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exceptions include research and experimentation, with or without commercial intent,
which is particularly important, taking into consideration scientific freedoms. They
also include uses by third parties who can prove the y were already using the
technology before it was patented. 24 In the context of medicines, the early-working
exception allows a generic producer to produce therapeutic equivalents and submit
them for marketing approval to national drug regulatory authoriti es before the patent
term has expired.
68. Article 31 allows countries to impose compulsory licenses for a very broad
range of reasons. A compulsory license grants a third party permission to produce
and market the patented technology without the consent of the patent-holder, so long
as reasonable compensation is paid and certain formalities are followed. It is one
mechanism through which Governments give precedence to the public’s interest in
having technical knowledge more immediately accessible. Article 31 does not
specify the grounds for such licences, but rather establishes procedure s that
Governments must follow. 6
69. Article 32 provides that an opportunity for judicial review of any decision to
revoke or forfeit a patent shall be available. The TRIPS Agreement does not
establish the grounds for revocation or forfeiture, which must be determined by
national laws. States may contemplate revocation on grounds of public interest.
Article 66 of the India Patent Act is one example of such legislation. 25
70. Article 8 of the TRIPS Agreement specifies that States may adopt measures
necessary to protect public health and nutrition, and to promote the public interest in
sectors of vital importance to their socio-economic and technological development,
provided that such measures are consistent with the provisions of the Agreement.
The WTO Doha Declaration on the TRIPS Agreement and Public Health, in
paragraph 4, confirmed that the Agreement “can and should be interpreted and
implemented in a manner supportive of WTO members’ right to protect public
health” and to promote “access to medicines for all”, and reaffirmed the right to use
the Agreement’s flexibilities for this purpose.
71. It is crucial that international legal regimes on patents continue to leave room
for countries to adopt and implement policies to abide by their human rights
obligations. New trade or investment treaties, whether bilateral or regional, already
concluded or still under negotiation, considerably reduce that margin of manoeuvre.
For example, the Trans-Pacific Partnership Agreement, involving 12 negotiating
States, is said to require much stronger intellectual property protection than the
TRIPS Agreement. Documentation also exists regarding the potential impact of
concluded free trade agreements on public health. 26 Some observers stress that
countries considering agreements like the Trans-Pacific Partnership or bilateral
“partnership” agreements with the United States and Europe should be wary as
“what are being sold as ‘free-trade agreements’ include intellectual property
provisions that could stifle access to affordable medicines, with a potentially
significant impact on economic growth and development”. 4
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Hans Morten Haugen, The Right to Food and the TRIPS Agreement: With a Particular Emphasis
on Developing Countries’ Measures for Food Production and Distribution (Leiden, The
Netherlands, Martinus Nijhoff Publishers, 2007).
UNAIDS and UNDP, The Potential Impact of Free Trade Agreements on Public Health (Geneva,
2012).
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