Neglected Dimension of the Inventive Step as Applied to Pharmaceutical and Biotechnological Products: The case of Sri Lanka’s patent law
By Ruwan Fernando
Apart from the basic statutory definition in section 65 of the Intellectual Property Act of Sri Lanka, there do not appear to be any detailed statutory guidelines or judicial decisions to provide any framework for the assessment of inventive step in Sri Lanka. The current statutory definition is highly insufficient to evaluate the standard of obviousness in relation to biotechnological and pharmaceutical claims based on a combination or modification of a prior art reference.
The Courts in both developed and developing countries have adopted a variety of tests to evaluate the obviousness standard of a claimed invention based on a combination or modification of a prior art reference. Sri Lanka, as a developing country, should look at the development that has taken place in other jurisdictions and adapt the patent law to local conditions when developing tests or guidelines in a manner that is compatible with the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and its biotechnology/pharmaceutical policy guidelines.
This approach that is appropriate to Sri Lanka is twofold. First, it is most likely to prevent the issuance of patents on trivial or incremental inventions that do not provide any technical advance to the existing prior art and are a mere extension of what is already known in the prior art. Second, it is most likely to protect genuine technical advances to the existing prior art while at the same time enhancing competition and promoting local innovations so that the local researchers will be able to draw on the existing knowledge for the purpose of follow-on innovations.
Reinvigorating the Non-Aligned Movement for the Post-COVID-19 Era
By Yuefen Li, Daniel Uribe and Danish
The Non-Aligned Movement (NAM) was born out of the need felt by newly emerging post-colonial nations not to be compelled to be part of any single political or military bloc during the Cold War. As the international community finds itself once again in the midst of heightened geo-political tensions, the principles of non-alignment have seen a resurgence in the Global South, providing NAM with the potential to become a major force in the configuration of a new international order.
Over six decades after its inception, the NAM stands at a crucial juncture, where consolidating non-alignment among developing countries can help build solidarity, promote collaboration and defend the interest of developing countries in the reconfiguration of global governance. Dealing with these challenges requires unprecedented levels of international cooperation, both North-South and South-South. As the grouping of non-aligned countries, the NAM could play an important role against global fragmentation, build solidarity, and strengthen multilateralism.
This paper therefore looks at the role and position of the NAM at this time, and how it can be reinvigorated to address the most critical challenges facing its Member States and other developing countries today. Considering the history, evolution and important achievements of the NAM, the paper provides some proposals that can support NAM Member States in their recovery from the COVID-19 pandemic and make progress in implementing the 2030 Agenda for Sustainable Development.
Hacia una Agencia Latinoamericana y del Caribe de Medicamentos (AMLAC)
Por Germán Velásquez
El 26 de abril de 2023 en Acapulco, México, las Autoridades Reguladoras de Medicamentos de Colombia (INVIMA), Cuba (CECMED) y México (COFEPRIS) firmaron la “Declaración de Acapulco” para la creación de la Agencia Latinoamericana y del Caribe de Regulación de Medicamentos y Dispositivos Médicos (AMLAC). Esta declaración fué confirmada en Bogotá, Colombia el 16 de junio de 2023 en una reunión titulada “Convergencia regulatoria” por los responsables de las agencias reguladoras de medicamentos de Argentina, Brasil, Chile, Colombia, Cuba y México que acordaron la creación progresiva de una Agencia Latinoamericana y del Caribe de Medicamentos -AMLAC-.
La AMLAC fué creada para contribuir a la integración regional a través de la armonización y convergencia en materia de regulación sanitaria, la creación de un mercado regional de medicamentos en busca del acceso a medicamentos y dispositivos médicos seguros, eficaces y de calidad.
Statement by the South Centre on the Two Pillar Solution to Address the Tax Challenges Arising from the Digitalisation of the Economy
28 July 2023
The South Centre takes note of the Outcome Statement by 138 member jurisdictions of the OECD/G20 Inclusive Framework (IF) made on 11 July 2023, on the Two-Pillar Solution to Address the Tax Challenges Arising from the Digitalisation of the Economy. In this statement the South Centre highlights the inclusion of rules that have the practical effect of reducing the tax payable to developing countries under Amount A, the limitations of Pillar Two and other key aspects of the OECD proposed rules that require attention by developing countries before they decide to be tied up by such rules.
COVID-19 impacted humanity in many ways and one such impact is wide acceptance of the concept of Work From Home (WFH) by the corporate sector. Previously, WFH did exist in some countries, perhaps at a much smaller scale, but compulsions of COVID-19 have made WFH a new normal. This new normal also creates new tax challenges for the Multinational Enterprises (MNEs). Does the employee create a taxable presence in the countries where they are working remotely through a ”permanent establishment” and if yes what are the profits attributable to such permanent establishment?
The existing treaty provisions are likely to result in widespread litigation on these issues. It is desirable that a new provision is introduced in the tax treaties to tackle these issues. The suggested remote worker permanent establishment provision adopts a very simple measurable threshold for determination of permanent establishment and also attempts to balance taxing rights of the country of source as well as residence. A simple standardised approach could be adopted for determining the profits attributable to such permanent establishment.
Assessing the State of Play in the WHO Pandemic Instrument Negotiations
By Viviana Muñoz Tellez
This Policy Brief discusses the state of play of the negotiations of the pandemic instrument at the World Health Organization. The Intergovernmental Negotiating Body (INB) is increasing its meetings as the target deadline for completion in the first half of 2024 draws closer. To advance, the political will needs to be scaled up in the next months. The expectations should not be lowered to focus on the lowest common denominator. Real progress needs to be made in priority areas of concern for developing countries to keep momentum.
Towards A Latin American and Caribbean Medicines Agency (AMLAC)
By Germán Velásquez
On 26 April 2023 in Acapulco, Mexico, the Medicines Regulatory Authorities of Colombia (INVIMA), Cuba (CECMED) and Mexico (COFEPRIS) signed the “Declaration of Acapulco” for the creation of the Latin American and Caribbean Medicines and Medical Devices Regulatory Agency (AMLAC). This declaration was confirmed in Bogota, Colombia on 16 June 2023 in a meeting called “Regulatory convergence” by the heads of the medicines regulatory agencies of Argentina, Brazil, Chile, Colombia, Cuba and Mexico who agreed on the progressive creation of a Latin American and Caribbean Medicines Agency (AMLAC).
AMLAC was created to contribute to regional integration through harmonisation and convergence in health regulation, the creation of a regional medicines market in pursuit of access to safe, effective and quality medicines and medical devices.
South Centre Statement to the 64th WIPO General Assembly (2023)
The South Centre, the intergovernmental organization of developing countries, actively promotes balancing public and private interests in the IP system. In accordance with the mandate of the 2007 Development Agenda (DA) and the Sustainable Development Goals (SDGs), which WIPO as a UN specialized agency must contribute to, development, sustainability and human rights should be at the core of WIPO’s activities. WIPO should remain a Member State-driven, development-oriented organization.
The South Centre remains available to all developing countries’ delegations to provide further information and support on these matters, during and after the Assemblies.
South Centre Statement to the Non-Aligned Movement (NAM) Ministerial Meeting
July 5-6, 2023
Baku, Azerbaijan
The South Centre supports developing countries with policy-oriented research, advice on international negotiations and capacity building. Since its inception, the South Centre has maintained a close relationship with NAM. We are strong supporters of its principles, appreciate its achievements, and believe in the central role that NAM can play in reforming the multilateral system.
The South Centre will continue to work with NAM and its member countries to support them in their efforts to shape a fairer multilateral system that is responsive to the needs of the Global South.
The global landscape of climate finance is highly fragmented and complex, involving multiple pathways, actors, institutions, and instruments. Funds provided by developed countries to developing countries for climate adaptation and mitigation actions are channelled through various multilateral funds – both within and outside the scope of the operating entities of the UNFCCC’s financial mechanism.
Developing countries indisputably need climate finance to flow at a sufficient scale and in a timely manner. While the options and possibilities for countries to access climate finance are expected to increase, with a multitude of funding channels, this can also make the process even more complicated and confusing. Which funds to turn to? For which activities? At what costs? These are a few of the many questions that climate change decision-makers must contend with. Each fund is administered with complicated rules and procedures, which makes it very challenging for developing countries to navigate when seeking to fund their domestic climate actions. There is currently no ‘one-stop-shop’ to provide useful and quick answers.
The Climate Finance Readiness E-book is a series of short briefs prepared by the South Centre to provide developing countries with a «help desk» to access and more effectively and efficiently utilise the complex web of climate finance information available to them. This brief will be updated periodically and will shine a spotlight on different geographical areas. The South Centre welcomes questions, comments, and suggestions for this series of briefs to continuously improve its help desk function on Climate finance.
Reinvigorating the Non-Aligned Movement for the Post-COVID-19 Era
By Yuefen Li, Daniel Uribe and Danish
The Non-Aligned Movement (NAM) was born out of the need felt by newly emerging post-colonial nations not to be compelled to be part of any single political or military bloc during the Cold War. As the international community finds itself once again in the midst of heightened geo-political tensions, the principles of non-alignment have seen a resurgence in the Global South, providing NAM with the potential to become a major force in the configuration of a new international order.
Over six decades after its inception, the NAM stands at a crucial juncture, where consolidating non-alignment among developing countries can help build solidarity, promote collaboration and defend the interest of developing countries in the reconfiguration of global governance. Dealing with these challenges requires unprecedented levels of international cooperation, both North-South and South-South. As the grouping of non-aligned countries, the NAM could play an important role against global fragmentation, build solidarity, and strengthen multilateralism.
This paper therefore looks at the role and position of the NAM at this time, and how it can be reinvigorated to address the most critical challenges facing its Member States and other developing countries today. Considering the history, evolution and important achievements of the NAM, the paper provides some proposals that can support NAM Member States in their recovery from the COVID-19 pandemic and make progress in implementing the 2030 Agenda for Sustainable Development.
Health, Intellectual Property and Biodiversity Programme, South Centre
The following matrix provides a factual overview and analysis of the standing and non-standing agenda items of the regular session of the WTO TRIPS Council. The matrix also discusses the TRIPS Implementation issues as part of the WTO Doha Development Round of negotiations.
