The promise to sell to an uncertain third party is not an exception to the administrative examination and approval of drugs and medical devices.

The infringement exception of the Patent Law on the administrative examination and approval of drugs and medical devices is only applicable to the actors who implement patents in order to obtain the information needed for the administrative examination and approval of generic drugs and medical devices and the actors who implement patents in order to obtain the administrative examination and approval of the aforementioned actors. When the latter subject raises a defense on the grounds of the exception of administrative examination and approval of drugs and medical devices, the actual existence of the former subject should be the premise and condition. If the latter entity promises to sell the patented products to an uncertain third party instead of the former entity that actually exists and has established a specific trading relationship with it, it does not have the preconditions and conditions for applying the infringement exception of administrative examination and approval of drugs and medical devices.