This chapter will analyze common pharmaceutical patent law provisions appearing in recent free trade agreements with a view to distilling the main purpose and effect of those provisions. The call for coherence between regulations in differing countries encompasses intellectual property laws and potentially impacts health policy, including access to medicines. The trend is clearly to both maximalist standards and harmonization of regulations. Existing literature is extensive on the types of ‘TRIPS-plus’ measures being incorporated into free trade agreements. This chapter will not simply decry this trend but instead makes the more nuanced argument that while harmonization can potentially yield benefits there are dangers to harmonization/regulatory coherence in the area of pharmaceutical patents. In some cases, harmonization will help efficiency and effectiveness but in other instances such standards tend to ignore context and result in inappropriate and misplaced rules. In the main, the chapter argues regulations which increase normative standards should be carefully tailored to the specific context of the country at issue while harmonization of practical standards could reduce costs and increase efficiencies in the public health system.
The Fair and Equitable Treatment (FET) standard in international investment agreements (IIAs) has expanded in coverage and scope over the past two decades, thereby exposing governments to the potential for increased liability. This chapter critically examines the FET standard in IIAs as it interacts with intellectual property (IP) rights, focusing on the interpretation and application of the FET standard by the investor-State dispute settlement (ISDS) tribunals in the disputes of Eli Lilly v Canada and Philip Morris v Uruguay. The chapter argues that tribunals are taking into account the context of IP and wider governmental/societal interests and narrowly construing potentially expansive provisions such as FET. It offers several takeaways from the disputes which could guide the development of policy and the assessment and evaluation of any future dispute.
Marina Foltea and Bryan Mercurio
Some countries regulate ENDS in the same way as traditional tobacco products, while others classify them as medicinal products or create a sui generis category subject to unique rules. A number of countries have simply prohibited their sale and possession. Although ENDS definitely require a regulatory response, applying highly trade restrictive measures to them may potentially damage business operators, while governments may be missing an opportunity to tackle the tobacco epidemic. Just as with any other product, highly trade restrictive measures may not be allowable under the system established by the WTO. Against this background, this chapter examines the applicability of the WTO nondiscrimination provisions to cases where a general ban on trade in ENDS is adopted. It is argued that so long as cigarettes are traded freely across borders, it is not at all obvious that a ban on ENDS will be compliant with the WTO rules.