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SOUTHNEWS

 
No. 404, 8 April 2022

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South Centre organizes a course for Colombian Judges on intellectual property and public health

 

The South Centre organized an in-person course on intellectual property rights and public health for members of the Colombian judiciary between 30 March and 1 April 2022, in the city of Cartagena, Colombia. The session had the participation of administrative judges and judicial assistants from the country, who are competent in intellectual property (IP) related matters. The discussion was particularly timely after the recent change in the legal mandate of administrative law courts in Colombia as they became competent to deal with IP-related issues. The course was opened by Dr. Carlos Correa, Executive Director of the South Centre.
 
 
 
Day 1
30 March 2022
 
The first session, with a presentation by Dr. Germán Velásquez, Special Advisor of the South Centre, dealt with contemporary debates on the access to medicines in global health. It addressed the recent discussions at the World Health Organization (WHO) as a response to the COVID-19 pandemic, including the structural limitations of the current mechanisms such as COVAX, and the strong inequality in access to vaccines. Dr. Velásquez also addressed the current pharmaceutical innovation model based on patent protection, and the rising costs of medicines. Large public investments are made to achieve pharmaceutical innovation, and therefore access mechanisms need to be ensured as part of the innovation process, concluded Dr. Velásquez, also noting that along these lines a binding research and development (R&D) treaty is required.
 
The second session provided an overview of the international, Andean and Colombian laws on IP and public health, presented by Dr. Viviana Muñoz, Coordinator of the Health, IP and Biodiversity Programme, South Centre. She described the right to health under international law and under the Colombian Constitutional law and addressed the issue of rising costs of medicines, Colombian exports and imports of pharmaceuticals, and implications on access to health. She further described the history and implications of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), including its main provisions, the Doha Declaration on the TRIPS Agreement and Public Health, the High-Level Panel on IP and Access to Medicines, and the recent interpretation by a World Trade Organization (WTO) panel of the Declaration as a ‘subsequent agreement’ of the TRIPS Agreement. Dr. Muñoz then described the regional framework of the Andean Community, based on Decision 486 and its harmonized regime, and how this relates to the commitments undertaken under trade agreements such as the one signed by Colombia with the United States. For example, the inclusion of five years of data exclusivity, a TRIPS Plus measure, was introduced in Colombia through such agreement.
 
 
 
Subsequently, Dr. Carlos Correa made a presentation on the rationale of the IP system (to promote the public interest), a historical background of the IP system (including the utilization of a flexible context by now developed countries) and the existing TRIPS flexibilities, which are particularly important for developing countries. He addressed the relation between IP and the right to health, the international framework on IP and the interpretation of flexibilities for public health. Early Latin American Constitutions considered IP to be privileges; the United States Constitution has an instrumental conceptualization of IP: it justifies it as a vehicle for the development of science and arts, not to create private fortunes for inventors, as declared by the US Supreme Court. He provided a historical overview which highlighted the flexible global scenario with respect to the protection of IP rights prior to TRIPS – and now developed countries such as the US benefitted from flexible IP rights protection in their development processes. He then explained how the situation drastically changed with TRIPS, with a minimum 20 years of protection for patents, the obligation to protect pharmaceutical patents, the shift of burden of proof in proceedings relating to process patents, the protection of test data, among others. On the other hand, flexibilities have been retained for countries on areas not covered by TRIPS, which include: the definition of invention and of patentability criteria, exclusions to patenting, exceptions to exclusive rights (such as the ‘Bolar’ and research exceptions), compulsory licensing and non-government use, parallel imports and those related to enforcement measures. Similarly, countries of the Andean Community also have their own national laws despite the harmonization at the regional level. An example of legislative diversity is found in how countries define in their national laws what can or cannot be patentable. Thus, Argentina and Mexico define invention as a “creation”, Brazil excludes from patentability genome even when isolated, and Ecuador excluded a number of subject matter. As another example, the US Supreme Court in eBay v. MercExchange (2006) ruled that the “decision whether to grant or deny injunctive relief rests within the equitable discretion of the district courts”, i.e., the grant of injunctions is not automatic. In fact, obtaining a preliminary injunction is quite difficult in the US in patent litigation.
 
Prof. Oscar Lizarazo, National University of Colombia, discussed the process of granting a patent, how they can be granted to both products or processes, and the exclusions to patentability, such as mathematical forms and methods of treatment. He discussed the applicability of the public order exception, as well as that referring to ‘good customs’ and ‘moral’, noting how they could be applied to medicines with high public interest and essentiality – despite the origin of such provisions as moralistic, religious forms of control. There is also some maneuver for countries to exclude the patentability of second (new) uses of known medicines – one example is zidovudine, created for cancer in the 1960s and then found to be a treatment against HIV/AIDS in the 1980s; another example is sildenafil (‘Viagra’). He noted the problem with patents with excessively broad scopes, such as the one on Remdesivir’s molecule, which could then be applied to various diseases and uses (including its use for COVID-19). Another dimension is the overlap of patent protection with other forms of IP, including trademarks (e.g., on medicine pills) and trade secret protections. Prof. Lizarazo also noted the impact of patent prosecution highways (PPH), which avoid duplication of patent procedures of filings in multiple jurisdictions, but which may lead to the adoption of different standards as those mandated by the law in Colombia. He exemplified by comparing the standards with those of a laxer jurisdiction in granting patents, namely the United States, as well as the outcome of the patentability of the cancer medicine imatinib in various jurisdictions, including the landmark Novartis case in 2013 at the Supreme Court of India. The patent not granted in most jurisdictions, including Argentina, Brazil, China, was however granted in Colombia.[1] Other cases were discussed on patentability criteria. He concluded the presentation with a discussion on the 2021 changes in the mandate in the Colombian judicial system: IP matters are now judged by administrative courts of Cundinamarca, raising issues of interdisciplinarity, impartiality of technical experts, and the harmonization of Andean Community Law.

 
 
 
Day 2
31 March 2022
 
Prof. José Manuel Álvarez-Zarate, Externado University, Colombia, made a presentation on exceptions to patent rights. He highlighted the interpretative room under international, regional, and Colombian law to decide upon patentability, noting the limits of protection – including the requirement that it must be interpreted restrictively and based on formally granted rights (and not expectations of rights). In Colombia, he explained that international norms such as Articles 7 and 8 the TRIPS Agreement (Objectives and Principles, including technological and socio-economic development, as well as the protection of public health) are part of domestic law, and are used to understand the objectives, flexibilities and exceptions in the IP regime. Along these lines, countries may establish exceptions to patent rights, including experimental use, private and non-commercial use, educational uses, the ‘Bolar’ exception, the research exception, as well as other flexibilities such as compulsory licenses and parallel imports. Under Article 30 of TRIPS, an exception should: (i) be limited (reasonable and proportional), (ii) cannot impede normal exploitation of a patent and (iii) should not cause unjustified harm to legitimate interests of patent holders. The issue of exceptions of rights is regulated by Article 53 of the Andean Community’s Decision 486 – but also requires that sufficient information should be disclosed by a patent holder (Article 29, TRIPS). He concluded by stressing that a patent should not impede a State to allow exceptions to patent rights such as private and non-commercial use, experimental use, educational or research use, or for regulatory approval in the case of pharmaceuticals. Such interpretation needs to take into account Articles 7 and 8 of TRIPS, he reiterated.
 
Dr. Carlos Correa continued with an in-depth analysis of patentability criteria, i.e., how to interpret novelty, inventive step, and industrial application. He dealt with the issue of proliferation of patents, and how even rich countries such as the United States struggle with access to medicines. The persistent high costs of the century-old insulin (to which there are still patent barriers) are a prime example. Others include: (i) Ritonavir, an anti-retroviral, has been protected by over 800 patents, (ii) Humira, to which AbbVie filed 247 patent applications that protect it for 39 years, and (iii) omeprazole (“Losec/Prilosec”), with an original patent in 1984 and various subsequent patents (on salts, polymorphs, among others – one of which valid until 2022). Dr. Correa discussed the expansion of patents on the chemical and pharmaceutical realms, including the following: polymorphs, salts, formulations, manufacturing processes, combinations, isomerism, and new indications of existing medicines. Common strategies of pharmaceutical filing practices, including Markush claims, were also discussed. Other doctrines and cases were presented, such as the reasons against the patenting of second use patents, which are discoveries (inherent properties, rather than an invention) and therefore not creations, equivalent to a method of therapeutic treatments, without industrial application.
 
Subsequently, Dr. Carlos Correa addressed the issue of compulsory licenses (CLs) and government use for non-commercial purposes. He noted how the US is actually the country with the largest number of issued CLs, both in competition-related instances and others. CLs had been included in the 1925 amendment of the Paris Convention, are part of the TRIPS Agreement (Article 31), have been reiterated as a legitimate tool by the Doha Declaration and with the Article 31bis amendment (originally WTO decision in 2003). However, many requirements need to be met for a CL to be issued, and there are various restrictions. The TRIPS Agreement does not limit the grounds for the issuance of CLs, but the Andean Regime focuses on three modalities: (i) lack of exploitation of patent; (ii) public interest (including emergency and national security); and (iii) licenses to remediate anti-competitive practices. Dr. Correa made critical comments on the recent decision by the Andean Tribunal on compulsory licensing, which overly restricts the conditions for a CL to be issued.
 
Dr. Francisco Rossi, Ifarma Foundation, presented the three requests made to the Colombian government for the issuance of compulsory licenses: Kaletra (for HIV), Imatinib (for cancer) and different direct acting antivirals (DAA), such as Sofosbuvir. Rossi presented the internal discussions, the various challenges and reception by distinct Colombian stakeholders of the three requests, which would request a public interest declaration as a first step towards CLs. He noted the intertwinement of legal, political, and economic issues with the relevant issue of access to health technologies, highlighting the pitfalls of the current system. He concluded by referring to the recent request for a non-commercial governmental use license for COVID-19 treatment Paxlovid, and discussions for applying for the same for the HIV treatment Dolutegravir.
 
Prof. José Manuel Álvarez-Zárate then concluded the day with a presentation on injunctions and enforcement under Colombian law, with a focus on balancing protection of rights with ensuring the public interest, particularly not impeding access to medicines. Infringement of patents may generally require the infringement to be terminated or damages to be paid. Prof. Álvarez specified the details under national and Andean law, and the elements that should be taken into account when adjudicating such cases – such as economic consequences of the decision and avoiding the abuse of petitions which would unduly restrict legitimate trade. Along these lines, inaudita altera parte injunctions (i.e., without hearing the other affected Party) should be an exception. He also made comments on the procedure to be adopted under the law, the legal status of provisional measures, among others. He also clarified what is mandated under the TRIPS Agreement, which requires minimal standards of enforcement but also leaves room for countries to craft their own policies – for example, separate judicial systems for IP are not required. The remedy in an injunction has three main aspects: (i) the IP right of the plaintiff; (ii) whether the defendant threatens or infringes this right, (iii) whether an injunction would really be suitable for the concrete case – which includes a balancing and reasonability test, as well as whether the infringement can be compensated by damages. In this context, a crucial issue is the balance of rights, making reference to a number of cases from other jurisdictions.
 
 
 
Day 3
1 April 2022
 
On the final day, Dr. Vitor Ido, Programme Officer of the Health, IP and Biodiversity Programme, South Centre, presented the issue of control of anticompetitive practices. He noted the ample freedom under international law (with the TRIPS referring to diffusion of technology and with provisions to control anticompetitive practices) and with no international harmonizing agreement on competition law, and the growing number of jurisdictions deciding cases at the interface of intellectual property, competition and access to health technologies. He noted how competition law should not only focus on efficiency gains – something which US and the European Union also acknowledge – and how developing countries should and do mandate in their laws other goals, including protection of consumers, promoting development and stimulating the market entry of small companies. This is also the case of Colombian law, as shown from the 1991 Constitution. He then made comments based on some selected landmark cases, which dealt with various practices: (i) the Hazel Tau case in South Africa, dealing with excessive pricing of patented HIV drugs; (ii) the Eli Lilly case in Brazil, related to sham litigation and regulatory/patentability abuses; (iii) GD Searle in Chile, another excessive pricing case of a patented drug, which led to an agreement and transfer of technology to competitors; (iv) the GSK/Pfizer merger in Colombia, which required the selling of drug trademarks to avoid excessive concentration; (v) the price gouging of face masks in South Africa during COVID-19; (vi) Roche’s refusal to license a Covid-19 test and its subsequent licensing after the threat of an investigation, and the (vii) AstraZeneca case at the EU Court of Justice for Losec, in which the company was sanctioned for regulatory abuse (removing registration of a drug to avoid competitors from entering market) and misleading authorities with respect to its patent and data exclusivity protection. Dr. Ido concluded the presentation by drawing comments on the interaction between judicial authorities and competition authorities, how they could be improved and how institutional gaps need to be filled as to avoid abusive practices and enable a pro-development competition policy.
 
Prof. Carlos Correa presented the issue of protection of test data under TRIPS, with a focus on the Colombian experience. Test data are the result of clinical trials. The US had proposed during TRIPS negotiations the inclusion of exclusivity rights regarding test data for pharmaceuticals for at least 5 years, i.e., to impede competitors from using or relying on test data (an additional protection different from patents). These data are empirical information (collected via standard protocols), and not creations/inventions, he noted. Article 39.1 makes reference to how Member States should protect data against unfair competition (distinct from competition law) – which is not the same as introducing a new form of exclusivity rights, as originally intended by the US. Article 39.3 makes reference to the protection of test data submitted to regulatory approval against unfair competition – the drafting of the article, when compared to other TRIPS article, makes clear that there is no exclusivity right in Article 39.3. However, the US and the European Commission interpreted such article by arguing instead that countries would be obliged to change their laws to provide such exclusivities, and the US filed a complaint at the WTO against Argentina in 2000, which had understood otherwise. At the end, the countries reached a deal approved by the Dispute Settlement Body in which each country maintained their respective positions. They also agreed that if a panel interpreted in another moment that such provision requires exclusivity, Argentina would amend its laws and include such data exclusivity rights in 1 year’s time (however, no other cases were filed afterwards). Many other countries also do not provide for data exclusivity for test data, including Brazil and India. However, some countries were mandated to include them via free trade agreements, such as Colombia-US (2007) and the Colombia-EU (2012). The US has attempted to expand this to biological products alike. Such treaties led to a major disagreement at the Andean Community, and the subsequent departure of Venezuela from the regional body. Decision 632 (2006) of the Andean Community provided that data exclusivity rights can be included by Member States. Colombia had already internalized such exclusive protection via Decree 2085 (2002). One important issue relates to the concept of “new chemical entity”, as the data exclusivity would be applicable only to such molecules (and not, for instance, to new uses, etc.); there are also some exceptions. In addition, companies have attempted to expand such rights in various instances: for example, in Argentina, which doesn’t have data exclusivity rights, multinational companies made 12 claims against domestic companies for the recognition of such exclusivities. All of them were rejected by the courts.
 
Dr. Francisco Rossi then presented a study by Ifarma Foundation on the impact of data exclusivity in Colombia after Decree 2085 in the period 2012-2019.[2] He explained the context of the decision in the context of the free trade agreement with the US, and how this changes a mechanism for regulation of medicines into a mechanism to ensure market power to companies. He described the main elements of data exclusivity protection in Colombia, and the direct impact in the country based on concrete cases. In practice, he noted, many cases entailed unmerited protection – for example, to entities which were not new. The study estimates around 857 million USD/year of impacts of data exclusivity for the country.
 
The session was closed by Dr. Carlos Correa, who thanked the speakers and participants.
 
[1] For a technical analysis of the Imatinib case in Colombia (in Spanish), see:
Díaz Pinilla, L.F., Guevara, R., Lamprea, N. y Lizarazo-Cortés, Óscar 2016. Caso Imatinib: análisis técnico y jurídico del trámite de patente en Colombia. Revista La Propiedad Inmaterial. 22 (dic. 2016), 141–172. DOI:https://doi.org/10.18601/16571959.n22.08.
[2] See: https://drive.google.com/file/d/1oRN1vs6zK-UOZ2WcuOk-6aKhK_C5GPxq/view

Author: Dr. Vitor Ido, Programme Officer of the Health, IP and Biodiversity Programme, South Centre.

SOUTHNEWS is an e-newsletter service of the South Centre providing information and news on topical issues from a South perspective.

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For more information, please contact Anna Bernardo of the South Centre: Email abernardo@southcentre.int, or telephone +41 22 791 80 50.
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