E-drug: Note on imports of drugs under Compulsory license
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I would like to clarify some important points regarding imports of drugs
under a compulsory license.
1. In general, a country can import a drug under a compulsory license if
its own domestic law permits this.
2. Countries that issue compulsory license must normally limit the
export of the products. The provision in the TRIPS is Article 31(f),
which reads:
(f) any such use shall be authorized predominantly
for the supply of the domestic market of the
Member authorizing such use;
Note that "predominantly" still permits some exports. Also, under 31
(k), the limitations on exports are waived if the CL is issued to
remedy a practice determined to be anticompetitve. This is what the US
typically does, for example, for its compulsory licenses on Monsanto
corn patents, the Anderson Gene patent, or the Dell Computer VL-Bus
patent.
3. Non-WTO countries do not have to comply with TRIPS, and a WTO member
country could import a drug under a CL from a non-WTO country, so long as
the importing country has issued a TRIPS compliant CL. There are many
countries that are not members of the WTO, but some, such as China, will
probably join later.
4. In our opinion, two WTO countries can engage exports and imports of
a product, if both the importing and exporting countries have issued a
TRIPS compliant CL. One claim would be Article 30 of the TRIPS, which
permits "exceptions" to rights conferred, if the exceptions do not
"unreasonably prejudice the legitimate interests of the patent owner,
taking into account the legitimate interests of third parties." I have
discussed this with WIPO officials, and I believe this is a very sound
use of Article 30, because the issuance of the TRIPS compliant CL in
both countries clearly addresses the "legitimate" interests of the
parties. Plus, if this isn't done, you have the irrational result that
only big market countries can benefit from CL provisions, and you
promote inefficient production. We have asked the WTO and WIPO to look
at this issue.
5. In many cases, drugs may be on patent is some countries, and off
patent in others. This is particularly true for developing countries,
because the US government, US Universities and some companies do not
bother to file in poor countries.
6. Some also argue that export issue can be addressed through Article
6, regarding exhaustion of rights. While some may think this is an
aggressive interpretation, note that Article 6 says that "nothing in
this Agreement shall be used to address the issue of the exhaustion of
intellectual property rights." And "nothing" is pretty broad.
In my mind, however, the approach number 4 above, involving Article 30
and CLs issued in both countries (if needed), is more appealing.
Jamie
Article 6
Exhaustion
For the purposes of dispute settlement under this Agreement, subject to
the provisions of Articles 3 and 4 nothing in this Agreement shall be
used to address the issue of the exhaustion of intellectual property
rights.
Article 30
Exceptions to Rights Conferred
Members may provide limited exceptions to the exclusive rights
conferred by a patent, provided that such exceptions do not unreasonably
conflict with a normal exploitation of the patent and do not
unreasonably prejudice the legitimate interests of the patent owner,
taking account of the legitimate interests of third parties.
James Love / Director, Consumer Project on Technology
http://www.cptech.org / love@cptech.org
P.O. Box 19367, Washington, DC 20036
voice 202.387.8030 / fax 202.234.5176
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