The international legal system regulating IPRs in plant varieties and plant genetic resources may be on the cusp of significant change. The sources of this change are twofold. First, in November 2001 the WTO membership agreed to a new round of multi-year trade negotiations which will include a review of the plant-related IPR obligations in the TRIPs Agreement. Second, in the same month, the FAO Conference adopted a new International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR). For governments considering the propriety and scope of IPR protection for plant varieties and plant breeders, both of these events merit significant attention. Within the WTO, states will revisit TRIPs article 27.3(b) and will consider whether to broaden or narrow it and whether to harmonize diverse and sometimes conflicting international and national approaches. The ITPGR, by contrast, seeks to establish a system of access to plant genetic resources and to further many of the other societal objectives discussed in section 1.3.6 above. In doing so, however, it attempts to limits the types of plant genetic materials that may be protected as intellectual property.
On 14 November 2001, trade ministers from the WTOs then 142 Members meeting in Doha, Qatar agreed upon the text of several official declarations to serve as the framework for a new round of trade negotiations. These declarations do not expressly address the issue of plant variety protection. They do, however, suggest that the WTO will conduct an expansive review of the relationship between IPRs in plants and competing policy objectives as it considers whether and in what ways to revise the current text of the TRIPs Agreement.
After the widely publicized failure of the WTO meetings held in Seattle, Washington in December 1999, industrialized countries were eager to commence a new round of trade negotiations to address the many issues that had arisen since the conclusion of the Uruguay Round of trade talks in 1994. Developing nations, however, had become resistant to many aspects of the international trading system and would consider negotiating new trade obligations only if they received substantial concessions to achieve their interests. According to one recent commentary, during the last two years "developing countries in general were more coordinated and outspoken, and better informed than in the past" (CIDSE, 2002, p. 2), and thus were in a more favourable position to bargain for these concessions. This coordination has continued during the Doha Round, as reflected, for example, in the creation of the "Group of 21" (or "G21") developing country governments with common negotiating positions. (WTO Under Fire, pp. 26-28)
In the area of plant variety protection, the debate between developed and developing nations during the period between Seattle and Doha centred on the scope of review of article 27.3(b). The United States and Japan sought to limit that review to measures WTO Members had adopted to implement their obligations under that article, with the UPOV 1991 Act serving as a preferred benchmark for determining whether a sui generis system protecting plant varieties was effective. (IP/C/W/162, 1999; IP/C/W/236, 2000) Developing countries, led by India, Brazil and African states, sought a far more expansive approach to the review process. In their view, the review of article 27.3(b) presented an opportunity to revisit whether plants and other life forms should ever be protected by an IPR. Even where IPR protection was appropriate, developing nations saw the review process as a means to harmonize TRIPs with the CBD and the Undertaking in order to promote biodiversity, recognize farmers rights and protect traditional knowledge and the rights of indigenous communities. (IP/C/W/228, 2000; IP/C/W/206, 2000; IP/C/W/161, 1999) European governments adopted a stance between these two polar perspectives, arguing that harmonization could be achieved not by revisions to article 27.3(b) but rather through national laws seeking to implement international treaty obligations. (IP/C/W/254, 2001)
A review of the declarations agreed to in Doha suggests that the position of developing countries regarding the scope of review of article 27.3(b) has largely prevailed. (See para. 4.2.2 above, discussing competing proposals by WTO Members relating to article 27.3(b))
Paragraph 19 of the Ministerial Declaration directs the TRIPs Council, in conducting its review of that article, to examine:
inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments raised by Members.... In undertaking this work, the TRIPS Council shall be 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 dimension. (WT/MIN(01)/DEC/W/1)
Although this paragraph in no way predetermines the outcome of the TRIPs review process, it expressly authorizes Members to raise not only implementation or technical issues relating to IPRs in plant varieties, but also more fundamental questions concerning the appropriate scope of protection in light of other competing societal objectives and international obligations. (IP/C/W/404, 2003) The reference to the objectives and principles in articles 7 and 8 is also telling. Article 7 emphasizes that the protection and enforcement of IPRs "should contribute to the promotion of technological innovation and to the transfer and dissemination of technology... in a manner conducive to social and economic welfare and to a balance of rights and obligations." Similarly, article 8 permits Members to "adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development...." The reference to these articles reaffirms that TRIPs is to be interpreted to permit its Members to adopt balanced systems of intellectual property protection. Two additional provisions offer further evidence that WTO ministers intended the article 27.3(b) review process to be a broad one.
First, paragraph 31 of the Ministerial Declaration contains a significantly narrower mandate for harmonizing Members trade and environment obligations than the paragraph relating to the review of TRIPs. Paragraph 31 calls for negotiations limited to "the relationship between existing WTO rules and specific trade obligations set out in multilateral environmental agreements" while preserving the rights of WTO Members that are not parties to the treaty in question. (emphasis added)
Second, the trade ministers adopted a separate "Declaration on the TRIPs Agreement and Public Health" to address the HIV crisis in developing nations unable to afford access to medicines. The declaration stated that the TRIPs Agreement "can and should be interpreted and implemented in a manner supportive of WTO Members right to protect public health and, in particular, to promote access to medicines for all." It also reaffirmed "the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose." (WT/MIN(01)/DEC/W/2, para. 4)
Taken together, the foregoing provisions suggest that the Doha Round of trade negotiations has opened a window of opportunity for states seeking to balance the protection of plant breeders rights against other societal objectives. (See GRAIN, 2003, which discusses whether the review of TRIPs is "at a turning point".)
In achieving such a balance, the full spectrum of options discussed in section 3.4 on sui generis systems of protection are available as potential policy tools. To take just one example, Members might require every applicant seeking a patent or protection of a new plant variety to disclose the origin of plant genetic material upon which the invention or variety was based, or to demonstrate that the material was acquired with the prior informed consent of the country or community of origin. (See para. 3.4.3 above) These or other options could be adopted on either a mandatory or a permissive basis. Under a mandatory approach, TRIPs would be amended to require all WTO Members to change their IPR laws to include such policy-balancing provisions. Under a permissive approach, TRIPs would be amended to clarify that individual Members may implement such provisions without violating the treaty. (See WTO Doc. IP/C/W/420, 2004, listing a "checklist of issues" on the relationship between TRIPs and the CBD.)
The mandatory option would create a harmonized international solution, but one that would be extremely difficult to negotiate. In the case of disclosure or prior informed consent requirements, for example, it would have the effect of obliging one WTO Member (the state in which IPR protection was sought) to protect rights of another WTO Member (the country of origin of genetic material) that have no relation to the protection of intellectual property rights or intellectual property products. An approach that requires an intellectual property agreement to protect non-IPR interests (such as the interest in receiving compensation for preserving plant genetic diversity) has no historical precedent in the international intellectual property system and thus its adoption within TRIPs would require a significant revision of the treaty.
The permissive option has the advantage of granting governments the discretion to tailor their national laws to domestic policy objectives without fearing that those laws will then be challenged under the WTO dispute settlement system. However, because this approach allows any Member to decline to implement the policy-balancing mechanisms, it would not provide a comprehensive international solution to the problems presented.
Whether WTO Members adopt a mandatory or permissive approach will depend not only upon the TRIPs Councils review of the provisions of article 27.3(b) relating to plant genetic resources, but also upon political compromises among WTO Members over trade issues wholly unrelated to IPRs (such as restrictions on trade in textiles). In the case of plant-related innovations, the options chosen may also depend upon on the obligations imposed by other international agreements, including the ITPGR.
On 3 November 2001, a conference of 120 government delegates concluded seven years of negotiations and adopted the text of a binding international agreement on access to plant genetic resources. (See Mekouar 2002, p. 3) The ITPGRs principal aim is to facilitate the exchange of seeds and other germplasm to be used for research, breeding and crop development. The treaty promotes this exchange by establishing a "multilateral system" to which member states and their nationals will be granted "facilitated access." In essence, the multilateral system is a communal seed treasury composed of 35 food and 29 feed crops now held by governments (both in situ on public lands and ex situ in national seed banks) and by the CGIAR in its extensive ex situ seed collections. In exchange for access to this common seed pool, those who create commercial products that incorporate plant genetic resources received from the multilateral system must pay a percentage of their profits into a fund to be administered by the treatys Governing Body. That fund will be used to promote conservation and sustainable use of plant genetic resources, particularly by farmers and indigenous communities, whose rights and contributions to genetic diversity the ITPGR expressly recognizes. (Id., pp. 5-10)
As the above overview illustrates, the ITPGR seeks to achieve many of the policy objectives discussed in section 1.3.6 above. Because the treaty is founded upon open access to plant genetic resources, it is necessarily in tension with any legal system that grants exclusive rights over those same resources. The treatys drafters were well aware of this tension, and IPRs were one of the most contentious issues during the seven years of treaty negotiations. On the one hand, the drafters recognized that the treaty could not function unless private parties were permitted to create and then commercialize derivative products using raw genetic materials acquired from the multilateral system. Only through such commercialization would sufficient revenue be generated to fund the treatys benefit sharing, conservation and sustainable use objectives. On the other hand, the multilateral system itself would be threatened if its component parts could be privatized through the grant of IPRs. (Helfer, 2004, pp. 40 and 41)
22.214.171.124. Debate over the patenting of isolated and purified genes
The fulcrum of the debate quickly focused on whether the treaty would bar the patenting of isolated and purified genes extracted from germplasm placed in the common seed pool. Reasserting the positions they had adopted in the WTO, the United States and Japan argued against such a ban, most developing nations argued in favour of it and European countries sought to broker a compromise.
126.96.36.199. Article 12.3(d.
The final text of the ITPGR reflects the views of the overwhelming majority of governments at the FAO Conference. In particular, article 12.3(d) states that facilitated access to the plant genetic resources contained in the multilateral system will only be provided on condition that:
Recipients shall not claim any intellectual property or other rights that limit the facilitated access to plant genetic resources for food and agriculture, or their genetic parts or components, in the form received from the multilateral system. (emphasis added)
Not only will this provision bind states parties to the ITPGR, but it will also be included in standardized Material Transfer Agreements that all private parties seeking access to the multilateral system must execute. (art. 12.4)
188.8.131.52. The drafting of Article 12.3(d)
Understanding the final stages of the ITPGRs drafting history is essential to deciphering the meaning of article 12.3(d). The two highlighted phrases - "or their genetic parts or components" and "in the form" - were included as separate bracketed texts going into the final round of negotiations. Developing states opposing IPR protection sought to retain the first clause and delete the second, whereas the United States wanted the first phrase deleted and the second retained. In the end, both clauses were retained after the United States lost, by a 97 to 10 margin, a vote to have article 12.3(d) deleted from the treaty. The entire treaty was then adopted by a vote of 116 in favour, zero against and two abstentions by Japan and the United States. (Earth Negotiations Bulletin, 2001, p. 8)
184.108.40.206. The meaning of Article 12.3(d)
As adopted, article 12.3(d) reflects an uneasy compromise between governments with opposing positions. The critical question is whether the act of extracting a gene from a seed is, in itself, a sufficient alteration of the seeds genetic material such that the extracted genetic product is no longer "in the form" received from the multilateral system. According to one view, the articles ban on IPRs extends only to raw germplasm, not to individual genes or DNA fragments that are isolated and purified and thus altered from their natural state. Other commentators have argued for a more expansive interpretation, asserting that the article permits "breeders to take exchanged germplasm, extract commercial genes, insert them into other plant varieties, and claim a patent either on the new variety or on the extracted genes as adapted to the new varieties." (Law of the Seed 2001, p. 4 (emphasis added)) According to this view, the original plant material, including its genetic components, would remain within the multilateral system free for others to use and exploit.
Neither textual interpretation nor national jurisprudence is likely to resolve this debate. Rather, following the ITPGRs entry into force in June 2004, its Governing Body now has an opportunity to clarify article 12.3(d) in light of the treatys goal of facilitating access to plant genetic materials for specified purposes. In interpreting article 12.3(d), the Governing Body may seek advice from WIPO or the TRIPs Council. Alternatively, a dispute over the proper interpretation of the provision may be submitted to arbitration or to the International Court of Justice, provided however that the states concerned have accepted one of those two methods of dispute settlement. (ITPGR, art. 22) Whether the Governing Body will seek to harmonize the interpretation of the ITPGR with the work of other intergovernmental organizations such as WIPO and the WTO is at this point uncertain and raises broader questions of how international institutions compete or cooperate in the creation of new legal norms. (Mosoti, 2004).
Regardless of which interpretation of article 12.3(d) the Governing Body ultimately adopts, the ITPGR creates the potential for conflicts with TRIPs, "TRIPs plus" treaties and national IPR laws. The next section reviews the provisions of the ITPGR that address its relationship with other international agreements and then identifies the potential conflicts that may arise, both with the current text of TRIPs and in the context of possible revisions that may be adopted during the Doha Round.
220.127.116.11. Treaty relationship clauses in the ITPGR
The drafters were deliberately ambiguous as to the ITPGRs relationship with other treaties. The drafters intended that all international agreements affecting plant genetic resources "should be mutually supportive" (Preamble, para. 9), but they consciously avoided adopting any statements to address conflicts with other treaties. To the contrary, the drafters consciously avoided conflict, stating that nothing in the ITPGR "shall be interpreted as implying in any way a change in the rights and obligations of the Contracting Parties under other international agreements" or as "creat[ing] a hierarchy between this Treaty and other international agreements." (Id., paras. 10 and 11) Although similarly ambiguous statements appear in environmental law agreements, they have yet to be tested in a dispute before the WTO or other international tribunal.
18.104.22.168. Potential conflicts between the ITPGR and TRIPs
There are two potential areas of conflict between the ITPGR and TRIPs: article 12.3(d) and the ITPGRs benefit sharing clause. Neither provision currently conflicts with TRIPs, since WTO Members may at present entirely exclude plants and plant varieties from patentability. Article 12.3(d) would, however, conflict with those "TRIPs plus" treaties that require developing countries to recognize such patents and with national IPR laws in industrialized countries that treat isolated and purified genes as patentable inventions. (See GRAIN, 2001, at 2 and 3 (identifying patent protection for plant varieties as a "TRIPs plus" standard and listing bilateral treaties that require developing countries to grant such protection.)) In addition, if WTO Members agree during the Doha Round to amend TRIPs to require patent protection for plants or plant varieties, then a conflict would arise for states parties to both agreements.
A conflict with article 12.3(d) is especially likely for states, including in particular industrialized countries, that award patents to inventors who have isolated plant genes from nature. The expansive reading of article 12.3(d) identified above is in tension with the national patent laws of such states, which grant patents to plant genetic material that has been isolated by human intervention or produced by means of a technical process. Ratification of the ITPGR would impose an obligation on these countries to refrain from granting patents in genes isolated from seeds or other germplasm received from the multilateral system. To give effect to this obligation, such states would need to amend their national patent laws to deny protection to genes isolated from such materials.
The conflict with the ITPGRs benefit sharing provisions arises from the fact that those who commercialize a product developed from genetic resources obtained from the multilateral system must pay "an equitable share of the benefits arising from the commercialization of that product." (art. 13.2(d)(ii)) This imposes an obligation in connection with biotechnology patents that is not imposed with other types of patents. For that reason, it may conflict with TRIPs article 27.1, which requires Members to make "patents... available and patent rights enjoyable without discrimination as to... the field of technology...." Whether such a disparate benefit sharing rule in fact conflicts with TRIPs is uncertain, however, given the decision in Canada - Patent Protection of Pharmaceutical Products (Generic Medicines). In that case, a WTO dispute settlement panel rejected the claim that a facially neutral provision of Canadas patent statute which in practice applied only to pharmaceutical patents violated TRIPs patent non-discrimination rule in article 27.1. (WT/DS114/R) (17 March 2000). The panel expressly refused to decide whether "measures that are limited to a particular area of technology... are necessarily discriminatory by virtue of that fact alone, or whether under certain circumstances they may be justified as special measures needed to restore equality of treatment to the area of technology in question." (Id., para. 7.105 and No. 439)
A second response to the argument that the ITPGRs benefit sharing provisions violate TRIPs article 27.1 is that the TRIPs Agreement nowhere prohibits WTO Members from imposing fees or levies associated with the holding of patent rights, such as those routinely imposed by national intellectual property offices. (Lettington, 2001, p. 11) It is unclear, however, whether TRIPs requires that such fees or levies be substantially equivalent for all categories of patents.
22.214.171.124. Harmonizing the ITPGR with a revised TRIPs Agreement?
In an effort to avoid the potential conflicts discussed above, there is likely to be significant interaction between the government officials negotiating in the WTOs TRIPs Council and those working with the ITPGRs Governing Body. This is particularly so given the WTO ministers broad instruction to the TRIPs Council to consider any "relevant new developments raised by Members" when reviewing the patent and plant variety protection provisions of TRIPs article 27.3(b). (See para. 4.2.3 above) However, because any agreement reached during the Doha Round of trade negotiations will incorporate numerous issues unrelated to plant genetic resources, it is difficult to predict the final form that such an agreement will take.