On November 7, 2023, the Federal Trade Commission issued a Press Release targeting more than 100 patents currently listed in the Orange Book. The Press Release elevates its position that certain device-related patents are not appropriate for listing and demands their removal.

10 Companies Notified, Sort-of

Over the past couple of months, FTC has notified 10 companies alleging that certain of their patents were improperly listed. The products affected are of the drug-device type including asthma inhalers, auto-injectors, and multi-dose bottles. The offending patents presumably cover the device portion of the product. Many of these products currently have pending PIV cases.

The Release contains links to the letters FTC sent. When reading them, the letters list the patents FTC wants removed but does not state its grounds for removal. FTC does cite that it is pursuing the FDA “regulatory process” and has “submitted patent listing dispute communications” to FDA. Perhaps more details will be available there for the sponsor, but the notice letter leaves the sponsor only to guess what the FTC position actually is or what legal or regulatory grounds FTC is relying on.

The Listing Conundrum

At the heart of this issue is what type of patent is listable in the Orange Book. The Regulations say these must be submitted: “drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method-of-use patents.” (21 CFR 314.53). While the regulations do not include drug devices, would some nonetheless qualify as part of a “drug product”? Possibly, but this is not overwhelmingly clear. When listing, FDA views its role as ministerial so will essentially list any patent. Not much help if you are a sponsor with a legitimate question of whether such a patent qualifies for listing.

The Best Course of Action?

FTC’s intentions seem noble enough, even virtuous. After all, if fewer patents are filed in the Orange Book, that means fewer obstacles for an ANDA filer. This is true, in theory, at least. But we can press this theory. The PIV process moves through the Orange Book with its 30-month stay in place when the PIV case is filed. With fewer patents, that means there will be fewer 30-month stays. Fewer 30-month stays means more generic drugs can reach the market sooner which does help the consumer. In theory….

However, and it’s a big however, if a brand company believes that an ANDA filer infringes one of its device patents – – now not listed in the Orange Book per the desires of the FTC — the brand company would need to wait for the generic product to launch. Once launched, it can then sue the generic company for infringement. The generic company would then be under a great deal of stress — if it is found to infringe, it can then be liable for treble damages. The brand could extract a royalty through a settlement, making it less desirable for the ANDA filer the next time around. Moreover, a judge (or even the ANDA holder itself) could remove an infringing product from the market, creating supply chain interruptions.

As the late British philosopher Alan Watts emphasized, beware of virtue; the road to hell is paved with good intentions.

Citations

The FTC Press Release. The Release includes links to the FTC letters to drug sponsors.

For Alan Watts, try this interesting video on his lecture on Fake Virtue courtesy of Youtube.