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Apotex and the United States—Round III: The First Application of res judicata in a NAFTA Arbitration by Martin King (London) Apotex Inc. (“Apotex”), a Canadian developer and manufacturer of generic drugs, commenced three arbitrations against the United States under the North American Free Trade Agreement (“NAFTA”) in the past six years, which have raised interesting issues of inter- national law and the status of new drug applications. These arbitra- tions, and similar investment treaty claims by others, signal a willing- ness of pharmaceutical companies to use investor-state arbitration to protect international interests. APOTEX I Apotex applied for U.S. Food and Drug Administration (“FDA”) approval to market a generic version of a Pfizer anti-depressant and sought a declaration from a U.S. District Court that Pfizer’s patent was invalid or would not be infringed by Apotex’s generic version. The District Court dismissed Apotex’s action for lack of subject matter jurisdiction; Apotex’s subsequent challenges in the Federal Circuit and Supreme Court were also denied. Apotex contended that the U.S. courts had wrongfully permitted Pfizer to “bottleneck” the generic market and delay regulatory approval of Apotex’s generic version. APOTEX II Apotex applied for FDA approval to market a generic version of a Bristol Myers Squib (“BMS”) statin. Other pharmaceutical companies, specifically Teva and Ranbaxy, had submitted appli- cations for generic versions, and BMS had taken no action. After BMS made representations that it would not sue Apotex, the FDA 43 K&L Gates: ARBITRATION WORLD 43