Biosimilar-Related Federal Circuit 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 Opening brief and responsive brief filed. Amgen’s reply brief due July 20, 2018
Amgen v. Coherus, No. 18-1993 Pegfilgrastim C.A. No. 17-546 (D. Del.) Coherus’ motion to dismiss granted Amgen’s opening brief due August 20, 2018

Pending Federal Circuit Appeals from USPTO Proceedings:

CAFC Case Biologic Appeal from Disposition Below Appellate Status
Momenta v. BMS, No. 17-1694 Abatacept IPR2015-01537 (PTAB) FWD of patentability of US 8,476,239 Awaiting decision after oral argument, held December 5, 2017. Supplemental papers submitted in June 2018.
Coherus & BI v. AbbVie, 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; joint appendix filed. Awaiting oral argument date.
Celltrion & Pfizer v. Biogen, No. 18-1885 (cons.) Rituximab IPR2016-01614, IPR2017-01115 (PTAB) FWD of patentability of US 7,820,161 Celltrion’s   opening brief due August 13, 2018
Pfizer v. Genentech, No. 18-1933 General Process (e.g., trastuzumab) IPR2016-01837 (PTAB) FWD of unpatentability of US 7,807,799 Genentech’s opening brief due August 17, 2018
Hospira v. Genentech, No. 18-1959 Bevacizumab IPR2016-01771 (PTAB) FWD of unpatentability of US 7,622,115 Genentech’s opening brief due August 20, 2018
Sandoz v. AbbVie, Nos. 18-2142, -2143 Adalimumab IPR2017-01824, IPR2018-00002 (PTAB) Decisions denying institution re: US 9,512,216 Docketed on July 10, 2018

Completed Federal Circuit Appeals:

CAFC Case

Biologic Appeal from Disposition Below

Outcome

Sandoz v. Amgen, No. 14-1693 Filgrastim 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.)

Last updated: July 13, 2018