9562016

Hatch-Waxman ANDA litigation brought by Array BioPharma against Alembic over generic binimetinib 15 mg tablets (ANDA No. 217678). The case was terminated by stipulated dismissal after a confidential settlement and license agreement, expressly not an adjudication on the merits, with no finding of infringement, invalidity, or unenforceability. A May 28, 2024 stipulated order addressed certain claims but did not become a final, appealable judgment.

Hatch-Waxman ANDA litigation brought by Array BioPharma against Sandoz over generic binimetinib. The case ended in a stipulated dismissal without prejudice under a confidential settlement and license agreement, expressly not an adjudication on the merits; Sandoz could maintain its existing Paragraph IV certifications and FDA was not barred from final ANDA approval. The dismissal order recited '9,850,299'; the narrative states the corresponding family patent is U.S. 9,850,229.

Hatch-Waxman ANDA litigation brought by Array BioPharma against Teva over Teva's generic binimetinib 15 mg tablets (ANDA No. 217509). The case ended in a stipulated dismissal/settlement after briefing on Teva's stay motion pending appeal of the crystallized binimetinib claim construction from the Alembic/Sandoz litigation. Although U.S. 9,314,464 appeared on the case's USPTO report, the narrative states Array asserted only the three Crystallized Binimetinib Patents (U.S. 9,562,016; 9,598,376; 9,980,944) against Teva, and Teva's Paragraph IV notice did not address the '464 patent.