Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astel­las Phar­ma and Gilead in a long-run­ning patent case over Pfiz­er-on­wed Hos­pi­ra’s gener­ic ver­sion of Lex­is­can.

The case kicked off in 2018, af­ter Hos­pi­ra sub­mit­ted an Ab­bre­vi­at­ed New Drug Ap­pli­ca­tion (AN­DA) for ap­proval to mar­ket a gener­ic ver­sion of Gilead’s Lex­is­can. The drug is used in my­ocar­dial per­fu­sion imag­ing (MPI), a type of nu­clear stress test.

Gilead and Astel­las al­leged that Hos­pi­ra’s AN­DA sub­mis­sion for re­gadeno­son in­fringed up­on sev­er­al patents, and sought a de­clara­to­ry judg­ment that Hos­pi­ra’s man­u­fac­tur­ing of the prod­uct would con­sti­tute a di­rect and in­duced in­fringe­ment. Hos­pi­ra de­nied the al­le­ga­tions, as­sert­ing in its de­fense that the patents are in­valid and fil­ing coun­ter­claims seek­ing judg­ments of non­in­fringe­ment.

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