3. The implementation of the TRIPS flexibilities in the Brazilian Patent Law 71
3.1. Origin and development of the current patent system and its interaction with access
The present decision shows the firm approach of the Indian Supreme Court to prevent patent ever- greening, whose importance goes beyond the patentability regime of a drug in India, but bears global implications. Most importantly, it highlights the significant role that Indian generic producers have in facilitating access to affordable medicines in developing and under-developed countries.257 Moreover, the judgment demonstrates that a balance between the promotion of R&D and the containment of monopolies could be reached with precise interpretations and clear guidelines for defining the scope of the patentability requirements. Conclusively, this decision supports the rights of governments to fully adopt the TRIPS flexibilities, with the aim to encourage access to affordable life-saving medicines.
3. THE IMPLEMENTATION OF THE TRIPS FLEXIBILITIES IN THE BRAZILIAN PATENT
products.259 Laws 8.080/90 and 8.142/90 regulate the three principles of universality, equality and integrated healthcare, upon which the SUS is based.260 Firstly, everyone, who cannot afford private health insurances, should receive full treatment from the SUS coverage; secondly, access to medicines and treatments should be equal for all citizens, in other words, no one should be prevented from having access to public healthcare services; thirdly, the SUS should provide full healthcare coverage, regardless the complexity of the treatment needed.261
As a result, the right to access to medicines, even though not expressly stated by Article 196 of the Constitution, is recognised as a fundamental social right of the country and fully implemented in Brazil.262
In 1991, the Brazilian Ministry of Health began free delivery of AZT to all citizens. However, the high demand of the drug and the expensive cost of the AZT, initially purchased from the multinational patent owner (now GlaxoSmithKline), led the country to promote the local production of these medicines. Therefore, at the beginning of 1990s, the federal government started the purchase of ARVs, at a much lower price, directly from domestic pharmaceutical producers.263 This was initially permitted, given that the previous IP law did not provide patent protection for drugs and other pharmaceutical treatments.264
In addition, in 1996, the Federal Law 9.313/96 was approved. The Law recognised the universal access to ARVs as a legislative right, investing the SUS with the obligation to guarantee its free access to all Brazilian population.265
259 M. S. G. Rosina, D. Wang & T. C. de Campos, Access to Knowledge in Brazil: New Research on Intellectual Property, Innovation and Development, in Access to Medicines: Pharmaceutical Patents and the Right to Health” in Lea Shaver (ed.), New Haven, CT: information Society Project, Yale Law School (2008), 169.
260 See M. S. G. Rosina, D. Wang & T. C. de Campos (note above) 168.
261 See D. Matthews, (note above) 127.
262 See M. S. G. Rosina, D. Wang & T. C. de Campos, (note above) 170.
263 See G. C. Chaves, M. Fogaça Vieira & R. Reis, “Access to Medicines and Intellectual Property in Brazil:
Reflections and Strategies of Civil Society” in Sur - International Journal On Human Rights, No. 8 (June 2008) English Edition, 164.
264 See Industrial Property Law 5.772/71, which came into force in December 1971 and allowed several private and public generic producers to manufacture generic pharmaceutical products.
265 M. S. G. Rosina, D. Wang & T. C. de Campos, (note above) 189. See also G. C. Chaves, M. Fogaça Vieira & R.
Reis, (note above) 165.
Also in 1996 a new IP system came into force, the Industrial Property Law 9.279/96 (hereinafter the “Industrial Property Law”), which extended patent protection to all pharmaceutical products as per Article 27.1 of the TRIPS Agreement.266 As previously shown, the TRIPS Agreement imposed to all WTO Members the obligation to grant patents in all fields of technology, including pharmaceuticals.
However, unlike India, Brazil did not use the TRIPS flexibilities granted to developing countries, which legitimately gave them transitional arrangements in order to delay the application of the provisions related to patents in all fields of technology.267 Moreover, Brazil went even further than what required by the TRIPS Agreement, by allowing retroactive patent protection.268 According to Article 230 and 231 of the Industrial Property Law, patent applications could be filed for previously non-patentable subject matter, but only in case the patent was already granted in a foreign legislation. This mechanism of retroactive patentability is known as “pipeline” patent protection. It had a strong impact in the public health Brazilian system, because it exponentially increased, in a very short time, the number of patents granted in the country, provided that a mere formal administrative review confirmed the existence of the foreign patent. Additionally, this TRIPS-plus mechanism dramatically raised the growth in health expenditure, given to the fact that generics, previously available in Brazil, were suddenly banned in the drugs market, forcing the Ministry of Health to purchase, at higher price, ARVs from the respective patent owner.269 Despite the drastic impact that the Industrial Property Law had on the public healthcare system provided in Brazil, the country attempted to reach a balance between patents, public health and access to medicines through the implementation of some of the flexibilities, granted to developing countries, in the TRIPS Agreement. The TRIPS flexibilities available in the Brazilian legislation will be analysed in the following.
266 See D. Matthews, (note above) 129.
267 See Article 65 of the TRIPS Agreement.
268 See G. C. Chaves, M. Fogaça Vieira & R. Reis (note above) 167. See also D. Matthews, (note above) 130.
269 See M. S. G. Rosina, D. Wang & T. C. de Campos, (note above) 186. See also D. Matthews, (note above) 130, who explains that “following the introduction of pipeline patent protection for pharmaceutical products, while the SUS could purchase significant quantities of generic ARVs that were invented before 1996, these drugs were all patented in Brazil via the pipeline mechanism that year, dramatically raising the public cost of supplying these drugs in Brazil by US$420 million per year.”