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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