Skinny Label and Induced Infringement: The Saga Continues
FDA Law
MAY 11, 2023
Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.” Whether the Court takes up Teva v. GSK is still up in the air.
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