Patented Past, Genetically Modified Future? Biotechnology and Developing Countries

Andrés Guadamuz González

Lecturer in E-Commerce Law,
University of Edinburgh

aguadamu@staffmail.ed.ac.uk

Summary

This article deals with some of the problems occurring in relation to intellectual property protection of biotechnology in developing countries.

Contents

Introduction
What is Biotechnology?
Legal Protection for Biotechnology Products
A Legal Void at The Frontier of Technology
Biotechnology and Developing Countries

Biopiracy: Patented past
Genetic modification: Patented present
Genomics: Patented future
Do developing countries need biotechnology?

Looking For Solutions

The existing framework
Some possible solutions

Conclusion
Glossary (From Wikipedia

Introduction

The issue of biotechnology and its interaction with the law has been gaining momentum in legal scholarship in recent years (Grubb, 2004). With the growing importance of the biotechnology field to the economy, the protection of biotechnological research has become a hotly debated topic, even catching the attention of mainstream media.  The intellectual property questions raised by biotechnology would seem to be initially straightforward. Should there be patent protection for life forms? If so, are there restrictions and exceptions with regards to the specific types of protection awarded? However, the questions are not as easy to answer as it could be imagined. It has become clear that many see unlimited patentability of biotechnology as a problem that goes beyond the legal technicalities of protection, and have wider moral implications with regards to ownership of life, and the origin of the patented materials. The moral and policy issues raised make this field not only a potential legal minefield, but also a topic that raises emotional responses.

Since the implementation of the Agreement of Trade Related Aspects of Intellectual Property (TRIPS) more than ten years ago, there has been a serious push for stronger international intellectual property protection. It is sometimes argued that the implementation of this model benefits developing countries by encouraging investment and by bringing poor economies into the global market – something that cannot be achieved without the enactment in those countries of legal protection of technology (DeLong, 2002). However, critics of this view argue that there needs to be more evidence that a stronger system of international intellectual property for developing countries will have detrimental effects on technology transfer efforts (Correa, 2000).

This article deals with some of the problems relating to  intellectual property protection of biotechnology in developing countries. The article does not pretend to present an exhaustive study about the subject (Dutfield, 2003), but to provide an introduction to the problems faced by developing nations. There are several circumstances in which this is of immense relevance for the international community. On the one hand, there is the case of genetic material originating from the developing world being catalogued, and in many cases patented, by firms from developed countries. On the other hand, we have the science of the future, the cracking of the human genome, the advent of genetic modification of organisms, and the patenting of applications of the knowledge acquired from the genetic code.(1) Developing countries are then caught between these two, with intellectual property as the mechanism that locks away this technological knowledge. With the patenting of traditional medicines and plants, they see their past being taken away. With the patenting of the application of genes and genetically modified organisms, they see their future taken away as well.

The more we are able to understand the shaping of our genetic makeup, the more we will be able to create medicines that will tackle specific health problems, identifying from birth potential genetic illnesses. And as we continue to understand this genetic makeup, the issue of the use and misuse of such information will be at the forefront of the debate. But the ethical issues have some explicit legal implications, with intellectual property located at the very heart of the problem.

What is Biotechnology?

Biotechnology is a combination of several disciplines in the wider area of the biological sciences. According to the Encyclopaedia Britannica, biotechnology is “the application to industry of advances made in the techniques and instruments of research in the biological sciences.” This covers a wide range of fields, from genetic manipulation, fertilisation and the application of the discovery of new species. In a similar manner, the Oxford English Dictionary defines biotechnology as “The branch of technology concerned with modern forms of industrial production utilizing living organisms, esp. micro-organisms, and their biological processes.” A much broader definition comes from the glossary of the Biotechnology Industry Organisation (BIO), which defines biotechnology as “The use of biological processes to solve problems or make useful products.” This definition in particular is so broad as to be useless, as any biological process application could be defined as biotechnology, including the use of pesticides or fertilisers.

There would appear to be a common denominator with these definitions, and that is the concept of manipulation or application of technical knowledge to biological material. This is consistent with the many definitions of technology that exist. By using the definition of technology in the context of biological products, one could define biotechnology as the systematic application of scientific knowledge in a biological process. This definition is the one that will be favoured in this work.

By reading the stated definitions, one may still question whether there is any distinguishing characteristic between biotechnology and any other sort of biological manipulation, such as agriculture. The important distinction here would then be to include in the definition the qualification that such application must not be about a natural process, but about a technical one. The European Directive on the legal protection of biotechnological inventions(Directive 98/44/EC, 1998, henceforth Biotechnology Directive) offers a basic distinction for what should be understood as a natural process, as opposed to a technical one. Art.2.2 of the Directive states, “A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.”  Hence, any biological form produced from a natural process would not be considered biotechnology. This definition then would play with the general distinction of technologies into high-technology and low-technology (Feenberg, 2002). Biotechnology, under this premise, would consist only of advanced technological use and manipulation of biological material, while low manipulation would result in low-technology, such as agriculture. This seems straightforward enough, but in practice it still presents some difficulties. It seems that most definitions of biotechnology do not include the protection of new plant varieties in their definition, as a plant variety is usually the result of a natural process as defined above. Most literature deals with the areas of plant varieties, biotechnology, traditional knowledge, and farmers’ rights as completely separate entities (Commission on Intellectual Property Rights, 2002). Along this line, the European Community Regulation on Plant Variety Rights (Council Regulation, 1994) defines a plant variety thus:

That definition would certainly exclude plant varieties from the field of biotechnology, yet they may still be grouped together for legal purposes, as they are subject to similar sets of rules. It would seem that despite the definition requirements, it would be useful to consider plant variety rights within the wider definition of biotechnology because the identification of these plants requires the application of technical knowledge, and in many instances these plant varieties are used for biotechnological applications. For the purpose of this work and to avoid having to deal with these important subjects separately, plant varieties will be considered as biotechnological products as well, and hence, as high-technology products (Helfer, 2002).

Legal Protection for Biotechnology Products

Having defined biotechnology, its relevance to developing countries may become clearer. Biotechnological products are subject to intellectual property law, and as such, they are relevant to the issue of access to technology by developing countries. These connections will be discussed later, but firstly, the type of protection given to this area of technology must be discussed in order to understand how it is a relevant issue for developing countries. 

It would not be difficult to assume that intellectual property protection for biological entities is a relatively new development. In fact, there is a long history of the allocation of patent protection for living organisms. The first recorded patent of a living organism took place in Finland in 1843, and there is a patent for isolated yeast in the United States that dates from 1873 (Westerlund, 2002). However, a mere living organism does not fit within the definition of biotechnology discussed. Under that definition, the first case of the allocation of intellectual property protection of biotechnology research came in 1980 when the United States Supreme Court allowed the patenting of engineered bacteria capable of breaking down crude oil, a property that no existing living organism possesses (Diamond v. Chakrabarty, 1980). The patent had initially been denied by the United States Patent and Trademark Office (USPTO) because it was believed that living organisms were not capable of being patented by a strict reading of existing American law, which stated that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent” (Title 35 U. S. C. § 101.). However, the Supreme Court held that an engineered micro-organism should be considered as a “manufacture or composition of matter” for all legal effects, as it did not occur in nature and was the result of human manipulation. This decision opened the floodgates for the protection in the United States of all sorts of biotechnological research, a process that continues to the present day. Further to that ruling, the USPTO has established the principle of “utility” of a patent application to warrant protection. This principle comes from the interpretation of the word “useful” in Title 35, and it is held by three subsequent tests that must be met by an application, which must show credible, specific and substantial uses for the invention (Westerlund, 2002).

Other jurisdictions have some limited protection for biotechnological research, but to a lesser extent than that observed in the United States. In Europe for example, the issue of biotechnology patents has been extremely controversial, creating legal uncertainty in many instances. The main problem with this was the passing in 1973 of the European Patent Convention (EPC), a legal instrument designed to ease the application and enforceability of a European-wide patent system. Article 53(b) of the EPC says that no European patent will be granted in the case of

This prohibition was then incorporated, almost unchanged, into the legislation of the signatory states.(2) The wording of the Convention and national legislation created several problems for the European Patent Office (EPO), as it became evident that the courts and regulatory bodies were producing conflicting interpretations of this prohibition. For example, the Board of Appeals of the EPO found in two occasions that plants were indeed patentable if they were produced or bred by a patentable process (T49/83 OJEPO 3/84; and T320/87 OJEPO 3/90). However, another board of appeals found that different plant varieties would not be patentable, even after manipulation (T356/93 OJEPO 8/95). These apparent contradictions prompted a couple of decisions by the Enlarged Board of Appeals in trying to bring together both interpretations. In 1995, the Enlarged Board found that there was no conflict in this issue as both boards had been requested to make completely different decisions in the aforementioned cases (G3/95 OJEPO 1996/169). Nevertheless, the Enlarged Board later found that certain plant varieties were indeed patentable, contradicting earlier decisions (G1/98 OJEPO 2000/111). To further complicate the issue, a large number of countries consider plant varieties to be subject to diverse rules other than patenting, such as the United Kingdom, where plant varieties are protected by the Plant Varieties and Seeds Act 1964. According to this legislation, distinctive plant varieties bred or discovered are granted a proprietary right not exceeding 30 years (Bently and Sherman, 2004).

To address all of these issues, the European Union passed in the year 2000 a new directive to harmonise the patentability of biotechnological products, the Biotechnology Directive, from which the definition applied here is drawn. The rationale behind the Biotechnology Directive is that the patenting of certain biotechnology products is in the best interest of the European Union because it serves as an incentive to advancement in this field. The need for an incentive is linked to the fact of large investments, the argument being that the firms involved require some means to recover them. The Directive’s most important contribution to the debate of patentability of biotechnological advances is that it establishes clear guidelines at a European level for the type of biotechnology creations which will be subject to patent protection. Towards this, Article 3 of the Directive specifies that:

1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.

This clause makes it clear that the required element for patentability at the European level will be that of manipulation or technical processing at some stage of the process of the material, regardless of its origin, and regardless of whether this material is biological or not. This rule eliminates the existing confusion about the application of the aforementioned provisions. The Directive also specifically allows for the patenting of the technical application of elements isolated from the human body, or such elements reached from a technical process, including gene sequences. This is compatible with the general rule established in Art. 3. These protections are extended to derivative products obtained from these elements, even if they have been obtained by natural means. The Directive is also useful in establishing what products will not be patentable, these include:

The European Parliament has also passed a community regulation to address separately the issue of plant varieties in the shape of the aforementioned regulation on plant variety rights (Council Regulation, 1994). Plant varieties are not patentable according to the Biotechnology Directive, but they will be subject to a sui generis industrial property right.  The regulation establishes that to be granted protection, the plant variety must be distinct, uniform, and stable (IPR Helpdesk, 2005).

There are additional international mechanisms relating to the subject of plant varieties. The main one is the International Union for the Protection of New Varieties of Plants (UPOV), which was created in 1961 by the International Convention of the same name. The Convention establishes a new intellectual property right for the protection of new plant varieties. Several later amendments have extended the protection awarded to new plant varieties to new breeds that have been created later using the protected variety (there are three amendments to this, in 1972, 1978 and 1991).

A Legal Void at The Frontier of Technology

From what has been discussed so far, it has become evident that biotechnology products are indeed protected by intellectual property legislation in a large number of cases in which manipulation of biological material can be proven. However, the epicentre of the debate appears to be at the frontier of the most recent advances in this field of research. This includes areas such as genetic modification, the cataloguing of the human genome, stem cell research, and cloning. It would seem that in some of these areas the level of intellectual property protection is not entirely clear.

Biotechnology is an issue that generates highly charged emotions from different sectors of society. The idea of humans manipulating biological materials for different reasons greatly resonates with a technophobe streak in our society. It seems that society is more willing to accept technology in the shape of cars, telephones and mobile phones than to accept cloning and genetic manipulation. Irrational fears are vocalised when talking about these subjects. Furthermore, the religious implications of the debate cannot be underestimated; after all, the fear of humans playing God is one of the oldest technophobic fears present in Western culture.  Nevertheless, familiarity with the technology seems to generate acceptance. In-vitro fertilization (IVF) was considered immoral when it was first proposed, but it is now a common feature of modern reproductive medicine. It could then be argued that the more familiarity there is with a biotechnological practice, the more likely it is to be the subject of protection. But this has not yet been truly achieved by some of the newest developments mentioned, evidenced by the dubious state of protection awarded to them.  

The line between protection and illegality has been crossed already in the area of the genetic modification of organisms – the most developed area of genetic research at present. From reading the rules in place in the United States and Europe in regards to biotechnology protection, it seems evident that the patenting of genetically modified organisms presents no problem at all for biotechnology companies, as there is certainly an element of manipulation that warrants protection in most cases. Despite some of the apparent differences in treatment of the protection of biotechnological products, there appears to be a unifying characteristic that would make the patenting of gene modification possible. The available data supports this analysis. In Europe, the EPO had received a total of 30,000 biotechnology patent applications between 1998 and the year 2002, of which 10,000 were applications for genetically modified organisms (OECD, 2002). There are no full figures for the United States, but there are already hundreds of patents for genetically modified organisms, protecting everything from modified cotton to soy beans, one of the largest commercial successes of Monsanto (Charman, 2001). It must be noted however, that it is difficult to find any unbiased information in the area of genetic modification, with the environmental camp against it and the biotech industry for it. The U.S. Supreme Court has also recognised that genetically modified organisms are subject to patentability in J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred International (J.E.M. v. Pioneer, 2001), forcing the debate of the patentability of biotechnological organisms further ahead.

It would seem from a cursory application of patent rules that there is no problem with the patenting of genetic modifications. The line starts to become blurred when there is no manipulation of the biological material, and what is being claimed is the simple patenting of gene sequences. It is in this area where some of the debate becomes more heated, and the legal solutions would seem to be different from one country to another. Most jurisdictions apply the “purification” concept (Merges and Nelson, 1990) in an attempt to establish which biological processes are patentable and which are not. At the heart of this concept is the distinction between purely natural phenomena and those in which human intervention is required. The application of “purification” by human means of a naturally-occurring phenomenon would be accepted if such purification allows the biological process to become of some utility, and therefore patentable. The purification concept seems to be embraced by patent offices around the developed world, evidenced by the steady increase in the application for the patenting of modified genetic material. The Nuffield Council on Bioethics (NCB) defines this concept thus:

This would appear to be straightforward, as the identification of some biological material or process may take a great amount of manpower, pushing the justification for patentability because of the investment required for the identification. This would certainly appear to be the case in the identification of Deoxyribonucleic Acid (DNA) sequences and the further claim for patenting.

The application of the purification concept is evidenced by the increase in the patenting of non-modified genetic sequences in the United States. By 1991, the USPTO had received 4000 applications for these types of patents. By 1996, the number had increased to 500,000 (Enriquez, 1998). The patenting of the human genome has received similar protection in the United States, as the figures for human DNA sequences indicate. Data gathered by researchers in 1995 stated that there were 652 patents of human DNA sequences filed worldwide in that year alone, mostly in the United States and Europe and mostly for product patents (Thomas, et al., 1997). Interestingly, almost 40% of those patent applications came from the public sector, mostly from universities and medical institutions. By 2001, the race for the patenting of the human genome had become a fully fledged competition. Four of the main biotechnology companies (based in developed countries) had applied for more than 20,500 human DNA sequences, and had been awarded 772 patents in the United States alone (Malakoff, 2001). This is a remarkable figure if one considers that the human genome is thought to consist of 35,000 to 45,000 gene sequences (Pearson, 2001). It must be pointed out that this data does not include Celera Genomics, one of the main participants in the human genome project. By 1999 this company had applied for the patenting of 6,500 human gene sequences, and hoped to be awarded from 100 to 300 patents (Parliamentary Office of Science and Technology, 2000).

The number of these “purified” patents in the United States has not gone unnoticed, and it has prompted some action from the USPTO to attempt to curb some of the more frivolous applications by enhancing the utility requirements for patents (USPTO, 2001). Under these new guidelines, the applicant of a biotechnology patent must show that there is a specific use for the gene sequence, which would in theory stop companies from patenting a sequence as soon as it has been isolated. This brings the United States closer to European standards of patentability, where a similar requirement for utility applies. The Biotechnology Directive and European case law clearly allow for the patenting of gene sequences if a specific technical use can be found for them (Straus, 1995). This is a principle that has been clearly applied by the local patent authorities around Europe. The UK’s Patent Office for example, points out that although the Biotechnology Directive does not allow the patenting of the simple discovery of the human body, nevertheless “an element isolated or otherwise produced from the human body by means of a technical process may be patentable even if the structure of that element is identical to that of a natural element.” (UK Patent Office, 2002).

It is important to point out that there are several different types of DNA sequences, and the type of protection they receive may well depend on the type of sequence that is the subject of the application. Most gene patent applications are for full gene sequences, which would appear to be consistent with the application of patent law mentioned above. However, there has been an increase in the application for the patenting of partial sequences in the shape of Expressed Sequence Tags (ESTs) and Single Nucleotide Polymorphisms (SNPs). Because they represent only partial sequences, they are much smaller than full ones and hence much easier to identify. Several companies have been trying to patent both of these in an attempt to have control over the whole gene once it is identified (Flattmann and Kaplan, 2001). It is needless to say that this has been met with justified opposition by those who believe that human sequences should be left as unprotected as possible(HUGO, 2000), an argument that is certainly justifiable as the main purpose of these patents appears to be to claim a stake in the patent race.

Although the patent rules are moving towards the necessity of human manipulation or selection for patentability, there is wide misunderstanding amongst the general public regarding the application of these rules. Public outcry is often incensed by commentators claiming that corporations are “patenting genes”, as though whole parts of our bodies are being placed under intellectual property protection.  For example, political commentator George Monbiot states that “New global trade rules have also allowed big corporations to patent crop varieties and, in effect, the genes of plants, animals and human beings. This has grave implications both for food security and the accessibility of medicines.” (Monbiot, 2002) This is an oversimplification of the issue of the patenting of un-modified genetic sequences that does not help the debate; it only serves to blur the distinctions of protection in the mind of the public.

The protection of biotechnology has not gone far enough down the road of familiarity so as to overcome the general fear of cloning and some other biotechnology products, which could be considered one of the last frontiers of biotechnology. The cloning of animals brought the subject to the forefront in terms of the ethical consequences of biotechnological research. Furthermore, the almost inevitable prospect of the cloning of a human being still receives renewed calls for the banning of cloning altogether. Nevertheless, it is clear that cloning techniques are not patentable under present rules, mostly because of ethical or public order provisions. An example of this is Art. 53(a) of the EPC, which contains a clause disallowing patenting for reasons of “ordre public”. As has been mentioned, Article 6(2) of the Biotechnology Directive specifically excludes cloning from patentability. Even the TRIPS agreement contains prohibitions against patenting to protect public order or morality, or to protect humans, animals and the environment (TRIPS Agreement, Art. 27(2)).

However, broad morality clauses are generally contested amongst intellectual property experts as a difficult way to create patentability exclusions. Byeleved et al list several reasons for opposition towards the application of morality exclusions. Some of these are utilitarian, like the existence of a supposedly competitive disadvantage between countries where this clause exists. Other objections are that morality standards are difficult to judge, and patent officers are not the right people to make those judgments (Beyleveld, et al., 2000). The authors point out that although this is a difficult area to regulate, morality exclusions can be adequately covered by patent law under the right circumstances and applications. These laws, however, should strive to make these exclusions specific when possible, avoiding the use of broad language (Beyleveld, et al., 2000). 

It will be interesting to follow the development in this field to see if these prohibitions will remain, or if it will be possible for the public to become so familiar with cloning that it will be awarded protection as well. 

Biotechnology and Developing Countries

Having dealt with the type of protection awarded to biotechnology products in the developed world, the importance of the field of biotechnology for developing countries should be made clear. If the results from biotechnological research are subject to intellectual property protection, it makes those benefits expensive for developing nations, particularly Least Developed Nations (LDCs). This could have tremendous effects on the efforts of these countries to acquire vital technology in order to compete in a global economy. If one looks at the protection of technology through patents as an ultimate goal in society in order to promote innovation (Kesan and Banik, 2000), then expensive biological research must be included in this social contract. But the award comes with a licensing price tag for those societies that cannot afford the fees, creating a vicious circle of poverty that enhances the existing technological gap between developed and developing societies. It is of the utmost important then to try to envisage a system in which intellectual property protection and the access of developing countries to the benefits of technological innovations coexist. However, when one looks at the practical applications of the patenting of biotechnology, it becomes clear that this is easier said than done.

Biopiracy: Patented past

The world is filled with different species of life. This huge variety of living organisms is what we know as biodiversity (Smith, 2001). It is a fact that warmer zones contain greater depth of biodiversity, and most of the areas with the greatest biodiversity can be found in the developing world, with countries like Brazil, Malaysia and Costa Rica boasting a large percentage of the world’s biodiversity in their rainforests. The cataloguing of such biodiversity has just begun with the establishment of several biodiversity centres in key locations, dedicated to categorising the immense amount of animal and plant varieties in these countries. Within such a large number of newly catalogued species, there are likely to be some key resources, that is, plants and animals that may hold medicinal powers or that may enrich our understanding of the life sciences, hence producing considerable benefits. One could argue that modern pharmacology is a continuation of the ancient tradition of searching for cures in plants. Coupled with this, many indigenous people have been using some of these traditional medicines for generations, and among these, there may be medicines that could be used all around the world (Posey and Dutfield, 1996). The search of these potentially profitable plants or animals has prompted several pharmaceutical companies to spend relatively small amounts of money in looking for possible sources of new medicines in the rich (in biodiversity terms) areas located in developing countries (Zebich-Knos, 1997). This has led to the possibility that traditional knowledge from developing countries could make its way to developed nations, where it would be converted into a medicine and then shipped back and sold at high prices in the same countries where it was originated. It can also create problems for countries wanting to export medicines or plant varieties derived from traditional knowledge and based on plants that can be found in those countries, as they could find that these innovations are already protected in developed countries under patents (Stenton, 2004). Some commentators have named this phenomenon “biopiracy”. Indian ecologist Vandana Shiva uses this definition:

The awareness of biopiracy has increased in recent years, particularly the bio-prospecting of plants and remedies in China and India. Shiva lists numerous examples of biopiracy in India, but perhaps one of the most indicative cases is that of the plant phyllanthus niruri, used in India for many years for the treatment of jaundice and liver deficiencies. In 1985, the Fox Chase Cancer Center in the United States applied for a patent for the extract of this plant as a cure for hepatitis B, which was granted in US patent 4673575. Shiva argues that this patent is the exact same use that has been applied in traditional Ayurveda medicine, which would seemingly invalidate the patent because it lacks the novelty requirement. In 1988, the same centre applied for another patent for the use of the same plant as an antiretroviral medicine, which they also obtained (Shiva, 2001).   Another well-publicised case is that of a patent awarded for basmati rice in the United States. Basmati rice is an increasingly popular variety of rice that has been cultivated and used in India and Pakistan for generations. In 1997, a Texan company called RiceTec Inc. was issued with patent 5663484, in which they claimed that:

Needless to say, such a patent generated considerable publicity and was immediately criticised in many circles. How could a Texan company claim ownership of the ancient basmati rice? The outrage was such that the Indian government spearheaded a campaign to have the patent cancelled (Browne, 2000).  Eventually, most of the claims from this patent were either dropped by RiceTec or cancelled by the USPTO for the existence of prior-art in the application. The patent remains in a very limited form that protects only certain specific basmati varieties bred by the company (Shiva, 2001).

India is not the only country affected; there are several examples in other developing nations. In 1986, researchers from the University of Illinois found some chemical compounds in the bintangor tree, used by the native tribes of the western Sarawak in Malaysia. These compounds (named Calanolide A and B) have been identified as possible HIV inhibitors. MediChem, an American biotech firm, has obtained permission to research and potentially exploit these compounds, and a drug based on this tree is under clinical trials in the United States (Munan, 1999). Although there are plans to share some of the eventual profits of a drug from these compounds with other local researchers, if the drug makes it to the market there is no reason to believe that it would not be subject to the same pricing as drugs in developed countries, making it prohibitive for the developing world. Another case occurred in 1990, when American researchers working for the NIH collected genetic material from a Guaymi indigenous woman in Panama, supposedly with her consent, who was suffering from leukaemia (Laurie, 2002). Later on, these researchers filed a patent for the human T-Lymphotropic virus Type 2 extracted from her genetic material, because her cells were believed to contain antiviral properties. Although a complaint was placed with the United States government and the USPTO, the patent still stands(Acosta, 1994).     

Despite the examples above, there would appear to be a new trend against biopiracy in official circles, with many patents granted being cancelled for lack of innovation. In 1986, an American citizen filed and obtained a patent for the Amazonian plant Banisteriopsis caapi (ayahuasca), on the basis that it was a new plant variety of the species. This plant is considered sacred by many indigenous peoples in the Amazon region, and its patenting led to a series of protests from several NGOs and charity organisations connected with these people. After several years of struggle, the USPTO reviewed and cancelled this patent on the basis that it was not distinct or new, part of the legal requirements for patenting a plant variety under US law. However, some time after the patent was reinstated for its duration, although it expired in 2003 (Wiser, 2003).  Another blow for biopiracy firms came with the revoking of the European patent on a fungicide extracted from the neem tree, which has been used for generations by the population of India.  The patent still exists in the United States, which is also being challenged (2000). United States patent 5401504, held by the University of Mississippi Medical Center, protected the use of the powder from the turmeric plant for the healing of wounds. The problem was that this plant had been used in India as an herbal remedy for generations (Agarwal and Narain, 1996). When challenged, this patent was also cancelled because it was shown that this remedy was not original.

These cases seem to indicate that the trend in granting patents for pharmaceutical and farming products based on existing plant varieties and folk knowledge is on the decrease, and many patents in this sector are either under review or have been cancelled. This is a welcome and encouraging development in this field, and raises the question of whether the recent interest in biopiracy is misplaced. Indeed, several pressure groups are ceaselessly reporting cases of biopiracy without stating the many instances of these same patents being revoked. There would appear to be a stake in publicising this phenomenon to convert it into a headline-grabbing political tool against intellectual property. The most publicised examples of biopiracy appear to be clear cases of corporate might deployed against the poorest people of the world. As a political issue, biopiracy is very compelling if one wants to demonise biotechnology companies as insensitive, money-grabbing enterprises. Although there have been obvious cases of abuse, it is unclear that the outrage is proportionate to the problem.   The debate should then move forward from the mere political one and into the proposal of solutions to the main problem presented by bio-prospecting; that is, the issue of access by the greatest number of people to the fruits of the cataloguing and research of plants and medicines located in developing countries. After all, it would appear that the existing intellectual property legislation may be adequately prepared to cancel any patent that has been obtained by biopiracy if it fails to adhere to innovation and prior-art requirements. Nevertheless, there are several ways in which patent application requirements could be modified to make the detection of biopiracy patents much easier. The way in which this could be done is by changing the patent application forms to require applicants to specify the origin of the biological product for which protection is requested. This solution will be explored in more detail in the final section of this article.

Genetic modification: Patented present

There can be no doubt that the area of biotechnology with potentially the most impact for the needs of developing countries is genetically modified organisms. Even in the 21^st century, there are entire regions of the world that suffer from famine. A recent report from Oxfam points out that the world’s food shortage is a real problem, with almost 800 million people suffering from malnutrition, mostly in poor countries (Oxfam, 1999). This creates severe problems of calorie deficiency, which is particularly worrying when present in children because it means that they are usually underweight and have problems further on in life, and when present amongst under-five-year-olds it can mean increased mortality rates (FAO, 1996).  If by technical means something could be done to alleviate the food shortage, the benefits would certainly be felt throughout the world.

The potential benefits of genetic modification of organisms in the area of farming are too numerous to enumerate, but some examples may suffice. One of the main objectives of recent research into the genetic modification of crops has been to produce plants with greater resistance to pests and herbicides, which would generate several benefits for farmers (Mazur, et al., 1999). Some other potential benefits for developing countries include the creation of rice with added vitamin A, which would help to stop the worrying phenomenon of deficiency of this important nutrient in large parts of the world (Ye, et al., 2000). The identification of and modification for genetic traits for salt tolerance, resistance to drought and extreme temperatures would also produce significant benefits for the countries where crops are lost due to these problems (Spinney, 1998). Many other studies point towards the potential benefits of genetic modification despite the environmental fears, which is one of the main problems that commentators can see with this technology at the moment (Ferber, 1999).

If genetically modified organisms are so potentially beneficial for less developed nations, then the problem of access to this technology becomes not only relevant, but vital. And it is precisely in this area that the protection that is being awarded to these types of organisms also becomes relevant to the present study. It is perfectly reasonable to assume that excessive protection of these new organisms, and in particular the protection of potentially vital crops, could become a major issue for developing countries. This is part of the cycle of poverty that has been discussed earlier; if farmers in the developed world produce crops that are more resistant to pests, produce higher yields, and even taste better, this places farmers that have no access to those advances in a disadvantaged competitive position. If these crops receive patent protection then one could assume that they would be subject to higher prices, with the potential to be priced out of reach of farmers in the developing world.

In the area of plant varieties, the existing UPOV Convention is not particularly helpful in the issue of access to these technologies for developing countries. As mentioned earlier, the Convention requires the enactment of intellectual property protection for new plant varieties and their derivatives, which can also help to create monopolies over important plant varieties in favour of researchers.

But the problem for poor countries is not only access to the new technologies, worrying as that may be. As it happens with the pharmaceutical industry (Guadamuz González, 2005), the problem of access must be coupled with the fact that the type of research that is being conducted is geared towards the needs of developed countries, with fewer concerns for the needs of the poorer nations that could profit the most from genetic modification techniques. A policy paper produced by the Institute for New Technologies of the United Nations University (UNU/INTECH), shows that the trials of genetically modified crops in Europe are centred on developing herbicide tolerance and pest resistance for crops, which are not so important for developing nations. According to the study, only 12.5% of trials are centred on increasing yield of crops, which is one of the most pressing needs for agricultural environments that require advances that will eventually feed more people with less arable land (Arundel, 2002).

The NCB has recognised that this is a serious problem as well, and has presented a “worst case scenario” in the area of genetically modified crops, if the current trends are maintained. They point out that developing countries could be faced with:

However, there are some positive developments as more public agencies and international organisms recognise the potential of genetic modification for less developed nations. There are several instances of publicly funded programmes that are trying to produce non-proprietary genetically modified crops to improve farming in poor areas of the world hit by famine. One of the best examples is a programme led by the West African Rice Development Association (WARDA) and funded by the UNDP and other agencies, which has produced a new variety of rice intended for consumption in Africa. As explained by the UNDP:

In the 2001 Human Development Report, the UNDP also highlighted some other positive developments coming from various biotechnology industries in regard to providing access to genetically modified crops for poor countries. This access was in the shape of aid or by the transferring of free licences of patented material. For example, the Report states that the biotech company Novartis had transferred a licence of patented insect-resistant corn to the International Maize and Wheat Improvement Center for free distribution in Africa. Other companies like Monsanto and Plantech have made similar gestures to countries in Africa, and to other NGOs (UNDP, 2001). It would be easy to be cynical about these actions and to dismiss them as mere public relations stunts, or to argue that they merely serve the objective of promoting genetically modified organisms by giving them away to needy and unsuspecting populations. However, the end result can be considered positive if the means serve to increase access to technologies by poor nations.

Despite these positive signs, it is evident that a large amount of improved crops may still be left out of reach from less developed nations, and what is worse, because of economic reasons, these countries will not have a say in the whole debate about the viability of transgenic organisms.

Genomics: Patented future

The final area of concern for developing countries in the field of biotechnology is the race for the decoding of the human genome, an issue that is creating several problems for traditional intellectual property legislation in the developed world. As discussed earlier, there would seem to be a growing consensus in specialised legal circles that the mere isolation of genes from the human genome does not automatically grant patent rights, and that the identification of a gene sequence requires also a specific use for that sequence to be patentable. This is certainly more evident in Europe, but the United States would seem to be moving towards that end as well. However, this growing consensus on the patentability of the human genome does not mean that the debate is over, or that the subject has been resolved to anybody’s satisfaction. On the one hand, biotechnology companies have great economic incentives with continuing to patent sequences from the human genome (Bjornstad and Dümmer, 2002). On the other hand, researchers would require less protection in order to be able to have as much access as possible with the minimum liability with regards to potential patent infringement (Campbell, et al., 2002). This is a struggle that could have severe implications for the future of this area of biotechnological research. 

One of the most publicised cases of the patenting of a human gene sequence is that of the BRCA1 and BRCA2 genes, which had been identified as being responsible for increased propensity of breast cancer in women (Matthijs, et al., 2002). It is thought that about 10 per cent of breast cancer cases are hereditary, so the identification of some genes apparently responsible appeared to open the door to the creation of genetic tests to identify women at increased risk (Henley, 2001). The genes were first identified in 1990 by a group of researchers from the School of Public Health at the University of California (Hart, et al., 1997). The biotechnology company Myriad Genetics later applied for a patent in the US for the test resulting from the identification of these genes, which was granted in 1999 with US patent 5905026, despite the fact that there was already a wide usage of tests in several European countries prior to the patent application (Matthijs, et al., 2002). In 2001, the EPC granted a European Patent to the same company, which was challenged by several European research centres and other NGOs, and which was eventually revoked (Wellcome Trust, 2004). To complicate the legal picture, the UK Patent Office granted a patent in 1997 for the BRCA2 gene to Cancer Research Campaign Technology, a commercial subsidiary of the UK Cancer Research Charity, but this test is licensed free of charge through the British public health system (UK Patent Office, 2002).

This legal minefield is just one example of how difficult this issue is, as the interests involved are very narrowly balanced. If the present debate about the patenting of human genes should shift towards the granting of patents over broad gene sequences, without the identification of its action, this could have severe implications for less developed nations. Increased protection in this area may mean that tests designed to screen for genetic diseases would become more expensive, as the companies performing them are made to pay licence fees to those holding the patent. Using again the case of the breast gene patent, the test from Myriad costs £1800, yet it is alleged that the same test as performed by a French research centre costs only a third of that (Henley, 2001). Another potential problem faced by developing countries would be that the sharing of information amongst researchers would be diminished because of fears of patent infringement, potentially hindering efforts to develop new medicines and cures from the wealth of new knowledge accumulated (Campbell, et al., 2002).

It may seem surprising that there should still be a debate about the human genome when one takes into consideration how a lot of the information gathered up to date came into existence. The race for the sequencing of the entire human genome has been the Holy Grail for many people involved in biotechnology for some years now. By the start of the 1990s, there had been several successful attempts to obtain the sequences of many small organisms, including the nematode worm and the fruit fly (Sulston, 2002). By the middle of that decade there were several groups attempting to crack the human genome, but most of the public efforts were made more evident in 1996 with the creation of the International Human Genome Sequencing Consortium, a collection of researchers from around the world, which included the Wellcome Trust, the UK Medical Research Council, the U.S. National Center for Human Genome Research, the German Human Genome Programme, the European Commission, the Human Genome Organisation and the Human Genome Project of Japan. These efforts seemed to be geared towards the principle of sharing the information obtained, towards the common goal of decoding the human genetic sequences. During two meetings of the members of the Consortium, staged in Bermuda, a set of principles were agreed upon, known as the “Bermuda Principles.” These Principles attempt to establish the spirit of the wider distribution and sharing of the results for the benefit of humanity.(3) The Principles clearly specify that the results of the research will be placed in the public domain and will be made available as soon as possible, even on a daily basis if such data were available. The Human Genome Organisation (HUGO) has been made responsible for coordinating the data and for using the Internet for its release.       

Despite these positive steps, the efforts towards the commercialisation of the human genome did not abate; on the contrary, they increased. In 1998 a member of the Consortium created the company Celera Genomics, which set off immediately to finish a sequence of the human genome before the Consortium did (Sulston, 2002). Celera eventually would fail in achieving the full genome first, and there was growing suspicion that they were using parts of the publicly made material by the Consortium. In the year 2000 a joint statement was made announcing that there was an initial draft of the full human genome, and the results from the public sector have already been made public in several websites. However, in 2001 the contending parties published their respective results at the same time, while claiming that the opposite camp was guilty of the copying by the other (Myers, et al., 2002;Sulston, et al., 2002).

It has to be disheartening that this race has made rivals of organisations that would have possibly helped to achieve the goals of the research much faster. Furthermore, it indicates the potential for intellectual property regimes and competition to hinder the dissemination of knowledge and progress of technology, in complete contradiction of the policies behind such protection. The problem here is that, as has already been stated, many companies are already lodging their claims of ownership of human gene sequences, despite the fact that the human genome has been publicly available for some time. It would seem evident that the commercialisation race will not stop. There is potentially too much money involved for that, and all countries – not only those in the developing world – could find themselves affected by this. It is of utmost importance that the sequence itself, the raw genetic data, should be left to the public domain as stated by the Bermuda Principles. It is also perfectly plausible that under this scheme, individual application for genes achieved through purification may receive some sort of protection. John Sulston, one of the founders of the International Consortium, expresses that:

This is a similar line as that adopted by the NCB in a comprehensive report on the subject (Nuffield Council on Bioethics, 2002), and echoed by many other experts in the field (Bunk, 1999). It not difficult to believe that some of the novel, and possibly life-saving treatments and tests that could come from the sequencing of the human genome could be locked away because of ownership concerns. This is not a debate about research funding and invention; this is a debate about whether or not commercial interests will be allowed to conceal information on large parts of the human genome from the world’s population.

Do developing countries need biotechnology?

It must be said that the problematic issue of the protection of biotechnology in developing countries may not be met with such pessimism in some circles. It cannot be stressed enough that biotechnology research is perhaps one of the most feared developments in recent years, prompting doomsday headlines from the popular press, touching some of the deepest apprehensions amongst the general public (Lawrence, 2001). Typical of the irrationality of the debate was the labelling by the UK’s tabloid media of genetically modified food as “frankenfoods”. But it is not only the press fuelling the debate; many of the groups that changes to intellectual property legislation in relation to developing countries are some of the most outspoken critics of biotechnology, mostly because of anti-corporate and ecological reasons. The examples are numerous, but maybe an important one taken from the subject matter discussed here may illustrate the point further. Well-known environmental activist Vandana Shiva is one of the most fervent defenders of indigenous plant variety rights and an outspoken attacker of biopiracy. At the same time, she is possibly one of the most visible critics of the use of genetically modified organisms in the developing world. She says:

Shiva goes so far as to state that all of the technology is not needed and that ecologically friendly farming techniques can be enough to feed the world’s poor (Shiva, 1999). Devinder Shandra – another Indian activist – also offers harsh words for those who advocate the use of biotechnology as a silver bullet to cure world hunger. He points out that the problem is that biotechnology products will not be affordable by poor countries because of their subjection to ownership, and that this problem is conveniently overlooked by decision makers (Brown, 2002). Other environmental activists from the left have joined Shiva in their dislike of biotechnology. Monbiot, for example, argues that there is a clear danger in allowing corporations to monopolise technological advance, as developing countries will not have a say in the direction in which the research should be going. He says that:

There are many examples of biotechnology corporations misusing their economic power to promote, and some would say force, genetic modification to developing countries. An example is that of Monsanto’s actions in Andhra Pradesh, India, where the company provided cotton seeds genetically engineered with Bacillus thuringiensis without the knowledge or approval of Indian officials. There are allegations that these untested seeds resulted in crop losses and a serious disturbance in the practices of the region (Lelio Basso International Foundation, 2001).

Another worrying development is the deployment of what is known as “terminator technology”. This is a method of genetic modification that produces sterile seeds that can only be used on the first generation of plants, and eventually they could be included with a switch that turns them on and off with the use of innocuous chemicals (Fisher, 1999). This technology could be promoted as a means of ensuring that genetically modified organisms can be easily and safely eliminated from the gene pool if they are proven to be hazardous to the environment. However, the implications for the technology to developing countries are obvious. Companies could use this technology to ensure that farmers come back to them to obtain seeds every season, and they could also serve to enforce their intellectual property for periods that go beyond current protection terms. Dutfield comments that:

Other concerns about the use of biotechnology must be underlined. An economic study by the Economic Research Service at the US Department of Agriculture has pointed out that the benefits of the use of genetically modified crops are not as high as expected, and it could be concluded that they vary from region to region (Service, 2000). This has tremendous implications for developing countries, because if the technology is not providing the benefits that have been expected, then there appears to be a reduced incentive for the adoption of these technologies.

These criticisms are warranted and must cause concern, in particular those that make the point about the possible marginalising of developing countries from the debate about the benefits of biotechnology because of economic reasons. Despite these concerns, there still appears to be an almost irrational fear in the assumption that biotechnology is wrong and should be avoided at all costs. A more reasonable approach has been taken by other organisations interested in developing world issues, in particular in the area of genetically modified crops. A report by Oxfam has controversially stated that the problem of hunger in the world could be helped with biotechnology; in particular it could be a great tool for providing high-yield, pest-resistant crops that can serve to alleviate the farming crisis in less developed countries. The report states that:

It is important to stress that this report by Oxfam is still cautionary against the use of genetically modified organisms as it also states that there must be more evidence to ensure that these types of biotechnological advance are environmentally safe. Nevertheless, the report is miles ahead in comparison to the more visceral attacks of biotechnology, and it certainly points towards the best way of conducting the debate as that of looking at the scientific evidence and not jumping to conclusions because of ideological reasons. It is heartening that this opinion is shared in official circles. Louise Fresco, head of the agriculture department of the UN Food and Agriculture Administration (FAO), has commented that:

Opinions like these are useful in the wider attempt to dissipate some of the irrationality from the debate. It is necessary that the issues are properly discussed, researched and explored. There should be a stress in the fact that developing countries should not participate in the decision-making about which technologies they should implement. In other words, whilst the application of intellectual property regimes to the dissemination of this technology may have disastrous effects for developing countries, this does not mean the technology is in itself culpable.

Looking For Solutions

The existing framework

The existing international legal framework for the protection of biotechnology products would seem to be biased in favour of owners and in detriment of developing countries.

It can be argued that the TRIPS agreement is the most important international IP treaty, and it has perhaps the most relevance with regards to biotechnology, as it provides a strong international system of patent protection. Because biotechnology is largely the subject of patents, it is subject to the international trade restrictions of protected technology that is at the centre of the agreement. One of the goals of the TRIPS agreement is to establish a wide-ranging international intellectual property protection system by requiring every member of the WTO to implement a series of measures in the form of national legislation that will provide adequate protection of ideas all around the world. TRIPS also has the strongest existing system of international enforcement of rights by its unique dispute resolution mechanism (Yerxa and Wilson, 2005). The most important part of TRIPS that relates to technology is the setting up of a strict system of international patent protection. Article 27.1 states that:

The effect of Art 27.1 is that it reduces the scope of patent exceptions by fields of technology, as every invention should be subject to patentability. While these provisions must be read in conjunction to ordre publique exceptions, developing countries will almost certainly have to follow in the footsteps of other nations in providing the widest possible scope for patentability.

Another relevant concept covered in the TRIPS agreement is that of the restrictions imposed to compulsory licences. In most countries, there are some situations in which the patent owner will be forced to provide a licence to a third parties to exploit the patented invention in a specific way. These are known as compulsory licences, and they are dealt largely by Article 31 of TRIPS. This article explains that member states should grant compulsory licences when there is overriding necessity because of an emergency that calls for the granting of a licence to use the technology. Other reasons to allow compulsory licences are a refusal to deal from the owner, the existence of anti-competitive practices from the owner, or for non-commercial purposes. However, TRIPS allows countries to provide compulsory licences for other reasons because this list is not exhaustive (Correa, 2000).  It must be pointed out that the compulsory licences granted through this mechanism are limited to a severe regime of restrictions. The licence should not be granted without first consulting with the owner, and then adequate compensation should be given. Another important restriction is that the licence can only be used in the domestic market where it was granted, and the use of patented materials will be subject to judicial review.

Parallel imports are also relevant for biotechnology protection. Parallel imports are the result of the disparity in prices between economies around the world. Some items tend to be offered in developing countries cheaper than in developed nations because of the disparity of acquisitive power. This disparity encourages the application of a policy of parallel importation (Rigamonti, 2002). While TRIPS does not forbid parallel imports directly, it is clear that Article 31(f) of TRIPS imposes restrictions on the export of products produced by compulsory licensing outside the territory in which it is granted, which could have an effect with regards to the export of patented technologies to developing countries that are unable to produce them (Guadamuz González, 2005). This would certainly include high-technologies, particularly new biotechnological advances.

The end result of the international strengthening of patent rights and other technology protection is that TRIPS serves to ensure a steady income of intellectual property related revenue for those countries that own a large percentage of patents of high technology (Drahos and Braithwaite, 2002).

Other than the general provisions included in TRIPS, the area that has been dealt with in more detail through other international instruments is the issue of the protection of plant varieties. The main treaty dealing with the issue of the protection of biotechnological advances is the 1993 Convention on Biological Diversity (CBD), which is the result of the 1992 Rio de Janeiro United Nations Conference on Environment and Development towards a strategy for sustainable development. The CBD establishes principles for the protection of the environment while ensuring ongoing economic development, emphasising conservation of biodiversity, sustainable use, and fair and equitable benefit sharing of that use of genetic resources. The CBD is of particular significance to the attempts to grant wider access to the world’s biodiversity and to provide for the sharing of “genetic resources”, which are understood as genetic materials of “potential value” (CBD, Arts.1-2). This is certainly a very relevant point to developing countries, and helps to create a much better system of access to biotechnology by most nations of the world. Furthermore, Article 15.7 states that:

The problem with the CBD is that it has been often criticised as lacking the widespread recognition of IP agreements such as TRIPS, and also in the fact that it does not posses a dispute settlement system available to the World Trade Organisation (WTO). This relative weakness diminishes the usefulness of the CBD (Safrin, 2002). 

As part of the CBD agenda, signatory countries agreed on the implementation of the Cartagena Protocol on Biosafety, a document that entered into force in 2000 as a result of a series of meetings prompted within the text of the Convention. The Cartagena Protocol embeds into the CBD system the precautionary principle present in environmental law and policy (Myers, 1994). As such, it focuses on the regulation of trans-border movement of any living modified organism resulting from modern biotechnology that may have adverse effect on biological diversity. While important for developing countries, the provisions of the Cartagena Protocol are geared towards prior information of import of genetically modified organisms, and little to do with their IP ownership and licensing.  

A more positive agreement for developing countries is the International Treaty on Plant Genetic Resources for Food and Agriculture, developed by the UN Food and Agriculture Organisation (FAO) (Cooper, 2002). The final text of the Treaty was approved at the end of 2001 after several years of discussions. In a similar line to the CBD, the main purpose of the Treaty is to facilitate access and sharing of genetic information to a list of crops that are basic for securing food resources to the widest number of people. In principle, the Treaty is similar to the CBD, but it has some important differences that make it a much tighter and better vehicle for attempting to obtain access to food genetic material. The Treaty generally deals with the issue of plant and biological resources that serve as food sources, ensuring the continued availability of food resources by developing countries. This is done by establishing a multilateral system of benefit sharing. The treaty protects a total of 64 plants and forages as basic resources, allowing for the production of commercial products from the resources while making provisions to share benefits for those developments. One of these is the fact that it specifically recognises the importance of traditional knowledge and farmers’ rights. The Treaty also establishes a multilateral knowledge system that has as its main objective the facilitation of “access to plant genetic resources for food and agriculture, and to share, in a fair and equitable way, the benefits arising from the utilization of these resources, on a complementary and mutually reinforcing basis” (Art. 10). It is still too early to ascertain the real effectiveness of this Treaty, but on paper it seems much better prepared to create the right circumstances for the sharing of genetic material, hence ensuring proper access by developing countries.

Some possible solutions

Although the debate of whether biotechnology is useful for developing countries is still open, one could put forward the thesis that there are enough indications that at least some of the technologies explained earlier would be beneficial for developing countries. The previous sections have demonstrated that this situation presents two different problems for developing countries: the problem of access to technology and the problem of biological materials from developing countries being patented in the developed world. How can these two problems be solved?  As evidenced by the previous section, the existing legal mechanisms offer some mechanisms, but not outright answers. 

As has been explained, the TRIPS agreement is by far the widest reaching intellectual property mechanism in the world because of its enforcement mechanisms in the area of the trade of technologies. As such, it would be an adequate vehicle for answering some of the questions about the access to biotechnology in cases of public interest, but it would be more suited for guaranteeing the protection of biological diversity originating from developing countries. Sadly, this is not the case. As the text of the Agreement stands, it specifies in article 27.3b that contracting members may not grant patents for: 

This paragraph seems to be in line with the type of protection awarded in most of the developed world. The phrase “essentially biological processes” allows member states to refuse to grant patents for non-manufactured biological products and varieties, and it leaves the same provisions about micro organisms found in Europe. It is also interesting to see that member states must provide protection of plant varieties in a similar way to the European plant variety regulations. What this means is that the Western model of biotechnology protection is being exported to the rest of the world without any consideration given to access and the protection against biopiracy. What has not gone unnoticed is the marked omission of the rights of countries to safeguard the interests of indigenous peoples in traditional medicines, or the rights of farmers to traditional plant varieties – an omission that would seem to stress just how slanted this Agreement is in favour of the ownership rights of the developed countries (Gibson, 2004).

In a set of recommendations by Oxfam regarding genetically modified crops, there is a specific request to make TRIPS more flexible in the area of plant varieties, in order to allow countries to decide for themselves on these issues (Oxfam, 1999). This would eventually move the theory that everything is patentable, to a system where each signatory state would choose if allowing genetically modification is good for them, an idea that is in line with the precautionary principle advocated by the Cartagena Protocol.

Another recommendation to reform the TRIPS agreement was made by a meeting of developing countries in Delhi in 1999, where they were looking to change the patent application process to include the geographical origin, group origin or personal origin of the knowledge subject to protection (Correa, 2000). This would have the effect of allowing patent offices to screen more easily for possible biopiracy applications within their jurisdictions. 

It is the view of the author that TRIPS should go farther and establish more flexibility for developing countries not only in the area of protection of traditional knowledge, but also in the area of granting access to basic technologies, which may lead to huge benefits in the poorer areas of the world. This could be done in line with general technology transfer recommendations already present in the agreement (Maskus and Reichman, 2005), and also in line with the Doha Ministerial Declaration of 2001, which encourages increased technology transfer to developing countries (WTO, 2001).

Beyond the TRIPS framework, the CBD would seem like the logical place to attempt to implement some sort of access and protection of biodiversity. The CBC provisions with regards to the protection of biodiversity studied in the last section clearly indicate that there should be an obligation to share the commercial results of research with the place of origin. It would be fair to assume that this would include the sharing of technological creations arising from the originating biological material, such as chemicals, pharmaceuticals or plant varieties. Gollin makes the point that the principle involved in the CBD is that of informed prior consent, which means that the country where the biological material originates must know at all times that the researchers are conducting the research, and must disclose the possible benefits arising from it (Gollin, 1999).

Although these provisions are quite wide-ranging and seem impressive on paper, they still suffer from lack of international compliance, and it could even be said that TRIPS directly contradicts some of these achievements by stressing protection and not dealing with access and sharing of biotechnological products. The main problem with the CBD is that it is plagued by the difficulty of bringing together the widely diverse interests in the area of development and environment, which makes it a much weaker tool than it would otherwise be. The lack of ratification from several countries, in particular the United States, is another terrible blow for the Convention, and serves to stress the wide gaps between developed and developing countries in these issues. 

To date, the most impressive set of proposals at an international level can be found in the actions of the World Intellectual Property Organisation (WIPO). Within the institutional framework of this important international organisation, there have been lengthy discussions with regards to traditional knowledge, folklore, traditional cultural expressions and indigenous resources (McManis, 2003). WIPO has created the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), which has been working on a set of provisions that will create a new sui generis right for traditional knowledge (WIPO, 2006). The draft version of the recommendations with regards to traditional knowledge proposes that there will be a new type of intellectual property protection against misappropriation of traditional knowledge. The most helpful suggestion is a recognition that no intellectual property should be granted over existing traditional knowledge or genetic resources. This principle is a stated policy objective of the IGC (WIPO, 2006).  If the WIPO proposals are eventually implemented not only as policy but as some form of international agreement, it would go a long way in alleviating some of the problems identified with regards to biopiracy.

Besides these three institutional solutions, there is no lack of proposals to change the system of protection of traditional and genetic resources. An important set of general proposals can be found in the report by the CIPR (Commission on Intellectual Property Rights, 2002), mostly dealing with an overhaul of the TRIPS system to fix some of the criticisms that have been expressed above. Blakeney also cites several worthwhile suggestions in these areas, made by representatives from developing countries, to reform the system of plant varieties and the patent system in order to curb biopiracy (Blakeney, 2002). Some other suggestions are more problematic. Drahos has suggested the creation of a Global Bio-collecting Society, an international private organisation that would allow indigenous groups to collect money from companies that use their traditional knowledge commercially (Drahos, 2000). There are also signs that the private industry is starting to get their act together and pull resources to provide some sort of sanity in the potentially mad rush to patent every sort of biological material. The SNP Consortium is a collection of large biotech multinational companies that provide a common ground to solve potential patent disputes (Marshall, 1999).

Despite some of these encouraging and numerous suggestions with regards to protection of traditional knowledge and genetic resources, there appears to be a scarcity of official proposals about widening access to biotechnology research and advances within the international intellectual property protection system.

The most disquieting lack of action must be that in the patenting of human gene sequences, as there are no serious attempts comparable in any way to those already mentioned. The few suggestions made so far do call for local and regional patent authorities to change the application of existing patent rules in order to avoid the patenting of entire or partial gene sequences without a useful application in mind. A strong call is made by the NCB in this respect, requesting several national bodies to restrict the unscrupulous commercialisation of the human genome and to stop those patents that may prove too general for the public, and may diminish the public domain applications of genetic knowledge (Nuffield Council on Bioethics, 2002). Also lacking international action is that of other ethical concerns, such as cloning and the protection of the genetic privacy of individuals.   

There should be recognition that the issue of biotechnology is part of the wider discussion of transfer of technology. The issue of technology transfer is usually categorised and studied as a problem of North-South technology flows. Biotechnology has elements of this problem, particularly with regard to genetically modified organisms, and the patenting of gene sequences and gene screening methods. However, the problem of biopiracy presents another interesting facet, which is the flow of technology from South to North. Developing countries are then faced with an interesting conundrum; they must find new ways to protect their existing low-technology from unwanted flows of these technologies to developed countries, while participating in a regime that allows them to imitate and adopt technologies from the North.

The protection-access dichotomy could then be answered eventually with a two-pronged approach. Firstly, developing countries can overhaul their own national legislation in order to accommodate better protection against bio-prospecting and biopiracy. Some countries are already in the threshold of doing just this. India has enacted new legislation protection of plant varieties that includes clauses against misappropriation of traditional plant resources (Sahai, 2002). Costa Rica has also passed legislation that protects biodiversity resources within the country, leading to some profitable agreements with pharmaceutical companies (Gibson, 2003).   Secondly, there should be an attempt to encourage access to the benefits of high technologies in the life sciences, but this is considerably more difficult to achieve. It is clear that biotechnology is an expensive endeavour, and many of the firms involved may not see any incentive in generating avenues of affordable technology transfer to developing countries. Any effort that can be done to achieve such access should be applauded, but it may yet remain elusive. There have been suggestions that open source software ideals translated into biotechnology could achieve improved access for developing countries, but this is the subject for an entirely different study (Guadamuz Gonzalez, 2006).

Conclusion

It would be good to end this article with a more positive outlook towards the future of developing countries in the area of biotechnological research. Unfortunately, it is difficult to generate optimism when looking at the development of intellectual property protection of biological products in the developed world. It would seem that unless there is a sudden change in the global climate of biotechnological research, the less developed countries of the world could well find themselves excluded from the potential benefits derived from biotechnological advances. 

The way forward is not merely a call for individual countries to try to stop some of the potential problems for developing countries already described. A serious overhaul of TRIPS in the general area of biotechnology would be very welcome. TRIPS could certainly benefit from a set of general rules for biotechnology products in line with some of the most positive efforts highlighted throughout this section. In the area of plant varieties, the spirit of the CBD should be incorporated into TRIPS and into the UPOV to allow for the wider sharing of biodiversity around the world. This could be done without hindering existing protection by making sure what types of new plant varieties are covered by protection. TRIPS should contain a set of rules for avoiding biopiracy along the lines suggested both by commentators and by the WIPO IGC; in particular the suggestion to incorporate country of origin of biological material is perhaps the best way to counter it.

Traditional knowledge should be specifically protected in TRIPS by considering that a patent will not be granted if it is the result of prior-art. There should be a set of rules for genetically modified organisms, including a general principle stating that the sharing of this type of knowledge should benefit humanity. There is a serious need for more public funding in this area, and the widening of the debate is to be encouraged. TRIPS should also contain a set of rules for the granting of gene patents. This could take the shape of a general set of rules for the granting of these patents in line with the requirements of the EPO in this area and by the incorporation of the purification concept into the agreement. There should also be a general principle against the patenting of partial DNA sequences unless they can be proven to have useful applications. Finally, cloning should also receive a specific mention, if only to recognise that it is a potential field of interest for the future. TRIPS should not rely on general morality clauses in national legislations to stop the patenting of cloning techniques, but the debate about this area should continue.

Glossary (From Wikipedia)

Chromosomes: A chromosome is, minimally, a very long, continuous piece of DNA, which contains many genes, regulatory elements and other intervening nucleotide sequences.

Cloning: Cloning is the process of creating an identical copy of an original. A clone in the biological sense, therefore, is a multi-cellular organism that is genetically identical to another living organism. Sometimes this can refer to "natural" clones made when an organism reproduces asexually, but in common parlance the clone is an identical copy by some conscious design. The word was coined by the British geneticist J. B. S. Haldane in 1963, and is derived from the Greek word for "twig", klōn.

DNA: Deoxyribonucleic acid (DNA) is the primary chemical component of chromosomes and the material of which genes are made. It is sometimes called the "molecule of heredity," because parents transmit copied portions of their own DNA to offspring during reproduction and because in doing so they propagate their traits. In fact, the units of DNA that reside in the nucleus of eukaryotic cells, and DNA pieces as people typically think of them, are not single molecules. Rather, they are pairs of molecules, which entwine like vines to form a "double helix" (top half of the illustration at the right). Each vine-like molecule, or strand of DNA, is a chemically linked chain of nucleotides, which each consist of a deoxyribose sugar, a phosphate, and one of four varieties of "aromatic" bases. Because DNA strands are composed of these nucleotide subunits, they are polymers. The diversity of the bases means that four distinct kinds of nucleotide exist, which are commonly referred to by the identity of their base. These are adenine (A), thymine (T), cytosine (C), and guanine (G).

Gene: The word "gene" is shared by many disciplines, including whole organism-based or "classical" genetics, molecular genetics, evolutionary biology and population genetics. It has multiple uses within each of these contexts. But in the primary sense "genes" are material things that parents pass to offspring during reproduction and through which they propagate their biological traits or characteristics. This sense, which is common to all of the above disciplines, is also the original historical meaning of "gene." Following the discovery of DNA, and in parallel more recently with the ascent of biotechnology and projects to sequence the human genome, common usage of the word in ever more instances has echoed uses in molecular biology. In the primary, molecular sense, genes are segments of DNA within chromosomes. In particular, they are the subset of such DNA which cells transcribe into RNAs and translate, at least in part, into proteins. Two organisms of the same species may carry different variants of the same gene, which appear at the same location or "locus" on their respective chromosomes, and are known as alleles. A gene's most common allele is called the wild type, and rare alleles are called mutants.

Gene sequence: In genetics, sequencing means to determine the nucleotides of a DNA strand. In biochemistry, sequencing means more generally the determination of the primary sequence of any linear heterobiopolymer. This includes nucleotide sequencing (for DNA or RNA) as well as protein sequencing (using Edman degradation, mass spectrometry, protease digests). This resulting symbolic linear depiction known as a sequence can succinctly summarize much of the atomic-level structure of the sequenced molecule.

Recombinant DNA: Genetic recombination is the process by which the combination of genes in an organism's offspring becomes different from the combination of genes in that organism. This definition is commonly used in classical genetics, evolutionary biology, and population genetics. However, in molecular biology, recombination generally refers to the molecular process by which two genes in a linkage group can become separated. One consequence of this mechanism is chromosomal crossing over, but recombination can also occur at homologous sites within one DNA molecule. Enzymes called recombinases catalyze this reaction.

RNA: Ribonucleic acid (RNA) is a nucleic acid. It is structurally distinguished from DNA by the presence of an additional hydroxyl group attached to each pentose ring and functionally distinguished by its role in the transmission of genetic information from DNA (by transcription) and into protein (by translation ).

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