Ellen 't Hoen
June, 2003
On May 15th we sent the letter copied below to the WTO in which we ask the
WTO to confirm our interpretation of paragraph 7 of the Doha declaration
that LDCs are under no obligation to enforce pharmaceutical product patents
that are already granted.
The WTO circulated our letter to the WTO Members together with a draft
response from the secretariat. However the answer that was sent to
MSF was different from the draft response and only says the following.
I am afraid that all that I can say is that the WTO Secretariat does not
have the authority to interpret WTO legal instruments. Only the Ministerial
Conference and the General Council have the authority to do this. I am
sorry not to be more helpful in regard to the issue you raised"
Certain Members apparently stopped the WTO secretariat from sending MSF a
full response.
This raises a number of questions:
As soon as I have the full draft response from the WTO I will be happy to
share this with ip-health readers.
- Ellen 't Hoen
P.S. Our letter mentions that LDCs so far have not used the par 7. This is
no longer true. For example Cambodia which is in the process of becoming a
WTO Member, has included in it's patent law the following article 136:
Ms Jayashree Watal
Paris, May 15, 2003
Dear Jayashree,
We are writing in respect of a matter arising from paragraph 7 of the Doha
Declaration on TRIPS and Public Health. We would much appreciate a response
to be provided by the WTO Secretariat.
Paragraph 7 of the Doha Declaration on TRIPS and Public Health (adopted 14
November 2001) reads as follows (with added italics):
Notwithstanding the fact that they have granted and continue to grant
patents for pharmaceutical products, we think that the italicised portion
of the Decision means that LDCs are under no international (WTO/TRIPS)
obligation to enforce the pharmaceutical patents that they have already
granted. This view would appear to be supported by comments in the WIPO
Draft Industrial Property Act, prepared by the Secretariat of WIPO, a
portion of which is reproduced as an appendix to this letter.
On this basis, should a patent holder bring an action for infringement of a
pharmaceutical patent in an LDC we think that, as far as obligations under
the WTO and the TRIPS Agreement are concerned, the courts (or other
relevant bodies) of the LDC may decline to enforce that patent.
Presumably, subject to the necessary national constitutional
considerations, some LDCs may treat the italicised portion of the Decision
as having direct effect while others will need to take the appropriate
action (including for example a national declaration that pharmaceutical
patents are not to be enforced) for the provision to have national effect?
We would much appreciate it if the WTO Secretariat could confirm our view
that the italicised portions of paragraph 7 of the Doha Declaration on
TRIPS and Public Health and the TRIPS Council Decision of 27 June 2002 are
to be interpreted as suggested above.
We look forward to your response,
With best wishes,
Ellen't Hoen
DRAFT INDUSTRIAL PROPERTY ACT FOR [COUNTRY]
AND COMMENTARY ON ITS MAIN PROVISIONS
prepared by the Secretariat of WIPO
1 (3) The following, even if they are inventions within
the meaning of subsection (2), shall be excluded from
patent protection:
[?]
(viii) [pharmaceutical products, until
January 1, 2016.]
Subsection (3)(viii):This provision may be adopted by Least Developed
Countries
(LDCs) and is based on paragraph 7 of the Declaration on the TRIPS
Agreement and Public Health (doc. ref. WT/MIN(01)/DEC/W/2), issued at the
World Trade Organization (WTO) Ministerial Conference which was held in
Doha from November 9 to 14, 2001. Paragraph 7 of the said Declaration
provides that least-developed country Members of the WTO will not be
obliged, with respect to pharmaceutical products, to implement or apply
Sections 5 (Patents) and 7 (Protection of Undisclosed Information) of Part
II of the TRIPS Agreement or to enforce rights provided for under those
Sections until 1 January 2016, without prejudice to the right of those
Members to seek other extensions of the transition periods as provided for
in Article 66.1 of the said Agreement. The TRIPS Council, was requested in
the said Declaration, to take the necessary action to give effect to this
decision pursuant to Article 66.1 of the TRIPS Agreement. In accordance
with the said request, the TRIPS Council, during its session on June 27,
2002, approved a decision to extend until January 1, 2016, the transition
period during which LDCs are not obliged, with respect to pharmaceutical
products, to implement or apply Sections 5 and 7 of Part II of the TRIPS
Agreement or to enforce rights provided for under those Sections without
prejudice to the right of those Members to seek other extensions of the
transition periods as provided for in Article 66.1 of the said Agreement.
The TRIPS Council also approved a waiver to exempt LDCs from having to
provide exclusive marketing rights for pharmaceutical products in the
period during which they do not provide patent protection for such
products. The waiver was submitted to, and approved by, the WTO General
Council on July 8, 2002. LDCs which adopt this provision may need to
introduce transitional provisions for patents granted in respect of
pharmaceutical products under any previous or current legislation. It
should also be noted, in this context, that Section 66.1 of the TRIPS
Agreement provides that least-developed country Members of the WTO are not
required to implement the TRIPS Agreement until January 1, 2006. As such,
and in light of Paragraph 7 of the said Declaration, and the said decision
of the TRIPS Council, an LDC is not obliged, under the TRIPS Agreement, to
enforce patents granted in respect of pharmaceutical products under any
previous or current legislation.
"Thank you for your letter of 15 May 2003 regarding paragraph 7 of the Doha
Declaration on the TRIPS Agreement and Public Health.
"The pharmaceutical products mentioned in the Article 4 of this Law
shall be excluded from patent protection until January 01, 2016, according
to the Declaration on Agreement on Trade-Related Aspects of Intellectual
Property Rights and Public Health of the Ministerial Conference of
World Trade Organization dated November 14, 2001 in Doha of Qatar."
Counsellor
Intellectual Property Division
World Trade Organization
Rue de Lausanne 154
CH - 1211 Geneva 21
Switzerland
7. We reaffirm the commitment of developed-country members to provide
incentives to their enterprises and institutions to promote and encourage
technology transfer to least-developed country members pursuant to Article
66.2. We also agree that the least-developed country members will not be
obliged, with respect to pharmaceutical products, to implement or apply
Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights
provided for under these Sections until 1 January 2016, without prejudice
to the right of least-developed country members to seek other extensions of
the transition periods as provided for in Article 66.1 of the TRIPS
Agreement. We instruct the Council for TRIPS to take the necessary action
to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.
The 27 June 2002 meeting of the TRIPS Council agreed a Decision to give
effect to the above paragraph, in the following terms (with added italics):
It is not clear at the present time that any LDCs have taken advantage of
the opportunity to remove pharmaceutical products from patentability till
2016. Many LDCs have continued their previous practice of granting patents
for pharmaceutical products.
Campaign For Access to Essential Medicines
Médecins sans Frontières
Tel 33 1 4021 2836
Fax 33 1 4021 2962
E-mail ellen.t.hoen@paris.msf.org
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