Document(s) 15 of 16

Viewpoint What is biopiracy?  Legalistic view Biopiracy refers to the appropriation of biological resources without the prior informed consent of the local people and/or of the competent authority of the respective state, for access and benefit sharing, under mutually agreed terms. With the implementation of national and international laws governing access to genetic resources and the development of sui generis IP laws for indigenous and local knowledge, biopiracy is becoming easier to identify in legal terms. When properly applied and enforced, IP will actually promote the objectives of the CBD by creating sustainable uses for biomaterials, providing the means for recovering value that can be fairly shared, and promoting technology transfer. This will not hinder traditional uses of biomaterials by indigenous and local communities. While patents are not benefit-sharing mechanisms, they can generate benefits that can be shared with indigenous and local communities through bioprospecting agreements, for example. Critical view The appropriation of genetic resources from Third World countries by private, often multinational companies and/or public institutions (or their intermediaries) from industrialized countries is a structural problem which reflects larger questions of equity — both historic and present-day. Biopiracy is not only a legal question, it is primarily a moral question. Even in those cases where companies or institutions follow legally binding rules on access and benefit sharing or sign bioprospecting agreements — it is still biopiracy, and that is because existing legal frameworks are inadequate to protect the rights of farmers and indigenous peoples. Patents and plant breeders’ rights are not benefit-sharing agreements. No plant breeder or genetic engineer starts from scratch when they develop a new plant variety. They are building on the accumulated success of generations of farmers and indigenous people. Biotech companies claim that they ‘invented’ their genetically engineered plants or new pharmaceuticals. In reality, they are fine-tuning and modifying plants that were developed by anonymous farmers and improved by the more recent contributions of institutional breeders. To claim exclusive monopoly control of these plants (or genes, or traits) is unjust and immoral.  Industry view Biopiracy is a highly emotive term. Knowledge and materials in the public domain may be freely used by anyone to make further advances: and such advances may properly be protected by IPRs, but only for a limited time. In those rare cases where it turns out that IP claims are based on indigenous knowledge or germplasm, such claims can be challenged and revoked — further evidence that the IP system is working effectively. Without strong IPRs, the world as a whole loses the wider dissemination of a useful technique, because no one will risk the necessary investment in the absence of IP protection. Real biopiracy is a serious and readily identifiable problem; it refers to the unauthorized use, multiplication or copying of privately owned innovations that are protected by patent or plant breeders’ rights. When farmers reuse patented seed without permission or payment of royalties, for example, that is piracy. To insure a level playing field, we need aggressive enforcement (and compliance) of the TRIPs agreement in all countries.

Viewpoint The basmati rice patent: biopiracy or invention? In September 1997, RiceTec Inc., a Texas-based company, was issued US patent no. 5 663 484, entitled ‘Basmati rice lines and grains’. Basmati rice has been grown in the Punjab region of India and Pakistan for centuries. Farmers in this region have selected and maintained basmati rice varieties that are recognized worldwide for their fragrant aroma and distinct taste. Right or wrong, the basmati patent has launched a firestorm of controversy.  Classic biopiracy RiceTec is capitalizing on the genius of South Asian farmers; germplasm is being pirated, as well as the basmati name. RiceTec’s US patent applies to breeding crosses involving 22 basmati varieties from Pakistan and India. The patent claims the invention of ‘novel rice lines with plants that are semi-dwarf in stature, substantially photoperiod-insensitive and high-yielding, and that produce rice grains having characteristics similar or superior to those of good quality basmati rice grains produced in India and Pakistan.’ The sweeping scope of the patent extends to such varieties grown anywhere in the western hemisphere! Specifically, the patent applies to breeding crosses involving 22 farmer-bred basmati varieties from Pakistan and India. These varieties were initially collected in the Indian subcontinent and deposited (among other places) in a US genebank. Not only does the patent claim genetic material that was developed by South Asian farmers, it also usurps the ‘basmati’ name — which is geographically specific to varieties grown in parts of India and Pakistan, just as ‘champagne’ is unique to France. Exports of basmati rice (worth $800 million per annum in India alone) could be threatened if they are forced to compete with ‘counterfeit’ basmati. The patent therefore jeoizes the livelihoods of thousands of Indian and Pakistani farmers who grow basmati for export.  No biopiracy The whole flap is based on a misunderstanding. RiceTec’s US patent protects the company’s seeds and breeding methods in the US alone, it does not patent or trademark the name ‘basmati’. The company has no claims on basmati rice anywhere in Asia. There is a misconception that RiceTec’s patent would prevent Indian farmers from exporting their product. This is not true. Basmati is a generic term. Just as durum refers to a class of wheat, basmati refers to a class of rice. Even if it were not, no country is obliged to protect it since neither Pakistan or India has legislation protecting geographical indications under the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPs), Article 24.9. The germplasm used for breeding RiceTec’s basmati rice came partly from publicly-operated gene banks in the US. The specific lines are identified in the patent and they are available to anyone for breeding purposes. The germplasm did not come from India; the basmati varieties claimed in this patent were developed using classical breeding over a period of 10 years. Even if the germplasm originated from India, the company simply used the varieties to create a novel product. This is not biopiracy; this is clearly an invention under US patent law! RiceTec’s basmati varieties are truly novel; for the first time it’s possible to cultivate high-quality, high-yielding basmati in the western hemisphere.

Viewpoint Terminating Terminator? Members of the Crucible Group do not agree on whether or not terminator technology could or even should be banned. There are different viewpoints on whether or not the public morality clause of TRIPs (Article 27.2) could be used to exclude terminator technology. GURT technology is not in conflict with the public morality clause of TRIPs It would be unfair to exclude a technology as a whole from patent protection, just because it may be abused for immoral purposes or may have negative side effects. Apart from that, the GURT technology can obviously be used for purposes that are perfectly moral — even beneficial — and do not violate the ordre public. Furthermore, to deny farmers the opportunity to make their own choice is restrictive paternalism, even if with good intentions.  The terminator technology is immoral The technology is intrinsically immoral and has been developed for no other purpose than to prevent farmers from replanting seeds. Given that the technology may even affect farmers who never used the terminator seeds, the technology should be banned. It is a positive sign that two major agrochemical corporations have made a commitment not to commercialize sterile seed technologies. However, we can’t depend on the goodwill and charity of corporations that may be acquired by another company next month. In order to discourage the development of similar technologies, governments should also ensure that their patent laws do not set any incentive to develop similar technologies. The monopoly control afforded by terminator technology goes far beyond patents and threatens national sovereignty. A patent is a time-limited, legal monopoly granted by a government in exchange for societal benefits. In the case of the Terminator, the biological monopoly is not time-limited, and is not necessarily approved by national governments.

Viewpoint Are the CBD and the WTO TRIPs chapter compatible? Leave it to national governments The two Conventions have been written carefully and, whilst dealing with different matters, both contain provisions related to the other one. CBD considers that intellectual property can be made supportive of its objectives. TRIPs excludes from patentability inventions that are contrary to the ordre public or morality, or those inventions that are dangerous to animal or plant life or seriously prejudicial to the environment. These are important safeguards.  Parties to both agreements must fulfill their obligations under both treaties and through thoughtful implementations there is no reason why they cannot do so without jeoizing the objectives of either.  TRIPs is in conflict with CBD TRIPs obligates members to adopt patents or sui generis systems for plant varieties, while CBD calls for the protection and promotion of indigenous knowledge, innovations and practices. Conservation and privatization are contradictory goals. Exclusive monopoly rights over biological products and processes restrict availability of genetic resources — and this is detrimental to food security and the wellbeing of local communities. Western-style IP regimes will promote uniformity and the introduction of new plant varieties that unintentionally displace farmers’ varieties. Patents are not benefit-sharing agreements, but are means by which the private sector, mostly in the industrialized world, is able to profit from the biodiversity that was conserved and developed by indigenous and local communities over millennia. The rights and objectives of the two treaties are clearly in conflict. Both treaties provide legally binding obligations for governments; which takes precedence? TRIPs supports CBD The slogan ‘patenting of life’ is emotionally effective but not accurate. According to the TRIPs Agreement, microorganisms which are living matter, must be patented. But TRIPs does not address the patenting of life per se, nor does it make it necessary for countries to patent higher life forms. That being said, TRIPs does require countries to implement effective sui generis protection (which is not as exclusive in nature as patents) for plant varieties. There is no inconsistency between private intellectual property rights granted for a well-defined invention, for a limited period of time, and the sovereign rights of nations over their biological resources.  If we want the private sector to be interested in developing new drugs, or new plant varieties from wild biota, it must have the possibility to protect the results of its work. Protection is the best trigger point for the sharing of benefits. Protection laws do not deprive local communities of continued use of their indigenous products and processes. The requirements for obtaining a patent are novelty, inventive step (non-obviousness) and industrial applicability (usefulness), and granting offices rigorously respect these criteria. Furthermore, indigenous knowledge may be the foundation on which a novel patentable process or product is developed. When this happens, industry believes that this must be acknowledged by the inventor and compensation should be provided for on mutually agreed terms, as required by CBD. Modern plant breeding is enhanced and promoted by IP legislation. The development of new plant varieties for food and agriculture increases biodiversity at the disposal of farmers. We can’t measure crop genetic diversity merely by a count of farmers’ varieties — as they are often very similar in terms of genetic background.

Viewpoint Did the FAO Commission satisfactorily resolve the issue of farmer plant-back?  No For the first time, the South abandoned the possibility of establishing Farmers’ Rights as an element of Human Rights and the Right to Food. By the tying of the right to save seed to national laws, the Human Rights of farmers have been taken away. Worse still, governments surrendered Farmers’ Rights largely by accident when they rushed a late-night decision they should have slept on. It’s not over yet Farmers’ Rights will come back on the table for further negotiation toward the end of the IU revision as governments weigh the plusses and minuses of the whole accord. Then, or sooner, governments can propose that elements of Farmers’ Rights be regarded as Human Rights.  Yes For the first time, the right of farmers to save, use, exchange and sell farm-saved seed is affirmed in the strongest possible terms in an international agreement. Of course, this right is subject to national law since only national law can protect farmers within a country, in accordance to national priorities and needs. The FAO Commission doesn’t even have the mandate to discuss and/or negotiate Farmers’ Rights as an element of Human Rights.

Viewpoint Is the FAO-CGIAR Trust Agreement satisfactory? Trust the breeding community Despite decades of efforts to prove otherwise, the incidents of PBR or patent abuse or other forms of so-called ‘biopiracy’ represent an infinitesimal portion of the flow of germplasm and of breeding work. Instances where real commercial gain has resulted from dubious practices are still more unusual. Rather than devoting scarce resources to the pursuit of alleged ‘pirates’, we should be building trust within the international breeding community and encouraging the most unimpeded flow of germplasm possible. Any new arrangement must, first and foremost, strengthen the international public good associated with the fullest and freest possible gene flow. Responsible Trust After decades of unsung and costly work conserving agricultural biodiversity leading to the world’s largest and most secure storage of unique crop germplasm, the CGIAR established a Trust Agreement with the intergovernmental community through FAO. Policy oversight now rests largely outside the CGIAR but the financial and material burden still remains with IARCs. It is time governments shouldered their full responsibilities and secured the future of these collections permanently. Maintain the principles — strengthen the Trust Two steps are needed: First, full legal ownership of the CGIAR collections should be transferred to the intergovernmental community through FAO. Second, a revised Trust Agreement (between FAO and governments) should define germplasm broadly, to include all elements of germplasm such as genes; and reaffirm that all of the germplasm encompassed by the trust accessions must remain in the public domain and cannot be privatized. The amended Trust Agreement should be incorporated into national laws, so that governments enforce it.

Viewpoint What about the CGIAR’s pre-CBD material? Waiting for a final solution The CGIAR–FAO Agreement has to be understood as an interim step pending the revision and completion of the FAO’s International Undertaking. The legal status of the CG’s centres collection remains to be clarified and the centres should claim no property rights on the material in interim phase. At the present time, the centres also have no right to transfer their ownership to any entity. The collections must be managed as if they are part of a governance system which is still being defined by the International Undertaking and subject to the principles of the CBD as appropriate. No change Since the CBD has offered no solution to the question of germplasm collected and exported prior to its coming into force, the situation remains as it has always been. Unless there is a general agreement on universal repatriation of all germplasm from all sources (which seems impractical), it is difficult to understand why the world community would agree to repatriate germplasm that is being held for everyone’s mutual benefit — especially given the difficulties in identifying the origin of much of the material. Repatriate The collection location of the majority of the germplasm in the CGIAR gene banks is known. Given the principle of sovereignty reaffirmed by the CBD and its recognition that pre-CBD collections are an unresolved issue, the resolution should logically be for IARCs to accede to the wishes of the governments involved and to repatriate the known material if requested to do so.

Viewpoint Is the CBD a useful forum for advancing the rights of indigenous peoples? One step forward The CBD is a legally binding document, unlike the Draft UN Declaration on the Rights of Indigenous Peoples, which is a ‘soft’ law. Article 8(j) is a victory for indigenous peoples because it acknowledges the need to promote and protect the knowledge of indigenous peoples in biodiversity conservation and sustainable use. Since it is legally binding, contracting parties are required to comply with its decisions. Indigenous peoples have to monitor closely how their governments are complying. While the implementation of Article 8(j) will not comprehensively address indigenous peoples’ issues, it is already a major building block in the struggle for indigenous peoples’ rights and self-determination. Two steps back CBD is a distraction from the bigger issues of territoriality and human rights. The CBD is not of much use to indigenous peoples because it is based on the principle of national sovereignty. And it emphasizes the commodification of biological resources under the guise of an environmental treaty. The de-contextualization of biodiversity from culture and rights to territory must be challenged. The Draft UN Declaration on the Rights of Indigenous Peoples enjoys broad support from indigenous peoples and it is the most comprehensive articulation of indigenous peoples’ rights — including the right to have control over territories and resources. This is the framework upon which all other rights should be based. Indigenous peoples should not be distracted from their focus of ensuring that the Draft Declaration gets adopted by the UN.

Viewpoint What should be indigenous peoples‘ representation at the CBD?  Driver‘s seat  Indigenous peoples should be recognized as full parties to all international fora addressing their concerns (especially but not exclusively the CBD), because only then will their interests be protected and promoted. Governments cannot adequately represent indigenous peoples’ interests because, in most cases, they are the key violators of indigenous peoples’ rights. The main reason why indigenous peoples bring their concerns into the international arena is that they are ignored and marginalized at the national level. The imperative for governments and the international community is to recognize and promote the rights of indigenous peoples. Back seat Indigenous peoples can be represented in various ways: Governments shall include indigenous persons in their delegation; They shall attend as observers with participation in the widest possible extent in the deliberations; Secretariats can choose indigenous peoples who will be considered as experts and they could become members of a subsidiary body. However, they cannot be parties to treaties and will be regarded as observers just like all non-state actors. Indigenous peoples can widen the space given to them once they are inside. Thus, even if this is a back seat, it still provides an opportunity where indigenous rights can be advanced.

Viewpoint Is intellectual property protection for indigenous knowledge and rights appropriate? Not appropriate The notion of retroactive protection for old ideas that may, or may not, have originated from one or more communities (or even countries) is absurd. IPRs has always offered a limited monopoly for new ideas. In general, ideas that have already been commercialized, or even published, cannot be protected. If protected, the protection lasts only for about two decades — not two millennia. We’ll have the discoverers of indigo dye suing Leonardo da Vinci for the Mona Lisa while the descendants of da Vinci sue Madonna for trademark infringement! Legal recognition of knowledge is always appropriate Ideas and/or the expression thereof should be protected, irrespective of their being originated by indigenous and/or local people or multinational corporations. The legal regimes may be differentiated, in order to be adapted to their respective subject matter, but the economic and ethical principles are the same. Evolutionary innovation  No one is trying to patent fire. Modern IPRs are merely acknowledging that different forms of innovation can exist and that, with respect to biological materials, individuals and communities are continuing to innovate medicines, preparations and agricultural varieties. ‘Evolutionary innovation’ implies that each generation of the bio-material has been improved over the previous generation in the same way that a commercial breeder establishes a key cross and then develops successive varieties from the cross over many years. The levels of protection for these different levels of innovation can also vary significantly. Intellectual integrity — no exclusive monopoly The task is not to protect specific communities but to safeguard the free flow of ideas and biological resources within global society. Therefore, intergovernmental bodies must ensure the intellectual integrity of those who claim innovations. Such persons must be able to ‘prove’ beyond reasonable doubt that they have actually contributed something new and useful to humanity. Under no circumstances should inventors be allowed exclusive monopoly over their inventions for any period of time. Life forms should not be subject to exclusive monopoly claims. After all, these are not inventions but discoveries.

Viewpoint Can TRIPs’ public morality exclusion be used to reject patents on life forms or controversial new technologies such as genetic seed sterilization? Inventions the use of which is necessary to be banned may be excluded TRIPs does not require an actual ban of the commercialization of an invention as a condition for its exclusion from patent protection; such a ban only has to be ‘necessary’ to protect ordre public/morality. Otherwise, many inventions, especially those nobody had thought of before, and which therefore are unregulated would pass the morality test, whether their exploitation ought to be prevented or not. It’s a non-issue Patents give a right to exclude others from using the patented invention without the patent holder’s consent; they give no positive right actually to use an invention. Patent law and lawyers should therefore not have to deal with the morality of an invention. Whether an invention may be used or not should be left to other fields of law, such as biosafety legislation. No rewards for immoral inventions It is said that patents are intended to act as incentives for intellectual efforts, for financial investments and as reward for the disclosure of knowledge that would otherwise be kept secret. Patent law should not reward immoral inventions. It should not reward the disclosure of knowledge about such inventions. And states should not set incentives for the development of such inventions. Inventions the use of which is not banned must not be excluded The TRIPs Agreement prohibits WTO members from refusing a patent for an invention whose application, or at least commercial exploitation, is not even prohibited by their national laws, such as biosafety laws. Even if prohibited under these laws, the exclusion must not be made merely because the exploitation is prohibited.

Viewpoint Should farmers’ varieties receive intellectual property protection? Well worth doing A class of protectable subject matter can be drawn up with clear guidelines that define a plant variety. A broad or narrow definition of the term would be determined by the extent and type of protection to be conferred. By providing for a broad definition of a plant variety, narrow limits would then be set for the level of protection. At the very minimum, varieties would need to be sufficiently distinguishable and describable in order to be eligible for protection. Varieties that satisfy a stricter criterion would qualify for stronger and/or longer protection. Possible but at what cost? The intention is commendable. But the actual task of drawing up a class of protectable subject matter is formidable. Laws can be written but must be enforceable. How wide should the definition of a variety be, so as not to disenfranchise any farming community and still be an incentive to innovation and conservation? Should all species that contribute to food and agriculture be considered or should species be limited to those considered vital for food security? Would the implementation of such a system overburden the appropriate authorities? Pointless This system must strike the right balance between the creation of new varieties and their spread, two inherently conflicting objectives. Bigger incentives and stronger rights lead to more innovation. This would, however, lead to a narrow definition of a variety with the risk of not covering farmers’ varieties. A wider definition but weaker rights would, at best, prevent misuse and misappropriation of farmers’ varieties but not provide any incentive to ensure food security and improve agricultural productivity, neither would it help conserve and create agricultural biodiversity.

Viewpoint Patenting life forms? No life patenting It is a corporate world: multinationals generally get what they want and governments do little to protect the interests of ordinary citizens. Living materials are not inventions. In the current scientific and commercial environment, any intellectual property for any form of living material will inevitably evolve into patent monopolies over every form of life. The line must be drawn as clearly as possible. TRIPs should forbid all patents on elements of life: as a minimum it must drop its requirements for protecting plant varieties and microorganisms. Steady as she goes The provisions of Article 27.3(b) of TRIPs have yet to lead to any of the disasters that some foretold. However, experience with the system has so far been short. Provisions for patenting plants and animals arouse strong emotions, and even supporters acknowledge that not all problems have yet been sorted out, even in developed countries. It is too early to make further extension compulsory. Move with the times Scientific and technological advances drove the economic progress of the 20th century. Intellectual property is as important now as physical property was in the past. IP in all areas is essential to fund further advances. Inevitably, the broadening of innovation to biological resources creates complication and uncertainty, but these are transitional problems quickly overcome. There is no logic to retreating into history. TRIPs must be strengthened to require strong patent protection for all new and inventive biological materials. All the exemptions of Article 27.3(b) should be eliminated.

Viewpoint CGIAR and intellectual property Pursuing IP  Proprietary science has profoundly changed publicly-funded agricultural research, and access to and exchange of genetic resources. More than 70% of cutting edge agricultural biotechnology is produced and controlled by the private sector, and those technologies are central to the goal of increasing food production. In order to gain access to relevant technologies, the IARCs need to develop partnerships with the private sector and participate proactively in global IP regimes. The IARCs need ‘bargaining chips’ so that they can begin to trade patented technologies with the private sector. New technologies that emerge from IARCs must be protected to ensure that they can be used for the benefit of developing country NARS and poor farmers. IP agreements are the key to facilitate commercialization and technology transfer. In the future, they may even become a source of revenue for CGIAR (though this is much less important than ensuring access to and use of the technology). Defensive use of IP  Most of CGIAR’s work is achievable without a major shift of emphasis toward the use of proprietary science. However, the CGIAR must seek and defend IP for innovations in those cases where it is necessary to prevent their appropriation by private claimants, and to ensure that they remain in the public domain. The important thing is not to lose sight of the primary mission: to serve the poor. In light of declining budgets, CGIAR must carefully weigh the substantial costs of increasing its capacity to manage IP against competing needs. CGIAR should take a cautious role in advocating IP for biological materials. It would be useful for CGIAR to campaign for a clearer definition of the research exemption under patent law, for example. All of this can be done without compromising CGIAR’s mission to produce international public goods. Rejecting IP CGIAR should avoid proprietary science because it has little or no relevance to its mission of alleviating hunger and poverty, and it will distort the CGIAR’s mandate to serve poor farmers. IP will become a barrier to accomplishing the CGIAR’s mission. IP claims on biodiversity often appropriate the resources and knowledge of farmers and indigenous people. Proprietary science is already inhibiting the open exchange of genetic resources and knowledge, and it has a chilling effect on agricultural research and innovation. Filing patents and defending them is expensive, and it will take already scarce resources away from agricultural research. Instead of forging commercial partnerships with the biotech industry for capital-intensive technologies that promote industrial monoculture, IARCs should instead focus on building partnerships with resource-poor farmers, and make use of indigenous knowledge in local agro-ecological systems. CGIAR should take a clear position against all IP agreements.

Document(s) 15 of 16