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Patent Litigation Pharmaceutical Patents Samsung Bioepis

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Alexion and Samsung Settle Eculizumab BPCIA Case

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​​​​​​​On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more

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Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®

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On August 30, 2024, Alexion and Samsung Bioepis filed voluntary dismissals in all of their pending patent proceedings related to Soliris® (eculizumab) biosimilar Epysqli® (eculizumab-aagh), including Case No. 1:24-cv-00005...more

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Amgen Files BPCIA Lawsuit Against Samsung Bioepis Prolia® / Xgeva® Proposed Biosimilar SB16

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On August 12, 2024, Amgen filed Case No. 1:24-cv-08417 (D.N.J.) against Samsung Bioepis, alleging SB16 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 34 of Amgen’s patents....more

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Amgen Files BPCIA Complaint Against Samsung Bioepsis Regarding Denosumab

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On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and...more

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PTAB Issues Final Written Decision Invalidating Regeneron’s EYLEA® Patent (IPR2023-00442)

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On June 14, 2024, the PTAB issued a Final Written Decision (FWD) in Samsung Bioepis’s IPR2023-00442 (“the -00442 IPR) determining that the challenged claims of Regeneron’s U.S. Patent No. 10,130,681 (the ’681 patent) that...more

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Eculizumab BPCIA Litigation Update: Court Denies Alexion’s Motion for an Injunction Pending Appeal

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​​​​​​​As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court...more

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The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

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Updates on Aflibercept BPCIA Litigation - January 2024

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On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the...more

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Alexion Sues Samsung over Proposed Eculizumab Biosimilar

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Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for the...more

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BPCIA Complaint Against Proposed Soliris® (eculizumab) Biosimilar SB12 Filed

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On January 3, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a BPCIA litigation in the District of Delaware (Case No. 1-24-cv-00005 (D. Del.)) against...more

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Regeneron’s Disputes with Celltrion, Samsung Bioepis, and Formcycon on Service and Personal Jurisdiction in Aflibercept BPCIA...

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As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion,  Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for...more

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Regeneron Sues Samsung Bioepis for Proposed Biosimilar of EYLEA in West Virginia District Court

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​​​​​​​Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement...more

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Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

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On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more

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Genentech and Samsung Bioepis Settle Bevacizumab Biosimilar Patent Dispute

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​​​​​​​As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under...more

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Pfizer Files Lawsuit in Australia to Halt Sales of BRENZYS (etanercept)

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Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept). Pfizer alleges that the...more

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Final Judgment and Order of Permanent Injunction Entered in Immunex v. Samsung Bioepis Etanercept Biosimilar Litigation

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The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO...more

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New BPCIA Complaint: Genentech Seeks to Block Samsung Bioepis’s Proposed AVASTIN Biosimilar

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On June 28, 2020, Genentech filed a complaint against Samsung Bioepis (Bioepis) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Bioepis’s submission of an aBLA for SB8, a...more

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Immunex and Samsung Bioepis Seek to Stay Etanercept Biosimilar Litigation

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This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits...more

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Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

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Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar...more

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New BPCIA Complaint: Genentech Sues Samsung Bioepis Regarding Proposed Trastuzumab Biosimilar

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Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar...more

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AbbVie and Samsung Bioepis Announce Global Settlement of Adalimumab Disputes

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Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for...more

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Scheduling Order Entered in Janssen v. Samsung Bioepis

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This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other...more

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BPCIA Litigation Roundup (Summer 2017)

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Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

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BPCIA Litigation Roundup (Spring 2017)

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Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

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