The Trans-Pacific Partnership’s patent linkage: Unfriending or befriending the right to biologics?

Author(s):  
Zeleke Temesgen Boru

The World Trade Organization brought Intellectual Property Rights into the multilateral trading system. The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which formed part of the Agreement Establishing the World Trade Organization, established a minimum level of protection with respect to various forms of Intellectual Property Rights. However, in the aftermath of its adoption, several Free Trade Agreements, which include Intellectual Property Rights provisions of different potency, have come into existence. These Free Trade Agreements have given rise to what is commonly known as TRIPS-plus IP provisions. The provisions may renege on States’ obligation to promote access to biologics, medicines which are derived from proteins through biotechnological process. In this light, one recent Free Trade Agreement is the Trans-Pacific Partnership Agreement, which requires its Parties to implement a number of TRIPS-plus obligations, including data exclusivity and patent linkage. Against the aforementioned backdrop, this article focuses on patent linkage and explores whether the provision allows the Trans-Pacific Partnership Parties to utilize TRIPS flexibilities to promote the right to biologics. In doing so, the article provides potential responses to the question, does patent linkage deter the realization of the right to biologic? With the purpose to do so, while the first section provides a concise introduction into the agreement, the second section discusses the TRIPS standard on patent. While the third part demonstrates the nature of obligations enshrined in the Trans-Pacific Partnership’s rule on patent linkage, the fourth section investigates the obligations’ implication on the right to biologics. The last section provides the conclusion.

2020 ◽  
Vol 10 (2) ◽  
Author(s):  
Danielle Trachtenberg ◽  
Warren A. Kaplan ◽  
Veronika J. Wirtz ◽  
Kevin P. Gallagher

AbstractThis paper develops new indicators that measure the strength of intellectual property rights (IPR) provisions in Chile’s free trade agreements (FTAs). We use these new indicators to examine the extent to which FTAs with strong IPR provisions impact the volume, unit value and overall value of imported biologic medicines into Chile. We find that FTAs with more stringent IPR provisions increase both the volume and the unit value of imported biologics, suggesting greater availability of imported biologics at a higher price. Further research, however, is necessary to determine whether the increases in volume and unit prices of imports lead to greater universal access to biologics or greater inequity in access to these medicines.


2016 ◽  
Vol 5 (2) ◽  
pp. 395-418 ◽  
Author(s):  
Stephen R. Tully

Abstract This article identifies 8 key lessons for those States contemplating a free trade agreement with the United States (U.S.) arising from Australia’s experience. The standards of intellectual property protection under the Australia-U.S. Free Trade Agreement and their impact on pharmaceutical prices in Australia are a particular focus. Prospective parties must first conduct a national interest self-assessment which reviews the desired strength of intellectual property protection under national law and their preference for using flexibilities available to them under the existing international intellectual property rights framework. The United States negotiates free trade agreements in light of previous ones, negotiating outcomes obtained in other fora and the decisions of international trade tribunals. Negotiations typically occur behind closed doors, which is a process having adverse implications for transparent decision-making, public consultation periods and contributions from interested non-governmental actors. A concluded agreement will build on prior treaties and influence the course of future international arrangements. But the impact of a United States free trade agreement is not always clear, including because of a lack of reliable data, and the extent of national legal change is a contested issue given existing reform agendas and external influences. The United States seek to redesign national health care systems in its own image and had little success in Australia’s case. National legal systems need not be harmonised: although there can be some convergence in intellectual property rights regimes, significant differences may also remain. Negotiators must reconcile competing cultures, philosophies and perspectives between States for a free trade agreement to be worthwhile.


Author(s):  
Henning Grosse Ruse-Khan

This chapter focusses on how ‘Free Trade Agreements’ (FTAs) fit within the existing multilateral framework, primarily with the Trade Related Aspects of International Property Rights (TRIPS) Agreement which most FTAs take as basis and benchmark from which the contracting parties modify rules among another (inter-se). In this context, the most prominent issue is the effect the continuous strengthening of the standards of intellectual property (IP) protection and enforcement has on the optional provisions and flexibilities of the TRIPS Agreement. The chapter examines whether and how the TRIPS addresses such further increases in protection and enforcement. It also looks at conflict clauses in FTAs and how they perceive their relation with the multilateral IP rules, especially the TRIPS Agreement. The principal question here is whether rule-relations within the international IP system are still primarily determined by harmonious interpretation — or if conflict resolution rather functions by choosing one rule over another.


Author(s):  
Ahan Gadkari ◽  
◽  
Sofia Dash ◽  

The availability of vaccinations against COVID-19 provides hope for containing the epidemic, which has already claimed over 2.84 million lives. However, inoculating millions of individuals worldwide would need large vaccine manufacturing followed by fair distribution. A barrier to vaccine development and dissemination is the developers' intellectual property rights. India and South Africa have jointly sought to the World Trade Organization that certain TRIPS rules of COVID-19 vaccines, medicines, and treatments be waived. This piece argues for such a waiver, highlighting the unique circumstances that exist. It believes that TRIPS's flexibilities are inadequate to cope with the present epidemic, particularly for nations without pharmaceutical manufacturing competence.


2001 ◽  
Vol 50 (3) ◽  
pp. 714-724
Author(s):  
Joe McMahon ◽  
Catherine Seville

This Journal's previous piece on current developments in EC intellectual property noted that this area of law is dominated by the drive towards harmonisation.1 This drive continues, and its success has been such that it can now begin to be seen in an overarching context of globalisation. The idea of a unified global system for the protection of intellectual property now seems at least conceivable, even if not immediately achievable. It is even possible to state that some stages have been achieved on the journey, most notably the TRIPs Agreement. Since adherence to this is a requirement of World Trade Organization (WTO) membership, the arguments in its favour have suddenly become “persuasive”. It represents a tremendous achievement in terms of the protection and enforcement of intellectual property rights throughout the world. The World Intellectual Property Organisation's contribution here and elsewhere has been immense.


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