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Table 2 The notification process

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
The person who provides notice An applicant arguing that the patent is invalid or will not be infringed (Paragraph IV) An applicant submitting an application for licensure of a biological products as biosimilar or interchangeable An applicant arguing that the patent is invalid or will not be infringed (An allegation) An applicant with the 26B(1)(b) certificate, an applicant arguing that the patent will not be infringed is not required to give a notice to the patent holder An applicant arguing that the patent is invalid or will not be infringed
Recipients of notification Owner of the patent and the MA holder The holder of biologic MA The MA holder The patent holder in cases where a patent will be infringed. The generic must certify to the TGA that the MAH has been notified Owner of the patent and the MA holder
Timing of notification Within 20 days after the date the is application filed Within 20 days after the date the application is filed After review of the application, but before marketing approval is granted Within 20 days after the date the application is filed