A.37
32. (1) Subject to section 31, the Minister may issue a licence to a
Government agency or any authorised person for the importation of patented
products such as generic pharmaceutical products from any legitimate
alternative foreign source without the approval of the patentee where —
(a) it is in the public interest to do so for purposes of national security,
nutrition, health, development of other vital sectors of the national
economy, social service; or
(b) the market for the patented product is not being supplied in sufficient
quantities or on reasonable terms in relation to market demand.
(2) The importation of the patented product by a Government agency
or any authorised person shall be solely for public non-commercial use
within Botswana, except where paragraph 1 or 3 of Article 31bis of the
TRIPS Agreement is applicable.
(3) A licence issued under subsection (1) shall include the name of
the pharmaceutical product and an estimate of the quantities of the
pharmaceutical product to be imported during the term of the licence:
Provided that the estimate shall not limit the quantity of the
pharmaceutical product required to address the public health problem
that the importation seeks to address.
(4) Where in respect of the pharmaceutical product referred to in
subsection (1) a compulsory licence has been granted in the exporting
country under the system set out in Article 31bis of the TRIPS Agreement
and the Annex thereto, and remuneration for the licence has been paid
accordingly in the exporting country, the obligation to pay remuneration
for the compulsory licence to import that product into Botswana shall
not apply.
33. (1) At any time after the expiration of three years from the date
of the grant of a patent or four years from the filing date of the application,
whichever occurs later, any person may apply to the High Court for an
order to be granted a licence under the patent on the grounds that a
market for the patent is not being supplied, or is not being supplied on
reasonable terms, in Botswana.
(2) Notwithstanding the provisions of subsection (1) an order to issue
a compulsory licence shall not be granted if the patentee satisfies the
High Court that circumstances exist which justify the non-exploitation
or insufficient exploitation of the patent.
(3) Where the High Court grants an order for the issue of a compulsory
licence under this section, it shall —
(a) set out the scope and function of the licence;
(b) fix the time limit for the exploitation of the patent; and
(c) set out the conditions and amount of remuneration to be paid to
the patentee.
(4) A request for the issue of a compulsory licence shall be made in
the prescribed form subject to payment of the prescribed fees.
Importation of
patented
products by
Government
or third party
Compulsory
licences for
failure to
exploit patent