The Federal Trade Commission (FTC) has officially challenged more than 100 patents listed by brand name drug manufacturers in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,” often known as the “Orange Book.” This action, which took place on November 7, 2023, has drawn considerable attention to listing requirements of these patents.
Drug manufacturers submit patents for inclusion in the Orange Book with the intention of alerting generic drug manufacturers of potential patent infringement risks. For a patent to be included, it must claim the drug substance, the drug product, or a method of use. However, as highlighted by the FTC’s recent challenges, there is concern that not all listed patents fulfill these stipulations. There are lingering questions over whether manufacturers are being allowed to list patents that do not meet these standards.
In this challenging scenario, the FTC’s action can be seen as a statutory obligation to maintain the integrity and proper functionality of the Orange Book. Despite this, it is a clear signal that the agency is placing significant focus on patent listing practices. Consequently, brand name drug manufacturers must ensure that only applicable patents are submitted to avoid future challenges from regulatory bodies like the FTC.
For more detailed information on this situation, please visit the original report here.