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Legal Matters (Tables)
9 Months Ended
Sep. 30, 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.
U.S. Patent Nos. 9,254,338 (the "'338 Patent") and 9,669,069 (the "'069 Patent")Mylan Pharmaceuticals Inc., Apotex Inc., and Celltrion, Inc.IPR petitions seeking declarations of invalidityMay 5, 2021
On November 9, 2022, the USPTO issued final written decisions finding that the 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")MylanIPR petitions seeking declarations of invalidity
July 1, 2022 ('681 Patent and '601 Patent)

October 28, 2022 ('205 Patent)
IPR proceedings concerning the '681 Patent and the '601 Patent instituted on January 11, 2023; oral hearing held on October 25, 2023.

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 Co., Ltd.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 petitions seeking declaration of invalidity
September 9, 2022
On March 10, 2023, the USPTO declined to institute an IPR proceeding.
Samsung Bioepis Co., Ltd.
IPR petition seeking declaration of invalidity
April 27, 2023
Decision whether to institute pending.
'992 Patent and '226 Patent
Celltrion
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 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
Oral hearing to be scheduled.