FTC cracks down on 100-plus ‘improper’ drug patents in comprehensive enforcement push

Under the leadership of Lina Khan, the Federal Trade Commission (FTC) has stepped up its enforcement actions, complicating its clearances of mergers, including Amgen’s acquisition of Horizon Therapeutics, which concluded in early October. Most recently, FTC has challenged what it deems are “improper” patent listings. At the receiving end of the FTC drug patent crackdown are Big Pharma companies such as AbbVie, AstraZeneca, and Boehringer Ingelheim. 

FTC drug patent crackdown targets 100+ patent listings

More than 100 patent listings are improper in the eyes of FTC because they do not meet the relevant statutory and regulatory requirements for inclusion in the FDA’s Orange Book, a publication of “Approved Drug Products with Therapeutic Equivalence Evaluations.” That is, FTC contends that the patents in question are either inaccurately listed or are not relevant to the approved drug products they are thought to cover. The agency notes a variety of reasons fo…

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