WIPO NATIONAL SEMINAR ON INTELLECTUAL PROPERTY RIGHTS Muscat, February 15 and 16, 2005 The State of Negotiations of IPR in the Multilateral Fora WIPO Secretariat

WIPO NATIONAL SEMINAR ON INTELLECTUAL PROPERTY RIGHTS

Muscat, February 15 and 16, 2005

The State of Negotiations of IPR in the Multilateral Fora

WIPO Secretariat

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The State of Negotiations

Topics of main interest:1. Geographical indications1

2. Access to pharmaceutical products3. Patents, biotechnology, biodiversity1

4. IP and the economic development agenda

1 TRIPS built-in agenda

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1. Geographical indicationsThe initial mandateTRIPS Agreement, Article 23.4: “In order to

facilitate the protection of geographical indications for wines, negotiations shall be undertaken in the Council for TRIPS concerning the establishment of a multilateral system of notification and registration of geographical indications for wines eligible for protection in those Members participating in the system.”

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1. Geographical indications (cont.)

The current mandateDoha Ministerial Declaration: “18. With a view

to completing the work started in the Council for Trade-Related Aspects of Intellectual Property Rights (Council for TRIPS) on the implementation of Article 23.4, we agree to negotiate the establishment of a multilateral system of notification and registration of geographical indications for wines and spirits by the Fifth Session of the Ministerial Conference.”

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The meaning of Art. 23.4a) purpose: “to facilitate the protection” (it seems

to be linked to Article 24.9)b) scope: “g.i.’s for wines” (and for spirits, added in

Singapore)c) nature: multilateral system of notification and

registrationd) extension: “eligible for protection in those

Members participating in the system”

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Option A: non-binding system that does not require Members to protected registered terms; the register would function as a database that would be consulted by a Member when making decisions regarding recognition and protection of g.i’s for wines and spirits. Option preferred by U.S., Canada, Australia, Chile, Argentina, Japan, and others.

Option B: Members would be allowed to challenge proposed registrations; they would be required to protect registered terms (even in non-participating Members). EC, Hungary, Czech Rep., Switzerland, and others

Option B-1: bilateral consultations in case of a challenge. EC.

Option B-2: arbitration in case of a challenge. Hungary and Switzerland.

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The (other) mandateDoha Ministerial Declaration. “18. […] We note that

issues related to the extension of the protection of geographical indications provided for in Article 23 to products other than wines and spirits will be addressed in the Council for TRIPS pursuant to paragraph 12 of this Declaration.” (paragr. 12 refers to implementation issues; thus, what permits Members to discuss the extension of g.i.’s protection is Article 71 of the TRIPS Agreement)

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Doha Work Programme, Decision Adopted by the General Council on August 1, 2004:

“The Council requests the Director-General to continue with his consultative process on all outstanding implementation issues under paragraph 12(b) of the Doha Ministerial Declaration, including on issues related to the extension of the protection of geographical indications provided for in Article 23 of the TRIPS Agreement to products other than wines and spirits, if need be by appointing Chairpersons of concerned WTO bodies as his Friends and/or by holding dedicated consultations. The Director-General shall report to the TNC and the General Council no later than May 2005. The Council shall review progress and take any appropriate action no later than July 2005.”

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2. Access to pharmaceutical products

The problem:TRIPS Article 31: “Where the law of a Member allows

for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

[…](f) any such use shall be authorized

predominantly for the supply of the domestic market of the Member authorizing such use;”

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2. Access to pharmaceutical products (cont.)

The problem (cont.):

1. WTO Member A is in need of a certain medicine which is not available on the international market (or which is, but at unaffordable prices)

2. But in A there is no company with technical knowledge and/or manufacturing capacity to manufacture that medicine; therefore there is no purpose for the government of A to issue a a c.l. for the local manufacture of the medicine in need

3. Besides, and because of Article 31(f), A cannot ask another WTO Member that it grants a c.l. with the exclusive or predominant purpose of exporting that medicine to its territories

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The mandate:Doha Declaration on the TRIPS Agreement and Public Health

(November, 2001):

“1. We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.

[…]

“6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.”

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Solution:Decision of the General Council of August 30, 2003:a) Under certain conditions and circumstances WTO

Members may grant c.l. of patents for medicines (or for processes for making medicines) with the exclusive or predominant purpose of exporting to other WTO Members with no manufacturing capacity

b) The remuneration of c.l. will take into consideration its economic value in the importing country. The remuneration is not supposed to be paid twice.

c) The Decision is indefinitely valid until the TRIPS Agreement is amended.

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(N.B.: Actually, this was not necessary; the Doha Declaration had identified a problem, but overlooked that Article 73 provides for a solution that is much more flexible for it does not impose any formality and is not subject to be scrutinized by other Members)

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2. Access to pharmaceutical products (cont.)Prospects:

In December 2004 Nigeria, on behalf of the African Group of countries, submitted a proposal aimed at amending the TRIPS Agreement (the proposal consists of adding a second paragraph to Article 31, which would transpose a summarized version of the General Council’s Decision into the Agreement; the proposal eliminates some of the transparency measures contained in the Decision).

...

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3. Patents, biotechnology, biodiversity

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a) In the WTO

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3. Patents, biotechnology, biodiversity

The initial mandate:TRIPS Agreement, Article 27.3: “Members may also exclude from

patentability:[…](b) plants and animals other than micro-organisms, and

essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”

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3. Patents, biotechnology, biodiversity (cont.)

The current mandate:Doha Ministerial Declaration:“19. We instruct the Council for TRIPS, in pursuing its work

programme1 including under the review of Article 27.3(b), the review of the implementation of the TRIPS Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of this Declaration, to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore […].”

1 “Work programme” does not mean negotiations necessarily; it also includes exploratory work.

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Proposals and positions:India (on behalf of a group of developing countries):

the TRIPS Agreement should be amended so as to require patent applicants to disclose the origin of genetic resources and prior informed consent of TK holders

African Group: no patents on plants, animals and micro-organisms; TK should be classified as IP; disclosure requirement; creation of a Committee on TK and GRs and adoption of a decision on the protection and documentation of TK

Switzerland: TRIPS and CBD are compatible; the issue should be discussed in WIPO; proposal of an amendment to the PCT enabling countries to impose the disclosure requirement

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Proposals and positions (cont.):EC: 27.3(b) does not need to be reviewed; accepts to discuss

the synergies between TRIPS and CBD; accepts the disclosure requirement but not as a condition of patentability; accepts discussion on TK but WIPO is a more appropriate forum; accepts that there may be other mechanisms for plant variety protection outside the UPOV model; supports the breeders’ and the farmers’ exceptions

US: contracts are the best approach to protect interests in GRs; the disclosure requirement is already covered by Article 29: no need for expanding it outside the contractual framework. Alternatively appropriate measures can be adopted to avoid erroneously granted patents (such as databases, the inequitable conduct doctrine and post-grant opposition or re-examination procedures)

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Prospects:Group of developing countries: submitted a

check-list of issues and detailed already two (out of three) of the elements of that list

Japan and the U.S.: opposed to the check-list

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b) In WIPO

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1. Negotiations in the SCP concerning the SPLT (the purpose is mainly better defining the substantive conditions of patentability, such as novelty and inventiveness; but a number of developing countries proposed to add a provision requiring the identification of the origin of genetic recourses and prior informed consent in patent applications; participating Members have decided to suspend discussions; Japan, the U.S. and the EPO proposed to separate the issues, but those developing countries rejected the idea)

2. Negotiations aiming at reforming the PCT (a working group established by the PCT Union is moving forward)

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3. Discussions in the Intergovernamental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (at the 6th session, in October/November 2004, participating members expressed no intention to move on as regards work concerning genetic resources; in the areas of TK and Folklore, the Committee has decided to invite the Secretariat to review two documents on general considerations on policy and legal issues; at the 7th session (July 2005), the IGC will prepare a report for the General Assembly of 2005, which will decide on the continuation of the work and its future mandate)

4. Negotiations at the SCT aiming at revising the TLT (the General Assembly, in September 2004) decided to approve the convening of a Diplomatic Conference for the Adoption of a Revised Trademark Law Treaty (TLT), in Geneva, from March 13 to 31, 2006, and to hold two additional sessions of the SCT and a preparatory meeting in order to conclude the preparatory work for that Diplomatic Conference.

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4. IP and the economic development agenda

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Proposal by Argentina and Brazil to the General Assembly of WIPO, September 2005:

1) To amend the WIPO Convention (1967) to ensure that the “development dimension” is unequivocally determined to constitute an essential element of the Organization’s work program

2) To include the development dimension in the discussions in the SCP. If discussions on the SPLT are to proceed, these should be based on the draft treaty as a whole, including all of the amendments that have been tabled by developing countries. Moreover, Members should strive for an outcome that unequivocally acknowledges and seeks to preserve public interest flexibilities and the policy space of Member States. Provisions on “objectives and principles”, reflecting the content of Articles 7 and 8 of the TRIPS Agreement, should be included in the SPLT and other treaties under discussion in WIPO.

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Proposal by Argentina and Brazil (cont.):

3) WIPO should consider undertaking activities with a view to exploring the promise held by open collaborative projects to develop public goods, as exemplified by the Human Genome Project and Open Source Software.

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Proposal by Argentina and Brazil (cont.):4) A new subsidiary body within WIPO could be

established to look at what measures within the IP system could be undertaken to ensure an effective transfer of technology to developing countries. A mechanism giving automatic access by the developing countries to the results of publicly funded research in the developed countries. Such a regime could take the form of a Treaty on Access to Knowledge and Technology. It is also important that clear provisions on transfer of technology be included in the treaties currently under negotiation in WIPO.

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Proposal by Argentina and Brazil (cont.):5) Particular attention should be paid to the need to

ensure that enforcement procedures are fair and equitable and do not lend themselves to abusive practices by right holders that may unduly restrain legitimate competition. In this regard, we note that Article 8 of TRIPS states that corrective measures may be necessary to curb practices that may adversely affect trade and the international transfer of technology. One should also bear in mind the related provision of Article 40 of TRIPS, which addresses anti‑competitive practices in contractual licenses. All of these provisions of the TRIPS Agreement should be adequately brought into WIPO’s framework.

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Proposal by Argentina and Brazil (cont.):6) Programs for technical cooperation in IP related

matters should be considerably expanded and qualitatively improved. Technical cooperation should contribute to ensuring that the social costs of IP protection are kept at a minimum.

7) WIPO’s legislative assistance should ensure that national laws on intellectual property are tailored to meet each country’s level of development and are fully responsive to the specific needs and problems of individual societies. It also must be directed towards assisting developing countries to make full use of the flexibilities in existing intellectual property agreements.

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Proposal by Argentina and Brazil (cont.):

7) WIPO should foster the active participation of public interest non‑governmental organizations in its subsidiary bodies to ensure that in IP norm‑setting a proper balance is struck between the producers and users of technological knowledge, in a manner that fully services the public interest.

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Thank you.

Nuno Pires de Carvalho

If you have any questions do not hesitate to contact me at

[email protected]

Documents

WIPO NATIONAL SEMINAR ON INTELLECTUAL PROPERTY RIGHTS Muscat, February 15 and 16, 2005 The State of Negotiations of IPR in the Multilateral Fora WIPO Secretariat