FTC Warns Pharma Companies That It May Go After Them For Sham Patent Listings Designed To Delay Generic Competitors

For many, many years we’ve detailed how big pharma companies, who only care about the monopoly rents they can receive on medicine while under patent, have concocted all sorts of scams and schemes to avoid having to compete with generic versions, even after their patents have expired (or been invalidated). But one of their older tricks is apparently popular yet again, though the FTC is now warning pharma that it might finally start cracking down.

If it does, it will just be reinforcing the kinds of actions the FTC used to bring. Twenty years ago, the FTC went after Bristol Meyer Squibb for false listings in the Orange Book. The Orange Book, managed by the FDA, is where pharma companies list the FDA-approved drugs they have under patent, which alerts generic drug companies basically not to make generic versions of those drugs.

But, of course, this creates a very tempting scenario: if pharma can get drugs not actually under patent into the Orange Book, they effectively save themselves from generic competition, and they get to profit massively (at the expense of the public and their need for affordable medicine).

However, despite enforcement against such abuse years ago, it seems that the FTC and the FDA have kinda let these things slip over the past few years. And Big Pharma has really taken advantage of that. Thankfully, it looks like the FTC is finally interested in cracking down on this practice again. In a new policy statement, it warns pharma companies that it’s looking into the abuse of the Orange Book and sham patent inclusions.

Brand drug manufacturers are responsible for ensuring their patents are properly listed. Yet certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it. When brand drug manufacturers abuse the regulatory processes set up by Congress to promote generic drug competition, the result may be to increase the cost of and reduce access to prescription drugs.

The goal of this policy statement is to put market participants on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.

Of course, this raises some questions, including why do we make the pharma companies themselves the party responsible for making sure their patents are “properly” listed. Why don’t we have at least some process in place for these listings to be reviewed, whether when they’re submitted to the Orange Book or even if another party (such as the generic drug manufacturers) contest an Orange Book listing.

It seems the dumbest possible system is to assume that the Big Pharma companies will be honest in their Orange Book listings.

And, even though the FTC is now putting these companies “on notice,” the fact that the FTC has brought these cases in the past seems like it should be “notice” enough. Instead, it sounds like the FTC let enough pharma companies get away with this for long enough that the big pharma firms felt cleared to abuse the system this way and to delay competition in the marketplace.

The one thing I find interesting in this statement, is that they note that improperly listing things in the Orange Book may “constitute illegal monopolization.”

The improper listing of patents in the Orange Book may also constitute illegal monopolization. Monopolization requires proof of “the willful acquisition or maintenance of [monopoly] power as distinguished from growth or development as a consequence of a superior product, business acumen, or historic accident.” This requires proof that “the defendant has engaged in improper conduct that has or is likely to have the effect of controlling prices or excluding competition,” and courts have recognized that improperly listing patents in the Orange Book may constitute an “improper means” of competition. Accordingly, improperly listing patents in the Orange Book may also be worthy of enforcement scrutiny from government and private enforcers under a monopolization theory. Additionally, the FTC may also scrutinize a firm’s history of improperly listing patents during merger review

This seems exactly correct, but notable in that very few people seem to recognize that (1) patents are government granted monopolies, and thus (2) an abuse of the patent system to get a patent or patent-like protections you don’t deserve are therefore an illegal monopoly seems like an important point. I would hope that this could get expanded to other abuses of patent and copyright law as well.

Still, given that we’ve been facing this and multiple other schemes from Big Pharma to delay generics for decades, I’m not sure anything is really going to change just yet, but at least the FTC is waking up (again?) to this issue. Now let’s see if it actually starts bringing cases…