The impact of patents on access to pharmaceuticals in developing
countries is a hot topic in Australia, the US and many other
countries. The concern is that most developing countries do not
have the infrastructure required for timely pharmaceutical
manufacture and that in developed countries where this
infrastructure is available, patents restrict the export and supply
of pharmaceuticals to those countries that need them. The WTO
recognised this concern in September 2003 with its '
Implementation of paragraph 6 of the Doha Declaration on the TRIPS
Agreement and public health' and the Australian Government
has now issued draft legislation based on the text of this
Identify the relevant patents - the importing
country and the Australian generic manufacturer identify that the
required product is patented in Australia.
Attempt to obtain authorisation - the generic
manufacturer makes reasonable attempts to obtain authorisation from
the innovator company to manufacture and export the product. This
step may be omitted if the public health problem amounts to a
national emergency, or other circumstance of extreme urgency, in
the importing country.
Notify intent to use the system - if the
generic company is unsuccessful in obtaining the innovator
company's authorisation within 30 days of seeking it, or
circumstances of national emergency or extreme urgency apply in the
importing country, the importing country notifies its intent to use
the Protocol system and other details. WTO members must notify the
TRIPS Council. Countries that are not WTO members must notify the
Commissioner of Patents.
Apply to the Federal Court for a compulsory
licence - the generic manufacturer applies to the Federal
Court for a compulsory licence of the patent. The Court hears the
application, using an expedited process in urgent cases.
Notify grant of the licence - if the Federal
Court grants the licence, the licensee must notify the Commissioner
of Patents of the licence and of the address of the website where
shipment information is to be posted (see no. 7 below). The
Commissioner then provides this information to the TRIPS
Manufacture and export of the patented
pharmaceutical - the generic manufacturer manufactures and
exports the patented pharmaceutical in accordance with the terms of
Notify details of shipment - before sending
the pharmaceutical to the importing country, the generic
manufacturer posts the quantities, destinations, labelling and
markings of the product on the website identified above.
Determine remuneration - the licensee and the
innovator company can negotiate the remuneration due to the
innovator company for the license. If they cannot agree, the
Federal Court can determine the remuneration. This can be done when
the court considers the application for the licence, or on a
separate application later on.
Submissions in relation to the exposure draft may be lodged
until 1 October 2012.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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