Historically India has supported the idea that possibilities for sustainable development exist, and has acquired a leadership role among the non-aligned countries (developing countries) alongside Brazil. The fundamental issue is the necessity to guarantee the fulfilment of the global population’s needs, without precluding future generations. This general position and the cultural heritage - profoundly diverse from those of the Western societies where economic growth is usually adopted as wealth indicator - are often causes of friction and misunderstanding between the North and the South of the world. Such divisions are particularly evident in the case of patents, as shown by Indian legislation on the mater and, in general, the different approach to the concept of knowledge, understood as a cumulative and collective process as opposed to superiority in the individualist Western model. The TRIPS agreement ((Trade-Related Aspects of Intellectual Property Rights) tries to mitigate these differences, universalising a system similar to the one in force in the United States. However, India in implementing it, took into consideration its well-established practice on patents and the sanitary crisis it has to face.

The agreement on the aspects of intellectual property rights related to commerce, known with the British acronym TRIPS, was negotiated during the Uruguay Round, which took place in the GATT sphere (General Agreement on Tariffs and Trade) from 1986 to 1994. The same working session brought about the institution of a permanent international organisation, the World Commerce Organisation (OMC), to which the TRIPS agreement is indissolubly bound: all the OMC members, as all the candidates waiting to join, must comply to the agreements on intellectual property rights. TRIPS‘s scope is extremely vast, and includes copyright, trademarks, patents, industrial design and commercial secrets, and many critics of the agreement underline a tendency of homogenisation of different sectors in a unique legislative scheme. However it is the patent’s regulation which seems destined to raise the most vexed questions, some paragraphs of the agreement are already objects of revision, as of the Doha Round meetings which began in 2001.

One of the most discussed aspects is the international recognition of patents on pharmaceutical products. The matter involves quite distant positions, on one hand the industrialised countries and the developing ones on the other: the former sustain the need to protect and recognise the innovation rights in pharmaceutics, the only way to guarantee fair investments in a sector as intense as research and development; the latter claim the right to produce generic medicines equivalent to those patented in the West without recognising the innovation rights, in order to control the costs and provide more accessibility to the medicines by the weaker sections of the population.

In India due to the pursuit of these aims and to the legislation on patents in the Patent Act of 1970 that essentially doesn’t provide protection for medicines (apart for a few exceptions), a thriving generic medicines’ manufacturing industry has developed. Thus, besides providing access to medicines for the Indian population, the pharmaceutical firms witnessed an increase in exports towards developing countries of generic medicines, an export that didn’t protect the intellectual property rights of the western manufacturers. It is significant that these companies provide the international ONG, Medici Senza Frontiere (MSF), around the 84% of retroviral medicines destined to the over 60.000 HIV positive patients in the 30 countries where MSF operates. All considered the Indian decision to ratify the TRIPS agreement ties into the policies of New Delhi’s Government to exploit the vast flow of foreign capital in order to turn its pharmaceutical industry, from simply manufacturer to an innovator in the field of research and development of new products.

In India the TRIPS agreement was brought about through an amendment to the Patent Act of 1970 and became active as of the 1st of January 2005 as required by the OMC, this caused protests by the interested groups, in particular doctors, patients and pharmaceutics firms, besides other organisations and lobbies variously effected by the agreement. However, two years after the new system for patents coming into force, only one pharmaceutical product has obtained the required protection from a list of over 9.000 requests. This result is due to some clauses of the Patent (Amendments) Act of 2005, that are the basis for legal cases. For example, the requests of the patent precognition will be taken into consideration only if registered after the 1st January 1995, and the Indian medicine manufacturers can continue any production started before the coming into force of the agreement, excluding almost automatically Western competitors from the market. Moreover, the act contains numerous examples regarding the adoption of compulsory authorisation, that is the obligation for who holds intellectual property rights to allow the exploitation of its innovation in certain conditions. Generally such conditions are the cases in which the Least Developed Countries do not possess the productive capacity to face national sanitary emergencies.

In May 2006 the Swiss pharmaceutics company Novartis referred to the Chennai Court the decision of the Indian Patent Office, which rejected the patent recognition of Glivec, a product against leukaemia realised by Novartis itself. The decision was based on the low level of innovation which had been used to create the product. Usually patent concession requires that the innovation is new, not obvious and useful; however some modern scientific sectors, among them the biochemical-pharmaceutical one, have made it more difficult to determine a clear demarcation for the fulfilment if the first and second criteria, and Indian law is extremely restrictive in this regard. The first examinations took place in November 2006, and are to be repeated in February 2007, highlighted the Swiss company’s position as well as the legal objections on which it is based. In particular there is incompatibility between the commitments taken by the Indian Government - as member of the OMC and signer of the TRIPS agreement - at international level and the national law’s dispositions, where the patenting of products derived from known substances is forbidden, unless they turn out to be more effective (Patent Act, section 3d). However, even the TRIPS agreement leaves a certain power of discretion to the national legislators as it declares that the innovations must involve an inventive step, conforming to the ‘non-obviousness’ principle, present in the US regulations, in order to obtain patent rights.

Novartis, in an official note, asserts the irrelevance of the Glivec case in comparison with the problem of access to therapy. However, the price of the new product’s treatment will not be less than 26.000 US dollars a year for each patient, an inaccessible sum for the largest part of the Indian population, as admitted by the company itself. For this reason Novartis promoted a free distribution programme of the medicine (Glivec International Patient Assistance Program, GIPAP), that reached 5.000 people. But unfortunately the dimension of the sanitary problem in India is on different level, as the Swiss NGO ‘Berne Declaration’ underlined, suggesting the number of 25.000 new cases of chronic myeloid leukaemia every year. The proportion of the national emergency seems even more evident if the diffusion of the HIV virus is considered: with 5 million infected people, India is in fact, according to the UNAIDS’ 2006 report (a combined UN programme against AIDS), the nation with the largest number of infected. Moreover, as the parts of the population suffering the most - and still scarcely reached by information and prevention programmes - are mostly the poorest and weakest ones, the access to medicine’s is destined to remain a crucial question on the Indian Government’s agenda.

The Doha Round negotiations represent probably the most important forum where India can speak of its requirements, and those of the countries that import generic medicines from India in order to solve the problem of access to therapies. However, a solution of the Glivec case in favour of Novartis could open the way to patents for other products, and the absence of governmental representatives at the first audiences leaves many questions on New Delhi’s future decisions.