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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable. that is described in the pending or approved NDA ” (emphasis added).

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Drugs Companies Clap Back at Congress…Then Get Sued

FDA Law Blog

As Abbvie wrote: “While your letter refers to ‘sham’ patents and concerns about ‘abusing the patent system,’ the FTC’s letter makes no assertions that these patents were ill-gotten or are otherwise illegitimate. In fact, federal law and regulation appear to require AbbVie to list these patents.”

Drugs 59