A/HRC/11/12
page 16
international exhaustion regime to promote affordability and availability of essential medicines,
a number of countries have adopted the national exhaustion regime.46 Others have applied the
regional exhaustion principle.47 Countries, which have incorporated an international exhaustion
regime, have greater ability to facilitate access to medicines.
5. Limited exceptions to the right of patent owners
46. Article 30 of TRIPS allows member States to design limited exceptions to the exclusive
rights conferred by a patent, as long as such exceptions do not unreasonably prejudice the rights
of a patentee. This leaves considerable flexibility to create exceptions that facilitate access to
medicines.
47. Exceptions for research and experimental use fall within the ambit of article 30. Such
exceptions can be a useful way for researchers and manufacturers to encourage innovation of
new medicines, particularly those for neglected diseases.
48. The “early working” or Bolar exception, allows competitors to import, manufacture and
use a patented product for the purpose of seeking regulatory approval. Allowing for the
completion of registration requirements before patent expiry, facilitates the prompt entry of
generic medicines on the market once a patent expires. The WTO Dispute Settlement Panel,
in 2000, upheld such an exception by Canada as permissible under article 30.
49. While the early working exception has been incorporated into the national patent laws
of many countries, it is not as commonly found as the “research or experimental use”
exception.48
6. Opposition and revocation procedures
50. As TRIPS is silent on procedural aspects relating to patent examination, it allows for
member States to establish mechanisms that subject patent applications to high levels of scrutiny.
In this regard, countries can permit oppositions by any persons to patent applications before
(pre-grant) and after (post-grant opposition and revocation proceedings) the grant of a patent.
This allows concerned stakeholders including, civil society organizations and patient groups to
oppose the grant of patents. Opposition proceedings can assist in subjecting patent applications
and granted patents to higher scrutiny as patent offices are often understaffed and overburdened.
India and Thailand allow for oppositions, which have been used successfully in relation to some
46
47
48
Brazil and Morocco for instance have adopted the principle of national exhaustion.
Countries in west Africa signatory to the Bangui Agreement.
See footnote 37 above, p. 56.
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