FTC Campaign Against Orange Book Patent Listings Extends To Mylan’s Battle With Sanofi
Sanofi’s Orange Book listings for its insulin glargine product ‘can be viewed as one part of an overarching monopolistic scheme,’ FTC says in amicus brief.
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GlaxoSmithKline, Amneal and Kaleo delist patents on inhalers and autoinjectors in drug-device combination products in response to FTC criticism. But AstraZeneca, Boehringer Ingelheim, and Teva hold firm, teeing up legal battles if the Commission takes enforcement action.
Deputy director of the Bureau of Competition notes in an interview that the FTC focused on older products it felt should have more generic competition in its letters to companies citing improper patent listings. He says it is clear which drug-device combo patents should not be listed.
In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap
Agency sends letters to 10 companies saying they improperly listed patents in US FDA’s Orange Book covering drug-device combination products. FTC does not specify why it believes the patents were improperly listed.