The following is the introduction of South Centre Research Paper no. 61, Guidelines on Patentability and Access to Medicines, by Germán Velásquez. The full paper is available here.
Until recently, the link between the examination of patents carried out by national patent offices and the right of citizens to access to medicines was not at all clear. They were two functions or responsibilities of the State that apparently had nothing to do with each other. Examining the growing literature on intellectual property and access to medicines, it seems that the analysis of one actor has been left out: the patent offices. And the reason is clear: patent offices are administrative institutions. Patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. There is now greater understanding that the examination of patents and the role played by patent examiners are key elements that could contribute to or obstruct access to medicines. Given the impact of pharmaceutical patents on access to medicines, patent offices should draw up public policies and strategies that respond to national health and medicine policies.
In 1994, the creation of the World Trade Organization (WTO) resulted in the establishment of a new treaty, the broadest on intellectual property rights: the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). This Agreement links issues of intellectual property and trade for the first time and provides a multilateral mechanism to resolve disputes between States. The TRIPS Agreement requires all WTO Member States to incorporate into their legislation universal minimum standards for almost all rights in this domain: copyright, patents and trademarks. In addition, the Agreement has considerably limited the freedom previously enjoyed by countries to develop and apply their own intellectual property systems. Such an obligation did not exist within the framework of previous international agreements. In the past, it was considered that each nation had the right to legislate in this respect. International agreements prior to the TRIPS Agreement did not specify minimum standards on intellectual property. Before the TRIPS Agreement, over 50 countries did not provide patent protection for pharmaceutical products; many provided patent protection for the processes but not the products and in a large number of countries, the duration was less than 20 years.
A patent is “a title granted by the public authorities conferring a temporary monopoly for the exploitation of an invention upon the person who reveals it, furnishes a sufficiently clear and full description of it, and claims this monopoly.” Monopolies generally lead to high prices that, in many cases, restrict access. The structure, patent – monopoly – high price – restricted access, does not present a problem when related to a patent for simple merchandise, such as a perfume or musical equipment. The problem arises when monopolies are granted for public goods or essential products used to prevent illness, improve health or prevent death.
According to the TRIPS Agreement, the patentability requirements used by national intellectual property offices require a product or manufacturing process to meet the conditions necessary to grant patent protection, namely: novelty, inventive step and industrial applicability (utility). These three elements, however, are not defined in the TRIPS Agreement and WTO Member States are free to define these three criteria in a manner consistent with the public health objectives defined by each country.
According to the report of the United Nations High Commissioner for Human Rights “The requirements under the TRIPS Agreement for the grant of patents – novelty, inventive step and industrial applicability – are open to interpretation under national legislation and each country can decide according to local conditions. Consequently, the High Commissioner encourages interpretations of these requirements that do not lose sight of the public interest in the wide dissemination of knowledge…”
The world has never had at its disposal such a wide arsenal of treatments to fight the diseases that afflict humanity. At the same time, many people die owing to a lack of certain medicines and/or vaccines. This applies to illnesses such as AIDS, malaria, tuberculosis, cancer, diabetes, hepatitis C, bacterial meningitis and pneumonia, among many others.
The growing concerns about the way international trade agreements, and particularly the TRIPS Agreement, could limit access to medicines led to the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001 (Doha Declaration). The Doha Declaration marked an important milestone in the discussions on intellectual property rights and access to medicines by affirming that the TRIPS Agreement should be interpreted and applied in a way that supports the right of WTO Member States to protect public health and, in particular, promote access to medicines for all. In this respect, the Doha Declaration contains the principles that the World Health Organization (WHO) has defended and promoted since the end of the 1990s, namely the reaffirmation of the rights of Members of WTO to fully apply the safeguarding provisions contained in the TRIPS Agreement in order to protect public health and promote access to medicines.
It is generally believed that patents are normally granted to protect new medications, but the number of patents obtained annually to protect truly new pharmaceutical products is very small and is decreasing. Each year, thousands of patents are granted for pharmaceutical products, however only a few are for new molecular entities (NMEs)
In a well-known and quoted article from 2002, P. Trouiller et al. found that of all of the pharmaceutical products developed in the world between 1975 and 1999, only 1.1 per cent were for neglected diseases, which should really be called ignored diseases. The same study was repeated recently and the results were not significantly better. Of the 850 products brought to market around the world between 2000 and 2011, only 4 per cent (exactly 37) were related to neglected diseases, which mainly exist in developing countries and include malaria, tuberculosis, Chagas’ disease, leishmaniasis and diarrhoeal diseases.
The cumulative nature of innovations owing to low patentability standards and weaknesses in the patent granting procedure has significant repercussions on patent systems, limiting the diffusion of the innovations that the system seeks to promote and hindering access to vital medicines. “Patents on broad scientific principles are generally bad, because in the words of the United States Supreme Court, they may confer power to block off whole areas of scientific development, without compensating benefit to the public”
All of the above led WHO, in collaboration with the United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme (UNDP) and the International Centre for Trade and Sustainable Development (ICTSD), to develop, in 2007, guidelines for the examination of pharmaceutical patents from a public health perspective.
These guidelines or directives were intended to contribute to improving the transparency and efficacy of the patent system for pharmaceutical products, so that countries could pay more attention to patent examination and granting procedures in order to avoid the negative effects of non-inventive developments on access to medicines.
The exercise to draft guidelines for patent examination sought a way to manage the pharmaceutical product patent system and, more specifically, the “strengthened patent system” arising from the TRIPS Agreement and current regional and bilateral trade and investment agreements. Patents are a social contract between the patent holder and society; therefore it is necessary to explore, identify and implement mechanisms to improve the functioning and transparency of the patent system in the interest of public health.
In order to develop a legal and normative framework to grant pharmaceutical products patent protection that ensures a balance between the producers and the users of technological knowledge (as required by Article 7 of the TRIPS Agreement), several issues need to be carefully examined at the national level so as to ensure access to medicines. In this context, the guidelines for the examination of patents are a contribution to tackle this significant challenge.
Three key questions that this document could address: 1) how to relate intellectual property and public health and what are the implications, particularly in terms of access to medicines; 2) how much room for manoeuvre and flexibility is permitted by new international trade rules, particularly the TRIPS Agreement; 3) third and central point of this reflection, what is the role of and, above all, the contribution that national patent offices could make to improving access to medicines, through guidelines for the examination of patents.
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