Here FTC Goes Again on Its Own

It was about a year and a half ago that we first proclaimed mass hysteria when FTC crossed streams into FDA territory, but perhaps our cries were premature.  As we mentioned last year, a large number of the drug companies targeted by FTC in its Orange Book delisting campaign refused to delist their device patents from the Orange Book.  The FTC took another swing in the courts with an amicus brief in Teva v. Amneal, in which the Court ultimately held that “to qualify for listing, a patent must claim at least what made the product approvable as a drug in the first place—its active ingredient,” but that case didn’t have the effect of causing mass delisting (according to an FTC press release, only about 22 of the 100 patents identified were delisted).  So, as of now, many of the device component patents to which FTC objected remained listed in the Orange Book.

Well, the FTC is back at it—again without the help of FDA.

Armed with the Federal Circuit opinion in Teva v. Amneal, the FTC sent another spate of “warning letters” on May 21, 2025 to Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities.  It also notified FDA that it disputes the appropriateness of more than 200 patent listings, most of which FTC “previously disputed” but remain in the Orange Book.  The FTC is again taking the position that “[t]hese patents do not meet the statutory criteria for listing in the Orange Book, as confirmed by a recent ruling in the U.S. Court of Appeals for the Federal Circuit.”

The warning letters and delisting requests are not, in and of themselves, groundbreaking.  They’re mainly a continuation of FTC’s activities from 2023 and 2024.  But what makes them noteworthy is the elephant in the room: the change in administration.  The Press Release makes clear that this is not just a Democrat-led initiative.  The Republican-led FTC is continuing to move the ball forward:

‘The American people voted for transparent, competitive, and fair healthcare markets and President Trump is taking action. The FTC is doing its part,’ said FTC Chairman Andrew N. Ferguson. ‘When firms use improper methods to limit competition in the market, it’s everyday Americans who are harmed by higher prices and less access. The FTC will continue to vigorously pursue firms using practices that harm competition.’

It seems that this FTC isn’t willing to let this go.

Yet mum is the word from FDA.  There was some hope that, with pressure from the FTC, FDA would issue a guidance on whether device patents can be listed in the Orange Book since, after all, the Orange Book is plainly an FDA issue.  But FDA has been radio-silent.  So, the FTC continues on alone.  Down the only road its ever known.  Because, like a drifter, it was born to walk alone.