The Patent Bill 2005: Impact on Agriculture
The Patents (Amendment) Ordinance amends the Indian Patents Act, 1970 for the third time to introduce product patent protection for drugs, food and chemicals. However, it equally affects the interests of the farmers by granting patent protection to GMOs especially the seeds of Genetically Modified crops.
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The Patent Bill 2005: Impact on Agriculture
Nowadays the present UPA govt. is trying to get the Patent (Amendment) Bill passed by the parliament which is being opposed in its present form not only by the opposition but also by the alliance parties particularly the Leftists. At present the Patents (Amendment) Ordinance, 2004 issued by the govt. on December 27,2004 is in force which came into effect from January 1,2005. The Ordinance amends the Indian Patents Act, 1970 for the third time to introduce product patent protection for drugs, food and chemicals. The Ordinance also makes a number of other changes in the Indian Patents Act. India is a signatory to the Agreement for the establishment of the World Trade Organisation, including the Agreement on Trade Related Aspects of Intellectual Property Rights which promotes the effective and adequate protection of intellectual property rights. The purpose of the amendments in the Patent Act is to fulfill the obligations under the said Agreement. A bill to replace the ordinance has to be passed by parliament within 6 months of promulgation or 6 weeks from commencement of the first parliament session after the issue the ordinance, hence the present Patent Bill. The drug industry of India is vehemently opposing the amendments as it affects the industry adversely. However, drug industry is not the only sector whose interests are adversely affected by the present bill. It equally affects the interests of the farmers by granting patent protection to GMOs (Genetically Modified Organisms) especially the seeds of Genetically Modified crops.
Let’s first of all see, what are Intellectual Property Rights (IPRs) and where have they come from? The Trade Related Aspects of Intellectual Property (TRIPs) agreement under WTO recognises Intellectual Property Rights as private rights. As early as in Uruguay round of General Agreement on Tariff and Trade (GATT) negotiations, agriculture was seen harmonious with Industrial Property Rights and has been brought at par with other industrial trade sectors in terms of common institutional framework for conducting trade relation among members, protection of IPR and services. The system to promote the invention by providing incentives in terms of Intellectual Property Rights protection to investors, who takes the risk of investing in an idea that might fail, was good so far as it covered only inventions and not discoveries. It started to be unfair, since it came to be applied to living things, as nobody has yet learned to create living things. Now the industrialised countries are patenting living things as if they have invented them. The TRIPS Agreement of the WTO includes three items related to agriculture: Geographical indications (Art 22-24); Patent protection of agricultural chemical products (Arts. 70.8 and 70.9); Plant Variety Protection (Art 27.3(b)).
Patents and Plant Variety Protection (PVP) are two different forms of IPRs. Both provide exclusive monopoly rights over the creation (such as new plant variety) for commercial purposes over a period of time. The provision for patenting on life form is the most contentious issue within TRIPS. A patent is a right granted to an inventor to prevent all others from making, using and/or selling the patented invention for 20 years. The criteria for a patent are novelty, non-obviousness and utility. PVP provides patent like rights to plant breeders. What gets protected in this case is the genetic makeup of a specific plant variety. The criteria for protection are: novelty, distinctness, uniformity and stability. PVP laws can provide some exemptions for breeders, allowing them to use protected varieties for further breeding, and for farmers, allowing them to save seeds from their harvest. For the seed industry, PVP is regarded as the weaker sister of patenting mainly because of these exemptions .
Commercial interests in the new developments in biotechnology led to pressure being exerted on WTO member states to provide better patent protection in this area. The text of Article 27.3(b) is the result of the attempt by certain Northern countries and the biotechnology lobby to impose private, monopolistic rights over biological resources. Article 27.3(b) represents a major new development in IPR law; since it blurs the distinction between "inventions", which are patentable under traditional patent law, and "discoveries", which are not. The majority of the developing countries, during the TRIPs negotiations, objected to the notion of the patentability of biological resources.
TRIPs is the first international instrument to require IPR protection for life forms, however the obligation at present is limited to micro-organisms and plant varieties. The TRIPs member states are under an obligation to implement Art 27.3(b) either through patents or effective sui generis system, with the least developing countries to develop such system by 2005. There is, however, a clause under Article 27.2 which makes allowances for patent exclusions where necessary to protect “…human, animal or plant life or health or to avoid serious prejudice to the environment…” There have been attempts to redress the imbalance between plant breeder’s rights versus farmers’ rights. Capitalising on the TRIPS flexibility to adopt the sui generis system for PVP and maintaining a balance between the rights of farmers and breeders, India have formulated farmer friendly PVP laws. The Protection of Plant Varieties and Farmers Rights Act, 2001 of India, for the very first time, put in place a law to grant Plant Breeder’s Rights on new varieties of seeds as well as grants Farmers rights. The other related Acts include the Patents Act, 1970; the Geographical Indications (Registration and Protection) Act, 1999; the Biological Diversity Act, 2002; the Environmental protection Act, 1986; and the Seeds Act 1966. The Patent Act 1970, amended twice in 1999 and 2002, is in harmony with the TRIPS Agreement. Product patent on genes however remains a grey area.
According to Section 3(i) of the Indian Patent Act, the following is not an invention:
In the 2nd Amendment however, the mention of “plants” have been deleted from this section. This deletion implies that a method or process modification of a plant can now be counted as an invention and therefore can be patented. Thus the method of producing Bt. cotton by introducing genes of a bacterium thurengerisis in cotton to produce toxins to kill the bollworm can now be covered by the exclusive rights associated with patents. In other words, Monsanto can now have Bt. cotton patents in India.
The Patent Ordinance, presently in force has also added a new section 3(j). This section allows for the production or propagation of genetically engineered plants to count as an invention. Its status as an invention thus deems it. But this section excludes as inventions “plants and animals including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”. Since plants produced through the use of new biotechnologies are not technically considered “essentially biological,” section 3(j) has found another way to create room Agribiotech companies. This loophole, couched in the guise of scientific advancement, thus allows patents on GMOs and hence opens the floodgate for patenting transgenic plants. What is most concerning is how the language of section 3(j) is a verbatim translation into India law of Article 27.3 (b) of TRIPS Agreement . While, Art 27.3(b) is under review, the Indian government should have insisted on the completion of the review instead of changing India’s Patent Law.
While having already an explicit law providing protection on plant varieties in the form of Protection of Plant Varieties and Farmers’ Rights Act, 2001, what was the need to provide product patents on seeds through amendment of the Patent Act? It creates confusion, as it does not make clear which protection shall be granted to seeds of Genetically Modified crops. Shall they be patented or shall they be protected as a plant variety? The USA already provides the most liberal scenario, providing both patent and PVP option to protect plant and plant varieties. The European Union has also issued a Directive on the legal protection of biotechnological inventions to clarify how patent laws should be applied to biotechnological inventions . The genes used for transforming the transgenic varieties may be construed to be biotechnological inventions and considered eligible for patent by some countries. However, others may not consider gene as ‘invention’ but only ‘discovery’, which cannot be patented. Judgement would rely only on the respective national patent laws . From the discussion above it is proved that India provides as liberal protection by providing both patent and plant variety protection to seeds of Genetically Modified crops as given by the USA.
The most important thing to assess is the possible implications, on the various stakeholders, of the new IPR regime in India, which are enacted in an attempt to fulfil the obligations under WTO? There are many issues emerging in the area of agriculture with respect to agricultural biotechnology esp. G M crops, which may have grave significance over agriculture in future that need to be looked into in time. For example Indian Protection of Plant Varieties and Farmers’ Rights Act simultaneously protects the rights of breeders, farmers, researchers and public interest as well, whereas the new Patent Bill makes way for product patent on seeds giving way to creating monopolistic rights. What are the possible implications of establishing such a system of multiple rights on the utilization and exchange of genetic resources among various actors? Could the attempt to distribute ownership rights to various stakeholders pose the threat of an ‘anti-commons,’ where resources are under utilized due to multiple ownership? Although the Multiple Rights system aims to equitably distribute rights, it could create problems of overlapping claims and result in complicated bargaining requirement for utilization of varieties. A potential implication is an ‘anti-common tragedy’ where too many parties independently possess the right to exclude giving rise to underutilisation of resources. India and other developing nations, in seeking to achieve the important goal of recognising the farmer’s rights, must not overlook the need for promoting exchange of agricultural resources .
It is thus advised that the Indian government should, instead of fulfilling its obligation in haste, shall make such amendments in the act which adequately safeguard and protect the interests of the domestic industries and market, taking advantage of the concessions given in the TRIPs agreement. The government shall exclude genetically modified crops from the ambit of patent protection and device an altogether new set of laws governing the new forms of food production like organically processed, chemically processed and genetic engineered food. These different foods have different safety risks and need different laws to regulate production and consumption. The patent bill shall be sent to the standing committee of the parliament, which would be able to listen to and take into account the views of different stakeholders including industries and NGOs and then suggest amendments. The government shall come up with a law which reflects the concerns expressed over pricing, availability of drugs and other products and take appropriate measures to safeguard the domestic interests while fulfilling the international obligations.