Blake Coblentz and Aaron Lukas co-authored an article about two issues that they will be watching closely this year relating to litigation involving small and large molecule therapies. In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit’s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court’s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.
Another case they’re watching concerns generics’ ability to seek Food and Drug Administration (FDA) approval for less than all of the indications for which the reference drug is approved—also known as a “skinny label.”
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