| 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 |
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