Legal Matters (Tables)

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Schedule of Loss Contingencies by Contingency

Post-Grant Proceedings Before USPTO

Company Patent(s)	Challenger(s)	Type of Challenge	Date of Challenge	Latest Events/Current Status
U.S. Patent Nos. 9,254,338 (the "'338 Patent") and 9,669,069 (the "'069 Patent")	Mylan Pharmaceuticals Inc., joined by Apotex Inc. and Celltrion	IPR petitions seeking declarations of invalidity	May 5, 2021	On November 9, 2022, the USPTO issued final written decisions finding that the challenged claims of the '338 and '069 Patents are unpatentable and, therefore, invalid. On January 10, 2023, the Company filed notices of appeal of these decisions to the United States Court of Appeals for the Federal Circuit (the "Federal Circuit"). On July 9, 2024, the Company's appeal was voluntarily dismissed.
U.S. Patent Nos. 10,130,681 (the "'681 Patent") and 10,888,601 (the "'601 Patent")	Mylan, joined by Celltrion ('601 and '681 Patents) and Samsung Bioepis Co., Ltd. ('601 Patent)	IPR petitions seeking declarations of invalidity	July 1, 2022	On January 9, 2024, the USPTO issued final written decisions finding that that the challenged claims of the '681 and '601 Patents are unpatentable and, therefore, invalid. On March 12, 2024, the Company filed notices of appeal of these decisions to the Federal Circuit. On August 20, 2024, the Company's appeal was voluntarily dismissed.
	Samsung Bioepis, joined by Biocon Biologics Inc. ('601 Patent)	IPR petitions seeking declarations of invalidity	January 6, 2023 ('681 Patent) March 26, 2023 ('601 Patent)	On July 19, 2023 and October 20, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent, respectively. On June 14, 2024, the USPTO issued a final written decision finding that the challenged claims of the '681 Patent are unpatentable and, therefore, invalid.
U.S. Patent No. 11,253,572 (the "'572 Patent")	Samsung Bioepis	IPR petition seeking declaration of invalidity	April 27, 2023	On November 17, 2023, the USPTO instituted IPR proceedings concerning the '572 Patent. On July 11, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '572 Patent.

Post-Grant Proceedings

Authority/Court	Company Patent(s)	Challenger(s)	Type of Challenge	Date of Challenge	Latest Events/Current Status
EPO	European Patent No. 2,944,306 (the "'306 Patent")	Anonymous parties	Opposition proceedings	October 26 and October 27, 2021	Oral hearing scheduled for November 2024
EPO	European Patent No. 3,716,992 (the "'992 Patent")	Amgen and three anonymous parties	Opposition proceedings	May 5–10, 2023	Oral hearing to be scheduled
EPO	European Patent No. 3,384,049 (the "'049 Patent")	Amgen and anonymous parties	Opposition proceedings	April 22–30, 2024	Oral hearing to be scheduled
German Federal Patent Court	German designation of European Patent No. 2,364,691 (the "'691 Patent")	Samsung Bioepis NL B.V.	Invalidation proceedings	June 22, 2023	Trial has been scheduled to begin in June 2025
High Court of Justice of England and Wales	United Kingdom designations of the '691 Patent and '306 Patent	Formycon AG and Klinge Biopharma GmbH	Invalidation proceedings and declaration of non-infringement by challengers' aflibercept 2 mg biosimilar	April 18, 2024	Trial has been scheduled to begin in June 2025
		Amgen	Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar	September 11, 2024	Trial has been scheduled to begin in June 2025
		Samsung Bioepis UK Limited	Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar	October 2, 2024	Trial has been scheduled to begin in June 2025
High Court of Justice of England and Wales	United Kingdom designation of the '992 Patent	Amgen	Invalidation proceedings	May 13, 2024	Stayed pending final resolution of the '992 Patent EPO opposition proceedings listed above
District Court of The Hague, the Netherlands	Dutch designation of the '691 Patent and '306 Patent	Samsung Bioepis NL B.V.	Invalidation proceedings	July 17, 2024	Trial for both patents has been scheduled for July 18, 2025
High Court of Justice of England and Wales	United Kingdom designation of the '992 Patent	Samsung Bioepis UK Limited	Invalidation proceedings	July 24, 2024	Stayed pending final resolution of the '992 Patent EPO opposition proceedings listed above
Judicial Court of Paris	French designation of the '691 Patent and '306 Patent	Formycon AG	Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar	August 19, 2024	Trial to be scheduled

Set forth below is a summary of patent infringement lawsuits filed by the Company and, as applicable, Bayer Consumer Care AG before the Seoul Central District Court based on allegations that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the relevant defendant(s) would infringe one or more claims of the Company's patents listed below.

Company Patent(s)	Defendant(s)	Relief Sought	Date of Action
Korean Patent No. 659477 (the "'477 Patent")	Samsung Bioepis Co., Ltd. and its parent company Samsung Biologics Co., Ltd.	Damages	January 16, 2023
	Sam Chun Dang Pharm. Co., Ltd. and OPTUS Pharmaceutical Co., Ltd	Damages	January 8, 2024
'477 Patent, '811 Patent, and Korean Patent No. 2519234 (the "'234 Patent")	Celltrion Inc.	Damages and injunctive relief	January 10, 2024
'811 Patent and '234 Patent	Sam Chun Dang Pharm. Co., Ltd. and OPTUS Pharmaceutical Co., Ltd	Damages and injunctive relief	May 8, 2024
	Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd	Injunctive relief	May 14, 2024
'811 Patent	Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd.	Injunctive relief	July 30, 2024
	Celltrion Inc. and Kukje Pharmaceuticals, Inc.	Injunctive relief	July 30, 2024