Big Molecule Watch

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

• Accused Biosimilar:  YESAFILI (aflibercept-jbvf)
• Marketing Status:  Approved by FDA on May 20, 2024
• 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.
    • On January 26, 2024, both Regeneron and the Biocon Defendants filed notices of appeal from the court’s judgment.  On April 12, 2024, the Federal Circuit dismissed the appeals (CAFC Appeal No, 24-1402 and Cross-Appeal No, 24-1405) for lack of jurisdiction.  The dismissal order states: “Following this court’s February 22, 2024 show cause order, the parties agree that the court lacks jurisdiction over both the appeal and cross-appeal from the district court’s December 27, 2023 decision resolving fewer than all claims at issue. Under the circumstances, we agree and conclude that dismissal is appropriate.”
  • On Jan. 26, 2024, Defendants filed a motion for summary judgment on certain counts (7, 9, and 11) for statutory disclaimer under 35 U.S.C. § 253(b).  On March 8, 2024, the Court granted the motion and ordered counts 7, 9, and 11 dismissed.
  • On March 5, 2024, the Court issued an order for a schedule for permanent injunction briefing.  Briefing was completed on April 18, 2024, and a hearing was scheduled for May 2, 2024.  On April 26, 2024, the Court cancelled the May 2, 2024 hearing.
  • On April 11, 2024, the Judicial Panel on Multidistrict Litigation (“JPML”) determined that the various aflibercept actions involve “common questions of fact and that centralization in the Northern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”  The JPML noted that Regeneron alleges that the defendants “infringed a common set of thirteen U.S. patents covering Regeneron’s ophthalmic drug, EYLEA^®, by submitting aBLAs and seeking to market their follow-on biologic products.”
  • On April 24, 2024, after the MDL was instituted, Judge Kleeh cancelled the May 2, 2024 hearings regarding Regeneron’s motion for a permanent injunction against Mylan and motions for preliminary injunctions against Celltrion, Formycon, and Samsung Bioepis, which had been scheduled for May 2, 2024.  Two days later, Judge Kleeh also cancelled status conferences that had been scheduled for May 13, 2024.  In their place, Judge Kleeh set an initial scheduling conference in the MDL for May 17, 2024.
  • On May 3, 2024, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.”  In that motion, Regeneron stated that FDA may begin approving biosimilars on May 18, 2024, and that none of the defendants have “confirm[ed] that they will not launch their infringing products until this Court has had time to decide the pending motions for injunctive relief.”  Regeneron stated its intention to move for temporary restraining orders (“TRO”) against Mylan, Celltrion, Formycon, and Samsung Bioepis on May 14, 2024, unless the court sets a different schedule.
  • On June 11, 2024, in a sealed order, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon.  The terms of the injunction are set forth in an Order that issued on June 21, 2024.   A redacted version of the June 11 order was also made available on June 21, 2024.  On June 21, 2024, Mylan/Biocon filed a notice of appeal.
  • On June 11, 2024, the Court also issued a partial Final Judgment, pursuant to Fed. R. Civ. P. 54(b), for Counts 12, 17, and 21 of Regeneron’s Complaint.  These counts correspond to Regeneron’s allegations of infringement of U.S. Patent No. 10,888,601 (Count 12), the ‘865 patent (Count 17), and U.S. Patent No. 11,253,572 (Count 21).  In the Court’s judgment that issued on December 27, 2023, the Court ruled that Mylan/Biocon infringed claims 4, 7, 9, 11, and 14-17 of the ‘865 patent, and that the same claims were not invalid; and that Mylan/Biocon will induce infringement of claims 6 and 25 of the ‘572 patent and claims 11 and 19 of the ’601 patent, but Mylan/Biocon had proven that these claims of the ’572 and ’601 patents are invalid.

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.
  • On Jan. 17, 2024, Celltrion filed a motion to dismiss for lack of personal jurisdiction or, alternatively, to transfer venue.
  • On Feb. 15, 2024, the Court set an amended schedule for motion to dismiss and preliminary injunction briefing.  Motion to dismiss briefing is to be completed by February 26, 2024.  Preliminary injunction briefing is to be completed by April 17, 2024, and a hearing on the motion is scheduled for May 2, 2024.
  • On April 11, 2024, the Judicial Panel on Multidistrict Litigation (“JPML”) determined that the various aflibercept actions involve “common questions of fact and that centralization in the Northern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”  The JPML noted that Regeneron alleges that the defendants “infringed a common set of thirteen U.S. patents covering Regeneron’s ophthalmic drug, EYLEA^®, by submitting aBLAs and seeking to market their follow-on biologic products.”
  • On April 24, 2024, after the MDL was instituted, Judge Kleeh cancelled the May 2, 2024 hearings regarding Regeneron’s motion for a permanent injunction against Mylan and motions for preliminary injunctions against Celltrion, Formycon, and Samsung Bioepis, which had been scheduled for May 2, 2024.  Two days later, Judge Kleeh also cancelled status conferences that had been scheduled for May 13, 2024.  In their place, Judge Kleeh set an initial scheduling conference in the MDL for May 17, 2024.
  • On May 3, 2024, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.”  In that motion, Regeneron stated that FDA may begin approving biosimilars on May 18, 2024, and that none of the defendants have “confirm[ed] that they will not launch their infringing products until this Court has had time to decide the pending motions for injunctive relief.”  Regeneron stated its intention to move for temporary restraining orders (“TRO”) against Mylan, Celltrion, Formycon, and Samsung Bioepis on May 14, 2024, unless the court sets a different schedule.  The Court held a case management conference on May 17, 2024, and, on May 21, 2024, denied Regeneron’s motion for guidance as moot.
  • On May 28, 2024, the Court granted Regeneron’s motion to partially withdraw its motion for preliminary injunction that do not relate to the ‘865 patent.  Accordingly, Regeneron’s motion for a preliminary injunction is limited to assertion of the ‘865 patent.
  • On June 28, 2024, the Court granted a preliminary injunction.  A redacted version of the order was made available on July 9, 2024.  On July 10, 2024, the Court issued an Order for Injunctive Relief Against Celltrion.

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

• Accused Biosimilar:  OPUVIZ (aflibercept-yszy)
• Marketing Status:  Approved by FDA on May 20, 2024
• Reference Product:  EYLEA
• Complaint Filed:  Nov. 22, 2023
• Litigation Status/Outcome:  Pending
  • On Jan. 4, 2024, Samsung Bioepis filed a motion to dismiss for lack of personal jurisdiction.
  • 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.
  • On Feb. 15, 2024, the Court set an amended schedule for motion to dismiss and preliminary injunction briefing.  Motion to dismiss briefing is to be completed by February 26, 2024.  Preliminary injunction briefing is to be completed by April 17, 2024, and a hearing on the motion was scheduled for May 2, 2024.
  • On April 11, 2024, the Judicial Panel on Multidistrict Litigation (“JPML”) determined that the various aflibercept actions involve “common questions of fact and that centralization in the Northern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”  The JPML noted that Regeneron alleges that the defendants “infringed a common set of thirteen U.S. patents covering Regeneron’s ophthalmic drug, EYLEA^®, by submitting aBLAs and seeking to market their follow-on biologic products.”
  • On April 24, 2024, after the MDL was instituted, Judge Kleeh cancelled the May 2, 2024 hearings regarding Regeneron’s motion for a permanent injunction against Mylan and motions for preliminary injunctions against Celltrion, Formycon, and Samsung Bioepis, which had been scheduled for May 2, 2024.  Two days later, Judge Kleeh also cancelled status conferences that had been scheduled for May 13, 2024.  In their place, Judge Kleeh set an initial scheduling conference in the MDL for May 17, 2024.
  • On May 3, 2024, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.”  In that motion, Regeneron stated that FDA may begin approving biosimilars on May 18, 2024, and that none of the defendants have “confirm[ed] that they will not launch their infringing products until this Court has had time to decide the pending motions for injunctive relief.”  Regeneron stated its intention to move for temporary restraining orders (“TRO”) against Mylan, Celltrion, Formycon, and Samsung Bioepis on May 14, 2024, unless the court sets a different schedule.
  • In a sealed order that issued on June 14, 2024, the Court granted a preliminary injunction against Samsung Bioepis.  Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with a vascular endothelial growth factor (VEGF) antagonist.

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

• Accused Biosimilar:  OPUVIZ (aflibercept-yszy)
• Marketing Status:  Approved by FDA on May 20, 2024
• Reference Product:  EYLEA
• Complaint Filed:  Dec. 27, 2023
• Litigation Status/Outcome:  Pending
  • On Jan. 4, 2024, Samsung Bioepis filed a motion to dismiss for lack of personal jurisdiction.
  • 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.
  • On Feb. 15, 2024, the Court set an amended schedule for motion to dismiss and preliminary injunction briefing.  Motion to dismiss briefing is to be completed by February 26, 2024.  Preliminary injunction briefing is to be completed by April 17, 2024, and a hearing on the motion was scheduled for May 2, 2024.
  • On April 11, 2024, the Judicial Panel on Multidistrict Litigation (“JPML”) determined that the various aflibercept actions involve “common questions of fact and that centralization in the Northern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”  The JPML noted that Regeneron alleges that the defendants “infringed a common set of thirteen U.S. patents covering Regeneron’s ophthalmic drug, EYLEA^®, by submitting aBLAs and seeking to market their follow-on biologic products.”
  • On April 24, 2024, after the MDL was instituted, Judge Kleeh cancelled the May 2, 2024 hearings regarding Regeneron’s motion for a permanent injunction against Mylan and motions for preliminary injunctions against Celltrion, Formycon, and Samsung Bioepis, which had been scheduled for May 2, 2024.  Two days later, Judge Kleeh also cancelled status conferences that had been scheduled for May 13, 2024.  In their place, Judge Kleeh set an initial scheduling conference in the MDL for May 17, 2024.
  • On May 3, 2024, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.”  In that motion, Regeneron stated that FDA may begin approving biosimilars on May 18, 2024, and that none of the defendants have “confirm[ed] that they will not launch their infringing products until this Court has had time to decide the pending motions for injunctive relief.”  Regeneron stated its intention to move for temporary restraining orders (“TRO”) against Mylan, Celltrion, Formycon, and Samsung Bioepis on May 14, 2024, unless the court sets a different schedule.
  • In a sealed order that issued on June 14, 2024, the Court granted a preliminary injunction against Samsung Bioepis.  Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with a vascular endothelial growth factor (VEGF) antagonist.

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

• Accused Biosimilar: FYB203 (aflibercept)
• Marketing Status:  July 1, 2024
• 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.
  • On Jan. 17, 2024, Formycon filed a motion to dismiss for lack of personal jurisdiction or, alternatively, to transfer the case.
  • On Feb. 15, 2024, the Court set an amended schedule for the motion to dismiss and preliminary injunction briefing.  Motion to dismiss briefing is to be completed by February 26, 2024.  Preliminary injunction briefing is to be completed by April 17, 2024, and a hearing on the motion was scheduled for May 2, 2024.
  • On April 11, 2024, the Judicial Panel on Multidistrict Litigation (“JPML”) determined that the various aflibercept actions involve “common questions of fact and that centralization in the Northern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”  The JPML noted that Regeneron alleges that the defendants “infringed a common set of thirteen U.S. patents covering Regeneron’s ophthalmic drug, EYLEA^®, by submitting aBLAs and seeking to market their follow-on biologic products.”
  • On April 24, 2024, after the MDL was instituted, Judge Kleeh cancelled the May 2, 2024 hearings regarding Regeneron’s motion for a permanent injunction against Mylan and motions for preliminary injunctions against Celltrion, Formycon, and Samsung Bioepis, which had been scheduled for May 2, 2024.  Two days later, Judge Kleeh also cancelled status conferences that had been scheduled for May 13, 2024.  In their place, Judge Kleeh set an initial scheduling conference in the MDL for May 17, 2024.
  • On May 3, 2024, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.”  In that motion, Regeneron stated that FDA may begin approving biosimilars on May 18, 2024, and that none of the defendants have “confirm[ed] that they will not launch their infringing products until this Court has had time to decide the pending motions for injunctive relief.”  Regeneron stated its intention to move for temporary restraining orders (“TRO”) against Mylan, Celltrion, Formycon, and Samsung Bioepis on May 14, 2024, unless the court sets a different schedule.
  • In a sealed order that issued on June 21, 2024, the Court granted a preliminary injunction against Formycon.  Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with a vascular endothelial growth factor (VEGF) antagonist.

Regeneron v. Amgen Inc., 2-24-cv-00264 (C.D. Cal.) (transferred to N.D. W.Va., C.A. 1:24-cv-00039)

• Accused Biosimilar: ABP 938 (aflibercept)
• Marketing Status: Not approved
• Reference Product: EYLEA
• Complaint Filed:  Jan. 10, 2024
• Litigation Status/Outcome:  Pending
  • On Jan. 23, 2024, the Court granted Regeneron’s request to set a preliminary injunction schedule.  The court set a scheduling conference for April 5, 2024.
  • On March 27, 2024, the Court continued the scheduling conference to April 19, 2024.  The court ordered the parties to file a joint status report no later than April 5, 2024, and to provide a proposed schedule for the preliminary injunction briefing.
  • On April 11, 2024, the Judicial Panel on Multidistrict Litigation (“JPML”) determined that the various aflibercept actions involve “common questions of fact and that centralization in the Northern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”  The JPML noted that Regeneron alleges that the defendants “infringed a common set of thirteen U.S. patents covering Regeneron’s ophthalmic drug, EYLEA^®, by submitting aBLAs and seeking to market their follow-on biologic products.”  The JPML also ordered transfer of the case against Amgen to the Northern District of Virginia for “coordinated or consolidated pretrial proceedings” before Chief Judge Thomas S. Kleeh.
  • On April 24, 2024, after the MDL was instituted, Judge Kleeh cancelled the May 2, 2024 hearings regarding Regeneron’s motion for a permanent injunction against Mylan and motions for preliminary injunctions against Celltrion, Formycon, and Samsung Bioepis, which had been scheduled for May 2, 2024.  Two days later, Judge Kleeh also cancelled status conferences that had been scheduled for May 13, 2024.  In their place, Judge Kleeh set an initial scheduling conference in the MDL for May 17, 2024.
  • On May 3, 2024, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.”  In that motion, Regeneron stated that FDA may begin approving biosimilars on May 18, 2024, and that none of the defendants have “confirm[ed] that they will not launch their infringing products until this Court has had time to decide the pending motions for injunctive relief.”  Regeneron stated its intention to move for temporary restraining orders (“TRO”) against Mylan, Celltrion, Formycon, and Samsung Bioepis on May 14, 2024, unless the court sets a different schedule.

Regeneron v. Sandoz Inc., 3-24-cv-08760)

• Accused Biosimilar: ENVEEZU (aflibercept-abzv)
• Marketing Status:  Approved on August 9, 2024
• Reference Product: EYLEA
• Complaint Filed: August 26, 2024
• Litigation Status/Outcome:  Pending

Amgen Inc. et al. v. Celltrion, Inc. et al., 1-24-cv-06497 (D. Del.)

• Accused Biosimilar:  Denosumab biosimilars
• Marketing Status: Not approved
• Reference Product: PROLIA, XGEVA
• Complaint Filed: May 28, 2024
• Litigation Status/Outcome:  Pending

Amgen Inc. et al. v. Samsung Bioepis Co., Ltd. et al, 1-24-cv-08417 (D. Del.)

• Accused Biosimilar:  SB16
• Marketing Status: Not approved
• Reference Product: PROLIA, XGEVA
• Complaint Filed: August 12, 2024
• Litigation Status/Outcome:  Pending

Amgen Inc. et al. v. Fresenius Kabi USA, LLC et al, 1-24-cv-09555 (N.D. Ill.)

• Accused Biosimilar: FKS518
• Marketing Status: Not approved
• Reference Product: PROLIA, XGEVA
• Complaint Filed: October 4, 2024
• Litigation Status/Outcome:  Pending

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 March 3, 2023, defendant Polpharma filed a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), on grounds that “Polpharma did not submit an application to FDA seeking approval for natalizumab biosimilar.”  The Court denied the motion on March 5, 2024.
  • 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.
  • On May 3, 2024, the parties filed a Stipulation of Dismissal of Biogen’s claims of infringement of U.S. Patent No. 9,109,015, and Sandoz’s counterclaims for invalidity of the ‘015 patent.  The Stipulation of Dismissal was so ordered by the Court the same day.
  • On July 12, 2024, the Court issued a claim construction order.

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; launched on July 1, 2023
• 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. Sandoz, No. 18-12668 (D.N.J.)

• Accused Biosimilar: HYRIMOZ (adalimumab-adaz)
• Marketing Status: Approved by FDA on October 30, 2018; launched on July 1, 2023
• 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. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.)

• Accused Biosimilar: AVT02 (adalimumab)
• Marketing Status:  Approved by FDA on Feb. 23, 2024; launched on May 20, 2024
• 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: Approved by FDA on Feb. 23, 2024; launched on May 20, 2024
• 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.

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

• Accused Biosimilar: MVASI (bevacizumab-awwb)
• Marketing Status: Approved by FDA on September 14, 2017; launched 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, 2019; launched 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. Centus, No. 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.

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

• Accused Biosimilar: JUBBONTI (denosuamb-bddz); WYOST (denosumab-dbbz)
• Marketing Status:  Approved on March 5, 2024
• Reference Product: XGEVA, PROLIA
• Complaint Filed: May 1, 2023
• Litigation Status/Outcome:  Voluntarily dismissed.
  • 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.
  • On March 25, 2024, the Court entered an amended scheduling order.
  • On April 22, 2024, the Court scheduled a hearing on April 29, 2024 to issue a decision on the record as to Amgen’s Motion for Preliminary Injunction.  The hearing was cancelled, in view of a Stipulated Order of Dismissal filed by the parties on April 29, 2024.  Pursuant to the Stipulated Order, Sandoz “including its Affiliates, its officers, agents and employees, and third parties acting on behalf of or in active concert with Sandoz is hereby enjoined from making, using, offering to sell, or selling Jubbonti or Wyost in the Territory, or importing Jubbonti or Wyost into the Territory, except as permitted under the Binding Term Sheet, or by 35 U.S.C. § 271(e)(1).”   As set forth in the Stipulated Order, “[t]he foregoing injunction expires on February 19, 2025.”
  • The case was terminated on May 9, 2024.

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

• Accused Biosimilar: EPYSQLI (eculizumab-aagh) (SB12)
• Marketing Status:  July 22, 2024
• Reference Product: SOLIRIS
• Complaint Filed: Jan. 3, 2024
• Litigation Status/Outcome:  Voluntarily dismissed.
  • On Feb. 12, 2024, Alexion filed a motion for preliminary injunction.  A hearing was scheduled for May 8, 2024.  On May 6, 2024, the Court denied the motion, and cancelled the hearing scheduled for May 8, 2024.
  • On May 14, 2024, Alexion filed a notice of appeal to the Federal Circuit (Case No. 24-1829), appealing the district court’s denial of its preliminary injunction motion.  The appeal was placed on the Federal Circuit’s November 2024 oral argument calendar.
  • On May 17, 2024, Alexion filed an emergency motion in the district court for an injunction pending appeal, and for a temporary restraining order pending resolution of the motion.  On June 17, 2024, the Court denied the motion, stating that the “motion constitutes a motion for reconsideration with respect to the Court’s prior injunction,” and that “Alexion has failed to show that the Court clearly erred and abused its discretion.”
  • On June 21, 2024, Alexion filed a motion in the Federal Circuit for an injunction of marketing and sales of Samsung Bioepis’s SB12 product pending the appeal.  On July 29 2024, the Federal Circuit denied the motion.
  • On August 30, 2024, the parties filed a stipulated order of dismissal without prejudice, pursuant to a settlement agreement.  On September 3, 2024, the order of dismissal was entered.  On September 4, 2024, the Federal Circuit dismissed the appeal under Fed. R. App. 42(b), in response to the parties’ joint stipulation of voluntarily dismissal.

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

• Accused Biosimilar: RETACRIT (epoetin alfa-epbx)
• Marketing Status: Approved by FDA on May 15, 2018; launched 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.
  • Appeal: Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019) (affirming judgment), rehearing denied, No. 19-1067 (Fed. Cir. Mar. 16, 2020).

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.
  • Appeal: Immunex v. Sandoz, 964 F.3d 1049 (Fed. Cir. 2020) (affirming judgment).

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

• Accused Biosimilar: ETICOVO (etanercept-ykro)
• Marketing Status: Approved by FDA on April 25, 2019; not yet launched in US
• Reference Product: ENBREL
• Complaint Filed: Apr. 29, 2019
• Litigation Status/Outcome
  • On November 3, 2021, the district court entered a final judgment and order of permanent injunction in favor of Immunex on each of its claims for infringement of the ’182 and ’522 patents. Not appealed.

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

• Accused Biosimilar: ZARXIO (filgrastim-sndz)
• Marketing Status: Approved by FDA on March 6, 2015; launched 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.
    • Appeal: Amgen 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.
    • Appeal: Amgen v. Apotex, 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement).

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

• Accused Biosimilar: (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. Hospira, Nos. 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. Tanvex, No. 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.

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

• Accused Biosimilar: INFLECTRA (infliximab-dyyb)
• Marketing Status: Approved by FDA on April 5, 2016; launched 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, 2017; launched 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.

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.
    • Appeal: Amgen 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, 2019; launched 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.
    • Appeal: Amgen 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, 2018; launched 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.
    • Appeal: Amgen v. Coherus, 931 F.3d 1154 (Fed. Cir. 2019) (affirming district court’s dismissal).

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

• Accused Biosimilar: FULPHILA (pegfilgrastim-jmdb)
• Marketing status: Approved by FDA on June 4, 2018; launched in US at least as of July 26, 2018
• Reference Product: NEULASTA
• Complaint Filed: Sept. 22, 2017
• Litigation Status/Outcome
  • On September 17, 2019, the district court entered a stipulation and order of non-infringement of the ’997 patent.

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: NEULASTA; NEUPOGEN
• 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.

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. Celltrion, Nos. 18-574, -11553 (D.N.J.)

• Accused Biosimilar: TRUXIMA (rituximab-abbs)
• Marketing Status: Approved by FDA on November 28, 2018; launched 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.

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 (rituximab)
• Marketing Status: Not approved
• Reference Product: RITUXAN
• Complaint Filed: Nov. 17, 2023
• Litigation Status/Outcome:  On April 9, 2024, the parties filed a stipulation of dismissal in view of a settlement agreement, which was so ordered by the court on April 10, 2024.

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.

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

• Accused Biosimilar: TRAZIMERA (trastuzumab-qyyp)
• Marketing Status: Approved by FDA on March 11, 2019; launched 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. Celltrion, Nos. 18-095, -1025 (D. Del.)

• Accused Biosimilar: HERZUMA (trastuzumab-pkrb)
• Marketing Status: Approved by FDA on December 14, 2018; launched 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. Amgen, No. 18-924 (D. Del.)

• Accused Biosimilar: KANJINTI (trastuzumab-anns)
• Marketing Status: Approved by FDA of June 13, 2019; launched 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 Bioepis, No. 18-1363 (D. Del.)

• Accused Biosimilar: ONTRUZANT (trastuzumab-dttb)
• Marketing Status: Approved by FDA on January 18, 2019; launched 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 Biopharm, No. 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.

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

• Accused Biosimilar: ABP 654 (ustekinumab)
• Marketing Status:  Approved on Oct. 31, 2023
• 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.  The case was terminated on May 23, 2023.