Appeals

Pending Federal Circuit Appeals from U.S. District Court BPCIA Litigations:

CAFC Case Biologic Appeal from Disposition Below Appellate Status
Amgen v. Sandoz, No. 18-1551 (cons.) Filgrastim, pegfilgrastim C.A. Nos. 14-4741, 16-2581 (N.D. Cal.) Sandoz’s motion for summary judgment of non-infringement granted Affirmed. On June 7, 2019, Amgen filed a petition for rehearing en banc, which is pending.
Amgen v. Coherus, No. 18-1993 Pegfilgrastim C.A. No. 17-546 (D. Del.) Coherus’ motion to dismiss granted Affirmed. Mandate to issue in due course.
Janssen v. Celltrion, Nos.  18-2321 (cons.)
Infliximab C.A. No. 17-11008 (D. Mass.) Celltrion’s motion for summary judgment of non-infringement of U.S. Patent No. 7,598,083 granted Janssen’s appeal and Celltrion’s cross-appeal consolidated. Briefing completed on June 18, 2019. Awaiting oral argument date.
Amgen v. Hospira, No. 19-1067 (cons.) Epoetin Alfa C.A. No. 15-839 (D. Del.) Final 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 Hospira’s appeal and Amgen’s cross-appeal consolidated. Briefing completed on Apr. 22, 2019.  Awaiting oral argument date.
Genentech v. Immunex, No. 19-2155 Bevacizumab C.A. No. 19-602 (D. Del.) (interlocutory appeal) Motion for TRO/PI denied Appeal docketed.  Genentech has moved for an injunction pending appeal.
Genentech v. Amgen, No. 19-2156 Trastuzumab C.A. No. 18-924 (D. Del.) (interlocutory appeal) Motion for TRO/PI denied The Fed. Cir. denied Genentech’s motions for an injunction pending appeal and to expedite briefing. Genentech filed its opening brief on July 26, 2019.

Pending Federal Circuit Appeals from USPTO Proceedings:

CAFC Case Biologic Appeal from Disposition Below Appellate Status
AbbVie v. US & Iancu (USPTO), No. 17-2304 (cons.) Adalimumab IPR2016-00172, -188, -189, -408, -409 (PTAB) FWDs of unpatentability (#1, 2, 3) of US 8,889,135, 9,017,680, and 9,073,987 Briefing completed but reopened after the US intervened regarding constitutionality. After Coherus and BI settled and withdrew from the appeals, the USPTO intervened to defend the PTAB’s FWDs in Coherus’s and BI’s IPRs.
Genentech v. Hospira & US, No. 18-1933 General Process (e.g., bevacizumab) IPR2016-01837 (PTAB) FWD of unpatentability of US 7,807,799 The U.S. intervened to address the issue of  constitutionality.  Briefing completed on Dec. 12, 2018.  Oral argument scheduled for Aug. 5, 2019.
Genentech v. Hospira & US, No. 18-1959 Bevacizumab IPR2016-01771 (PTAB) FWD of unpatentability of US 7,622,115 Affirmed. Mandate to issue in due course.
Genentech v. Iancu (USPTO), Nos. 19-1263, -1265, -1267, -1270 Trastuzumab IPR2017-00731, -00737, -01121, -01122 (PTAB) FWDs of unpatentability of US 7,846,441 and 7,892,549 Celltrion and Pfizer/Hospira withdrew from the appeals in view of settlements, and the USPTO has intervened in their stead. Samsung Bioepis also withdrew in view of settlement, and the USPTO has the opportunity to intervene in its stead.  Genentech’s opening briefs filed July 9, 2019.
Biogen v. Iancu (USPTO), No. 19-1364 Rituximab IPR2017-01168 (PTAB) FWD of unpatentability of US 8,821,873 The US intervened to address constitutionality. The USPTO also intervened, replacing the US as a party after Pfizer settled and provided notice of its non-participation. Briefing completed on June 27, 2019. Awaiting oral argument date.
Amgen v. Apotex, No. 19-2171 Filgrastim, pegfilgrastim IPR2016-01542 (PTAB) FWD of unpatentability of US 8,952,138 Appeal docketed on July 24, 2019.

Completed Federal Circuit Appeals:

CAFC Case

Biologic Appeal from Disposition Below

Outcome

Sandoz v. Amgen, No. 14-1693 Etanercept C.A. No. 13-2904 (N.D. Cal.) Dismissal of Sandoz’s declaratory judgment suit 773 F.3d 1274  (Fed. Cir. 2014) (affirming dismissal)
Amgen v. Sandoz, No. 15-1499 Filgrastim C.A. No. 14-4741 (N.D. Cal.) 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  794 F.3d 1347 (Fed. Cir. 2015) (holding that the patent dance is not mandatory and that 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. 16-1308 Pegfilgrastim C.A. No. 15-61631 (S.D. Fla.) Grant of Amgen’s motion for preliminary injunction 827 F.3d 1052 (Fed. Cir. 2016)(affirming grant of injunction), cert. denied, 137 S. Ct. 591 (2016).
Amgen v. Apotex, No. 17-1010 Pegfilgrastim, filgrastim C.A. Nos. 15-61631, -62081 (S.D. Fla.) Judgment of non-infringement 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement)
Amgen v. Hospira, No. 16-2179 Epoetin alfa C.A. No. 15-839 (D. Del.) Denial of Amgen’s motion to compel certain fact discovery 866 F.3d 1355 (Fed. Cir. 2017) (dismissing appeal)
In re Janssen Biotech, Inc., No. 17-1257 Infliximab Ex parte reexamination, Control No. 90/012,851 (PTAB) Rejection of claims of U.S. 6,284,471 based on obviousness-type double patenting 880 F.3d 1315 (Fed. Cir. 2018) (affirming rejection)
Janssen v. Celltrion, No. 17-1120 Infliximab C.A. No. 15-10698 (D. Mass.) Judgment of invalidity of U.S. 6,284,471 based on obviousness-type double patenting 2018 WL 2072723 (Fed. Cir. Jan. 23, 2018) (dismissing appeal as moot in view of affirmance in In re: Janssen Biotech, Inc.)
Sandoz v. AbbVie, No. 18-2142 (cons.) Adalimumab IPR2017-01824, IPR2018-00002 (PTAB) Decisions denying institution re: US 9,512,216 Appeal dismissed pursuant to settlement
Celltrion v. Genentech, No. 18-2160 (cons.) Trastuzumab, rituximab C.A. Nos. 18-274, -276 (N.D. Cal.) Dismissal of complaints for declaration judgment Appeal dismissed pursuant to settlement
Momenta v. BMS, No. 17-1694 Abatacept IPR2015-01537 (PTAB) FWD of patentability of US 8,476,239 915 F.3d 764 (Fed. Cir. 2019) (dismissing appeal for lack of standing/ jurisdiction and for mootness)
Biogen v. Iancu, No. 19-1253 Rituximab IPR2017-01095 (PTAB) FWD of unpatentability of US 9,296,821 Appeal voluntarily dismissed.
Pfizer v. Biogen, No. 18-1885 Rituximab IPR2016-01614, IPR2017-01115 (PTAB) FWD of patentability of US 7,820,161 Appeal dismissed after Celltrion and then Pfizer settled.
Samsung Bioepis v. Genentech, Nos. 19-1173, -1174
Trastuzumab IPR2017-00804, -00805, -01958, -01959 (PTAB) FWDs of patentability of US 6,627,196 and 7,371,379 Appeal dismissed pursuant to settlement

Last updated: August 8, 2019

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