World Intellectual Property Organization

Flexibilities in the context of the Development Agenda

The Development Agenda, agreed by the member states of WIPO in 2007, contains 45 recommendations to enhance the development dimension of the Organization’s activities. Key among these are recommendations focused on enhancing the understanding and use of flexibilities in the intellectual property (IP) system.

In particular, the Development Agenda provides:

  • Recommendation 13: WIPO’s legislative assistance shall be, inter alia, development-oriented and demand-driven, taking into account the priorities and the special needs of developing countries, especially least developed countries (LDCs), as well as the different levels of development of member states and activities should include time frames for completion.
  • Recommendation 14: Within the framework of the agreement between WIPO and the WTO, WIPO shall make available advice to developing countries and LDCs, on the implementation and operation of the rights and obligations and the understanding and use of flexibilities contained in the TRIPS Agreement.
  • Recommendation 17: In its activities, including norm-setting, WIPO should take into account the flexibilities in international IP agreements, especially those which are of interest to developing countries and LDCs.
  • Recommendation 22: WIPO’s norm-setting activities should be supportive of the development goals agreed within the United Nations system, including those contained in the Millennium Declaration. The WIPO Secretariat, without prejudice to the outcome of member states considerations, should address in its working documents for norm-setting activities, as appropriate and as directed by gember states, issues such as:
    • safeguarding national implementation of IP rules;
    • links between IP and competition;
    • IP-related transfer of technology;
    • potential flexibilities, exceptions and limitations for member states, and;
    • the possibility of additional special provisions for developing countries and LDCs.
  • Recommendation 25: To explore IP-related policies and initiatives necessary to promote the transfer and dissemination of technology, to the benefit of developing countries and to take appropriate measures to enable developing countries to fully understand and benefit from different provisions, pertaining to flexibilities provided for in international agreements, as appropriate.

Implementation of the Development Agenda as regards flexibilities

At the fourth session of the Committee on Development and Intellectual Property (CDIP) held in November 2009, in the context of discussions on Recommendation 14, the Committee requested WIPO to prepare a document on flexibilities in the area of patents.

At its fifth session, held in April 2010, the Committee discussed document CDIP/5/4 on Patent-Related Flexibilities in the Multilateral Framework and their Legislative Implementation at National and Regional Levels, as a preliminary document and requested its revision to reflect members’ comments and include new flexibilities. The CDIP also requested the Secretariat to present a proposed work program on flexibilities for consideration by the Committee.

At its sixth session, held in November 2010,the Committee agreed a future work program on flexibilities in the IP system on the basis of document CDIP/6/10, addressing:

A. Work in the area of patents;
B. Stocktaking of WIPO’s activities relating to flexibilities in the IP system;
C. Technical assistance in the use of flexibilities.

The CDIP agreed the following activities on flexibilities:

1.) Work on five new patent-related flexibilities - The CDIP agreed that WIPO should continue work on: transitional periods; patentability of substances existing in nature; disclosure-related flexibilities; ex-officio IP Office control of contractual anticompetitive clauses; and examination systems. This work is currently being undertaken by the Innovation and Technology Sector, Patents and Innovation Division.

2.) Regional seminars and workshops - The CDIP agreed that WIPO should organize national and regional seminars for the exchange of practical experiences in the implementation of flexibilities at the national level. In this context, the Innovation and Technology Sector has organized a regional seminar to be held in Bangkok in March 2011, on the effective implementation and use of several patent-related flexibilities. The CDIP’s request has been drawn to the attention of other, non patent-related, areas at WIPO with a view to further seminars and workshops being organized to address other fields of IP.

3.) Incorporating information on flexibilities in WIPO’s technical assistance program, and raising awareness of the issue across the Secretariat - The CDIP agreed that information on flexibilities should be integrated into WIPO’s technical assistance activities, legislative advice and capacity-building activities, bearing in mind that Recommendation 1 of the Development Agenda provides that such assistance shall be “inter alia development oriented”, and demand driven. The CDIP has informed all divisions of WIPO that undertake technical assistance of the decisions of the CDIP as a confirmation of WIPO’s practice in the area.

4.) Web page - The CDIP agreed that a web page should be established on WIPO’s site dedicated to the use of flexibilities, to indicate the areas of WIPO whose work relates to flexibilities, and make available materials and output from WIPO seminars, workshops and technical assistance activities dealing with the flexibilities. A resources section will make available links to studies on flexibilities produced by WIPO, and WIPO-commissioned experts, and to relevant materials produced by other IGOs.

5.) Database - The CDIP agreed that a database should be established on the web page to allow users to access relevant provisions on flexibilities in national IP laws, as well as information on national experiences and case studies in implementing flexibilities at the national level. The database is available on this web page, and will be updated regularly.

At its seventh session, held in May 2011, the Committee considered CDIP/6/10, entitled Future Work Program on Flexibilities in the IP system. The Committee agreed that the Secretariat would revise the document, taking into account the comments of the delegations, for consideration by the Committee at its next session. The Committee further considered document CDIP/7/3, entitled Patent-Related Flexibilities in the Multilateral Legal Framework and their Legislative Implementation at the National and Regional Levels – Part II.  During the discussion of this document divergent views were expressed and it was decided that the document continue to be considered at the eighth session of the Committee. Delegations were requested to provide their comments in writing to the Secretariat and it was agreed that at its next session, the Committee would resume discussions on the document together with the comments received by the Secretariat.

At its eighth session, held in November 2011, the Committee considered document CDIP/8/5, entitled Future Work Program on Flexibilities in the IP system, and agreed that the Secretariat should implement the activities suggested in the document taking into account the comments of member states. The Secretariat was requested to submit a document containing a compilation of new elements suggested by various member states for consideration by the Committee at its next session.

At its ninth session, held in May 2012, the Committee discussed the Work Program on Flexibilities in the IP system – New Elements Proposed at CDIP/8 (CDIP/9/11). Some delegations emphasized the importance of WIPO’s work in the field of flexibilities in the IP system. Some delegations emphasized the need for the Committee to undertake this work efficiently and without duplications of the work taking place in other committees and/or forums. The Committee agreed on the element in 2(f) to provide information submitted by Members on their practical experience in the implementation of flexibilities through a database. In respect of paragraph 2(c) of document CDIP/9/11, the Committee decided as follows: 

  • The Secretariat would prepare, for the next session of the Committee, a document showing if any of the four patent-related flexibilities listed in paragraph (ii) have already been addressed in the Standing Committee on the Law of Patents, and whether such work would be addressed from the same or a different perspective by the Committee. That document would also contain further explanation on the latter two points in paragraph (ii).
  • The Secretariat would invite member states of the Committee to submit written comments on the list of the following four patent–related flexibilities by August 31, 2012:
    • The scope of the exclusion from patentability of plants (TRIPS Art. 27)
    • Flexibilities in respect of the patentability, or exclusion from patentability, of software-related inventions (TRIPS Art. 27)
    • The flexibility to apply or not criminal sanctions in patent enforcement (TRIPS Art. 61)
    • Measures related to security which might result in a limitation of patent rights (so-called “security exception”) (TRIPS Art. 73) 

The Secretariat would compile the comments received by the above date in a document to be submitted to the next session of the Committee. The four above flexibilities and the comments received would form the basis for discussions at the next session of the Committee on patent–related flexibilities. 

  • Additional flexibilities, including those in Article 27 of the TRIPS Agreement, may also be submitted and presented at the next session of the Committee, and members may submit comments thereon intersessionally between the tenth and eleventh sessions of the Committee, for discussion and decision at the eleventh session of the Committee. 

The Committee also discussed two documents on patent-related flexibilities:  Patent‑Related Flexibilities in the Multilateral Legal Framework and their Legislative Implementation at the National and Regional Levels – Part II (CDIP/7/3 and CDIP/7/3 Add.). Some delegations raised the importance of Article 27 of the TRIPS Agreement in the context of flexibilities, while other delegations noted that this issue was being addressed in other committees and forums.

At its tenth session, the Committee discussed Further Steps in the Work Program on Flexibilities in the Intellectual Property System (CDIP/10/10). The Secretariat took note of the Member States’ guidance on the agreed areas of work for further implementation. The Committee also considered Future Work on Patent-Related Flexibilities in the Multilateral Legal Framework (CDIP/10/11).

At its eleventh session, the Committee continued discussions on Future Work on Patent-Related Flexibilities in the Multilateral Legal Framework (CDIP/10/11 and CDIP/10/11 Add.). The Committee requested the Secretariat to undertake work on the following flexibilities:

  • the scope of the exclusion from patentability of plants (TRIPS Art.27); and
  • (b) flexibilities in respect of the patentability, or exclusion from patentability, of software-related inventions (TRIPS Art.27).

The Secretariat would use existing internal resources to prepare a factual document on the implementation in national laws of these flexibilities and avoiding duplication with other work taking place at WIPO while building on work being undertaken by the Standing Committee on the Law of Patents.

At its thirteenth session, the Committee discussed the document on Patent-Related Flexibilities in the Multilateral Legal Framework and their Legislative Implementation at the National and Regional Levels - Part III (CDIP/13/10), requested at its eleventh session. A number of delegations expressed interest and appreciation for the work of the Secretariat in this field. Certain delegations offered factual corrections to the annexes. Delegations also commented on the substantive aspects of the document. Interest was also expressed to extend this work to other areas of Intellectual Property.

The Committee also discussed the document on Future Work on Patent-Related Flexibilities in the Multilateral Legal Framework (CDIP/10/11). The Committee agreed that a document, based upon factual compilation with no recommendations whatsoever, on two new patent-related flexibilities be prepared for discussion, namely, the flexibility to apply or not, criminal sanctions in patent enforcement (TRIPS Art. 61) and measures related to security which might result in a limitation of patent rights (so-called “security exception”) (TRIPS Art. 73).

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