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Reply of Claimants Apotex Holdings Inc. and Apotex Inc

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Reply of Claimants Apotex Holdings Inc. and Apotex Inc Public Version IN THE ARBITRATION UNDER CHAPTER ELEVEN OF THE NAFTA AND THE ICSID ARBITRATION (ADDITIONAL FACILITY) RULES _____________________________________________ APOTEX HOLDINGS INC. AND APOTEX INC., Claimants, – and – THE GOVERNMENT OF THE UNITED STATES OF AMERICA, Respondent. ICSID CASE NO. ARB(AF)/12/1 _________________________________________________________________ REPLY OF CLAIMANTS APOTEX HOLDINGS INC. AND APOTEX INC. ________________________________________________________________ ARBITRAL TRIBUNAL: V.V. Veeder J. William Rowley John R. Crook Attorneys for Claimants Apotex Holdings Inc. and Apotex Inc. May 24, 2013 CONFIDENTIAL Paris 9084347.1 NOT USG CLASSIFIED CONTENTS GLOSSARY OF TERMS ....................................................................................................... V INTRODUCTION.................................................................................................................... 2 EVIDENCE: BURDEN OF PROOF ..................................................................................... 9 COUNTER-STATEMENT OF FACTS ............................................................................... 11 I. APOTEX PRODUCTS POSED NO RISK TO CONSUMERS ............................... 12 A. THE RECORD DOES NOT SUPPORT THE US’S SUGGESTION OF CONTAMINATION ............ 12 B. FDA’S OWN ACTIONS ARE INCONSISTENT WITH APOTEX PRODUCTS POSING ANY PUBLIC SAFETY RISK ................................................................................................................... 13 II. FDA’S SUSPICIONS LEADING TO THE IMPORT ALERT PROVED UNJUSTIFIED ............................................................................................................. 15 A. CARBIDOPA-LEVODOPA AND THE ETOBICOKE INSPECTION............................................. 15 B. CONSUMER COMPLAINTS IN 2009 ................................................................................... 16 C. “WITHDRAWN” ANDAS AND REJECTED BATCHES ......................................................... 17 D. FDA’S DECISION TO ADOPT THE IMPORT ALERT ............................................................ 19 E. THE ETOBICOKE WARNING LETTER ................................................................................ 21 1. Apotex’s Batch Rejection System .......................................................................... 22 2. Field Alert Reports and Labels ............................................................................. 22 F. THE SIGNET INSPECTION ................................................................................................. 23 G. THE IMPORT ALERT......................................................................................................... 25 III. NO OTHER REGULATOR ADOPTED A MEASURE EQUIVALENT TO FDA’S IMPORT ALERT......................................................................................................... 27 A. HEALTH CANADA’S “SUPERVISION” OVER APOTEX WAS NOT EQUIVALENT TO FDA’S IMPORT ALERT ................................................................................................................ 27 B. THE IGZ, MEDSAFE AND TGA MEASURES WERE NOT EQUIVALENT TO FDA’S IMPORT ALERT ............................................................................................................................. 28 COUNTER-MEMORIAL ON JURISDICTION ................................................................ 29 I. THE IMPORT ALERT RELATES TO APOTEX-US............................................. 31 A. THE CONNECTION PRESCRIBED BY THE NAFTA’S SUBSTANTIVE PROVISIONS IS LEGALLY SIGNIFICANT.................................................................................................................... 32 (i) Paris 9084347.1 B. THE NAFTA DOES NOT SUPPORT THE US’S APPARENT VIEW THAT THE MEASURE MUST “APPLY TO” THE INVESTMENT ........................................................................................ 36 C. THE IMPORT ALERT DIRECTLY APPLIED TO APOTEX-US ................................................ 40 1. Relevant Provisions of US Law Apply to Both the Owner and the Consignee ..... 41 2. The FDA Notices of Action Were Addressed to Apotex-US Directly.................... 43 3. The US Fails to Distinguish Cargill...................................................................... 46 D. THE US ARGUMENTS BASED ON DISTRIBUTORSHIP ARRANGEMENTS AND APOTEX-US’S RELATIONSHIP WITH APOTEX-CANADA LACK SUPPORT ................................................. 48 1. Apotex-US Is the Sole Commercial Importer from Apotex-Canada in the United States 50 a) Apotex Recall Documents Do Not Support the US .................................... 51 b) The Three FDA Spreadsheets Do Not Support the US ............................... 52 (i) Unrelated Third Party Shippers Do Not Support the US ................... 52 (ii) Non-Commercial Shipments from Apotex Do Not Support the US.. 54 (iii) 99% of the Shipments to Consignees Other than Apotex-US Were Allowed into the United States .......................................................... 55 2. The US Arguments as to Apotex-Canada’s Relationship with Apotex-US Are Without Substance................................................................................................. 59 a) Apotex-US and Apotex-Canada Operate Within a Vertically Integrated Group........................................................................................................... 61 b) Apotex-US Received No Loans or Capital from Apotex-Canada But It Received Other Resources........................................................................... 62 c) Apotex-US Was Set Up Specifically as the Distributor of Apotex Drugs in the United States.......................................................................................... 64 d) Apotex-US and Apotex-Canada Are Mutually Dependent ......................... 65 e) Apotex-Canada Decides Which Products Will Be Developed for the US Market.......................................................................................................... 66 f) Apotex-US Plays a Significant Role in the ANDA Process........................ 67 g) US Litigation Is a Key Part of Apotex’s Regular Activity in the US.......... 70 II. APOTEX-CANADA’S ANDAS ARE COVERED INVESTMENTS...................... 72 A. APOTEX-CANADA’S ANDAS ARE “INVESTMENTS” UNDER CHAPTER ELEVEN .............. 72 1. Apotex-Canada’s ANDAs Are Intangible Property Within the Meaning of Article 1139 (g)................................................................................................................. 73 a) The NAFTA Does Not Support the US Argument That Revocable Intangible Rights Fail to Qualify as Investments ........................................ 74 b) The Takings Clause Cases the US Cites Do Not Support It........................ 77 c) The NAFTA Jurisprudence Does Not Support the US................................ 81 (ii) Paris 9084347.1 2. Apotex-Canada’s ANDAs Constitute “Interests Arising From the Commitment of Capital or Other Resources” Within Article 1139(h) ........................................... 83 a) Apotex-Canada Contributes Various Resources to the United States in Order to Obtain Marketing Authorizations – But These Resources Are Not the “Investment” .......................................................................................... 85 b) It Is Not Apotex’s Case That Cross-Border Services Contracts Constitute an “Investment”................................................................................................ 86 c) The US Does Not Dispute that Filing and Maintaining ANDAs Is a Commitment of Resources .......................................................................... 87 d) ANDA-Related Litigation Constitutes “Resources” ................................... 88 e) The NAFTA Protects Interests Arising From the Commitment of Foreign Capital in the Host State .............................................................................. 88 B. THE IMPORT ALERT RELATED TO APOTEX’S FINALLY-APPROVED ANDAS ................... 90 REPLY ON THE MERITS ................................................................................................... 92 I. THE US FAILS TO REBUT APOTEX’S NATIONAL TREATMENT AND MOST-FAVORED-NATION TREATMENT CLAIMS .......................................... 92 A. APOTEX RECEIVED TREATMENT ..................................................................................... 93 B. COMPARATORS WITH DRUG MANUFACTURING FACILITIES IN THE UNITED STATES ARE IN “LIKE CIRCUMSTANCES” WITH APOTEX.......................................................................... 93 1. The Pertinent Legal Regime Is That of cGMP Regulations.................................. 97 2. The Import Alert Is the Measure That Accorded Treatment................................. 98 C. THE RECORD SHOWS THAT APOTEX WAS TREATED LESS FAVORABLY THAN THE COMPARATORS.............................................................................................................. 105 1. The US Treated Apotex Less Favorably Than the Comparators With Facilities Outside the United States.................................................................................... 105 a) The Record Shows that Apotex Received Less Favorable Treatment Than Sandoz / Novartis ...................................................................................... 106 b) The Record Shows that Apotex Received Less Favorable Treatment Than Teva ..........................................................................................................
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