The WTO TRIPS Council

Since the late 1990s, deliberations about genetic resources and patents have featured at almost every session of the TRIPS Council, the body which oversees the implementation of the TRIPS Agreement. These de-liberations first took place und er the mandated review of TRIPS Article 27.3(b) which deals with patentability or non-patentability of plant and animal inventions, and the protection of plant varieties. The review, which began in 1999, opened the door for requests by many developing countries to revise this TRIPS provision, taking into consideration that though the TRIPS Agreement was adopted in 1994, as part of the Final Act of the Uruguay Round, the negotiation of most of its provisions had already been concluded by 1991 before the adoption of the CBD.

In 2001, the Doha Ministerial Declaration¹² which launched the Doha Development Round of negotiation addressed the relationship between the TRIPS Agreement and the CBD. Paragraph 19 of the Doha Decla-ration formally instructed the TRIPS Council "in pursuing its work programme including under the review of Article 27.3(b) ( ... ) to exam-ine, inter alia, the relationship between the TRIPS Agreement and the CBD, the protection of traditional knowledge and folklore." lt also specified that "in undertaking this work, the TRIPS Council shall be

11 ICTSD, ABS Text Ad van ces in Montreal, but Mu ch Work Remains, Bridges Trade BioRes, 19 July 2010, available online at http://ictsd.org/i/trade-and-sustainable-development-agenda/81017 /, last accessed 28 June 2012.

12 WTO, Ministerial Declaration, WT/MIN(01)/DEC/1, 20 November 2001.

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guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development di-menswn.

,,

Although discussions at the TRIPS Council on these issues have lasted now for more than a decade, no consensus has been reached. A report by the WTO Director General, in April 2011, delineated the areas of convergence and divergence between the positions of WTO mem-bers.13

In terms of convergence, the report indicated that there was "broad sup-port for the general principles of prior informed consent and equitable sharing of benefits that are enshrined in the CBD; and agreement on the need to avoid erroneous patents, on securing compliance with national benefit-sharing regimes, and on ensuring patent offices have available the information needed to make proper decisions on patent grants for inventions linked to genetic resources and TK.,

However, the report stated that while countries voiced support for the CBD objectives, they remained divided as to the best means to fulfil them within the TRIPS framework. The report examined the proposais which are favoured by different WTO members: a disclosure

require-ment, a database system, and contracts- "considering how each of these options could effectively help achieve the agreed objectives, while not crea ting undue burd ens.,,

In summarizing the state of play, the report underlined that "none of the proposais discussed was argued to be a stand-alone response or com-plete solution to ail problems outlined. ,, lt further indicated that WTO members "continue to differ on whether the formulation and applica-tion of a specifie, tailored disclosure mechanism relating in particular to genetic resources and ATK would be useful and effective in ensuring that the patent system promoted CBD objectives, or whether other mechanisms should be preferred., The report concluded by mentioning that "discussions underscored the benefits of understanding more fully the practical and operational context of the existing disclosure mecha-nisms that have been implemented in national systems.,

13 WTO General Council, 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 and those Related to the Relationship between the TRIPS Agreement and the Convention on Biological Diversity, Report by WTO Director General, TN/C/W/61, 21 April2011.

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It is not surprising that the report of the WTO Director General con-cluded with a mention of the disclosure mechanism. This proposai has received strong backing over the past decade from a large group of de-veloping countries which have repeatedly requested an amendment of the TRIPS Agreement incorporating a mandatory disclosure require-ment for deterrnining the country of origin of any biological material and ATK in patent applications as evidence of prior informed consent and benefit-sharing. At the same time, the proposai has been the subject of heated discussions as sorne industrialized countries have vigorously opposed it for a number of legal and practical reasons ranging from questions about its legal compatibly with the TRIPS Agreement to its possible detrimental effect on the role of the patent system in encourag-ing mnovation.

Against this background, it should be recalled that the mandatory dis-closure requirement is not the most controversial proposai which bas been made in the context of deliberations on these issues. Under the on-going review of Article 27.3(b), a number of developing countries, most notably the African Group in 2003 and Boiivia in 2010 and 2011 have made subrnissions to the TRIPS Council demanding the prohibition of patents on alllife forms, as they consider them contrary to the moral and cultural norms of many cultures and peopies around the world.¹⁴ How-ever, such proposais have not received wide support including among sorne developing countries, which have witnessed a significant expan-sion of their biotechnology sector.

In contrast, the mandatory disclosure requirement proposai is widely adhered to by a large group of developing countries as previously men-tioned. The most recent iteration of the disclosure propos al was submit-ted to the TRIPS Council, in April2011, by a large coalition of develop-ing countries, including Brazil, China, Colombia, Ecuador, lndia, Indonesia, Peru, Thailand, the African, Caribbean and Pacifie Group of States (ACP), and the African Group.

14 WTO TRIPS Cou neil, Taking F01·ward the Review of Article 27.3(b) of the TRIPS Agreement, Joint Communication from the African Group, IP/C/W /404, 26 June 2003; WTO TRIPS Council, Review of Article 27.3(b) of TRIPS Agreement, Communication from the Plurinational State ofBolivia, IP/C/W/545, 26 February 2010; WTO TRIPS Council, Article 27.3(b) of TRIPS Agreement and the Legalization of Biopiracy: Trends, Impacts and Wh y It Needs to be Amended, IP/

C/W /554, 28 March 2011.

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Similar to sorne previous submissions, the Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the CBD¹⁵ proposes amending the TRIPS Agreement by inserting a new Article 29 bis to introduce a disclosure requirement where the subject matter of a patent application involves utilization of genetic resources and/or ATK.

In this regard, the draft decision stipulates that "Members shall require applicants to disclose: (i) the country providing such resources, that is, the country of origin of such resources or a country that has acquired the genetic resources and/or ATK in accordance with the CBD; and, (ii) the source in the country providing the genetic resources and/or associ-ated traditional knowledge."

More importantly, the draft decision incorporates certain elements of the Nagoya Protocol, such as the IRCC, to strengthen the implemen-tation of the disclosure requirement. It states that "Members shall also require that applicants provide a copy of an Internationally Recognized Certificate of Compliance (IRCC)." The draft decision further specifies that "If an IRCC is not applicable in the providing country, the appli-cant should provide relevant information regarding compliance with prior informed consent and access and fair and equitable benefit sharing as required by the national legislation of the country providing the ge-netic resources and/or ATK, that is, the country of origin of such re-sources or a country that has acquired the gene tic resources and/ or ATK in accordance with the CBD." The preamble of the draft decision makes reference to article 17 of the Nagoya Protocol which establishes that Parties shall take measures, to monitor and to enhance transparency about the utilization of genetic resources, including designating effec-tive "check-points" to collect or receive, as appropriate, relevant infor-mation regarding their utilization.

In terms of non-compliance, the draft decision obliges Members "to put in place appropriate, effective and proportionate measures so as to per-mit effective action against the non-compliance" with the disclosure re-quirement adding that "patent applications shall not be processed with-out completion of the disclosure obligations." It also requires Members to "impose sanctions, which may include administrative sanctions, crim-inal sanctions, fines and adequate compensation for damages" if it is

dis-15 WTO Trade Negotiations Committee, Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the Convention on Biological Diversity, TN/C/W /59, 19 April2011.

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covered after the grant of a patent that the applicant failed to disclose the information required, or submitted false and fraudulent information, or it is demonstrated by the evidence that the access and utilization of ge-netic resources and/or ATK violated the relevant national legislation of the country providing genetic resources and/or ATK, that is, the coun-try of origin of su ch resources or a country that has acquired the genetic resources and/or ATK in accordance with the CBD. The draft decision indicates that "Members may take other measures and sanctions, in-cluding revocation," against the violation of the disclosure obligation.

Beyond developing countries, the positions of sorne industrialized coun-tries have evolved over the years on this issue at the TRIPS Council. In particular, the European Union, Switzerland and Norway have accepted the principle of introducing a disclosure requirement related to genetic resources and ATK in patent applications though its modalities differ from the one proposed by developing countries.

In 2002 already, the EU had manifested its agreement to examine the possible introduction of a "self-standing disclosure requirement that would allow Members to keep track, at globallevel, of all patent appli-cations with regard to genetic resources for which they have granted ac-cess." It stated that "such disclosure requirement should not act, de facto or de jure, as an additional formai or substantial patentability criterion. "¹⁶

As a result, there has been one instance where the traditional North-South divide in discussions about the relationship between the TRIPS Agreement and the CBD have given place to a new dynamic where many developed and developing countries have joined forces to seek a resolution to the matter.

This was the case, in 2008, wh en a coalition of 110 countries-including the EU, Switzerland and other countries interested in enhanced protec-tion of geographical indicaprotec-tions (Gis) as well as developing countries demandeurs on biodiversity- came together to support a common

pro-16 WTO TRIPS Council, Review of Article 27.3(b) of the TRIPS Agreement, and the Relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the Protection of Traditional Knowledge and Folklore. A Concept Paper, Communication from the European Commission and its Member States, IP/C/W /383, 17 October 2002.

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posal for "Draft Modalities"¹⁷ which sought to achieve movement on three TRIPS issues at the same time: the creation of a registry for Gis, the establishment of a biodiversity related disclosure requirement, and the extension of protection of Gis provided for in TRIPS Article 23 to products other than wines and spirits. The proponents suggested the adoption of "modality texts that reflect Ministerial agreement on the key parameters for negotiating final draft legal texts with respect to each of these issues as part of the single undertaking."

Under the Draft Modalities proposai, "Members agree to amend the TRIPS Agreement to include a mandatory requirement for the disclo-sure of the country providing/source of genetic resources, and/or ATK for which a definition will be agreed, in patent applications." It envis-aged that "patent applications will not be processed without completion of the disclosure requirement."

The 2008 Draft Modalities were met with opposition from sorne devel-oped countries and developing countries which did not favour the en-hanced protection of Gis or the introduction of a biodiversity disclo-sure requirement. This group, which included countries such as the United States, Australia, Canada, New Zealand, Argentina and Chile, also argued that the three issues responded to different mandates and thus could not be bundled together. While the mandate for negotiations to establish a multilateral system of notification and registration of geo-graphical indications for wines flowed from Article 23 ( 4) of the TRIPS Agreement itself, discussions on the relationship between the TRIPS Agreement and the CBD and the extension of protection of Gis pro-vided for in TRIPS Article 23 to products other than wines and spirits are considered "implementation" issues discussed under paragraph 12 b) of the 2001 Doha Ministerial Declaration.

While the Draft Modalities incorporate a mandatory biodiversity re-lated disclosure requirement, they leave out severa! important elements.

This includes reaching a definition of "traditional knowledge" which may prove difficult as there is no generally admitted one and even the WIPO Intergovernmental Committee on Intellectual Property and Ge-netic Resources, Traditional Knowledge and Folklore (IGC) has not been able to reach such a definition after many years of deliberations. In addition, prior informed consent and access and benefit are considered

17 WTO Trade Negotiations Committee, Dra ft Modalities for TRIPS Related Issues, TN/C/W/52, 19 July 2008.

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"additional elements" as an integral part of the disclosure requirement which may be raised and shall be examined but with no specifie obliga-tion regarding outcome. The "nature and extent" of a reference to them is yet to be defined. Finally, while the proposai states that "patent appli-cations will not be processed without completion of the disclosure re-quirement," the issue of "post grant sanctions" demanded by develop-ing countries, such as revoking a patent or declaring it non-enforceable when it is found that false or incomplete information was provided by the patent applicant, may just be raised and "shall be considered" in these negotiations but again with no obligation of outcome.

In light of the above, the question that begs to be asked is whether for many developing countries a "soft" disclosure requirement could be traded off against enhanced protection of Gis. While it might be a suit-able trade-off for developing countries which consider that increased Gis protection may benefit their trade interests, it may not be suitable for a number of other developing countries that are much less enthusi-astic about such an enhancement.¹⁸

In any case, the 2008 Draft Modalities revealed a possible trade-off be-tween enhanced protection for GIs and the introduction of a mandatory biodiversity related disclosure requirement that would have been diffi-cult to envisage a few years earlier. Given the nature of the WTO forum as a trade negotiating forum which operates under the principle of the

"single undertaking", it would not be impossible to envisage other trade-offs between TRIPS and non-TRIPS related issues in the future. Ulti-mately, the Draft Modalities proposai had the positive effect of showing the possibilities of going beyond the North-South divide on this matter and has prompted countries to carefully think about the types of "trade-offs" that they could accept taking into account their broader implica-tions as well as costs and benefits.

According to sorne, even the United States could reconsider its current position on the disclosure requirement, if a conclusion of the Doha round is in sight. As noted by one academie familiar with the US posi-tiOn:

18 CARLOS CoRREA, Geographical Indications and the Obligation to Disclose the Origin of Biological Materials: Is a Compromise Possible und er TRIPS?, ICTSD Po licy Brief, Geneva,201 O,availableonlineathttp:/ /ictsd .org/i/publications/8635 7/, last accessed 28 June 2012.

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"lt is unlikely that the political constellation in the United States will change so dramatically asto allow not only a disclosure requirement to be accepted, but also to incorporate a rcquirement to provide evidence of prior informed consent and bcnefit sharing (in light of the US refusai to ratify the CBD or ITPGR). On the other hand, though this is perhaps the most difficult 'cali' among the TRIPS elements, the United States may be able accept a soft disclosure requirement - because this truly would provide patent examiners with useful information. Biotechnology lobbyists in the United States have sorne considerable power, but not so muchas to cause the Doha Round to collapse because of an 'irrational prejudice' against the disclosure of relevant and useful information. "¹⁹

Useful suggestions have also been made about how a biodiversity dis-closure requirement could be designed in such a way as to be compati-ble with US patent law.2o

Despite the limited prospects for progress on TRIPS issues in the near future given the current stalemate in the Doha round, it could be the case thar countries would be willing to move beyond their entrenched positions if and when the "end game" in the Do ha Round discussions approaches.

lV. WIPO

At WIPO, discussions on GRs and ATK have taken place in a number of bodies such as the Standing Committee on Patents (SCP), the Work-ing Group on Reform of the Patent Cooperation Treaty (PCT), and the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge (TK) and Folklore/Traditional Cul-tural Expressions (TCEs ).

During discussions on the substantive harmonization of patent law at the SCP between 2000 and 2005, a number of developing countries

ex-19 ^FREDERlCK M. ABBOTT, Post-mortem for the Geneva mini-ministerial: Where does TRIPS go from hcre?, UNCTAD-ICTSD, Information Note 7, Geneva, 2008, pp. 3-4, available online at http:/ /ictsd.org/i/publications/16949/, last accessed 28 June 2012.

20 LAURA GREllE, Requiring Genetic Source Disclosurc in the United States, Marquette University Law School Legal Studics Paper No. 10-25, 4 May 2010, available online at http:/ /papers.ssrn.com/sol3/papers.cfm ?abstract_id=1600254#, last accessed 28 June 2012.

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pressed the view that disclosure of the origin of GRs and ATK in patent applications should be among the issues addressed.²¹

It is to the Working Group on Reform of the PCT that Switzerland submitted, in 2003, its proposai regarding the declaration of the source of GRs and traditional knowledge in patent applications.²² The proposai would amend PCT regulations to explicidy enable PCT Contracting Parties to require patent applicants to declare the source of GRs and tra-ditional knowledge in patent applications. Switzerland made follow up submissions to this proposai with additional comments and observa-tions in 2004²³ and in 2005.24

However, it is no doubt the IGC which has been the main focus of de-liberations on these issues at WIPO, since its creation in 2000, with the active participation of a range of stakeholders including, in particular representatives of indigenous groups. Throughout its existence, the IGC has witnessed a rich po licy discussion and contributed to a better

However, it is no doubt the IGC which has been the main focus of de-liberations on these issues at WIPO, since its creation in 2000, with the active participation of a range of stakeholders including, in particular representatives of indigenous groups. Throughout its existence, the IGC has witnessed a rich po licy discussion and contributed to a better