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ARTICLE · 17 JULY 2024

Pharmacyclics LLC v. Alvogen Pine Brook LLC

Alvogen filed an ANDA with FDA seeking approval to market generic ibrutinib tablets. Pharmacyclics filed suit, alleging patent infringement of 18 patents.

United StatesIntellectual Property

Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.)

Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309 ("the '309 patent"), 8,754,090 ("the '090 patent"), 9,655,857 ("the '857 patent"), and 9,725,455 ("the '455 patent")

Nature of the Case and Issue(s) Presented: Alvogen filed an ANDA with FDA seeking approval to market generic ibrutinib tablets. Pharmacyclics filed suit, alleging patent infringement of 18 patents. The Alvogen was litigated alongside a related action involving other defendants seeking approval for generic versions of Imbruvica capsules (the Capsule Action). The Capsule Action and the Alvogen action were not fully consolidated, but parts of the suits were coordinated with respect to discovery, and the actions were tried together in October 2020. After the pretrial conference, Pharmacyclics narrowed its case to nine claims across

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