Table 2 The notification process
| Â | 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 |