Hikma V. Vanda Exaggerates Treatments' Patent Eligibility

Law360 (March 15, 2019, 3:57 PM EDT) -- Method-of-treatment patents are one of the three types of pharmaceutical patents listed in the Orange Book of the U.S. Food and Drug Administration for a branded drug — the other two being active ingredient and formulation/composition patents. As such, when a generic pharmaceutical company files an abbreviated new drug application seeking approval to market a generic version of a particular branded drug, it must address any Orange Book listed method-of-treatment patent in its ANDA application.

A Paragraph IV filing of the ANDA, in turn, often triggers a patent infringement lawsuit between the Orange Book patent owner and the ANDA filer, and...

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