Title: Regional training for patent office representatives
Date: 4 June, 2019
Venue: Kyiv, Ukraine
Organizers: The South Centre, International Treatment Preparedness Coalition (ITPC Global), Scientific Research Institute of Intellectual Property (National Academy of Law Sciences of Ukraine) and All-Ukrainian Network of People Living with HIV
Intellectual Property and Electronic Commerce: Proposals in the WTO and Policy Implications for Developing Countries
This policy brief explains the mandate of the World Trade Organization (WTO) on electronic commerce under the work program on e-commerce, which was adopted by the WTO Ministerial Conference in 1998 and periodically renewed by subsequent Ministerials. It describes what has taken place on intellectual property related issues pertaining to e-commerce in the WTO TRIPS (Agreement on Trade Related Aspects of Intellectual Property Rights) Council. It also summarizes various proposals and suggestions that have been advanced in the Council since the Nairobi Ministerial Conference in December 2015 as well as recent proposals that have been advanced in the General Council until December 2018, some of which contain specific intellectual property (IP) related issues. As part of the recently launched plurilateral negotiations on e-commerce, a forum that is likely to become more prominent for this discussion, proposals have been re-submitted in March 2019, as well as others which have been tabled in April and May 2019. Finally, this brief presents an explanation of how IP issues may also affect other elements of e-commerce and the digital economy. Such issues are not the subject of existing proposals in the WTO, but may feature in future discussions.
South Centre Statement on Access to Biosimilars/Biogeneric Medicines at the WHA 72
The revision of the guidelines on similar therapeutic products mandated by Resolution WHA67.21 is crucial for promoting the availability of and access to biosimilars. The reduction in prices ensuing from the introduction of these products has become essential to address public health needs in developed and developing countries. The WHO Document A72/59 under consideration by the WHA 72 (agenda item 21.3) states in paragraph 80 that “WHO expert committees have approved guidance on (…) biotherapeutics, including an update of the 2009 similar biotherapeutic products guidelines”. This statement is not accurate, as the guidelines were not updated as mandated by Resolution WHA67.21. Below is the South Centre statement in relation to this issue.
The US-Mexico-Canada Agreement: Putting Profits Before Patients
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
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.
Will the Amendment to the TRIPS Agreement Enhance Access to Medicines?
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
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?
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
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.