Hong Kong Ordinances

PATENTS ORDINANCE - SECT 72L

Application for export compulsory licences for patented pharmaceutical products

(1) At any time after the grant of a standard patent or a short-term patent in
respect of a patented pharmaceutical product, any person may apply to the
Director for the grant of an export compulsory licence under the patent
concerned in relation to the product under section 72M.

(2) The application shall be made in writing and—

   (a)  shall specify the following information—

        (i)    the name and address of the applicant and of any agent or
               representative authorized by the applicant for the purpose of
               the application;

        (ii)   the name of the patented pharmaceutical product to be made and
               sold for export under an export compulsory licence the subject
               of the application;

        (iii)  the amount of the patented pharmaceutical product to be made
               and sold for export under the export compulsory licence;

        (iv)   the name of the eligible importing member to which the
               patented pharmaceutical product is to be exported under the
               export compulsory licence;

        (v)    the duration of the export compulsory licence applied for by
               the applicant;

        (vi)   the Hong Kong patent number or Hong Kong patent numbers in
               relation to the patented pharmaceutical product;

        (vii)  the proposed labelling, marking, packaging, colouring or
               shaping for the patented pharmaceutical product required by
               section  72N (1)(b)(ii);

        (viii) the address of a website on which the applicant is required to
               post the information referred to in section 72N(1)(b)(iii);

        (ix)   any information obtained pursuant to subsection (3);

        (x)    any other information as the Director may reasonably require
               for the purposes of granting the export compulsory licence; and

   (b)  shall be accompanied by—

        (i)    a copy of the written request from the eligible importing 
               member, any representative, non-governmental organization or
               international health organization authorized by the
               eligible importing member to the applicant for the
               patented pharmaceutical product and the amount of the product
               requested;

        (ii)   a copy of the notification made by the eligible importing 
               member to the TRIPS Council stating— (A) the name and the
               amount of the patented pharmaceutical product requested by the
               eligible importing member; (B) where the
               eligible importing member is not a least-developed country
               recognized by the United Nations, that the eligible importing 
               member has no or insufficient capacity to manufacture the
               patented  pharmaceutical product; and (C) where the
               pharmaceutical product is patented in the eligible 
               importing member, that the eligible importing member has
               granted or intends to grant a compulsory licence to import the
               product in accordance with the
               relevant instrument or legislation;

        (iii)  where applicable, a copy of notice of the intended application
               given to the proprietor of the patent concerned under
               subsection (4)(b)(i) or (5)(a)(i);

        (iv)   where applicable, a declaration made by the applicant under the
               Oaths and Declarations Ordinance ( Cap 11) declaring that he
               has made reasonable efforts in accordance with subsection
               (4)(a) to obtain authorization from the proprietor of the
               patent concerned on reasonable commercial terms and conditions
               but the efforts have not been successful within 28 days after
               they had been made; and

        (v)    if the pharmaceutical product is patented in the eligible 
               importing member, documentary evidence of any compulsory
               licence granted by the eligible importing member for
               importation of the product.

(3) A person who intends to make an application under subsection

(1) shall, before he makes the application, take reasonable steps to obtain
from the eligible importing member information on the amount of the
patented pharmaceutical product to be made and exported to the eligible 
importing member by any exporting member other than Hong Kong under any
compulsory licence granted elsewhere.

(4) Where a person intends to make an application under subsection

(1) and the eligible importing member has not notified the TRIPS Council that
it is faced with a national emergency or other circumstances of extreme
urgency, the person shall—

   (a)  not later than 28 days before the date of the application, make
        reasonable efforts to obtain authorization from the proprietor of the
        patent concerned on reasonable commercial terms and conditions to make
        and sell for export the patented pharmaceutical product of such amount
        as requested by the eligible importing member; and

   (b)  not later than 14 days before the date of the application—

        (i)    give the proprietor of the patent concerned notice of the
               intended application containing the information required under
               subsection

(2)(a) (except subparagraphs (viii) and (x) of that subsection); and

        (ii)   attach to the notice all the documents and documentary evidence
               required under subsection (2)(b) (except subparagraphs (iii)
               and

        (iv)   of that subsection).

(5) Where a person intends to make an application under subsection

(1) and the eligible importing member has notified the TRIPS Council that it
is faced with a national emergency or other circumstances of extreme urgency,
the person shall—

   (a)  (i) at any time before the application is made, give the proprietor of
        the patent concerned notice of the intended application containing the
        information required under subsection (2)(a) (except subparagraphs
        (viii) and (x) of that subsection); or

        (ii)   as soon as practicable after the application is made, give the
               proprietor of the patent concerned notice of the application
               containing the information required under subsection (2)(a);

   (b)  attach to the notice all the documents and documentary evidence
        required under subsection (2)(b) (except subparagraphs (iii) and (iv)
        of that subsection); and

   (c)  as soon as practicable after notice is given under paragraph

   (a)  , submit a copy of the notice to the Director. (Part IXB added 21 of
        2007 s. 5)