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Table 1 The patent list, including submission of patent information

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
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
  1. aSpecifically for the purpose of administering the patent linkage mechanism