Category Access to Medicine

Sustainable Innovation: Intellectual Property, Technology Transfer, and Global Public Goods

QUT News, 22 February 2024 22nd February 2024 The role of intellectual property rights in technology transfer to developing countries and least developed countries to achieve the UN Sustainable Development Goals (SDGs) is a major theme of a new international…

Neglected Dimension of the Inventive Step as Applied to Pharmaceutical and Biotechnological Products: The case of Sri Lanka’s patent law

[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.

Colombia to Challenge AIDS Drug Patents

[Public Citizen Press Release] Colombia will soon decide whether to authorize price-cutting generic competition with a critical patented AIDS drug, directly challenging pharmaceutical industry power under a new health ministry resolution in one of the hemisphere's most influential states. In anticipation of the decision, https://www.citizen.org/article/letter-to-colombias-minister-of-health-supporting-colombias-right-to-issue-a-compulsory-license-for-hiv-treatment-dolutegravir/ Colombian Minister of Health Guillermo Alfonso Jaramillo to support expanding access to dolutegravir, calling the move a "stand for health justice."

Time for a stocktaking exercise and the way forward in technology transfer

[Guillermo Rodrigo Corredor] The technological stocktaking for developing countries after the pandemic is quite ambiguous. Although the crisis was stopped using state-of-the-art vaccines that reached the most disadvantaged and remote places in record times, effective access to the new technologies that became available to curb the pandemic is, at least for the time being, less spectacular.

Impacts of LDC Graduation on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in Cambodia, Djibouti, Senegal and Zambia

[Nirmalya Syam and Shirin Syed] Abstract: Least developed countries (LDCs) benefit from specific flexibilities under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), including an extended transition period for implementation of the agreement. These flexibilities cease to apply when countries graduate from the LDC category. Cambodia, Djibouti, Senegal and Zambia are among the countries that have recently started the graduation process, which consists of a series of stages over several years and involves analysis of quantitative and qualitative information, including the expected impacts of graduation. In that context, this study analyses the policy and developmental implications for these countries of no longer benefitting from the LDC-specific provisions of the TRIPS Agreement.

Global Inequities In Access to COVID-19 Health Products and Technologies: A Political Economy Analysis

[Deborah Gleeson, Belinda Townsend, Brigitte F. Tenni, and Tarryn Phillips] Abstract: This paper presents a political economy analysis of global inequities in access to COVID-19 vaccines, treatments, and diagnostic tests. We adapt a conceptual model used for analysing the political economy of global extraction and health to examine the politico-economic factors affecting access to COVID-19 health products and technologies in four interconnected layers: the social, political, and historical context; politics, institutions, and policies; pathways to ill-health; and health consequences. Our analysis finds that battles over access to COVID-19 products occur in a profoundly unequal playing field, and that efforts to improve access that do not shift the fundamental power imbalances are bound to fail.

Ensuring Access to New Treatments for Ebola Virus Disease

[Médecins Sans Frontières Access to Medicines Campaign] ... Although the approval of these products was a great achievement, the process of ensuring that people who need them can access them is at a standstill. As crucial contributors to the R&D of these treatments, survivors, affected countries and NGOs should have a say in this process. However, we see that decisions related to access and affordability are currently left only to the private corporations holding legal rights and regulatory data, and to the goodwill of these corporations and national governments.

Excluding Intellectual Property from Bilateral Trade and Investment Agreements: A Lesson from the Global Health Crisis

[Christophe Geiger] Abstract: This chapter critically analyses the inclusion of intellectual property (IP) in the investment chapters of free trade agreements and bilateral investment treaties as well as their submission to their related investor state dispute settlement (ISDS). It argues that these developments pose a serious threat to a balanced and ethical innovation system. In part this is because when regulating IP to foster non-economic interests, the possibility of ISDS creates uncertainty about the ability of states to protect human rights and matters of public interest by limiting IP rights, even when such action is perfectly legitimated by the international IP system and its flexibilities.

Anticompetitive Patent Strategies by Pharmaceutical Companies

[Olga Gurgula] Abstract: Pharmaceutical companies have been increasingly exploiting the patent system to delay or even block generic competition. Some of these practices, such as ‘pay-for-delay’ agreements, have attracted the attention of competition authorities. However, other practices remain outside of competition authorities’ investigative activities in most jurisdictions.

Sens. Jayapal, Warren Call on Patent Office to Take Critical Steps to Lower Drug Prices and Fight Big Pharma’s Patent Abuse

[Office of Senator Pramila Jayapal] U.S. Representative Pramila Jayapal (D-Wash.) and U.S. Senator Elizabeth Warren (D-Mass.) sent a letter to Kathi Vidal, Director of the United States Patent and Trademark Office (USPTO), calling on USPTO to take immediate action and use its existing administrative authorities to help lower drug prices and hold pharmaceutical companies accountable for anti-competitive business practices. The lawmakers outline six specific actions that the USPTO should take. 

On the Appeal of Drug Patent Challenges

[Charles Duan] Abstract: ... In this Article, I review the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. I find that a large fraction of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and that administrative cancellation of drug patents correlates closely with subsequent generic drug competition and reduced drug prices. The data suggests that these effects are not due to bias against patents, but rather because of the expertise of administrative adjudicators and the remarkably low quality of the drug patents challenged. Indeed, I find that nuanced aspects of these administrative proceedings, particularly at the appellate level, in fact are biased in the opposite direction — against patent challengers. These findings suggest that inter partes review and other administrative challenge proceedings likely serve an important purpose for lowering the costs of medicines, and those proceedings could potentially be improved.