Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents
FDA Law Blog
JUNE 13, 2024
The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable. While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R.
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