FTC Finally Goes After Big Pharma And Its Fraudulent Orange Book Patent Listings

Fucking finally. I’ve been somewhat critical of the glaring failures of this FTC, which has been something of a mess, seemingly spending more time on questionable academic theories, rather than focusing on all sorts of obvious low-hanging fruit, clearly within its authority to protect consumers. So, it was nice a few months ago to see the FTC suggest it was finally going to target big pharma abusing the Orange Book to list drugs as being protected under patents, even if they weren’t, which had the impact of massively delaying the competitive generic market from coming together and offering cheaper solutions.

As we noted, the FTC had targeted such abuse, but it had been decades, and then they just kinda… stopped?

So the good news is that the FTC has now gone after about 100 patents and basically all of Big Pharma for abusing the Orange Book process.

Today, the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

The Commission has also notified FDA that it disputes the accuracy or relevance of the listed information for these patents, which may require that the manufacturers remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.  

The FTC sent notice letters to 10 companies, which include: AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of Glaxo-Smith Kline and Teva. The notice letters and the patent listing dispute notifications provided to FDA identify specific patents that FTC contends are improperly listed for specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors, also commonly known as EpiPens.

These are the kinds of things the FTC has had at its disposal to help deal with patent abuse creating scam monopolies (basically telling the world that the pharma giant has a state-authorized monopoly when it really doesn’t, leading generic drug makers not wanting to risk the liability of creating competing drugs).

So while I’ve criticized this FTC over plenty of stuff, I’m happy to see it doing this and using its authority in a clear way to benefit the public and to stop actual abusive monopolistic practices.