Judges of Latin American countries gathered in a seminar co-organized by the South Centre and the Consejo de Estado de Colombia (Council of State of Colombia) to discuss the relationship between intellectual property (IP) and access to medicines, considering international, regional and national laws. The meeting took place in Cartagena de Indias, Colombia, on 19-21 November 2019, as part of the South Centre activities to promote a public health approach to intellectual property protection.
The seminar brought together 25 members of the judiciary from Argentina, Brazil, Colombia, Ecuador, Paraguay and Peru. Debates were facilitated by experts from South Centre, including the Executive Director, as well as scholars. The Former president of Colombia, Ernesto Samper Pizano, gave the key-note speech.
The TRIPS flexibilities were discussed on the basis of national and regional communitarian legislation. Relevant case law was also analysed by participants. The right to health is recognized as a fundamental right in all of the six Latin American countries, which generates a diversity of legal situations requiring the intervention of the courts, particularly due to the region's many individual claims requesting access to medicines and treatments.
The interpretation of patentability criteria was emphasised as a crucial TRIPS flexibility. Another topic that was given high attention was the exercise of judicial discretion in the grant or refusal of interim and final injunctions as well as other remedies.
The participants discussed arguments typically deployed in patent litigation across the region, highlighting insufficient expertise for judges to assess technical arguments in cases involving pharmaceutical patents and the need for more diversity of experts that judges hear in these cases.
Expert technical assessment reports play a crucial role, yet often the technical experts preparing the reports are unable to provide a balanced analysis, which means that adjudication may typically favour the party with more economic power (namely, the patent holder).
Throughout the seminar, it was noted by the participants that there was a major need for judicial and administrative courts to improve the understanding of the applicable legal frameworks on the matter across the region. In this regard, it was suggested to adopt robust legal interpretations in matters of patentability criteria, as well as enabling rather than restrictive interpretations of exclusions, limitations and licensing practices of patents that, while fully compliant with the TRIPS Agreement and other free trade agreements, are also consistent with public health goals and the right to health. The fact that such proposed reconciliation can take place through legal interpretations by courts was a key takeaway of the workshop. Finally, the need for more inter-agency interaction (between national and regional courts, between competition and regulatory agencies and courts, and between national policymakers and judges, and even between judges themselves) was another relevant outcome of the meeting.
A more detailed analysis of the workshop can be found below.
International trade and human rights frameworks, including the Doha Declaration on IP and Public Health and the SDGs, mandate countries to promote access to medicines
An overview of the history and intersection of global IP and access to medicines was presented, including how trade rules, particularly through the TRIPS Agreement, led to an important rise in the costs of patented medicines, with paramount effects on developing countries.
It was noted that the tension between public health and the exclusive rights granted by intellectual property (IP) needed to be addressed. Multiple international institutions and resolutions have reiterated the need for the implementation of TRIPS flexibilities to enhance access to medicines and to integrate human rights concerns into the IP agenda. These include the Doha Declaration on the TRIPS Agreement and Public Health of the World Trade Organization (2001), the United Nations (UN) Secretary-General's High-Level Panel on Access to Medicines (2016) and the UN Sustainable Development Goal (SDG) 3 on health for all, in its target 3b. In this sense, the overall aim to ensure that the IP system does not hinder access to medicines was in fact a widespread shared concern.
A rigorous legal analysis of the TRIPS flexibilities and interpretation of national and regional IP laws was perceived by participants as necessary to make them consistent with public health goals without compromising compliance with the IP protection legislation.
Litigation on the right to health and TRIPS Plus measures
Participants and experts recalled that in Latin America the right to health was an integral part of national constitutions, which provided an added importance to the efforts of ensuring access to medicines for all. Within this framework, courts play a very relevant role in the region as they are the institutions who decide on the admission or not of multiple specific individual requests for pharmaceuticals and treatments. This distinctive phenomenon is known as ‘judicialization of health’ (judicialización de la salud/judicialização da saúde), which bears major consequences to both the right to health and to national health budgets, as well as implications for the availability to patients of patented and off-patented medicines.
In some countries, the free trade agreements entered into with the United States imposed the adoption of certain IP norms that go beyond the minimum standards of the TRIPS Agreement. This includes the grant of data exclusivity on pharmaceuticals, although the TRIPS agreement only provides for an obligation to provide protection to undisclosed test data against unfair competition. Experts noted that even in those countries, there is some leeway for implementing the provisions in a less restrictive way with regard to access to medicines. In this respect, it was noted that judges are called to interpret free trade agreements in accordance with constitutional mandates to ensure the right to health.
Judges define the contours of IP protection and the application of TRIPS flexibilities, requiring comprehensive and balanced views when deciding individual cases
Participants discussed that judicial and administrative courts are the entities responsible for deciding the contours of intellectual property protection when interpreting national and regional laws. In Brazil, for instance, the majority of cases that reach certain judicial courts specialised in IP are attempts to invalidate granted patents, or review the refusal thereof. In other countries, such as Colombia, Ecuador and Peru, administrative courts – either related to the patent authorities or independent bodies – conduct similar assessments. Therefore, the outcomes of individual cases may directly impact competition, market dynamics, public health expenditure and patients’ access to medicines.
The role of competition authorities in addressing anti-competitive practices in the pharmaceutical sector, such as such as excessive pricing and discriminatory licensing conditions, was also discussed. There is also the possibility of judicial review at the highest national levels, typically the Supreme Court. The decisions of the regional Andean Court of Justice are also highly relevant for the harmonised application of the Andean Community IP legislation that is binding in the four member States of the Andean Community – Bolivia, Colombia, Ecuador and Peru.
Implementation of TRIPS flexibilities through legal interpretation in Latin America
Participants discussed the main flexibilities provided by the TRIPS Agreement and how cases related to the application of TRIPS flexibilities are brought to courts, sharing their experiences and perspectives.
The application of patentability criteria of pharmaceutical products and their legal doctrines was a topic of key interest. Experts highlighted that the TRIPS Agreement leaves significant discretion to countries to define what their patentability criteria are. There is no harmonised definition of “invention”, neither as what precisely entails “novelty”, “inventive step” and “industrial applicability”. In developing countries, relaxing the patentability criteria to allow for minor inventions to be patentable in the pharmaceutical field is not the right policy choice for furthering access to medicines and promoting domestic capacity. In this regard, specific case laws were brought forward and discussed. Participants were particularly interested in discussing cases related to “evergreening”, which refers to practices by the pharmaceutical industry to extend patent monopolies for a single product beyond the patent term of the primary patent, through new patent applications for minor technical improvements, i.e. dosage forms, alternative formulations of the medicinal product, routes of administration, or uses in new therapeutic classes or combinations. Participants and experts agreed with the view that the adoption of rigorous patentability criteria was an adequate approach to render the IP system compatible with public health objectives.
Other topics of discussion during the seminar included the compulsory licensing of patents and government use, exceptions to the rights conferred by a patent (such as excluding living organisms and mere discoveries from patentability), and parallel imports as a legal avenue for procuring affordable medicines.
Participants also discussed how the judiciary should use its discretion in assessing whether to grant provisional and final injunctions as well as in determining remedies in cases of alleged pharmaceutical patent infringement. Experts also discussed with participants on the importance of improving the regulation of medicines of biological origin and biosimilars in Latin America to promote access to quality products.
Former president of Colombia Ernesto Samper Pizano reminds need for governments to ensure affordable medicines, sharing own experience as Hepatitis C patient
The Former president of Colombia, Mr. Ernesto Samper Pizano, gave a special key-note speech. President Samper shared his personal testimony of having survived Hepatitis C and the difficulties in receiving timely and adequate treatment. The creation of new drugs with better efficacy rates and less side effects, such as Sofosbuvir, has provided new opportunities for curing patients from Hepatitis C, but treatment remains largely inaccessible in many countries due to the high pricing. President Samper attested that even privileged people were subject to extremely costly treatments, and noted that governments should step up with policies to ensure affordability and availability, particularly for the poorer parts of the population.
President Samper also proposed the creation of a global list of “humanitarian medicines”, a list of the essential medicines that should be made available regardless of their patent status, and advocated for the generic production of all medicines in this category.
Increase inter-agency communication, more dialogue between courts and technical expertise needed
Participants expressed interest in more dialogue to exchange information on cases and approaches in different jurisdictions in the Latin American region. The seminar was considered to provide a fruitful platform for the region, considering that the countries largely share the same legal traditions and some even similar law provisions. Despite the regional differences, such as the higher integration level in terms of IP interpretation due to the role of the Tribunal of the Andean Community, all the countries share to a certain extent a number of similar issues. The participants agreed that a platform to share and discuss cases from within the region would be very beneficial.
Finally, an important issue referred to the perceived lack of technical skills by judges to properly assess arguments rooted in chemistry, pharmacy and/or medicines, which are often brought to courts through technical reports. Many participants delineated the scenario under which an effective asymmetry in information exists: patent applicants with significant economic resources are able to provide multiple reports by renowned professionals to support their arguments, but there is in most cases no single divergent approach. Participants discussed how to address this asymmetry. The goal, as discussed, was not to provide a bias to decision-making. Instead, this would be a way to provide more comprehensive and balanced decisions in specific cases.
Trainings and other technical support provided by the South Centre on public health
The participants appreciated the regional seminar and requested that national seminars be held. The South Centre provides technical assistance for developing country officials and judges on matters related to intellectual property and access to medicines through trainings and an expert advisory service. For more information and to benefit from the expert advisory service, see: https://ipaccessmeds.southcentre.int/
Author: Vitor Ido is Programme Officer of the Health, Intellectual Property and Biodiversity (HIPB) programme of the South Centre.