WIPO NATIONAL SEMINAR ON INTELLECTUAL PROPERTY RIGHTS Muscat, February 15 and 16, 2005

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WIPO NATIONAL SEMINAR ON INTELLECTUAL PROPERTY
RIGHTSMuscat, 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 products
• 3. Patents, biotechnology, biodiversity1
• 4. IP and the economic development agenda
• 1 TRIPS built-in agenda

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The State of Negotiations

• 1. Geographical indications
• The initial mandate
• TRIPS 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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The State of Negotiations

• 1. Geographical indications (cont.)
• The current mandate
• Doha 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 State of Negotiations

• 1. Geographical indications (cont.)
• The meaning of Art. 23.4
• a) 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 registration
• d) extension eligible for protection in those
  Members participating in the system

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The State of Negotiations

• 1. Geographical indications (cont.)

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.is 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 State of Negotiations

• 1. Geographical indications (cont.)
• The (other) mandate
• Doha 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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The State of Negotiations

• 1. Geographical indications (cont.)
• 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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The State of Negotiations

• 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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The State of Negotiations

• 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 State of Negotiations

• 2. Access to pharmaceutical products (cont.)
• 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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The State of Negotiations

• 2. Access to pharmaceutical products (cont.)
• 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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The State of Negotiations

• 2. Access to pharmaceutical products (cont.)
• (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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The State of Negotiations

• 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 Councils Decision into
  the Agreement the proposal eliminates some of
  the transparency measures contained in the
  Decision).
• ...

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The State of Negotiations

• 3. Patents, biotechnology, biodiversity

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The State of Negotiations

• a) In the WTO

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The State of Negotiations

• 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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The State of Negotiations

• 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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The State of Negotiations

• 3. Patents, biotechnology, biodiversity (cont.)
• 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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The State of Negotiations

• 3. Patents, biotechnology, biodiversity (cont.)
• 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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The State of Negotiations

• 3. Patents, biotechnology, biodiversity (cont.)
• 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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The State of Negotiations

• b) In WIPO

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The State of Negotiations

• 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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The State of Negotiations

• 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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The State of Negotiations

• 4. IP and the economic development agenda

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The State of Negotiations

• 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 Organizations 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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The State of Negotiations

• 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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The State of Negotiations

• 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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The State of Negotiations

• 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
  WIPOs framework.

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The State of Negotiations

• 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) WIPOs legislative assistance should ensure
  that national laws on intellectual property are
  tailored to meet each countrys 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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The State of Negotiations

• 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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The State of Negotiations

• Thank you.Nuno Pires de CarvalhoIf you have
  any questions do not hesitate to contact me
  atnuno.carvalho_at_wipo.int