By Patrick O’Brien, JD, General Counsel, American Med Spa Association (AmSpa)

In November 2023, the U.S. Federal Trade Commission (FTC) sent out letters to drug makers challenging more than 100 patents they hold with the U.S. Food and Drug Administration (FDA), arguing that the patents are “invalid.” The FTC recently issued a press release stating that it sent additional letters covering more than 300 patents across 20 drug families. Notably for medical aesthetics, Novo Nordisk received a letter challenging 17 patents related to Ozempic. AmSpa previously discussed other news involving Ozempic and other semaglutide based drugs here. In this post, we will look at why the FTC is doing this and what effects this action might have.

When a drug manufacturer develops a new drug, it can file for patent protection with the FDA. The FDA patent list is referred to as the “Orange Book.” Currently, patents have a term of 20 years and they provide a period when the manufacturer is the only one who can make the drug. The FTC believes that patents that were improperly listed in the Orange Book have the effect of limiting innovation, reducing supply and increasing costs to consumers. In the FTC’s view, if these drugs no longer had patent protection, more manufacturers could produce them, increasing the supply and lowering the cost. Additionally, more manufacturers could investigate and develop new related drugs. The FTC doesn’t have unilateral regulatory power to overturn these patents so, instead, it has elected to utilize the FDA’s own administrative process for challenging patents.

This process involves sending a letter to the FDA and the drug manufacturer disputing the validity of the patent. The patent holder then has 30 days to either withdraw its patent, amend the patent listing or certify, under penalty of perjury, that the patents comply with the statutory requirements. Interestingly, the dispute letters do not appear to require a reason or a statement of the fact that the FTC believes to be improper with the patents. The FTC provides links to these letters through its press release and, as an example, the PDF of the letter to Novo Nordisk is linked here. So, there is little way the public can tell what the alleged issues are with these patents. However, the FTC likely has identified enough concrete issues that it feels confident in targeting these listings and characterizing them as “junk” patents.

What does this mean for these patents, including those related to Ozempic? In the short term, nothing will really change in terms of the status of these drugs. The manufacturers have 30 days to either declare that these are proper and valid patents or make amendments to bring them into compliance. In this part of the process, the only way the drugs’ status would change is if the manufacturers choose to withdraw all the patents related to a particular drug. That outcome seems unlikely, given the manufacturer’s financial interest in the drugs it develops. The FTC does mention that it has other methods of enforcement, including its traditional role of investigating unfair methods of competition. So, once the manufacturers have responded to these letters, it is somewhat likely that the FTC will move on to disputing more factual issues with these patents or decide to utilize other methods available to it. AmSpa is monitoring this ongoing story and will report on additional developments.