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 for the discrepancies, such as the patents in question not claiming the drug substance, the drug product, or the specific method of use in the approved product.
FTC said in a press release that the affected manufacturers may need to “remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.” The process of updating the Orange Book can be detailed, requiring precise adherence to regulatory protocols and timely responses from patent holders.
In all, some 10 companies were targeted in FTC’s list. In addition to those mentioned earlier are Mylan Specialty and subsidiaries of GSK and Teva.
Product types in particular included some asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors (EpiPens).
FTC steps up enforcement in 2023
On May 16, FTC filed a lawsuit to block Amgen’s acquisition of Horizon Therapeutics, a $27.8 billion transaction that the commission argued would lead to monopoly control over drugs for treating two serious illnesses. In September 1, the agency settled with Amgen, which agreed to changes in its drug portfolio that FTC worried would disadvantage rivals and requiring prior approval for future related acquisitions.
On July 19, 2023, DOJ joined FTC to release draft merger guidelines for public comment, which seeks to prevent anticompetitive mergers. On August 10, the agencies extended the public comment period by 30 days on proposed changes to the premerger notification form.
In October, the pharma industry announced the launch of a coalition known as the Partnership for the U.S. Life Science Ecosystem (PULSE) aiming to resist FTC’s growing scrutiny. The consortium includes more than 30 companies and biopharma associations, including Amgen, AbbVie, Gilead, Merck, and Novartis.
Filed Under: Regulatory affairs