in Global Challenges in Intellectual Property Law: TRIPS Beyond 30 (I. Calboli and K. Maskus, eds.), World Scientific Publishers (forthcoming 2027), Available at SSRN: https://ssrn.com/abstract=7375678 or http://dx.doi.org/10.2139/ssrn.7375678
Working Draft
Abstract
We are in the midst of a technological revolution. Advances in the computational power of computer hardware, the introduction and rapid increase in the capacity of artificial intelligence (AI) and envisioned artificial general intelligence (AGI), our understanding of the mechanics of human biology, the development of advanced robotics, and other innovation are transforming the way in which new drug development is taking place, and the way pharmaceutical products will be manufactured and distributed. The WTO TRIPS Agreement, as a supplement to the WIPO IP treaties, addressed technologies of an earlier age -- principally the Industrial Revolution of the 1860s. Even before the ink was dry on the TRIPS Agreement, developments in the Internet space required further normative codification at WIPO by means of the WIPO Copyright Treaty and Performances and Phonograms Treaty. The battles recently fought at WHO regarding TRIPS flexibilities in the Pandemic Agreement, and the ongoing struggle regarding access to genetic materials and resource information for incorporation in the Pathogen Access and Benefits (PABS) Annex, are addressing well-worn issues.
The role of intellectual property in the development, production and distribution of pharmaceutical products (as broadly defined) has generated the most substantial controversy around the TRIPS Agreement worldwide since its entry into force in 1995. This can be explained by the importance of the subject matter to individuals, and the corollary importance to industry, government policymakers and other interested groups. In a nutshell, individuals with medical conditions, or who are threatened by dangerous pathogens, may depend on pharmaceutical innovation, and having access to that innovation, for their well-being. Industrial policy instruments, i.e., intellectual property rules, affecting the scope and pace of innovation and the ability of individuals to secure that innovation, are touching something vital. Of course, there are other subject matter areas where IP norms are important, but human health is at or near the top of the list of “human interests”.
The chapter looks to the future. This is a future when based on present evidence the WTO is not likely to play a significant role given the shift in trade negotiation and agreement priorities toward bilateral and plurilateral arrangements. Moreover, it is a future in which IP law will be adapting across a range of subject matters and issues, and in which we may see a shift from patents on inventions to protection of data by trade secret, market exclusivity and other confidentiality protection as the more significant factors in access.
Download File