

Biogen v. Iancu (USPTO), No. 19-1364

  • Biologic: Rituximab
  • Appeal from: IPR2017-01168 (PTAB)
  • Disposition: FWD of unpatentability of US 8,821,873
  • Outcome: AFFIRMED on December 16, 2021

Bevacizumab+

Genentech v. Hospira & US, No. 18-1933

  • Biologic: General Process (e.g., Bevacizumab)
  • Appeal from: IPR2016-01837 (PTAB)
  • Disposition: FWD of unpatentability of US 7,807,799
  • Outcome: 946 F.3d 1333 (Fed. Cir. 2020) (affirming FWD)

Genentech v. Hospira & US, No. 18-1959

  • Biologic: Bevacizumab
  • Appeal from: IPR2016-01771 (PTAB)
  • Disposition: FWD of unpatentability of US 7,622,115
  • Outcome: 774 F. App’x 677 (Fed. Cir. 2019) (affirming FWD without opinion, pursuant to Fed. Cir. R. 36)

Genentech v. Immunex, No. 19-2155

  • Biologic: Bevacizumab
  • Appeal from: C.A. No. 19-602 (D. Del.) (interlocutory appeal)
  • Disposition: Motion for TRO/PI denied
  • Outcome: AFFIRMED on July 6, 2020.

Last updated: May 13, 2021