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Table 3 Stay of generic registration or sales

From: Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States

  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