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Legal Matters (Tables)
3 Months Ended
Mar. 31, 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 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 these decisions to the United States Court of Appeals for the Federal Circuit (the "Federal Circuit").
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.

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")
Samsung Bioepis
IPR petition seeking declaration of invalidity
April 27, 2023
On November 17, 2023, the USPTO instituted IPR proceedings concerning 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 partiesOpposition proceedingsOctober 26 and October 27, 2021
Oral hearing scheduled for November 2024.
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.
EPOEuropean 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 proceedingsJune 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 to be scheduled.