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Use of Intellectual Property Rights in Relation to Modern Biotechnology!
There are many arguments for and against the use of intellectual property rights in relation to modern biotechnology. The patent system, as a system for the protection of intellectual property, is an integral part of the market economy and therefore can be a driving force for innovation in many technological questions.
The same resolution notes that living organisms are able to reproduce themselves even if they are patented, and in view of this special quality of living organisms the scope of a patent is difficult to define, which makes it nearly impossible to find a balance between private and public interests.
Over the last few decades the global trading importance of biotechnology has been recognised and as a result there have been concerted and concentrated efforts to protect the results of research and development involving genetic material. The result of this has been the extension of intellectual property protection to most forms of biological material.
The trade importance of biological information has been underlined the adoption of the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS) within the World Trade Organisation. This requires states party to the agreement to provide protection for all types of inventions irrespective of the field of technology.
The aim of the Agreement is to ensure that all member states provide effective and appropriate intellectual property protection and protect the intellectual property rights by the appropriate enforcement mechanisms. The Agreement sets down the minimum standards of protection.
The TRIPS agreement permits countries to exclude from patentability those inventions whose commercial exploitation may be contrary to order public or morality. Countries may exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals, and more importantly.
Article 27(2) allows Members to exclude from patentability innovations in order to protect animal, plant life or health or to avoid serious damage to the environment and Article 27(3) provides for exclusion from patentability of .plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.
What constitutes sui generis protection for new plant varieties are not defined hence countries are free to adopt a system that ensures intellectual property protection for plants. One option is for countries to implement the International Convention for the Protection of New Varieties of Plants (UPOV) but this form of protection has been criticised for focusing too much on the rights of plant breeders, and too little on the rights of those using the seeds, farmers.. Whilst obliging member states to provide protection systems, those .inventing, new products do not need to obtain that protection. The rights only apply in the country in which the inventors have chosen to invoke protection.
In most African countries many of the biotechnology inventions will not have been protected through patent rights and can legally be used as if in the public domain. It is only when products developed using patent protected materials or methods are exported into countries where protection exists that the rights of the inventor must be respected.
There is an underlying assumption that the introduction of an intellectual property system will result in a dramatic increase in the innovative capacity of the private sector, while allowing the public sector to become more self-financing. This may be true to an extent in countries with a substantial research capacity but is unlikely to be the case in developing countries where the research and development sector is not as strong.
A Northern intellectual property system may provide an incentive but there may be limited local capacity to exploit it. Even when technologies are developed, firms in developing countries can seldom bear the costs of acquisition and maintenance of rights and to an even greater extent, enforcement (especially in those countries where substantial earnings may be realisable). The costs of establishing an infrastructure to support a intellectual property rights regime may be substantial, and mechanisms for the enforcement of IP rights is costly both to government and to private stakeholders.
If there is a policy commitment to the implementation of a rights system, then perhaps the best way to proceed would be to look at the systems in Europe and the United States and adapt them to local and cultural needs. The required patent system would need to balance the costs and benefits to local needs and requirements.
There is real concern about the use of intellectual property law in developing countries, particularly in relation to health care but also in relation to that which is emotively called biopiracy or bio-prospecting.
Pharmaceutical companies worldwide are interested in finding new and alternative therapies and have widened their search to include traditional medicines and practices largely based on medicinal plants endemic to developing countries. There are many traditionally used herbal medicines which may have real therapeutic properties.
If a company takes the knowledge as the starting point for a search for new pharmaceuticals, extracts the active product it is entitled to a patent on the extracted product even though it cannot replace the traditional product itself. Developing countries are thus faced with the acute dilemma of their valuable indigenous wealth being taken away and exploited commercially by the resource and technology rich trans-national pharmaceutical companies.
The International Center for Tropical Agriculture (CIAT) is legally challenging the patent, arguing that the patent claims are invalid, failing to meet novelty and non- obviousness requirements and disregarding available prior art. In the US under Section 35 U.S.C. §102(a) the invention cannot be known or used in this country, or patented or described in a print publication (emphasis added) in this or a foreign country. Therefore, mere use in Mexico without printed publication is insufficient to show a lack of novelty.
Membership of the WTO requires countries to have in place an effective intellectual property regime. However the simple implementation of the Agreement into national law is insufficient to protect a country’s genetic resources as Article 27(3b) is inadequate to meet their protection requirements. What is required is the enactment of legislation that incorporates the framework of current agreements and negotiations. TRIPS, the requirements of the Convention on Biological Diversity and the International Treaty for the Protection of Plant Genetic Resources.
Hence Developing countries should consider the manner in which they implement the various agreements in order to protect their people and their resources, including:
1. Enacting appropriate biodiversity protection legislation including benefit sharing consistent with Article 8j of the CBD and access to genetic resources (Article 15)
2. The TRIPS agreement does not require countries to institute a patent regime for plant material but replace it with a sui generis system for protection of the plant intellectual regime. The replacement system could be designed to protect extant varieties that are in the public domain as well as new plant varieties and provide for the needs of the country taking into account, for example, the communitarian approach to property that are often part of the culture of developing countries as well as the needs for innovation.
3. Developing countries may need to document and catalogue their biological assets not only to ensure protection but also to assure future collaboration and exploitation. States have sovereign rights over their biodiversity and are responsible for conserving their biological diversity and for using their biological resources in a sustainable manner.
Article 3 of the Convention of Biological Diversity states that .States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction.
There are many who are concerned at the way in which IP protection has been used in many countries. The balance in many IP systems seems to be shifting too far in favour of technology producers. Negotiations over IPRs have been powerfully influenced by industry lobby groups and are being driven by concerns of trade liberalisation and international investment between developed countries.
The legitimate technological and developmental objectives of developing countries generally technology users are not being given due consideration. This shift in the ownership and control of information, and the resulting boon to private investors, has been called an .information land grab.