Extract from SIGNPOSTS TO SUI GENERIS RIGHTS:

Strategy Ideas for the 1999 TRIPS Review & Beyond  

by GRAIN. Background paper for BioThai/GRAIN workshop Dec 1997.

 

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SUI GENERIS OPTIONS AT THE NATIONAL LEVEL

 

Identifying where the national manoeuvring space stops and starts under the grip of the WTO's new jurisdiction is a matter of debate, interpretation and a lot of other subjective factors. It has also much to do with sheer power dynamics. The WTO's legal and institutional set-up, and the TRIPS Agreement itself, reflects how industrialised countries threaten and arm-twist developing countries into concessions draped as consensus. This is a sad reality that has to be taken into account when strategies and options for dealing with TRIPS are elaborated at the national level.

 

The push to patent life goes back decades. So does the resistance against it. A number of developing countries have been discussing and drafting legislation that tries, despite the patent pressure, to somehow protect the rights of local communities who innovate with biodiversity, develop it and conserve it. It is important to note that in many cases these initiatives are not born of or guided by the requirements of TRIPS. Many built their momentum under the Convention on Biodiversity or are simply the result of long-standing pressure from civil society. A brief review of what has been proposed and developed so far as sui generis options follows.

 

SUI GENERIS OPTIONS UNDER DEVELOPMENT

 

INTELLECTUAL PROPERTY RIGHTS FOR COMMUNITIES

The idea here has been to vest IPR in communities given that communities are the source of many biodiversity-related innovations whose "origin" is negated by conventional IPRs. In more recent years, the word "property" has been deleted from such proposals because the sense of "property" was found to be inimical to community views (see below). However, Brazil's access law and the framework for Ethiopia's biodiversity rights legislation still refer to Community Intellectual Property Rights. Also, some countries are trying to evolve sui generis legislation explicitly for traditional knowledge related to biodiversity: The Andean Pact has such an agenda built in to its common regime on access and the Southern African Development Community may take up the same under the initiative of the new Southern African Regional Conference of Traditional Leaders. [2] Articulating the rights of local communities under any IPR umbrella clearly carries risks and drawbacks. While trying to "bring in" people who seem "left out" of the IPR system, it obviously reinforces the corporate sectors' justification for monopoly rights on life forms and inventions derived from traditional knowledge. As a means to achieve some kind of benefit-sharing toward communities, it commits them irrevocably to assign a market value to their resources, knowledge and culture and trade them as commodities in the commercial marketplace. Allowing the IPR system to further penetrate areas of knowledge and innovation now still largely seen as "the commons" could simply be the next step in the destruction of those commons.

 

COMMUNITY INTELLECTUAL RIGHTS & COLLECTIVE RIGHTS

Community Intellectual Rights (CIR) have been tabled as legislation in India and the Philippines, among other countries. It aims to protect the rights of communities -- "formal or informal, organised or disorganised, monolithic or reticulate" [3] -- who have knowledge of biodiversity, maintain it, innovate with it and utilise it, to be able to continue doing so and to benefit more fully from it. This is construed as effective anti-biopiracy legislation. It aims to recognise the sovereignty of communities over the resources they live with, and assert their rights from being trampled by researchers and others claiming IPR on what belongs to the communities, even if slight modifications are made. In its various formats, CIR legislation does not interfere with community processes of exchange and development of materials and knowledge. It articulates community rights as collective and permanent, which the State has to abide by. In a draft made for India, [4] it provides for co-ownership across communities and sets out the terms and mechanisms for commercial use of community resources and knowledge. In several countries in Latin America, NGOs have been pushing for Collective Rights developed along similar lines.

 

"POLLUTED" PVP

This is plant variety protection legislation based on UPOV but with "beyond UPOV" provisions for farmers. This often means the establishment of a Community or Farmers Rights Fund whereby part of the royalties charged on protected seeds is channelled to communities (cf. Tanzania, India). In countries going further adrift from UPOV orthodoxy -- like Thailand, the Philippines and perhaps India still -- the PVP draft takes on a lot more complexity meant to safeguard community and biodiversity interests. This ranges from in-built links to national biosafety regulations, a grace period for filing applications on farmers' varieties, a narrowing of PVP's operating field to exclude certain categories of farmer-controlled plant materials, environmental impact assessments as requirement for protection, etc. No country working on PVP as a sui generis law under TRIPS has been found to deviate from the UPOV criteria of distinction, uniformity and stability (DUS) for varietal protection. The DUS criteria are considered one of the main reasons by plant variety protection erodes biodiversity at the farm level, as they encourage breeders to produce uniformity.

 

COMPREHENSIVE BIODIVERSITY LEGISLATION

This path is being approached by Costa Rica, perhaps Thailand, probably Ethiopia and South Africa, and is advocated in India as well. Here, the mechanisms affecting the rights of communities related to biodiversity are bundled together in an almost all-encompassing law. Following common precepts, the legislation spells out mechanisms on access, biosafety, intellectual property, community rights, and national action for the conservation and sustainable use of biodiversity. For many legislators, this is an ideal approach as it can assure greater consistency. For the corporate sector it is something of nightmare as it creates too many cross-sectoral pressures. For NGOs and others advocating rights for local communities, it could carry an all-your-eggs-in-one-basket risk. Depending how it is developed, it could also end up too watery, thus not really providing specific mechanisms for local communities to protect and promote their interests.

 

SECTORAL COMMUNITY RIGHTS REGIMES

Thailand and Laos, among others perhaps, are taking "pragmatic" approaches and tabling community rights legislation for different sectors. Both countries are evolving Community Forestry Acts with specific attention to the needs of communities who depend on forest resources and whose management rights have been decimated by both logging operations and nature conservation schemes. [5] Thailand is finalising separate legislation on traditional medicinal biodiversity and knowledge systems. One could imagine -- and many NGOs see the need for -- community rights legislation specifically for small-scale fisherfolk living in coastal areas. Farmers dealing with crops and livestock are another group with specific dynamics and needs, while the special situation of indigenous peoples should also be taken into account. The appeal of the sectoral approach is the amount of fine-tuning that can be achieved for different communities' specific needs and realities. It can also result in at least some groups achieving new powers at the local or national level should an all-your-eggs-in-one-basket approach fail. In principle, it also allows for more direct involvement of the relevant communities in the legislative process. The problem with the sectoral approach is that it cuts biodiversity and people into separate categories, which can never fully reflect reality.

 

 CONSTITUTIONAL AMENDMENTS

This is not an objective in itself but lends more power to community rights legislation related to biodiversity. India has recently adopted amendment 73 to its Constitution recognising village-level authority over management of natural resources in conformity with local customs. Thailand has just adopted a new Constitution which explicitly identifies as the duty of the State "to promote and support people's participation in the conservation and use of natural resources and biodiversity in a balanced manner ... according to the principles of sustainable development" (Art. 79). Namibia has also highlighted biodiversity management as a constitutional concern. Colombia, Brazil and other Latin American countries have gone far to articulate the rights of indigenous peoples in their constitutions, which can lend force to sui generis community rights systems.

 

GRASSROOTS ACTION: COMMUNITY REGISTERS

Peoples' action is ubiquitous in the shadow of the State and can never be supplanted by laws except by force. Community registers of local biodiversity and knowledge are spreading very fast, as are initiatives to upgrade conservation and innovation systems at the local level. Whether in Indonesia, India, Brazil, Chile, Ethiopia or elsewhere, documentation of local resources and knowledge by communities themselves is gaining ground. This option helps sensitise people to the problem of biopiracy. It establishes "prior art" (legal documentation to prove that the resource has long been known as useful for certain purposes) to ward off near-sighted patent examiners and their biased protocols. And it encourage local groups to take heed and enhanced responsibility for dwindling resources that are increasingly under threat. However, when it is institutionalised as part of formal legal systems (e.g. under PVP, CIR or even access laws) without sufficient protection against misappropriation, it carries an immense drawback of making local resources and knowledge even more accessible to global actors at the expense of local actors.

 

TRAPS UNDER TRIPS

The diversity of initiatives under way can be confusing. For most NGOs working on these issues, the patenting of life forms is unacceptable as it clashes head-on with many local cultures and value systems, and undermines the very conditions by which innovation and options thrive. Still, many groups which hold that position -- especially those working at the national level, faced with an onslaught of new legislative proposals resulting from outside pressures and agreements -- also have to work with or lobby their policy makers to avoid the worst within the IPR context. Continuous action is needed on both fronts: the frontal fight against the patenting of life needs to be broadened and strengthened, while the day to day struggle to keep spaces open for local communities in national legislation and international agreements also has to be vigorously pursued. But there are number of traps that are clear by now.

 

TRAP 1: FACILITATING CORPORATE CONTROL

Any sui generis rights legislation which does not purposefully narrow or frustrate the operating field of the industrial IPR system, if not close off certain "territories", will do nothing to address the basic problem of biopiracy or the alienation of peoples' rights to control their local resources. Sui generis proposals that take a typical IPR system -- like patents or PVP -- and add a mechanism to redistribute royalties or put a farmer on the Board do little more than justify the status quo. This is already happening with emerging access laws, which provide for some prior informed consent and benefit-sharing procedures. The reason is that the very framework of access laws -- like TRIPS -- is to facilitate trade. Access regimes assume commercial relationships and cater to them. (They often do not deal with access and exchange of biodiversity between communities and sometimes directly hinder these.) Sui generis rights proposals can and should take a more fundamental approach by answering the question: "What rights have to be granted to whom to make community-based resource management work under truly popular control?" As with access, sui generis rights geared to simply "level-off" the commercial monopoly "playing field" will probably only help justify corporate biopiracy and do nothing to enhance biodiversity-based livelihoods systems at the community level. Amending IPR is not the same thing as vesting rights in communities.

 

TRAP 2: NAMING THE NAMELESS?

Another problem apparent in most current approaches to sui generis legislation is the dilemma of how to avoid that legislating rights in the race to please WTO or CBD or just to fend off biopirates leads to imposing an unwanted juridical personality on communities. "Indigenous and local communities" exist in international law -- states have committed themselves to take action with regard to their knowledge, innovations and practices in the CBD alone. How will states identify these people for the purpose of recognising their sui generis rights? One thing is devolving power as far down to the community level as possible in the administrative jigsaw puzzle of legal authority. Quite another thing is demanding that for the purpose of allocating jurisdiction over whatever biodiversity or whatever knowledge and practices, NGOs and the government collude in forcing a new identity on communities. Legalisation of the people themselves can be artificial and disastrous, especially if it is imposed from the outside. This dilemma is compounded by the fact that similar innovations can span across communities, and governments are feeling pressured to rework juridical boundaries to apportion the benefits.

 

TRAP 3: PRIVATISING THE COMMONS

If sui generis rights related to biodiversity are to legally protect the space that belongs to communities, then they will need to recognise the collective nature of the resources, the knowledge and the innovations in question. It is well acknowledged that farmers' seed systems, healers' health care systems, and indigenous and other peoples' livelihood systems based on biodiversity are collective. The collective nature of these systems cuts across both time and space and is the foundation of various rights and obligations already long in practice. Any sui generis rights legislation aiming to protect and promote these systems would have to recognise such principles and draw clear lines between them and private property -- same as it would have to draw clear lines between community rights and IPR.

 

In many countries, industrialisation and privatisation of livelihood systems has reached such levels that it might seem impossible to question current tendencies and fight for communities, anonymity and commons as opposed to corporations, legal name tags and private property. Governments, which have set their hopes on the route dubbed globalisation as the path to progress, are often not willing to listen to anything else. If sui generis rights are to make any dent in this route, they have to be based on very clear principles. Any strategy, which embraces the patenting of life, will not make the dent. This does not mean that NGOs shouldn't be involved in distorting PVP laws, introducing hurdles into patent legislation, or participating in debates on national legislative drafts where chances of imposing new precepts are often scant. But it does mean that these traps and numerous others have to be carefully avoided.

 

OPTIONS AT THE GLOBAL LEVEL

 

The battle at WTO during the 1999 TRIPS Review of Art 27.3(b), which relates so intimately to day-to-day struggles over the fate of people's life resources, is bound to capture the imagination more and more in the coming months. It should not detract from serious work that still needs to be pursued under other jurisdictions and political colours, be it CBD, FAO, the EU or other regional houses of co-operation among countries. However, thoughtful plans have to be devised and strategically allied processes have to be developed if further space is not to be foreclosed -- and if new spaces are to be wrenched open -- within the multilateral trade regime.

 

Policy research and advocacy groups are just starting to devise possible strategies for the 1999 TRIPS Review and beyond. Little has been put on paper, much less discussed in collective NGO fora. Yet ideas are beginning to be articulated that can get the ball rolling on possible approaches, tactics, and specific goals for the Review process in relation to national realities. The following highlights a few aspects of the situation for WTO members in relation to the sui generis option as it now stands (the Marrakech starting point) and in relation to the Review of Article 27.3(b) (the Geneva turning point).

 

FROM MARRAKECH TO GENEVA TO....

THE MARRAKECH STARTING POINT

•Countries availing of the sui generis option under Art 27.3(b) have two immediate choices: UPOV-style PVP and/or "other". Most observers are of the opinion that the sui generis "other" has to be some form of IPR, but it is not clear what that exactly means -- especially whether it necessarily implies exclusive rights.

•For the purposes of TRIPS, whatever right is afforded must be "effective". What this means is open for debate. Some argue that it simply means that the right can be properly enacted and defended by the holder of the right. Others (including several NGOs) stress that a sui generis right on plant varieties is only effective if it provides equitable protection for all stakeholders involved -- farmers and local communities included.

•The plants/animals clause will be renegotiated in 1999. The full TRIPS treaty will be renegotiated in 2000. Any "freeze" on the implementation of TRIPS that is called for in 1999 will reverberate on the rest of the TRIPS schedule.

 

THE GENEVA TURNING POINT

•The United States wants to broaden IPR coverage on life forms at the 1999 TRIPS Review. This would mean a proposal to reword the Marrakech-agreed Article 27.3(b). At the very least, the US might want the sui generis option clarified to explicitly refer to PVP and perhaps name UPOV as the reference convention. Better for the biotechnology industry, but not necessarily breeders, the US might propose a deletion of the sui generis option altogether, leaving patents as the only means of required protection for plant varieties. At most, the United States could swing the axe and say, "Delete subparagraph (b) entirely." In this case, no exclusion from patentability for any form of plant or animal will be permitted.

•The EU might try to play the broker between a hard-line "No exclusions! Patents on everything!" US position and a more appropriate "Let us choose!" South position. After all, it was European patent law, which justified the wording of 27.3(b) originally. By playing the broker, the EU might try to coax developing countries to make a trade-off and let the US radically amend or delete Art 27.3(b) in exchange for TRIPS coverage of traditional knowledge. Traditional knowledge might be swept under the "geographical indications" rug, tossed into a new WIPO register or promised a separate sui generis system -- all with dangerous implications. However, if the draft EU patent directive, which legalises the patenting of plants and animals in the Union, is approved -- as might occur before the end of 1997 -- many European countries will have little incentive to fight hard on this issue. The risk that the broker keeps quiet, and South is alone in the 1999 Review, is high.

•The question is how hard the South is prepared to fight. Ideally, the main objective should be the opposite of the US intention: allow WTO members to exclude plants and animals from patentability, with no "howevers" attached. But since Marrakech, a number of developing countries have been adjusting their IPR laws already in reaction to US pressures, while others are filling UPOV's ranks as a fast ticket to sui generis compliance. These countries may be less inclined to put up a fight for any form of community rights.

•Social advocacy groups will see nothing achieved in the 1999 TRIPS Review unless they specifically, and well in advance, prepare their governments to take certain positions. Some collective alignment within a South bloc, e.g. through the G-77 or regional groups, is always better.

 

The baseline goal for most development-oriented NGOs concerned with biodiversity is to ensure that commitments to IPR do not expand in 1999. If possible, they should retract.

 

How to achieve this is no simple matter, especially since the US is already trying to build a fait accompli situation whereby developing countries will have stuck their necks out to reform their patent laws in the most "no exclusions" fashion already. This has happened in Indonesia, which often assumes a lighthouse role within the ASEAN. It is being impressed upon most Latin American countries and forms an integral part of the FTAA process. The fait accompli is a very strong power position to build, particularly under the terms and "spirit", depending on whom you ask, of the TRIPS Agreement. Any enhancement of IPR obligations can be readily written into the multilateral trading rules by mere acknowledgement of higher standards being practised under another multilateral framework and simple acquiescence to that "given".

 

 South countries will have a hard time arguing for more biodiversity-related "space" under TRIPS, unless they have laws in place or under development which really honour broader rights which are free from IPR constraints. Credibility will not be won even from national constituencies unless the broader, non-IPR rights are the subject of state commitment. A few strategy ideas can be culled together from different organisations' thoughts and proposals so far. None of them are mutually exclusive, and of course, the possibilities listed here are only a starting point for discussion.

 

DELETE THE ENTIRE "HOWEVER" CLAUSE

TRIPS Article 27.3(b) starts off by allowing countries to exclude plants and animals from patentability and continues with: "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". Perhaps the most straightforward, desirable and clear approach to the 1999 Review by those concerned about local biodiversity management would be to campaign for the deletion of this entire "However" clause. The result would be that members may exclude from patentability plants and animals -- full stop.

 

The obvious advantage of this approach is its simplicity and directness. It is a logical position to advocate among people fighting against patents on life forms already, and it can build on existing coalitions and campaigns. It would also be a logical position for many developing countries to defend since a good number have legislation which does not allow for the patenting of plants and animals or may contain multiple safety nets. Even though the WTO members committed themselves to implement 27.3(b) as per its Marrakech wording, developing countries do have the option to recast that commitment in 1999 before their implementation deadline of 2000. If some countries can walk into the Geneva negotiating round in 1999 to raise the stakes, why can't other countries walk in and lower the stakes?

 

 The obvious drawback is that it will be very difficult to achieve. The commercial biotech and seed trade sectors are acutely aware of biodiversity debates, and their interest in developing countries' markets is increasing by the day. As explained above, the US and to a lesser extent other OECD countries are geared towards the opposite objective, perhaps even the deletion of the whole subparagraph (b) of Article 27. The countries of the European Union might lose interest in the debate if the EU patent directive is adopted by the time of the 1999 Review, and might even align with the US on this matter. Yet another drawback is that recasting Article 27.3(b) to permit the exclusion of plants and animals from national laws does not, as such, put a halt on biopiracy of indigenous knowledge.

 

 Even if the deletion of the "However" clause might look difficult from the start, it has important tactical value. If anything, it would help to balance off the intentions of those who want to delete every possibility to exclude certain subject matter from patent law. But perhaps most importantly, this campaign would clearly lay on the table what is non-negotiable for most NGOs involved in the management of biodiversity: "No patents on life!"

 

ENTRENCH THE PUBLIC DOMAIN

One fundamental way in which policy makers may wish to limit the damage incurred by TRIPS as it now stands is to broaden out the non IPR-protectable space called "public domain". Public domain refers to tangible and intangible goods or creations that are not appropriable under private law. In many countries marked by Roman legal traditions, the state is the ultimate owner of all natural resources on its territory. Centralised state jurisdiction is tempered by the state's agreement to recognise private rights to the same goods and resources, including physical property rights and IPR. As regards the evolution of laws concerning biodiversity, the borderlines of public domain are being shifted around right now, refined, reconditioned and rediscussed. At the same time, the global tendency is that the public domain -- "the commons", in some cultures -- is increasingly eroded and privatised, be it through corporatisation of university research or through the biopirating of local resources and knowledge. NGOs may wish to examine how entrenching a new legal status for (parts of) biodiversity under the banner of public domain could add a layer of protection to community resources since protection from misappropriation is clearly needed.

 

Within the context of the TRIPS negotiations, this can be done in various ways. One way would be to add a simple paragraph to Article 27.3 reading as follows:

 

3. Members may also exclude from patentability:

 

(a.) ...

 

(b.) ...

 

(C.) INVENTIONS WHICH ARE ESSENTIALLY DERIVED FROM BIOLOGICAL MATERIALS AND ASSOCIATED KNOWLEDGE IN THE PUBLIC DOMAIN

 

Another way would be to insert it as a conditioner to the requirement to provide protection on plant varieties:

 

3. Members may also exclude from patentability:

 

(a.) ...

 

(b.) plants and animals other than micro-organisms, and essentially biological processes for the production of plants and 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. THIS PROVISION SHALL NOT APPLY TO PLANT VARIETIES AND ASSOCIATED KNOWLEDGE, WHICH ARE ESSENTIALLY DERIVED FROM MATERIALS AND KNOWLEDGE IN THE PUBLIC DOMAIN.

 

The first option has wider implications, as it allows countries to exclude all inventions based on biodiversity and related knowledge in the public domain from patentability. The second only offers that option with regard to the TRIPS requirement for IPR on plant varieties. Either way, no patent law would exclude inventions in the public domain as such. Technically, such inventions are not patentable since they are not novel. But by extending the non-patentability of materials and knowledge in the public domain to inventions clearly derived from them -- one level up -- one can try to diminish the space for biopirates to legally operate. It is a matter of raising the entry barrier for IPR, making the system more demanding of innovativeness for the corporate players. Thus it would broaden the unappropriable space called public domain. Further, it would use a concept of "essentially derived" innovation which is already accepted in international IPR law, namely the UPOV Convention of 1991.

 

In the 1991-revised treaty, UPOV introduced the concept of "essentially derived" plant varieties. These cannot get independent titles of plant variety protection. They are too close to previously developed varieties. They are not new enough. But in the world of patent law, novelty comes a lot cheaper these days. If the measuring stick of novelty is going up for breeders in countries that subscribe to UPOV, then they can go up for inventors under patent law too. Rather than spending time trying to revoke patents on biopiracy -- things claimed "new" in the North but based on long-time realities in the South -- maybe governments should agree to raise the stakes for innovation and broaden the sphere of what is not patentable to incorporate inventions too close to the public domain for comfort. UPOV can lend a hand in showing how to do this.

 

In the same spirit, India -- which has a lot of experience fighting against specific patents which have misappropriated Indian innovations -- is keen to revitalise and formalise the concept of "prior art" in patent law. [7] The point is essentially the same: to expand the borders surrounding what is recognised as lying in the public domain and hence being unappropriable by IPR. Prior art could include all forms of existing knowledge and raise the standards for when and where novelty is established in a patent application on an invention derived from biodiversity or indigenous knowledge developed in the South.

 

OPEN BIODIVERSITY-RELATED WINDOWS

Proposals to introduce special considerations for biodiversity into the WTO TRIPS Agreement have been sprouting forth since some time. There is an increasing realisation that the promotion of grassroots strategies is central to the conservation and sustainable use of biodiversity. It is also becoming clear that local communities need special rights, incentives and protection, if they are to play any role in stewardship and development of biodiversity within economically viable systems. Current IPR laws do little in this direction and in most cases undermine such rights. While much of the "community rights" momentum is being developed under the CBD's need to further articulate and implement Article 8(j), and through the FAO negotiations on Farmers' Rights, the TRIPS Agreement does offer a direct link to those debates: its very own Article 27.2.

 

TRIPS Article 27.2 allows WTO Members to exclude from patentability those inventions "the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality" (see the "Resources" section of this report for the full text of the Article). It further specifies, among other things, that measures to avoid serious prejudice to the environment may form part of this exclusion.

 

The WTO's Committee on Trade and Environment (CTE) has tried to look at interfaces between the WTO agreements and the CBD, but has fallen short of making substantial recommendations. Still, India -- the developing country most vocal in the TRIPS discussion -- has recently called on the CTE to reconsider the relation between TRIPS and the CBD, stating that TRIPS should be modified to remove inconsistencies with the CBD. [8] The WTO's first Ministerial Conference in December 1996 in Singapore already agreed to develop a common appreciation of how TRIPS relates to "the creation of incentives for conservation of biological diversity (...) including protection of knowledge, innovations and practices of indigenous and local communities embodying traditional life-styles relevant to the conservation and sustainable use of biodiversity."

 

In a meeting with NGOs called by the WTO Secretariat the following May, proposals were made to consider amending TRIPS to take account of the CBD provisions and specifically the needs of local communities who depend on biodiversity and related knowledge. As the report of this meeting states, "Different suggestions were made, including amending the TRIPs Agreement (...) to include precise references to biodiversity and environmental goals." [10] This last point is clearly a lead worth following.

 

Some NGOs are arguing that Article 27.2 should be amended to expand the provision related to "ordre public or morality" to ensure that it can encompass whole groups of patents, such as patents on life forms as a class. [11] The ethics angle is clearly a vital cornerstone in the battle against life patenting. Currently, the TRIPS provision on ordre public and morality can only be invoked on a case-by-case basis, subject to "necessity" -- it is not the patent or the invention that must be afoul of morality for the TRIPS exclusion to be applicable, but its commercial exploitation. Although a lot depends on how this article will be interpreted, rewording this provision to exempt patents on life would probably require lifting the "necessity" clause as well. That might be as tough a battle as expanding the exemptions, or sui generis space, under 27.3(b).

 

The TRIPS Agreement in full -- and hence Article 27.2 -- is not scheduled for review until the year 2000. Any blockage on the 1999 Review of Article 27.3(b) could reverberate negatively on this built-in schedule. One strategy could be to argue for the revision of both articles 27.2 and 27.3 together, as they are both clearly interconnected.