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Legal Matters (Tables)
12 Months Ended
Dec. 31, 2023
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. 10,406,226 (the "'226 Patent") and 10,464,992 (the "'992 Patent")Anonymous parties
Ex parte reexamination
February 11, 2020
On September 11, 2023, the USPTO dismissed the '226 Patent reexamination proceedings following the Company's filing of a Notice of Disclaimer, disclaiming all claims of the '226 Patent.

On September 8, 2023, the '992 Patent reexamination proceedings were stayed by the USPTO pending resolution of the inter partes review ("IPR") of the '992 Patent initiated by Celltrion, Inc., as discussed further below. On January 17, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '992 Patent.
Company Patent(s) (continued)
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 invalidityMay 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 the USPTO written decisions concerning the '338 and '069 Patents with the Federal Circuit.
U.S. Patent Nos. 10,130,681 (the "'681 Patent"), 10,888,601 (the "'601 Patent"), and 10,857,205 (the "'205 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 ('681 Patent and '601 Patent)

October 28, 2022 ('205 Patent)
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 1, 2023, the USPTO denied institution of Mylan's IPR petition against the '205 Patent following the Company's filing of a Notice of Disclaimer with the USPTO, disclaiming all claims of the '205 Patent.
'681 Patent and '601 Patent
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.
U.S. Patent No. 11,253,572 (the "'572 Patent")
Apotex
IPR petition seeking declaration of invalidity
September 9, 2022
On March 10, 2023, the USPTO declined to institute an IPR proceeding based on the Apotex IPR petition.
Samsung Bioepis
IPR petition seeking declaration of invalidity
April 27, 2023
On November 17, 2023, the USPTO instituted IPR proceedings concerning the '572 Patent based on the Samsung IPR petition.
'992 Patent and '226 Patent
Celltrion, joined by Samsung Bioepis ('992 Patent)
IPR petitions seeking declarations of invalidity
January 17, 2023 ('992 Patent)

February 28, 2023 ('226 Patent)
On July 20, 2023, the USPTO instituted an IPR proceeding concerning the '992 Patent. On January 17, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '992 Patent.

On September 1, 2023, the USPTO denied institution of Celltrion's IPR petition against the '226 Patent following the Company's filing of a Notice of Disclaimer with the USPTO, disclaiming all claims of the '226 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 partiesOpposition proceedingsOctober 26 and October 27, 2021
Oral hearing to be scheduled.
EPO
European Patent No. 3,716,992 (the "EP '992 Patent")Amgen and three anonymous partiesOpposition proceedingsMay 5-10, 2023
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 proceedingsJune 22, 2023
Trial has been scheduled to begin in June 2025.