Table 3 Stay of generic registration or sales
| Â | United States | Canada | Australia | South Korea | |
|---|---|---|---|---|---|
Small molecules | Biologics | ||||
Requirements for stay in approval | Patent litigation | Patent litigation after notice of commercial marketing of the biological product | Make application to the Federal Court | – | Patent litigation and statement that the request is made with respect to a genuine duly registered patent |
Timing of request | Within 45 days of the date of receipt | – | Within 45 days after the date of receipt | _ | Within 45 days after the date of receipt |
Judgment of request | – | Reviewed by the court | Reviewed by the court | _ | Reviewed by the MFDS |
Specific measures | Administrative process by the FDA, a 30-month automatic stay-in-approval | Judicial process, a preliminary injunction | Quasi-administrative process by the MOH, a 24-month stay-in-approval | Injunction may be sought against sale but no process to prevent grant of marketing approval | Administrative process by the MFDS, a 9-month stay of sales |
The starting point of the measures | The date of receiving the notification | – | The date on which the action is brought | – | The date of receiving the notification |
Penalty against a misused stay of marketing approval | – | – | Yes, an MAH must compensate for any damage to an ANDA applicant | Yes, patent holder must provide compensation for losses by generics company and the relevant jurisdiction if unsuccessful in litigation | – |