The US-Mexico-Canada Agreement: Putting Profits Before Patients
By Maria Fabiana Jorge
In the US-Mexico-Canada Agreement (USMCA, NAFTA 2.0), the U.S. Trade Representative negotiated intellectual property provisions related to pharmaceuticals that would enshrine long and broad monopolies. This policy brief focuses primarily on the negative effects of the USMCA intellectual property provisions on access to medicines in the U.S. Such effects may be even worse for Canada and Mexico. The impact of this trade agreement goes well beyond the three countries involved as this is the first one negotiated by the Trump Administration and is likely to set a precedent for future trade agreements. A careful review of the USMCA text raises very serious concerns about the impact that this agreement would have on the generic/biosimilar industry and therefore on access to more affordable drugs throughout the world.
The ‘obvious to try’ method of addressing strategic patenting: How developing countries can utilise patent law to facilitate access to medicines
By Olga Gurgula
The current patentability standards for pharmaceutical inventions, as well as strategic patenting used by pharmaceutical companies, have substantially impacted access to affordable medicines. This has been especially detrimental for developing countries, which are under significant pressure to remain compliant with their international and bilateral obligations, while also providing their people with essential drugs. In order to improve access to medicines, developing countries may choose from a range of various mechanisms that may help to facilitate such access, while also allowing them to remain compliant with their international and bilateral obligations. This policy brief suggests that one of such mechanisms is to strengthen the obviousness requirement by applying the ‘obvious to try with a reasonable expectation of success’ test to pharmaceutical follow-on inventions. It is argued that the application of this test may be an effective tool in addressing the negative effect of strategic patenting. It may help to prevent the extension of patent protection and market exclusivity of existing drugs by pharmaceutical companies and, as a result, may open such medicines up to generic competition.
The Status of Patenting Plants in the Global South
Over the last few decades, the number of patents on plants and plant parts has greatly increased in various parts of the world. This has triggered social debate about possible negative consequences for the breeding sector, farmers and society. Despite the urgency of these questions, most research and literature has focused exclusively on developed countries – the USA and European Union, in particular – while little is known about the extent to which plants are being patented in other parts of the world. This research report, conducted and written by Prof. Carlos M. Correa, aims to fill this information gap by providing an overview of the status of patenting plants in the developing countries and emerging economies of the Global South.
South-South cooperation for confronting the neglected problem of snakebite envenoming: the role of Costa Rica
By Dr. Jose María Gutiérrez and Ambassador Elayne Whyte Gómez
As of 2018, the international community has a global framework to address the problem of snakebite envenomings, an acute problem that affects rural populations in tropical areas of the world, which mainly affects people from the most vulnerable sectors of the population and leaves significant negative consequences in millions of people around the world. This global framework was adopted by a resolution of the World Health Organization (WHO) at its 71st World Assembly on May 24, 2018, thus providing for a strong mandate to develop a comprehensive plan to address this health problem, work with affected countries, partners, stakeholders and industry, and develop a comprehensive approach that will allow countries to implement an effective response to this health issue.
Will the Amendment to the TRIPS Agreement Enhance Access to Medicines?
By Dr. Carlos M. Correa
An amendment to the TRIPS Agreement by incorporation of the text of the decision of the WTO General Council on 30 August 2003 (as article 31bis) has been made in response to the problem identified in paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. This paragraph sought a solution to situations where patented pharmaceuticals which are not available in a country with no or insufficient manufacturing capacity can be supplied by a foreign provider. As originally adopted, the TRIPS Agreement did not allow the grant of compulsory licenses for exports only, thereby preventing generic manufacturers from exporting the required products to countries unable to produce them. While the new article 31bis is a step forward as it reflects public health concerns, it would be necessary to streamline the procedures to effectively ensure broader access to pharmaceutical products at low cost and in a timely manner.
IP Licence, Trademarks and ISDS: Bridgestone v. Panama
By Pratyush Nath Upreti
Can an intellectual property right or a license authorizing its use be deemed an ‘investment’ under bilateral investment treaties? This policy brief discusses the arguments submitted by the parties in the Bridgestone Licensing Services, Inc. and Bridgestone Americas, Inc. v. Republic of Panama case on questions regarding a trademark license agreement. Bridgestone Licensing Services, Inc. (BSLS) and Bridgestone Americas, Inc. (BSAM) together initiated arbitration proceedings on the grounds that Panama’s Supreme Court decision was unjust and arbitrary, violated Panama’s obligations under the United States-Panama Trade Promotion Agreement (TPA), expropriated their investments, and violated the requirement of fair and equitable treatment (FET) to BSLS’s and BSAM’s investments.
Compulsory Licensing Jurisprudence in South Africa: Do We Have Our Priorities Right?
By Yousuf A Vawda
Compulsory licences are generally available on a variety of grounds, most notably on patents where the patentee is found to have abused its rights in one manner or another. This research paper attempts to review South African case law on applications for compulsory licences since the inception of the current legislation, analyse the interpretations placed on the relevant sections, and draw conclusions about judicial reasoning, impediments to the grant of such licences, and generally the courts’ approach to disputes relating to patents.
The Use of TRIPS Flexibilities for the Access to Hepatitis C Treatment
By Dr. Germán Velásquez
In late 2013, a new Hepatitis C treatment called direct-acting antivirals (DAAs) was introduced in the market at unaffordable prices. The eradication of the disease is possible if medicines can be purchased at AFFORDABLE prices within health budgets. IF THIS IS NOT THE CASE, governments should consider the use of the TRIPS flexibilities to facilitate access to the treatment.
South Centre Statement to the WIPO Assemblies 2018
The South Centre is the intergovernmental organization of developing countries with 54 member States across Africa, Asia and Central and Latin America, that is supportive of multilateral work towards an inclusive, balanced and flexible international intellectual property system that benefits all countries and all types of users.