ICSID Tribunal Dismisses Claims by Apotex against the United States (August 25, 2014) [1]
On August 25, 2014, a Tribunal established under the North American Free Trade Agreement (NAFTA) at the International Centre for Settlement of Investment Disputes (ICSID) dismissed [3] all claims brought by Apotex Holdings Inc. and Apotex Inc. against the United States. According to a press release [4], the case concerned a prior arbitration from 2012 where Apotex argued that when the U.S. Federal Drug Administration (FDA) implemented an “Import Alert” on two Apotex facilities in Canada, the U.S. violated “obligations under NAFTA Chapter Eleven to accord Apotex and its U.S. investments national and most-favored-nation treatment [and] adopted the Import Alert without due process, in violation of the customary international law minimum standard of treatment.” In the present arbitration, the Tribunal determined, by a majority, “that Apotex was barred from relitigating the issue of whether Apotex Inc.’s ‘abbreviated new drug applications’ constituted ‘investments’ in the United States for purposes of NAFTA Chapter Eleven, given a previous tribunal’s determination of that issue.” Additionally, “[o]n the merits, the tribunal unanimously concluded that the Import Alert was a lawful and appropriate exercise of FDA’s regulatory authority [and] did not violate the United States’ obligations under NAFTA Chapter Eleven.”