Three pharmaceutical companies, including the UK’s GSK (NYSE: GSK), have responded to the Federal Trade Commission’s (FTC) allegations of “abusive” patents by withdrawing several listings from the US Orange Book. This action follows the FTC’s challenge in November against over 100 patents held by manufacturers of branded asthma inhalers, epinephrine autoinjectors, and other pharmaceutical products. The FTC claimed these patents were improperly or inaccurately listed in the US FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the “Orange Book,” potentially obstructing the entry of generic competitors and inflating drug prices.
The FTC’s initiative was prompted by US Representative Pramila Jayapal (D-Wash.) and US Senator Elizabeth Warren (D-Mass.), who have released a new letter detailing the companies’ responses to the FTC’s accusations. According to the letter, GSK has addressed the FTC’s criticisms by delisting 12 of the 14 patents identified by the FTC, as well as an additional five patents due to evolving policies and legal developments concerning drug-device combination listings.
Manufacturers Kaléo and Amneal have indicated they will delist all patents challenged by the FTC, plus an additional five patents in total (three for Kaléo and two for Amneal). However, several other companies, including Boehringer Ingelheim, AbbVie, Teva, AstraZeneca, and Viatris, have declined to delist any of the patents identified by the FTC.
The letter’s authors state, “This was a remarkable success for the FTC, with drug manufacturers announcing the withdrawal of 27 challenged patents within weeks of being asked to do so. At the same time, this rapid response reveals the extent to which drug manufacturers have been blatantly misusing the patent system and gaming FDA’s Orange Book policies, demonstrating that more work remains.”- Flcube.com
