Commonwealth Consolidated Regulations

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PATENTS REGULATIONS 1991 - REG 12.2B

PPI compulsory licences--notification requirements

  (1)   This regulation sets out the notification requirements for paragraph   136E(1)(f) of the Act in relation to the importation of a pharmaceutical product into an eligible importing country.

  (2)   Subregulation (3) applies if the eligible importing country is a WTO member.

  (3)   The eligible importing country must have notified the Council for TRIPS in accordance with paragraph   2(a) of the Annex to the TRIPS Agreement .

  (4)   Subregulation (5) applies if the eligible importing country is:

  (a)   a least developed country; and

  (b)   not a WTO member.

  (5)   The eligible importing country must have given the Commissioner a written notice:

  (a)   stating:

  (i)   the name of the eligible importing country; and

  (ii)   the name of the pharmaceutical product; and

  (iii)   the expected quantity of the pharmaceutical product to be imported into the eligible importing country; and

  (b)   confirming that, if the pharmaceutical product is patented in the eligible importing country, it:

  (i)   has granted; or

  (ii)   intends to grant;

    a compulsory licence that would accord with Articles 31 and 31bis of the TRIPS Agreement and the Annex to that Agreement if the Agreement and Annex applied to the eligible importing country .


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