| United States | Canada | Australia | South Korea | |
---|---|---|---|---|---|
Small molecules | Biologics | ||||
Including patents belonging to biologics | Separate system | Separate system | Yes | Yes | Yes |
Patent lista | Yes | No | Yes | No | Yes |
Patents that may be listed | 1) drug substance 2) drug product (composition and formulation) 3) pharmaceutical use | – | 1) medicinal ingredient 2) formulation 3) dosage form 4) pharmaceutical use | – | 1) drug substance 2) composition 3) dosage form 4) pharmaceutical use |
Timing of submission of patent information | With NDA or within 30 days of patent grant | – | With MA application or within 30 days of patent grant | – | Within 30 days of the date of MA or patent grant |
Excluded patents | None if consistent with above list | – | Patents granted after MA | – | Patents granted after MA |
Management of the list | FDA, with administrative process | – | MOH, with effective examination | _ | MFDS, with effective examination |
Amendments to the list | Possible, by the NDA applicant | – | Possible, by the NDA applicant or the Minister | _ | Possible by the NDA applicant or MFDS |
Deletion from the list | Possible, through counterclaim against patent litigation | – | Possible, by the Minister | – | Possible, by MFDS or the NDA applicant |