BPCIA Litigations

Pending U.S. District Court BPCIA Litigations

Aflibercept+

Regeneron v. Mylan, 1:22-CV-00061 (N.D. W. Va.)

  • Accused Biosimilar: M710 (aflibercept)
  • Marketing Status: Not approved
  • Reference Product: EYLEA
  • Complaint Filed: Aug. 2, 2022
  • Litigation Status/Outcome:  Pending
    • An expedited trial was held in June 2023.  On December 28, 2023, the Court issued a judgment, as follows:
      • Regarding infringement: Regeneron demonstrated that Defendants infringed claims 4, 7, 9, 11, 14, 15, 16, and 17 of U.S. Patent No. 11,084,865.  Regeneron demonstrated that Defendants will induce infringement of claims 6 and 25 of U.S. Patent No. 111,253,572 and claims 11 and 19 of U.S. Patent No. 10,888,601.
      • Regarding invalidity: Mylan failed to prove that claims 4, 7, 9, 11, 14, 15, 16, and 17 of the ’865 Patent were invalid.  Mylan had proven that claims 6 and 25 of the ’572 Patent are invalid as obvious, and that claim 11 and 19 of the ‘601 Patent are invalid as obvious.

Regeneron v. Celltrion, 1:23-CV-00089 (N.D. W. Va.)

  • Accused Biosimilar: CT-P42 (aflibercept)
  • Marketing Status: Not approved
  • Reference Product: EYLEA
  • Complaint Filed: Nov. 8, 2023
  • Litigation Status/Outcome:  Pending
    • On Jan. 9, 2024, the Court set a briefing schedule for preliminary injunction proceedings.  Briefing is to be completed by April 18, 2024.  A hearing for Regeneron’s motion for a preliminary injunction is scheduled for May 2, 2024.

Regeneron v. Samsung Bioepis Co., Ltd., 1:23-CV-00094 (N.D. W. Va.)

  • Accused Biosimilar: SB15 (aflibercept)
  • Marketing Status: Not approved
  • Reference Product: EYLEA
  • Complaint Filed:   Nov. 22, 2023
  • Litigation Status/Outcome:  Pending
    • On Jan. 9, 2024, the Court set a briefing schedule for preliminary injunction proceedings.  Briefing is to be completed by April 18, 2024.  A hearing for Regeneron’s motion for a preliminary injunction is scheduled for May 2, 2024.

Regeneron v. Samsung Bioepis Co., Ltd., 1:23-CV-00106 (N.D. W. Va.)

  • Accused Biosimilar: SB15 (aflibercept)
  • Marketing Status: Not approved
  • Reference Product: EYLEA
  • Complaint Filed:   Dec. 27, 2023
  • Litigation Status/Outcome:  Pending
    • On Jan. 9, 2024, the Court set a briefing schedule for preliminary injunction proceedings.  Briefing is to be completed by April 18, 2024.  A hearing for Regeneron’s motion for a preliminary injunction is scheduled for May 2, 2024.

Regeneron v. Formycon AG, 1:23-CV-00097 (N.D. W. Va.)

  • Accused Biosimilar: FYB203 (aflibercept)
  • Marketing Status: Not approved
  • Reference Product: EYLEA
  • Complaint Filed: Nov. 29, 2023
  • Litigation Status/Outcome:  Pending
    • On Jan. 9, 2024, the Court set a briefing schedule for preliminary injunction proceedings.  Briefing is to be completed by April 18, 2024.  A hearing for Regeneron’s motion for a preliminary injunction is scheduled for May 2, 2024.

Regeneron v. Amgen Inc., 2-24-cv-00264 (C.D. Cal.)

  • Accused Biosimilar: ABP 938 (aflibercept)
  • Marketing Status: Not approved
  • Reference Product: EYLEA
  • Complaint Filed:  Jan. 10, 2024
  • Litigation Status/Outcome:  Pending

Denosumab+

Amgen v. Sandoz, 2:23-CV-02406 (D. N.J.)

  • Accused Biosimilar: Denosumab biosimilar
  • Marketing Status: Not approved
  • Reference Product: XGEVA, PROLIA
  • Complaint Filed: May 1, 2023
  • Litigation Status/Outcome:  Pending
    • On September 5, 2023, the Court entered an amended scheduling order.
    • On September 8, 2023, Amgen filed a motion for preliminary injunction.  An evidentiary hearing on Amgen’s motion took place starting on October 30, 2023.  The Court has not yet issued an opinion.

Eculizumab+

Alexion Pharmaceuticals, Inc. et al. v. Samsung Bioepis Co. Ltd., 1-24-cv-00005 (D. Del.)

  • Accused Biosimilar: SB12 (eculizumab)
  • Marketing Status: Not approved
  • Reference Product: SOLIRIS
  • Complaint Filed: Jan. 3, 2024
  • Litigation Status/Outcome:  Pending

Natalizumab+

Biogen v. Sandoz, 1:22-CV-1190 (D. Del.)

  • Accused Biosimilar: PB006 (natalizumab)
  • Marketing Status: Approved on August 24, 2023
  • Reference Product: TYSABRI
  • Complaint Filed: Sept. 9, 2022
  • Litigation Status/Outcome:  Pending
    • On October 19, 2022, Biogen filed a Motion for Preliminary Injunction.  Oral argument was held on May 17, 2023.  On June 20, 2023, in a sealed filing, the Court denied Biogen’s Motion for Preliminary Injunction.  On June 27, 2023, the Court filed a redacted version of its order.  The Court held that Biogen did not satisfy its burden to show two requirements: (1) that it would suffer irreparable harm in the absence of an injunction and (2) that it would likely succeed on the merits.
    • On August 25, 2023, the Court issued a Scheduling Order (modified on Jan. 9, 2024).  The case is set for trial beginning on May 5, 2025.

Rituximab+

Genentech, Inc., Hoffmann-Roche Inc. and Biogen, Inc. v. Dr. Reddy’s Labs, Inc., Fresenius Kabi USA, LLC et al., 2:23-cv-22485 (D. N.J.)

  • Accused Biosimilar: DRL_RI (aflibercept)
  • Marketing Status: Not approved
  • Reference Product: RITUXAN
  • Complaint Filed: Nov. 17, 2023
  • Litigation Status/Outcome:  Pending

Resolved U.S. District Court BPCIA Litigations

Adalimumab+

AbbVie v. Amgen, No. 16-666 (D. Del.)

  • Accused Biosimilar: AMJEVITA (adalimumab-atto)
  • Marketing Status: Approved by FDA on September 23, 2016; launched in US on January 31, 2023
  • Reference Product: HUMIRA
  • Complaint Filed: Aug. 4, 2016
  • Litigation Status/Outcome
    • On September 28, 2017, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

AbbVie v. Boehringer Ingelheim, No. 17-1065 (D. Del.)

  • Accused Biosimilar: CYLTEZO (adalimumab-adbm)
  • Marketing Status: Approved by FDA on August 25, 2017; not yet launched in US
  • Reference Product: HUMIRA
  • Complaint Filed: Aug. 2, 2017
  • Litigation Status/Outcome
    • On May 15, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

AbbVie v. SandozNo. 18-12668 (D.N.J.)

  • Accused Biosimilar: HYRIMOZ (adalimumab-adaz)
  • Marketing Status: Approved by FDA on October 30, 2018; not yet launched in US
  • Reference Product: HUMIRA
  • Complaint Filed: Aug. 10, 2018
  • Litigation Status/Outcome
    • On October 16, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

AbbVie v. AlvotechNo. 21-2258, 21-2899 (N.D. Ill.)

  • Accused Biosimilar: AVT02 (adalimumab)
  • Marketing Status: Not approved
  • Reference Product: HUMIRA
  • Complaint Filed: April 27, 2021, May 28, 2021
  • Litigation Status/Outcome
    • On March 9, 2022, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Alvotech USA v. Abbvie, No. 2-21-00265 (E.D. Va.)

  • Accused Biosimilar: ATV02 (adalimumab)
  • Marketing Status: Not approved
  • Reference Product: HUMIRA
  • Complaint Filed: May 11, 2021 – Declaratory judgment claims filed by Alvotech for non-infringement, invalidity, and unenforceability of Abbvie patents
  • Litigation Status/Outcome:
    • On Oct. 22, 2021, the court granted Alvotech’s motion to transfer venue to the N.D. of Illinois.  Upon transfer to the N.D. Illinois, the case (No. 1-21-cv-05645) was voluntarily dismissed.

Bevacizumab+

Genentech v. Amgen, Nos. 17-1407, -1471, 19-602 (D. Del.)

  • Accused Biosimilar: MVASI (bevacizumab-awwb)
  • Marketing Status: Approved by FDA on September 14, 2017launched in US on July 18, 2019
  • Reference Product: AVASTIN
  • Complaint Filed: Oct. 6, 2017
  • Litigation Status/Outcome
    • On July 19, 2019, the district court denied Genentech’s motions for a preliminary injunction and temporary restraining order.
      • Appeal: Genentech v. Amgen, 964 F.3d 1109 (Fed. Cir. 2020) (affirming on interlocutory appeal)
    • On July 7, 2020, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Pfizer, No. 19-638 (D. Del.)

  • Accused Biosimilar: ZIRABEV (bevacizumab-bvzr)
  • Marketing Status: Approved by FDA on June 28, 2019launched in US on December 31, 2019
  • Reference Product: AVASTIN
  • Complaint Filed: Apr. 5, 2019
  • Litigation Status/Outcome
    • On September 20, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. CentusNo. 20-361 (E.D. Tex.)

  • Accused Biosimilar: FKB238 (bevacizumab)
  • Marketing Status: Not approved
  • Reference Product: AVASTIN
  • Complaint Filed: November 12, 2020
  • Litigation Status/Outcome
    • On July 2, 2021, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Samsung Bioepis, No. 20-859 (D. Del.)

  • Accused Biosimilar: SB8 (bevacizumab)
  • Marketing Status: Not approved
  • Reference Product: AVASTIN
  • Complaint Filed: June 28, 2020
  • Litigation Status/Outcome
    • Voluntarily Dismissed on Sept. 7, 2022.

Epoetin alfa+

Amgen v. Hospira, No. 15-839 (D. Del.)

  • Accused Biosimilar: RETACRIT (epoetin alfa-epbx)
  • Marketing Status: Approved by FDA on May 15, 2018launched in US on November 12, 2018
  • Reference Product: EPOGEN/ PROCRIT
  • Complaint Filed: Sept. 18, 2015
  • Litigation Status/Outcome
    • On September 22, 2017, the jury found that Hospira infringed the ’298 patent and awarded Amgen $70M. On August 27, 2018, the district court denied Hospira’s post-trial motion for judgment as a matter of law of no infringement and invalidity, or, in the alternative, a new trial or recalculation of damages.
    • AppealAmgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019) (affirming judgment), rehearing denied, No. 19-1067 (Fed. Cir. Mar. 16, 2020).

Etanercept+

Immunex v. Sandoz, No. 16-01118 (D.N.J.)

  • Accused Biosimilar: ERELZI (etanercept-szzs)
  • Marketing Status: Approved by FDA on August 30, 2016; not yet launched in US
  • Reference Product: ENBREL
  • Complaint Filed: Feb. 26, 2016
  • Litigation Status/Outcome
    • On August 9, 2019, the district court held that the ’182 and ’522 patents were not invalid. Sandoz did not contest infringement of the patents.
    • AppealImmunex v. Sandoz, 964 F.3d 1049 (Fed. Cir. 2020) (affirming judgment).

Immunex v. Samsung Bioepis, No. 19-11755 (D.N.J.)

Filgrastim+

Amgen v. Sandoz, No. 14-4741 (N.D. Cal.)

  • Accused Biosimilar: ZARXIO (filgrastim-sndz)
  • Marketing Status: Approved by FDA on March 6, 2015launched in US on Sept. 3, 2015
  • Reference Product: NEUPOGEN
  • Complaint Filed: Oct. 24, 2014
  • Litigation Status/Outcome
    • On March 19, 2015, the district court denied Amgen’s motion for preliminary injunction and motion for partial judgment of the pleadings, finding that the patent dance is not mandatory and that notice of commercial marketing (NCM) may be provided prior to FDA approval. The district court also dismissed Amgen’s state law claims.
      • Appeal: Amgen v. Sandoz, 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 to Federal Circuit, 877 F.3d 1315 (Fed. Cir. 2017) (affirming dismissal of state law claims on preemption grounds).
    • On September 3, 2017, the district court entered a stipulation of non-infringement of the ‘427 patent.
    • On December 9, 2017, the district court granted summary judgment of non-infringement of the ‘878 patent in favor of Sandoz.
      • AppealAmgen v. Sandoz, 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. Apotex, No. 15-62081 (S.D. Fla.)

  • Accused Biosimilar: GRASTOFIL (filgrastim)
  • Marketing Status: Not approved
  • Reference Product: NEUPOGEN
  • Complaint Filed: Oct. 2, 2015
  • Litigation Status/Outcome
    • On September 6, 2016, the district court ruled that Apotex’s proposed biosimilar would not infringe the asserted claims of the ’138 patent.

Amgen v. Kashiv (formerly Adello), No. 18-3347 (D.N.J.)

  • Accused Biosimilar: TPI G-CSF (filgrastim)
  • Marketing Status: Not approved
  • Reference Product: NEUPOGEN
  • Complaint Filed: Mar. 8, 2018
  • Litigation Status/Outcome
    • On November 25, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Amgen v. HospiraNos. 18-1064, 20-561 (D. Del.)

  • Accused Biosimilar: NIVESTYM (filgrastim-aafi)
  • Marketing Status: Approved by FDA on July 20, 2018; launched in US on October 1, 2018
  • Reference Product: NEUPOGEN
  • Complaint Filed: July 18, 2018
  • Litigation Status/Outcome
    • On September 8, 2021, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Amgen v. TanvexNo. 19-1374 (S.D. Cal.)

  • Accused Biosimilar: TX-01 (filgrastim)
  • Marketing Status: Not approved
  • Reference Product: NEUPOGEN
  • Complaint Filed: July 23, 2019
  • Litigation Status/Outcome
    • On December 20, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Infliximab+

Janssen v. Celltrion, No. 17-11008 (D. Mass.)

  • Accused Biosimilar: INFLECTRA (infliximab-dyyb)
  • Marketing Status: Approved by FDA on April 5, 2016launched in US on November 28, 2016
  • Reference Product: REMICADE
  • Complaint Filed: Mar. 6, 2015 (refiled May 31, 2017)
  • Litigation Status/Outcome
    • On July 30, 2018, the district court granted summary judgment of invalidity as to the ’471 patent and further granted summary judgment of non-infringement as to the ’083 patent.
      • Appeal: Janssen v. Celltrion, 796 F. App’x 741 (Fed. Cir. 2020) (affirming judgment of invalidity of the ’083 patent without opinion pursuant to Fed. Cir. R. 36) (appeal of the judgment as to the ’471 patent was dismissed as moot in light of the Federal Circuit’s affirming the PTAB’s invalidation of the patent during ex parte reexamination).

Janssen v. Samsung Bioepis, No. 17-3524 (D.N.J.)

  • Accused Biosimilar: RENFLEXIS (infliximab-abda)
  • Marketing Status: Approved by FDA on April 21, 2017launched in US on July 24, 2017
  • Reference Product: REMICADE
  • Complaint Filed: May 17, 2017
  • Litigation Status/Outcome
    • On November 30, 2017, the district court entered a stipulation of voluntary dismissal in light of Janssen’s proposal and Samsung’s consent to dismiss of all remaining counts of the complaint.

Pegfilgrastim+

Amgen v. Apotex, No. 15-61631 (S.D. Fla.)

  • Accused Biosimilar: LAPELGA (pegfilgrastim biosimilar)
  • Marketing Status: Not approved
  • Reference Product: NEULASTA
  • Complaint Filed: Aug. 6, 2015
  • Litigation Status/Outcome
    • On December 10, 2015, the district court granted Amgen’s motion for a preliminary injunction, preventing Apotex from marketing its biosimilar product until 180 days after Apotex notifies Amgen that its biosimilar application has received FDA approval and that Apotex intends to begin commercial marketing.
      • Appeal: Amgen v. Apotex, 827 F.3d 1052 (Fed. Cir. 2016) (affirming grant of injunction), cert. denied, 137 S. Ct. 591 (2016).
    • On September 6, 2016, the district court ruled that Apotex’s proposed biosimilar would not infringe the asserted claims of the ’138 patent.
      • AppealAmgen v. Apotex, 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement).

Amgen v. Sandoz, No. 16-2581 (N.D. Cal.)

  • Accused Biosimilar: ZIEXTENZO (pegfilgrastim-bmez)
  • Marketing Status: Approved by FDA on November 4, 2019launched in US on December 2, 2019
  • Reference Product: NEULASTA
  • Complaint Filed: Mar. 4, 2016
  • Litigation Status/Outcome
    • On December 19, 2017, the district court granted summary judgment of non-infringement of the ’878 patent in favor of Sandoz.
      • AppealAmgen v. Sandoz, 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. Coherus, No. 17-546 (D. Del.)

  • Accused Biosimilar: UDENYCA (pegfilgrastim-cbqv)
  • Marketing Status: Approved by FDA on November 2, 2018launched in US on January 3, 2019
  • Reference Product: NEULASTA
  • Complaint Filed: May 10, 2017
  • Litigation Status/Outcome
    • On March 27, 2018, the district court entered a memorandum order granting Coherus’s motion to dismiss for failure to state a claim upon which relief may be granted.
      • AppealAmgen v. Coherus, 931 F.3d 1154 (Fed. Cir. 2019) (affirming district court’s dismissal).

Amgen v. Mylan, No. 17-1235 (W.D. Pa.)

Amgen v. Accord (previously Apotex)No. 18-61828 (S.D. Fla.)

  • Accused Biosimilar: LAPELGA (pegfilgrastim); GRASTOFIL (filgrastim)
  • Marketing Status: Not approved; not approved
  • Reference Product: NEULASTANEUPOGEN
  • Complaint Filed: Aug. 7, 2018
  • Litigation Status/Outcome
    • On November 15, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Amgen v. Hospira, No. 20-201 (D. Del.)

  • Accused Biosimilar: NYVEPRIA (pegfilgrastim-apgf)
  • Marketing Status: Approved by FDA on June 10, 2020; launched in US (launch date unclear)
  • Reference Product: NEULASTA
  • Complaint Filed: Feb. 11, 2020
  • Litigation Status/Outcome
    • On March 21, 2022, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Rituximab+

Genentech v. Sandoz, No. 17-13507 (D.N.J.)

  • Accused Biosimilar: GP2013 (rituximab)
  • Marketing Status: Not approved
  • Reference Product: RITUXAN
  • Complaint Filed: Dec. 21, 2017
  • Litigation Status/Outcome
    • On December 6, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. CelltrionNos. 18-574, -11553 (D.N.J.)

  • Accused Biosimilar: TRUXIMA (rituximab-abbs)
  • Marketing Status: Approved by FDA on November 28, 2018launched in US on November 11, 2019
  • Reference Product: RITUXAN
  • Complaint Filed: Jan. 12, 2018
  • Litigation Status/Outcome
    • On November 1, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Tocilizumab+

Genentech, Inc., Hoffmann-La Roche, Inc., and Chugai Pharmaceutical Co., Ltd. v. Biogen MA Inc. and Bio-Thera Solutions, Ltd., 1:23-cv-11573 (D. Ma.)

  • Accused Biosimilar: BIIB800 (tocilizumab)
  • Marketing Status: Approved on Sept. 29, 2023
  • Reference Product: ACTEMRA
  • Complaint Filed: July 13, 2023
  • Litigation Status/Outcome:  On October 23, 2023, the parties filed a joint stipulation of dismissal in view of a settlement agreement.

Trastuzumab+

Genentech v. Pfizer, No. 17-1672 (D. Del.)

  • Accused Biosimilar: TRAZIMERA (trastuzumab-qyyp)
  • Marketing Status: Approved by FDA on March 11, 2019launched in US on February 15, 2020
  • Reference Product: HERCEPTIN
  • Complaint Filed: Nov. 17, 2017
  • Litigation Status/Outcome
    • On December 4, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. CelltrionNos. 18-095, -1025 (D. Del.)

  • Accused Biosimilar: HERZUMA (trastuzumab-pkrb)
  • Marketing Status: Approved by FDA on December 14, 2018launched in US on March 16, 2020
  • Reference Product: HERCEPTIN
  • Complaint Filed: Jan. 12, 2018
  • Litigation Status/Outcome
    • On December 27, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. AmgenNo. 18-924 (D. Del.)

  • Accused Biosimilar: KANJINTI (trastuzumab-anns)
  • Marketing Status: Approved by FDA of June 13, 2019launched in US on July 18, 2019
  • Reference Product: HERCEPTIN 
  • Complaint Filed: June 21, 2018
  • Litigation Status/Outcome
    • On July 19, 2019, the district court denied Genentech’s motions for a preliminary injunction and temporary restraining order.
      • Appeal: Genentech v. Amgen, 964 F.3d 1109 (Fed. Cir. 2020) (affirming on interlocutory appeal).
    • On July 7, 2020, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Samsung BioepisNo. 18-1363 (D. Del.)

  • Accused Biosimilar: ONTRUZANT (trastuzumab-dttb)
  • Marketing Status: Approved by FDA on January 18, 2019launched in US on April 15, 2020
  • Reference Product: HERCEPTIN
  • Complaint Filed: Sept. 4, 2018
  • Litigation Status/Outcome
    • On July 1, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Tanvex BiopharmNo. 22-CV-0809 (S.D. Cal.)

  • Accused Biosimilar: TX05 (trastuzumab)
  • Marketing Status: Not approved.
  • Reference Product: HERCEPTIN
  • Complaint Filed: June 2, 2022
  • Litigation Status/Outcome
    • On February 1, 2023, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Ustekinumab+

Janssen Biotech v. Amgen, 1:22-CV-1549 (D. Del.)

  • Accused Biosimilar: ABP 654 (ustekinumab)
  • Marketing Status: Not approved
  • Reference Product: STELARA
  • Complaint Filed: Nov. 29, 2022
  • Litigation Status/Outcome
    • A joint stipulation of dismissal was filed on May 22, 2023 due to a settlement.

Last updated: Jan. 11, 2024