|Act||US Federal Food, Drug and Cosmetic Act|
|ANDA||Abbreviated New Drug Application|
|API||Active Pharmaceutical Ingredients|
|Apotex-Canada||Apotex Inc. (the Second Claimant)|
|Apotex-Holdings||Apotex Holdings Inc. (the First Claimant)|
|Apotex-US||Apotex Corp., a corporation organized under the laws of Delaware, USA|
|Apotex I & II Award||The award on jurisdiction and admissibility dated 14 June 2013 made by the NAFTA tribunal (Toby T. Landau, Clifford M. Davidson, Fern M. Smith) in the UNCITRAL Arbitration between Apotex Inc. and the Respondent|
|Apotex Costs Submission||The Claimants’ first submission on costs filed on 17 January 2014|
|Apotex Second Costs Submission||The Claimants’ second submission on costs filed on 7 February 2014|
|Arbitration Agreement||The arbitration agreement invoked by the Claimants resulting from their Request, NAFTA Articles 1116(1), 1117(1) and 1120(1)(b) and the ICSID Arbitration AF Rules|
|BNM||Business Neatness Magnanimity BNM srl|
|BVL||Ben Venue Laboratories in Bedford, Ohio, USA|
|[C.] [R.] [number]||Exhibit [Claimant] [Respondent]|
|CDER||The FDA’s Center for Drug Evaluation and Research, Office of Compliance|
|cGMP||Current Good Manufacturing Practices|
|Counter-Memorial||The Respondent’s Counter-Memorial dated 14 December 2012|
|DIOP||The FDA’s Division of Import Operations and Policy|
|DWPE||Detention Without Physical Examination|
|ECJ||European Court of Justice|
|EIRs||FDA’s Establishment Inspection Reports|
|Etobicoke||The drug production facility operated by Apotex Inc. and located at Etobicoke, Ontario|
|Etobiocoke warning letter||The warning letter issued by the FDA on 25 June 2009 in respect of Etobicoke|
|FAA||The US Federal Arbitration Act|
|FARs||Field Alert Reports|
|FDA||The US Food and Drug Administration|
|Form 483||A standard form on which FDA inspectors record their written observations at the conclusion of an inspection of a drug production facility|
|GAO||The US General Accounting Office|
|GMP||Good Manufacturing Practices|
|Guide||FDA’s Guide to Inspections of Foreign Pharmaceutical Manufacturers|
|Hearing||The hearing on jurisdiction and the merits (liability) which took place at the World Bank in Washington DC, USA, from 18 November to 26 November 2013|
|ICAA||Ontario’s International Commercial Arbitration Act|
|ICJ||The International Court of Justice|
|ICSID (or the Centre)||The International Centre for Settlement of Investment Disputes|
|ICSID Arbitration AF Rules||ICSID Arbitration (Additional Facility) Rules in force as of April 2006|
|ICSID Convention||Convention on the Settlement of Investment Disputes Between States and Nationals of Other States dated 18 March 1965|
|Import Alert||The FDA’s amendment of Import Alert 66-40 on 28 August 2009 to include all products produced by the Etobicoke and Signet facilities|
|Jamaica-USA BIT||Jamaica-USA bilateral investment treaty of 4 February 1994, which entered into force on 7 March 1997|
|Medsafe||New Zealand’s Medicines and Medical Devices Safety Authority|
|Memorial||The Claimants’ Memorial dated 30 July 2012|
|NAFTA||North American Free Trade Agreement|
|NAI||No Action Indicated|
|NDA||New Drug Application|
|New York Convention||The 1958 UN Convention on the Recognition and Enforcement of Foreign Arbitral Awards|
|OAI||Official Action Indicated|
|PCIJ||The Permanent Court of International Justice|
|PQA||Product Quality Assessment|
|Rejoinder||The Respondent’s Rejoinder dated 27 September 2013|
|Rejoinder on Jurisdiction||The Claimants’ Rejoinder on Jurisdiction dated 18 October 2013|
|Reply||The Claimants’ Reply dated 24 May 2013|
|Reply Supp||The Claimants’ Supplement to Reply dated 22 July 2013|
|Request (for Arbitration)||The Claimants’ Request for Arbitration dated 29 February 2012|
|Sandoz||The Sandoz/Novartis group of companies|
|Signet||The drug production facility operated by Apotex Inc. and located at Signet Drive in Toronto, Ontario|
|Signet warning letter||The warning letter issued by the FDA on 29 March 2010 in respect of Signet|
|TD. [day] [page]||Transcript of the oral hearing from 18 to 26 November 2013, with day and page reference|
|Teva||The Teva group of companies|
|TGA||Australia’s Therapeutic Goods Administration|
|UNCITRAL Notes||The UNCITRAL Notes on Organising Arbitral Proceedings|
|USA Costs Submission||The Respondent’s submission on costs filed on 17 January 2014|
Abbott v. Abbott, 560 U.S. 1 (2010).
ADF Group Inc. v. United States of America, ICSID Case No. ARB(AF)/00/1, Award (9 January 2003) (Florentino P. Feliciano, Armand de Mestral, Carolyn B. Lamm).
Ahmadou Sadio Diallo (Republic of Guinea v. Democratic Republic of the Congo), 2007 I.C. J. Reports, p. 582 (24 May 2007).
Amco Asia Corp. v. Republic of Indonesia, ICSID Case No. ARB/81/1, Resubmitted Case, Decision on Jurisdiction (10 May 1988), 27 ILM 1281 (1988) (Rosalyn Higgins, Per Magid, Marc Lalonde).
Apotex Inc. v. United States, UNCITRAL, Award on Jurisdiction and Admissibility (14 June 2013) (Toby T. Landau, Clifford M. Davidson, Fern M. Smith).
Archer Daniels Midland Company and Tate & Lyle Ingredients Americas, Inc. v. The United Mexican States, ICSID Case No. ARB(AF)/04/5, Award (21 November 2007) (Bernardo M. Cremades, Arthur W. Rovine, Eduardo Siqueiros T).
Argentina v. BG Group PLC, 665 F.3d 1363 (D.C. Cir. 17 January 2012).
Argentina v. BG Group PLC, 572 U.S. — (5 March 2014).
Asteris & Greece v. Commission  ECR 2181.
Bayview Irrigation District et al. v. United Mexican States, ICSID Case No. ARB(AF)/05/1, Award (19 June 2007) (Vaughan Lowe, Ignacio Gómez-Palacio, Edwin Meese III).
Bellarno International Ltd v. FDA, 678 F. Supp. 410 (E.D.N.Y. 1988).
Breardv. Green, 523 U.S. 371 (1998) (per curiam).
Case Concerning the Delimitation of the Continental Shelf (U.K. v. France), 18 R.I.A.A. 272 (14 March 1978).
Chemtura Corporation v. Government of Canada, UNCITRAL, Award (2 August 2010) (Gabrielle Kaufmann-Kohler, Charles N. Brower, James R. Crawford).
Chevron Corporation (USA) and Texaco Petroleum Company (USA) v. The Republic of Ecuador, UNCITRAL, PCA Case No. 34877, Partial Award (30 March 2010) (Karl-Heinz Bockstiegel, Charles N. Brower, Albert Jan van den Berg).
Commission of the European Communities v. BASF AG & Others,  ECR1-2555.
Cook v. FDA, No. 12-5176, 2013 U.S. App. LEXIS 14883 (D.C. Cir.) (23 July 2013).
Corfu Channel case, Judgment of 9 April 1949, 1.C.J. Reports 1949, p. 4.
Duke Energy Electroquil Partners and Electroquil, S.A. v. Republic of Ecuador, ICSID Case No. ARB/04/19, Award (18 August 2008) (Gabrielle Kaufmann-Kohler, Enrique Gómez Pinzón, Albert Jan van den Berg).
Effect of Awards of Compensation Made by the U.N. Administrative Tribunal, Advisory Opinion of 13 July 1954, 1.C.J. Reports 1954, p. 47.
Europe Cement Investment and Trade S.A. v. Republic of Turkey, ICSID Case No. ARB(AF)/07/2, Award (13 August 2009) (Donald M. McRae, Laurent Lévy, Julian D.M. Lew).
Gami Investments, Inc. v. The Government of the United Mexican States, UNCITRAL, Award (15 November 2004) (Jan Paulsson, Julio Lacarte Muró, W. Michael Reisman).
Gemplus S.A. et al. v. United Mexican States, ICSID Cases No. ARB(AF)/04/3 & ARB(AF)/04/4, Award (16 June 2010) (V.V. Veeder, L. Yves Fortier, Eduardo Magallón Gómez).
Genin v. Republic of Estonia, ICSID Case No. ARB/99/2, Award (25 June 2001) (L. Yves Fortier, Meir Heth, Albert Jan van den Berg).
Glamis Gold, Ltd. v. The United States of America, UNCITRAL, Award (8 June 2009) (Michael K. Young, David D. Caron, Kenneth D. Hubbard).
Gonzales v. O. Centro Espirita Beneficíente Uniao do Vegetal, 546 U.S. 418 (2006).
Grand River Enterprises Six Nations, Ltd., et al v. United States of America, UNCITRAL, Award (12 January 2011) (Fali S. Nariman, James Anaya, John R. Crook).
Hamdan v. Rumsfeld, 548 U.S. 557 (2006).
International Thunderbird Gaming Corporation v. United Mexican States, UNCITRAL, Award (26 January 2006) (Albert Jan van den Berg, Agustin Portal Ariosa, Thomas W. Walde).
Interpretation of Judgments Nos. 7 & 8 Concerning the Case of the Factory at Chorzow, 1927 P.C.I.J, (ser. A) no. 13 (16 December 1927).
L.F.H. Neer and Pauline Neer (U.S.A.) v. United Mexican States, 4 R.I.A.A. 60 (2006) (15 October 1926).
Lozano v. Alvarez, No. ll-2224-cv,, — F.3d —, 2012 WL 44790007 (2d. Cir. 1 October 2012).
Marvin Feldman v. United Mexican States, ICSID Case No. ARB(AF)/99/1, Award (16 December 2002) (Konstantinos D. Kerameus, Jorge Covarrubias Bravo, David A. Gantz).
Medellin v. Texas, 552 U.S. 491 (2008).
Merrill & Ring Forestry L. P. v. The Government of Canada, UNCITRAL, Award (31 March 2010) (Francisco Orrego Vicuña, Kenneth W. Dam, J. William Rowley).
Methanex Corporation v. United States of America, UNCITRAL, First Partial Award (7 August 2002) (V. V. Veeder, Warren Christopher, J. William Rowley).
Mexico v. Cargill, Inc., 2011 ONCA 622 (Can.) (4 October 2011).
Mobil Investments Canada Inc. and Murphy Oil Corporation v. Canada, ICSID Case No. ARB(AF)/07/4, Procedural Order No. 1, Decision of the Tribunal on the Place of Arbitration (7 October 2009) (Hans van Houtte, Merit E. Janow, Philippe Sands).
The Pious Fund of the Californias, Permanent Court of Arbitration, Award (14 October 1902).
Pope & Talbot Inc v. The Government of Canada, UNCITRAL, Award on the Merits of Phase 2 (10 April 2001) (John Murray, Murray J. Belman, Benjamin J. Greenberg).
Rachel S. Grynberg, Stephen M. Grynberg, Miriam Z. Grynberg and RSM Production Corporation v. Grenada, ICSID Case No. ARB/10/6, Award (10 December 2010) (J. William Rowley, Edward W. Nottingham, Pierre Tercier).
Request for Interpretation of the Judgment of 15 June 1962 in the Case Concerning the Temple of Preah Vihear (Cambodia v. Thailand), Judgment of 11 November 2013 (ICJ).
Request for Interpretation of the Judgment of 20 November 1950, in the Asylum Case (Colombia v. Peru), Judgment of 27November 1950, I.C.J. Reports 1950, p. 395.
Rompetrol Group N.V. v. Romania, ICSID Case No. ARB/06/3, Award (6 May 2013) (Franklin Berman, Donald Francis Donovan, Marc Lalonde).
S.D. Myers, Inc. v. The Government of Canada, UNCITRAL, Partial Award (13 November 2000) (J. Martin Hunter, Edward C. Chiasson, Bryan P. Schwartz).
Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010) (14 January 2010).
Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010) (2011) (7 December 2010).
Southern Pacific RR Co. v. United States, 168 U.S. 1 (1897).
Sumitomo Shoji America, Inc. v. Avagliano, 457 U.S. 176 (1982).
Textilwerke Deggendorf GmbH (TWD) v. Commission,  ECR 1-2549.
Trail Smelter Case (United States of America v. Canada), 3 R.I.A.A. 1938 (11 March 1941).
United Parcel Service of America Inc. v. The Government of Canada, UNCITRAL, Award on the Merits (24 May 2007) (Kenneth Keith, Ronald A. Cass, L. Yves Fortier).
Waste Management, Inc. v. United Mexican States, ICSID Case No. AB(AF)00/3, Award (30 April 2004) (James Crawford, Benjamin R. Civiletti, Eduardo Magallón Gómez).
White Industries Australia Limited v. Republic of India, UNCITRAL, Award (30 November 2011) (J. William Rowley, Charles N. Brower, Christopher Lau).
Amerasinghe, Chittharanjan F, International Arbitral Jurisdiction (2011).
American Law Institute, Restatement (Second) of Foreign Relations Law of the United States (1965).
Bederman, David J., Agora: Medellin: Medellin’s New Paradigm for Treaty Interpretation, 102 Am. J. Int’l L. 529 (2008).
Cheng, Bin, General Principles of Law as Applied by International Courts and Tribunals (1953).
Claim of Company General of the Orinoco Case, Report of French-Venezuelan Mixed Claims Commission of 1902 (1906, Ralston, Jackson H., ed.).
Dodge, William, National Courts and International Arbitration: Exhaustion of Remedies and Res Judicata Under Chapter Eleven of NAFTA, 23 Hastings Int’l & Comp. L. (2000).
Dumberry, Patrick, The Fair And Equitable Treatment Standard: A Guide To NAFTA Case Law On Article 1105 (2013).
FDA, Guide to Inspections of Foreign Pharmaceutical Manufacturers (May 1996).
FDA, Guide to International Inspections and Travel.
Grand River Enterprises Six Nations, Ltd., et al v. United States of America, UNCITRAL, Rejoinder of the United States (13 May 2009).
Hudson, Manley O., The Permanent Court of International Justice (1934).
ICSID Arbitration (Additional Facility) Rules (2006).
International Law Association, Interim Report, "Res Judicata" and Arbitration, International Law Association, Berlin Conference on International Arbitration (2004).
Kinnear, Meg N., Bjorkland, Andrea K., and Hannaford, John F. G., Investment Disputes Under NAFTA: An Annotated Guide to NAFTA Chapter 11 (2006, updated March 2008).
Lowe, Vaughan, Res Judicata and the Rule in International Arbitration, 8 RADIC 38 (1996).
NAFTA Free Trade Commission, Notes of Interpretation of Certain Chapter 11 Provisions (31 July 2001).
North American Free Trade Agreement, U.S.-Can.-Mex. (17 December 1992) 32 I.L.M. 289 (1993).
Rosenne, Shabtai, III The Law and Practice of The International Court, 1920-1995 (2006).
Schreuer, Christoph and Reinisch, August, Legal Opinion, CME Czech Republic B.V. v. Czech Republic, UNCITRAL (20 June 2002).
Sohn, Louis B. and Baxter, R. R., Responsibility of States for Injuries to the Economic Interests of Aliens, 55 Am. J. Int’l L. 545 (1961).
Statute of the International Court of Justice, United Nations Charter.
Treaty Between the United States of America and Jamaica Concerning the Reciprocal Encouragement and Protection of Investment, U.S.-Jam. (4 February 1994) T.I.A.S. No. 00103.
UNCITRAL Notes on Organising Arbitral Proceedings (2012).
Vandevelde, Kenneth, U.S. International Investment Agreements (2009).
Vienna Convention on the Law of Treaties, (24 April 1970) S. Treaty Doc. No. 92-12, 1155 U.N.T.S. 331.
This arbitration takes place under an arbitration agreement invoked by the Claimants resulting from their Request for Arbitration dated 29 February 2012, NAFTA Articles 1116(1), 1117(1) and 1120(1)(b) and the ICSID Arbitration (Additional Facility) Rules (the "ICSID Arbitration AF Rules"). For ease of reference, this arbitration agreement is here called the "Arbitration Agreement."
On 15 March 2013, the Claimants and the Respondent requested the Tribunal to decide on the production of documents disputed between them. To that end, pursuant to Paragraph 14.2.7(v) of Procedural Order No. 1, the Claimants and the Respondent submitted to the Tribunal disputes under their respective schedules for document production for decision by the Tribunal. On 20 March 2013, the Respondent filed observations on the Claimants’ request; and the Claimants made submissions on 22 and 24 March 2013 regarding the Respondent’s observations. On 29 March 2013, the Tribunal issued a "Procedural Order on the Parties’ Respective Requests for Document Production."
For the Claimants:
Mr. Barton Legum Salans FMC SNR Denton Europe LLP
Ms. Anne-Sophie Dufêtre Salans FMC SNR Denton Europe LLP
Ms. Brittany Gordon Salans FMC SNR Denton Europe LLP
Ms. Lara Elbomo Salans FMC SNR Denton Europe LLP
Mr. John Hay Dentons US LLP
Ms. Ulyana Bardyn Dentons US LLP
Ms. Kristen Weil Dentons US LLP
Mr. Johan Buys Dentons US LLP
The Claimants’ Representatives
Dr. Jeremy Desai Apotex Inc.
Ms. Roberta Loomar Apotex Inc.
Mr. Sheldon T. Bradshaw Hunton & Williams LLP Mr. Ron M. Johnson Becker & Associates Consulting
For the Respondent:
Ms. Mary McLeod U.S. Department of State
Ms. Lisa J. Grosh U.S. Department of State
Mr. John D. Daley U.S. Department of State
Mr. Jeremy K. Sharpe U.S. Department of State
Mr. Neale H. Bergman U.S. Department of State
Mr. David M. Bigge U.S. Department of State
Mr. John I. Blanck U.S. Department of State
Ms. Alicia L. Cate U.S. Department of State
Ms. Nicole C. Thornton U.S. Department of State
Ms. Abby Lounsberry U.S. Department of State
The Respondent’s Representatives
Ms. Wendy Vicente U.S. Food and Drug Administration
Ms. Elizabeth Philpy U.S. Food and Drug Administration
Mr. Diogo Simas U.S. Food and Drug Administration
Mr. Maan Abdulda U.S. Food and Drug Administration
Ms. Hidee Molina U.S. Food and Drug Administration
Ms. Jennifer Thornton Office of the United States Trade Representative
Mr. Gary Sampliner U.S. Department of Treasury
Mr. Zachary Gold U.S. Department of State
Mr. Daniel Michaeli U.S. Department of State
Mr. Zachary Stuart U.S. Department of State
Ms. Lana Ulrich U.S. Department of State
Mr. Thomas Weatherall U.S. Department of State
Factual Witnesses(subject to sequestration)
Cdr. Debra M. Emerson U.S. Food and Drug Administration
Mr. Michael R. Goga U.S. Food and Drug Administration
Mr. Lloyd Payne U.S. Food and Drug Administration
Dr. Carmelo Rosa U.S. Food and Drug Administration
Mr. William W. Vodra Arnold & Porter LLP (retired)
For the United Mexican States:
Mr. Salvador Behar The Embassy of Mexico in Washington DC, USA
(i) Called by the Claimants:
Mr. Sheldon T. Bradshaw [x TD2,265, xx TD2,277]
(ii) Called by the Respondent:
Cdr. Debra M. Emerson [x TD3,696, xx TD3,703];
Mr. Lloyd Payne [x TD3,739, xx TD3,744];
Mr. Michael R. Goga [x TD3,808, xx TD3,812];
Dr. Carmelo Rosa [x TD3,824, xx TD3,828, xxx TD4.1023]; and Mr. William W. Vodra [x TD4.1094, xx TD4.1118, xxx TD4.1161],
Merits: The named Claimants (i.e. Apotex-Holdings and Apotex Inc.) make claims for breach by the Respondent of several of its obligations under NAFTA and the Treaty Between the United States of America and Jamaica Concerning the Reciprocal Encouragement and Protection of Investment of 4 February 1994 ("Jamaica-USA BIT") both for themselves and also (by Apotex-Holdings) for Apotex-US. The Claimants also claim interest and costs (the latter under Article 52(1)(j) of the ICSID Arbitration AF Rules). The Respondent, without prejudice to its jurisdictional objections, denies any liability to the Claimants (for themselves and also for Apotex-US); and, in turn, the Respondent claims costs (also under Article 52(1)(j) of the ICSID Arbitration AF Rules).
(a) Finding that the United States of America has breached its obligations under the NAFTA;
(b) Directing the United States of America to pay damages in an amount to be proven at the hearing but which the Claimants presently estimate to be in the hundreds of millions of US dollars;
(c) Directing the United States of America to pay interest on all sums awarded;
(d) Directing the United States of America to pay the Claimants’ costs associated with these proceedings, including professional fees and disbursements;
(e) Ordering such other and further relief as the Tribunal deems appropriate in the circumstances."
(a) Declaring that the United States of America has breached its obligations under Articles 1102, 1103 and 1105 of the NAFTA;
(b) Ordering the United States of America to pay damages in an amount to be proven at the hearing but which the Claimants presently estimate to be in the hundreds of millions of US dollars, including pre-award interest;
(c) Ordering the United States of America to pay the Claimants’ interest and taxes on all sums awarded;
(d) Ordering the United States of America to pay the Claimants’ costs associated with these proceedings, including professional fees and disbursements;
(e) Ordering such other and further relief as the Tribunal deems appropriate in the circumstances."
(a) Dismissing the US jurisdictional objections;
(b) Declaring that the United States of America has breached its obligations under Articles 1102, 1103 and 1105 of the NAFTA;
(c) Ordering that the Claimants’ claims to damages and interest be addressed in the subsequent phase of this arbitration, and decided in the final award;
(d) Reserving decision on Claimants’ request for an award of costs, including professional fees and disbursements, until the next phase of this arbitration;
(e) Ordering such other and further relief as the Tribunal deems appropriate in the circumstances."
(1) Upholding the Respondent’s jurisdictional objections; and/or
(2) Dismissing the Claimants’ claims in their entirety and with prejudice; and
(3) Ordering that the Claimants bear the costs of these proceedings, including the Respondent’s costs for legal representation and assistance.
This claim for relief was re-stated in the Respondent’s Rejoinder to like effect (Paragraph 378, page 192).
Jurisdiction: The Claimants contend that no jurisdictional issue can arise in regard to Apotex-Holdings and Apotex-US respectively as a qualified "investor" and a covered "investment" under NAFTA Chapter Eleven. As regards the Import Alert, the Claimants submit that it did "relate to" Apotex-US within the meaning of NAFTA Article 1101(1): Apotex-US was established specifically as the marketing and distribution arm of Apotex Inc. (to which the Import Alert was directed); Apotex Inc. sold its products exclusively through Apotex-US in the USA; Apotex-US was the sole commercial importer and distributor of record for drugs manufactured at the Etobicoke and Signet facilities; following the Import Alert, Apotex-US was a named addressee of the Respondent’s notices of detention; and the Import Alert directly prevented Apotex-US from carrying on its business for almost two years, causing it to suffer severe financial losses. Hence, so the Claimants argue, the Import Alert "related" both to Apotex-US as an "investment" and also to its "investor", Apotex-Holdings.3
As regards Apotex Inc., the Claimants contend that its ANDAs are "intangible property" under NAFTA Article 1139(g). The Claimants further submit that ANDAs are "interests" under NAFTA Article 1139(h). Hence, so the Claimants argue, Apotex Inc. is an "investor" with its ANDAs as "investments" and, further, Apotex-Holdings is an "investor" with the same "investments", given its status as the ultimate (indirect) owner of Apotex Inc.4
Articles 1102 & 1103: During the relevant time period, the Claimants contend that the FDA accorded more favourable treatment to US investors and US owned investments in like circumstances to Apotex-Holdings, Apotex Inc. and Apotex-US in violation of NAFTA article 1102. The Claimants submit that no such investor or investment was subjected to a measure as severe as the Import Alert imposed on the Apotex companies. The Claimants also contend that investors of other countries and investments owned by such investors in like circumstances also received more favourable treatment than the treatment accorded to the Apotex companies in violation of NAFTA Article 1103. The Claimants refer to a number of such comparators, particularly the Teva group of companies ("Teva") and the Sandoz/Novartis companies ("Sandoz").7
Article 1105: The Claimants complain at the FDA’s lack of basic procedural due process, amounting to a violation by the Respondent of NAFTA Article 1105 and Article II of the Jamaica-USA BIT.8 Whilst the Claimants do not agree in this proceeding with the FDA’s determination that Apotex Inc.’s two facilities were not compliant with cGMP, the Claimants do not, however, here seek to impugn the FDA’s substantive decisions: i.e. "[w]hether FDA was right or wrong about Apotex’s cGMP compliance... is not a part of the claims presented in this case."9
According to the Respondent, the issue of jurisdiction in regard to Apotex Inc. turns decisively upon the character of its ANDAs. The Respondent submits that ANDAs, whether unapproved, tentatively approved or finally approved (in whole or in part) are incapable of being "investments" under NAFTA Article 1139(g) or Article 1139(h). Even after approval, ANDAs remain revocable by the FDA; and, in the Respondent’s submission, an ANDA is no more than an application by a foreign drug manufacturer for permission to export its drug products to the USA.14
Further, the Respondent relies upon the reasoning to this effect, operating as res judicata in this arbitration, contained in the Apotex I & II Award. Although that earlier arbitration decided claims relating to tentatively approved ANDAs (rather, as here, finally approved ANDAs), the Respondent submits that this is a distinction without a difference. The Respondent invites the Tribunal to reject jurisdiction over all claims made by Apotex Inc. and related claims by Apotex-Holdings.15 (The Respondent does not here contend that the Apotex I & II Award has any preclusive effect on Apotex-Holdings’ claim to be an investor by virtue of its investment in Apotex-US, being "a jurisdictional issue obviously not arbitrated or determined in the previous proceeding.")16
The Respondent submits that NAFTA’s Chapter Eleven also requires that the challenged measure "relate to", or in other words have a "legally significant connection" to the investor or the investor’s investment. The only measure challenged by the Claimants in this case is the Import Alert; but that Import Alert did not "relate to" Apotex-Holdings as an investor, nor to Apotex-US as an investment which continued to market generic drugs in the USA throughout the period of the Import Alert.18
First, the Claimants cannot establish a national or most-favoured-nation treatment claim because the Import Alert (which applied to Apotex Inc.’s two Canadian manufacturing facilities) had no legally significant connection to Apotex-Holdings as an "investor" or to Apotex-US as its "investment" under NAFTA Article 1101; and neither Apotex-Holdings nor Apotex-US received any relevant "treatment" under NAFTA Articles 1102 and 1103.22
Third, the Claimants cannot establish a most-favoured-nation treatment claim under NAFTA Article 1103, because the Claimants have failed to identify any third country-owned comparator that received in like circumstances more favourable treatment than the Claimants. Of the comparators cited by the Claimants, for instance, one drug manufacturer shut down the operations of its non-compliant facilities; and another manufacturer had two facilities placed on import alert for more than three years, forfeited dozens of drug applications and set aside US$ 500 million for potential civil and criminal penalties. The Respondent submits that the Claimants’ allegation that the Respondent discriminated in favour of these foreign manufacturers is factually wrong.24
Article 1105 NAFTA: The Respondent submits that the Claimants’ claim under NAFTA Article 1105 claim is baseless on the merits. The Respondent notes that the Claimants contend that the FDA (i.e. the Respondent) should have allowed Apotex Inc. to continue exporting adulterated drugs to the USA until it had been afforded six "procedural safeguards": (i) a hearing; (ii) with advance notice; (iii) before an impartial body; (iv) where the party may present evidence and contest the decision; (v) with a reasoned decision relying on all relevant legal and factual considerations; and (vi) with judicial review of that decision. Failure to provide these, so the Claimants assert, put the Respondent in violation of the customary international law minimum standard of treatment. The Respondent denies that these are customary rules of international law that form part of the minimum standard of treatment under NAFTA Article 1105.25
Jamaica-USA BIT: The Respondent submits that the Jamaica-USA BIT does not assist the Claimants’ case under NAFTA Article 1105 or at all: its terms add nothing to NAFTA Article 1105 (read with the Free Trade Commission’s binding interpretation); and NAFTA Article 1103 cannot expand the substantive scope of NAFTA Article 1105. For all these reasons, the Respondent denies any breach of NAFTA Article 1105 and Article II of the Jamaica-USA BIT.27
To the extent that a comparison of NAFTA’s three language versions may reveal a difference of meaning in the text of NAFTA Article 1139(h), Mexico submits, by applying Article 33(4) of the Vienna Convention on the Law of Treaties, that any perceived discrepancy between the English and French texts (on the one hand) and the Spanish text (on the other) is best reconciled by upholding the territoriality requirement in Article 1139(h).35 Mexico bases this submission upon the consistency of the English and French versions of Article 1139(h) with Article 1101(1).36
a. Apotex Inc. had failed to transfer the methods for testing products between the different Apotex laboratories;
b. Apotex Inc. had failed to submit timeously to the FDA certain FARs (Field Alert Reports) regarding problems observed in the manufacture of approved drugs;24
c. Apotex Inc. had failed to include complete production and process controls in all approved productions records;
d. Apotex Inc. had failed to include a copy of all approved labels and labelling in the master batch records; and
e. Apotex Inc. had changed the expiry date on a certain product without conducting proper stability testing.25
"...the pathways for enforcement action can be too long and arduous when the public’s health is in jeopardy. We are fixing these pathways to improve the effectiveness of our enforcement system. Today, the FDA is taking several initial steps in this direction.
First, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, we expect a prompt response to our findings. Once the FDA provides inspection findings identifying a serious problem, the firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action. This will help FDA issue warning letters on a timely basis and facilitate prompt corrective action.
Second, the FDA will take responsible steps to speed the issuance of warning letters. I have approved a new policy brought forward by the FDA’s Chief Counsel to limit warning letter review to significant legal issues. As a result, most enforcement letters will be able to move forward through a more streamlined process. This approach is consistent with the FDA’s longstanding historical practice.
Third, the FDA will seek to work more closely with our regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA. When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses.
Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.
Fifth, the FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action - even before we have issued a formal warning letter.
These five procedural changes will help to ensure that violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible..."
Year Additions Removals
2003 0 0
2004 1 6
2005 1 0
2006 0 0
2007 2 1
2008 3 0
2009* 10 0
2010 12 0
2011 19 3
2012 20 7
(* The Tribunal accepts the explanation for part of this increase from 2009 onwards, as involving foreign facilities in China manufacturing crude heparin during the heparin crisis, as Dr. Rosa testified.)47
a. "Failure to thoroughly investigate the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed";
b. "Failure to submit NDA59/ANDA field alert reports (FARs) in the required timeframe, within 3 working days of becoming aware of information concerning any significant chemical, physical, or other change or deterioration in the distributed drug product"; and
c. "Failure to include a specimen or copy of each approved label and all other labeling in the master production and control record."60
a. Apotex Inc. had distributed drugs to the US which were produced from contaminated drug batches;
b. Apotex Inc. had failed to submit timeously FARs to the FDA regarding problems observed in the manufacture of approved drugs;
c. Apotex Inc. had failed to follow its written procedures for cleaning and maintaining equipment used in the manufacturing, processing, packing, or holding of drug products; and
d. Apotex Inc. had failed sufficiently to investigate and document defective batches.80
a. "Deficiencies found at both Etobicoke and Signet Campus facilities include...[c]orporate culture of reprocessing and retesting products into specification...[p]oor, inadequate, or incomplete OOS [out-of-specification] and process deviations investigad ons.,.[n] on-timely submission of Field Alert Reports (FARS)"; and
b. "Failure to have an appropriate global quality culture and system...[d]eficiencies were found in all six systems for the manufacture of drugs/drug products... [l]ack of root cause determinations and effective corrective actions to ensure reliable and reproducible manufacturing processes are in place."126
Following these two re-inspections, Apotex Inc. prepared a "US Re-Entry Product Assessment Protocol" on 24 February 2011.198 The protocol was designed to assess all commercial ANDA products in order to assure product robustness, quality and regulatory compliance.199 Each product was to be reintroduced into the US market only after meeting the protocol’s requirements.200
On 1 March 2011, Apotex Inc. submitted to the FDA its written response to the two Forms 483.201 Apotex Inc. there outlined the overhaul of its quality systems and noted its intention to begin manufacturing for the US market as soon as possible.202 Apotex Inc. also requested approval from the FDA to release new products from Etobicoke and Signet upon regulatory approval (with third party oversight for the Signet facility).203
manufacture Propofol Sterile Emulsion for Injection, and provide the date(s) and reason(s) you ceased production."235
This Novartis warning letter stated: "... During our April 19 to May 6, 2011, June 6 to 22, 2011, and July 26 to August 4, 2011 inspections of your pharmaceutical manufacturing facilities, Sandoz Inc., located at 2555 W. Midway Blvd, Broomfield, Colorado; Sandoz Inc., located at 4700 Sandoz Dr., Wilson, North Carolina; and Sandoz Canada Inc., located at 145 Jules-Leger Street, Boucherville, Quebec, Canada, investigators from the Food and Drug Administration (FDA) identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals... These violations cause your drug products to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. The August 2011 inspection also revealed that Sandoz Canada Inc. failed to submit NDA Field Alert Reports (FARs) to FDA in compliance with 21 CFR § 314.81(b)(l)(ii), as required by section 505(k) of the Act [21 U.S.C. § 355(k)]. An applicant is required to submit, within three working days of receipt, information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of drug product to meet the specifications established for it in the application. We have reviewed your firm’s responses of May 31, 2011, July 13, 2011, and August 25, 2011, and note that they lack sufficient corrective action. Specific violations observed during the inspections include, but are not limited to, the following: [here follow several numbered and unnumbered violations]"; and, after the formal warning, the letter continued: "Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction..."
19 February 2012: The Globe and Mail, Canada’s national newspaper, reported:279 "... Today, Sandoz Canada’s reputation lies in tatters after chronic problems at its state-of-the-art plant on Montreal’s south shore caught the eye of U.S. regulators [i.e. the Boucherville facility]. Much of its production is halted as it tries to fix the problems, leaving pharmacists and health-care providers alarmed at what could be months of shortages of injectable medications that treat everything from nausea among cancer patients and abnormal heart rhythms to endometriosis. Last week, Sandoz told Canadian health-care providers it would discontinue certain products and temporarily suspend production on the heels of a scathing ‘warning letter’ from the U.S. Food and Drug Administration three months ago that criticized the plant’s ‘ineffective quality system’. ‘As we progress with our remediation activities, all production processes will be affected, significantly reducing output from our Boucherville plant and likely resulting in temporary supply disruptions,’ Sandoz Canada president Michel Robidoux said in a Feb. 16  letter to pharmacists, obtained by The Globe and Mail. He didn't specify how long the disruption would last, but that Sandoz Canada would focus on ‘optimizing’ supplies of medically necessary drugs to the Canadian market and had halted production of ointments, ophthalmics, suppositories and all non-medically necessary drugs.... In a statement to The Globe and Mail, Sandoz Canada said it was intensifying efforts ‘to ensure high quality standards’... It said the decision to halt production was voluntary and related to efforts to restore ‘high quality standards in manufacturing operations’... In total, Sandoz said it had committed a total of over $170-million (U.S.) to improve quality at the Boucherville plant as well as two other plants in Colorado and North Carolina that were also cited in the FDA letter..."
29 February 2012: A Sandoz Canada media release stated:283 "Sandoz Canada is continuing its efforts to maintain reliable supply of essential medicines following a temporary slow-down of production, resulting from increased investment in strengthening manufacturing compliance at its Boucherville, Quebec, site. In light of the November 2011 Warning Letter from the US Food and Drug Administration, Sandoz Canada has intensified its ongoing efforts to ensure high quality standards at this manufacturing plant. As production continues, the company is focusing its efforts on essential medicines and prioritizing resources to ensure normal supply is restored as quickly as possible. As part of this prioritization, the company has discontinued production of some non-essential drugs, including ointments, ophthalmics, suppositories and certain injectable drugs, for most of which it has already identified potential alternative supply from within Sandoz/Novartis or other qualified third-party suppliers.... ‘Our objective is to restore normal levels of supply as soon as possible, and we will make every effort to meet patient needs...’ said Sandoz Canada President Michel Robidoux. ‘We will focus all available capacity on the supply of medically necessary injectable medicines to try to ensure that patients with critical medical conditions continue receiving adequate treatment... "’