This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology (here), suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book (OB). She addresses the Hatch-Waxman Act’s patent listing provisions and discusses other views held on the benefit of patent listings, which give applicants a chance to litigate challenged patents both during the application review process and prior to approval (which can sometimes take longer than the thirty-month stay afforded innovators if they sue generic applicants within forty-five days after proper paragraph IV challenge notices are given).

However, not listing some of these “improperly listed” patents (for instance, those for devices used for delivery in drug-device combinations, as well as others), some which may be valid, won’t cause their force to go away simply because they are no longer listed in the Orange Book. If an ANDA or 505(b)(2) applicant must then seek approval without being able to avail itself of the patent challenge procedures under Hatch-Waxman, then it could be subject to a lawsuit once its application is approved, delaying the potentially lengthy patent-litigation process until after approval, or it could choose to go to market at risk, not knowing whether it is going to be sued for infringement after approval and marketing. If the applicant markets its product, is sued, and loses, it could be liable for treble damages (see previous post here).

One of the opinions stated in the article is that “Regulatory agencies, such as the FDA, play a crucial role in addressing the impact of sham patents. Along with approving generic drug applications, the FDA must evaluate the legitimacy of patents listed in the Orange Book and ensure that competition thrives.” This would be all well and good if funding were not an issue. Historically, the FDA has said that its role in the patent listing process is purely administerial. While it has taken a more active role over the years, in my view, for the FDA to take on a patent validation role is not a viable alternative for an already resource-strapped Agency. Requiring that the FDA take on this additional role would necessitate that it hire patent experts to determine whether patents are, indeed, shams and devote additional legal resources to litigate against patent holders that refuse to delist patents it declares as shams.

In light of the current FDA budget situation and pressure on the FDA to ramp up its facility inspections, the Pink Sheet’s Hannah Daniel reports today that “The US Food and Drug Administration could fall behind in its inspection workload without more funding in the fiscal year 2025 budget to help recruit and retain staff, said Michael Rogers, associate commissioner for regulatory affairs” (here; subscription required). It all comes down to the Benjamins and, without additional funding, certain tasks must be parceled out to other agencies that are better equipped to deal with the issues. CDER’s job is to review and approve drugs. The FDA can’t be all things to everyone and expect to be able to maintain its primary missions.