Apotex Inc. v. The Government of the United States of America, UNCITRAL, Submission of Claimant (October 29, 2010)
I. Introduction
1. In accordance with the Tribunal’s correspondence, dated October 15, 2010, Apotex hereby respectfully submits the grounds upon which it seeks a stay of arbitration relating to its Notice of Arbitration dated June 4, 2009 (the “second-filed claim” or “Pravastatin Claim”), pending the Tribunal’s consideration and resolution of matters relating to Apotex’s Notice of Arbitration dated December 10, 2008 (the “first-filed claim” or “Sertraline Claim”).
2. As explained in more detail below, Apotex’s two NAFTA claims arise from entirely different factual scenarios pertaining to separate investments; involve separate and independent legal issues; and involve wholly separate injuries at the hands of wholly separate Party actors. Apotex’s first-filed Sertraline Claim arises from the U.S. federal courts’ unlawful refusal to apply the controlling “case or controversy” standard under Article III of the U.S. Constitution in determining whether subject matter jurisdiction existed over Apotex’s declaratory judgment action involving certain patents purporting to cover Apotex’s generic sertraline drug product. In stark contrast, Apotex’s second-filed Pravastatin Claim arises from the U.S. federal courts’ unlawful interpretation of the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and departure from Congressional intent and controlling federal court precedent in refusing to treat the dismissal of Apotex’s patent litigation involving the drug product pravastatin as a so-called “triggering court decision” for purposes of triggering the 180-day generic marketing exclusivity period under the FFDCA.
3. As explained below, Apotex will suffer tremendous prejudice if the two cases proceed concurrently, as both claims involve complex factual and legal issues that bear no relevance to each other, but easily could lead to confusion. In addition, hearing the two claims together could create unnecessary burdens on counsel and the Tribunal, waste time and resources, and create unnecessary accounting problems.