1 Estimates of the research and development costs of bringing a successful medicine to market, including the cost of failed products, ranged from a low of $110 million to over $880 million. Junod, Valerie, Drug Marketing Exclusivity under United States and European Union Law, 59 Food & Drug L.J. 479, 481 (2004)Google Scholar.

2 “It is a well-known fact that the pharmaceuticals industry is one of the most profitable businesses in the world.” Rossi, Francisco, Free Trade Agreements and TRIPS-Plus Measures, 1 Int’l J. Intell. Prop. Mgmt. 150, 151 (2006)Google Scholar; see Gottlieb, Scott, Drug Companies Maintain “Astounding” Profits, 324 Brit. Med. J. 1054, 1054 (2002)Google Scholar.

3 See Eisenberg, Rebecca S., The Role of the FDA in Innovation Policy, 13 Mich. Telecomm. & Tech. L. Rev. 345, 351-53 (2007)Google Scholar; Junod, supra note 1, at 481 & n.9.

4 See The Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, 35 U.S.C. § 156 (2000) [hereinafter the Hatch-Waxman Act].

5 The Hatch-Waxman Act provides for patent term extensions of up to five years to compensate patent holders for some of the time spent on clinical trials and for regulatory delays in the FDA approval process. Id. §156(d)(5)(E), (g)(6). However, the restoration of patent term cannot exceed fourteen years from the date of initial marketing approval. Id. § 156(c), (g)(1)(B), (g)(6). The Patent Term Guarantee Act of 1999 also restores patent term lost due to unusual administrative delays by the Patent Office, guaranteeing a minimum 17 year term. Patent Term Guarantee Act of 1999, 35 U.S.C. § 154(b) (2000).

6 Eisenberg, supra note 2, at 354.

7 See Shoibal Mukherjee, Here's a Penny for Your Pill, Hindustan Times (India), Aug. 8, 2006, available at http://www.hindustantimes.com/StoryPage/StoryPage.aspx?id=7c40030cc09f-43ab-a3da-1df4307060a5.

8 This latter choice is made to restrict generic manufacture both for domestic consumption and possible export to other countries where a patent may not have been filed.

9 Junod, supra note 1, at 484.

10 Judit Rius Sanjuan et al., Protection of Pharmaceutical Test Data: A Policy Proposal 5 (Nov. 21, 2006), available at http://www.keionline.org/miscdocs/KEI_TestDataProtectionProposal.doc (also arguing for a compensation system and offering several alternatives).

11 Merrill, Richard, The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1792-93 (1996)Google Scholar.

12 Junod, supra note 1, at 491.

13 See Food & Drug Admin., Guidance for Industry: Applications Covered by Section 505(b)(2), at 3 (Oct. 1999) (Draft), available at http://fda.gov/cder/guidance/2853dft.pdf.

14 Eisenberg, supra note 3, at 357.

15 Id. at 357-59.

16 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j) (2000 & Supp. 2005). Abbreviated new drug applications (ANDAs) must contain information demonstrating that the proposed product is virtually identical in active ingredient, dosage, strength, route of administration, labeling, quality, performance, and intended use when compared to a previously approved product. Id. ANDA applicants are required to prove bioequivalence – a close match in the rate and extent of absorption and elimination of the ADNA product and the reference product in a relatively small number of cross-over studies. Id.; see 21 C.F.R. pt. 320 (2007); Food & Drug Admin., Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations (2002) (Draft), available at http://www.fda.gov/cder/guidance/4964dft.pdf.

In addition to the ANDA process, the Hatch-Waxman Act also introduced a new kind of application for drugs that are only somewhat similar to another drug, i.e., for a new indication, but which rely at least partially on data not developed by the applicant, such as published data or the FDA's prior approval of the underlying product. 21 U.S.C. § 355(b)(2); see Food & Drug Admin., supra note 13.

17 See 21 C.F.R. pt. 211 (2007).

18 35 U.S.C. § 271(e)(1) (2000 & Supp. 2005). Although they could seek registration pursuant to abbreviated processes, generic companies might still be barred from actually producing and marketing the generic equivalent because of the innovator's patent rights. See id.

19 21 U.S.C. § 355(j)(5)(B)(iv) (2000 & Supp. V 2005). The prices charged are usually lower than the innovator prices, but higher than those eventually charged in truly competitive generic markets. Reiffen, David & Ward, Michael, Generic Drug Industry Dynamics, 87 Rev. Econ. Stat. 37, 48–49 (2005)Google Scholar. Prices are lowest when there are 8-10 competitors in the market for a particular medicine. Id. at 43.

20 See Orphan Drug Act, 21 U.S.C. § 360aa-ee (2000 & Supp. 2005).

21 21 U.S.C. §§ 355(c)(3)(E)(ii), (j)(5)(F)(ii) (Supp. 2005). The actual length of marketing exclusivity is usually 6.5 years because of the 18 months it takes the FDA to approve a generic application. Junod, supra note 1, at 493.

22 21 U.S.C. §§ 355(c)(3)(E)(ii), (j)(5)(F)(ii).

23 21 U.S.C. §§ 355(c)(3)(E)(iii), (j)(5)(F)(iii). The industry gained another six month period of data exclusivity as a reward for conducting pediatric trials on drugs via the Food and Drug Administration Modernization Act of 1997. 21 U.S.C. § 355a(b) (Supp. 2005). See The FDA's Frequently Asked Questions in Pediatric Exclusivity (July 27, 1999), http://www.fda.gov/cder/pediatric/faqs.htm for additional details. Pediatric-related exclusivity was extended by the Best Pharmaceuticals for Children Act of 2002, Pub. L. No. 107-109, 1115 Stat. 1408 (codified as amended in scattered sections of 21 U.S.C.).

24 21 U.S.C. § 355(c)(3)(E)(iii); Junod, supra note 1, at 496.

25 See discussion supra note 5.

26 See 21 U.S.C. § 355 (2000 & Supp. 2005). A list of patent claims concerning previously registered medicines can be found in Food & Drug Admin., Electronic Orange Book, http://www.fda.gov/cder/ob/default.htm (last visited Mar. 13, 2008).

27 21 U.S.C. §§ 355(b)(2)(A), (j)(2)(A)(vii) (2000).

28 21 U.S.C. § 355(j)(5)(B)(iii) (2000 & Supp. 2005); 35 U.S.C. § 271(e)(5) (Supp. 2005).

29 Council Directive 87/21/EEC, Amending Directive 65/65 EEC on the Approximation of Provisions Laid Down by Law, Regulation, or Administrative Action Relating to Proprietary Medicinal Products, 1987 O.J. (L 015) 36, was in effect during the time period 1987-2001. Council Directive 2001/83/EC. On the Community Code Relating to Medicinal Products for Human Use, 2001 O.J. (L 311) 67 [hereinafter Directive 2001/83/EC], codified key aspects of Directive 87/21/EEC regulating exclusivity in the time period 2001-2004 under the old system that allowed exclusivity periods ranging from six to ten years. See Junod, supra note 1, at 502-09. Because of the absence of an early-working provision, the second-comer would have to wait until the expiration of the entire period of exclusivity before being permitted to institute abridged procedures based primarily on evidence of bioequivalence. Id.

30 Council Directive 2004/27/EC. Amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, 2004 O.J. (L 136) 34 [hereinafter Revised Directive]. For a discussion of the Revised Directive, see Junod, supra note 1, at 510-14.

31 Revised Directive, supra note 30, art.10.1, ¶ 1.

32 Id. art. 10.6.

33 Id. art. 10.1, ¶ 2 .

34 Id. art. 10.1, ¶ 4.

35 See Int’l Fed’n of Pharm. Mfrs. Assocs. [IFPMA], Encouragement of New Clinical Drug Development: The Role of Data Exclusivity (2000), available at http://www.ifpma.org/documents/NR643/DataExclusivity_2000.pdf.

36 Background - originator drug registration: Drug registration for products not previously granted marketing approval is usually granted through one of two processes. In the first process, the drug regulatory authority examines voluminous pre-clinical and clinical data (animal studies, toxicity studies, stability studies, Phase I, II, and III clinical trials, and specification of manufacturing process) to ascertain the safety, efficacy, and quality of the pharmaceutical product. This is the process followed by the FDA and most stringent regulatory authorities. Preparing these complex registration applications/dossiers is expensive and time-consuming, and requirements can and do vary from country to country, adding the expense of multiple filings. Moreover, processing this complex data within the drug regulatory authority is also time-consuming, even in the U.S., and can often take many months or even years to complete.

In the second process, rather than reviewing all the underlying data, the drug regulatory authority relies on the fact of registration elsewhere to establish the safety, efficacy, and quality of the product. Here, the registration application is much simpler and more straightforward. The registrant essentially files a limited application and a certificate confirming the fact of registration by an “approved” foreign drug regulatory authority and evidence of Good Manufacturing Practice (GMP). The second drug regulatory authority can thereafter quickly register the new product because it does not have to review underlying data. A variation of this process is when the drug registration authorities examine a limited set of published studies or product specifications, i.e. Pharmacopeias, to determine product safety, efficacy, and quality.

Background - registration of a follow-on product: Just as there are two processes for registering an originator product, there are two basic abbreviated processes for registering follow-on generic equivalents. In the first process, the drug regulatory authority actually references or reviews the originator's data to confirm that the follow-on product is therapeutically equivalent and thus entitled to expedited registration without the full panoply of clinical trial data. In most countries, the follow-on registrant merely provides evidence of bio-equivalence (or a lesser standard of therapeutic similarity) between the originator and the follow-on product, and separate evidence of the product's quality (usually via evidence that it was produced pursuant to GMP). Thereafter, the drug regulatory authority reviews that limited evidence and via reference to the originator's underlying data assesses whether the follow-on product is therapeutically equivalent and of good quality or not.

In the second follow-on process, the drug regulatory authority does not actually reference or examine the originator's data, it simply relies on the fact of the originator product's registration to determine whether or not to register a therapeutically equivalent follow-on products. The follow-on producer ordinarily submits the same kind of evidence of bioequivalence (or similarity) and GMP as it would in the first follow-on process.

Background – fast track registration: In addition to these basic variations, some countries have also adopted “fast-track” procedures for the registration of priority medicines. This has resulted from pressure both by producers of pharmaceutical products who want to shorten the period of regulatory delay and by consumers who want expedited or special access to medicines for currently incurable conditions. Priority can be established by moving applications to the front of the line, by devoting more human resources, or by applying simplified standards. See Carlos María Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement 1-11 (2002), available at http://www.southcentre.org/publications/protection/protection.pdf. Sauwakon Ratanawijitrasin & Eshetu Wondemagegnehu, Effective Drug Regulation: A Multicountry Study 73-96 (2002), available at http://whqlibdoc.who.int/hq/2002/9241562064.pdf.

37 Less than one sixth of WHO Member States, mostly developed countries, have welldeveloped medicine regulatory systems that can review and assess a full registration file for a new pharmaceutical product. World Health Organization, Effective Drug Regulation: What Can Countries Do?, at 13, WHO/HTP/EDM/MAC(11)/99.6 (1999) (prepared by Eshetu Wondemagegnehu), available at http://www.who.int/medicinedocs/collect/medicinedocs/pdf.s2216e/s2216e.pdf. Another fifty percent have varying degrees of regulatory capacity, though few of these can undertake start-to-finish assessment of new product dossiers. Id. The remaining one-third has no medicines registration capacity or only very limited capacity. Id.

38 See Sisule F. Musungu, Susan Villanueva & Roxana Glasetti, Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks, South Centre 65-68 (2004), http://www.southcentre.org/publications/flexibilities/flexibilities.pdf. There have been regional, sub-regional, and other harmonization efforts by the Southern African Development Community (SADC), the Pharmaceutical Product evaluation Group of the Association of South-East Asian Nations (ASEAN), the Cooperation Council for the Arab States, and PAHO involving CARICON, MERCOSUR, TLCA, Latin American Association for Integration, and the Andean Community. European harmonization is the most advanced, though there are still ongoing efforts especially concerning Accession States. There have been efforts to harmonize standards globally through the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), led by the U.S. E.U., and Japan. See ICH, History and Future of the ICH (2001), available at http://www.ich.org/cache/compo/276-254-1.html.

39 See Rossi, supra note 2, at 156. The WHO set up a comprehensive system of trying to regulate procedures for certifying the safety and efficacy and GMP of pharmaceutical products moving in international commerce as a way of facilitating registration of medicines in developing countries. See WHO, Action Programme on Essential Drugs, Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, WHO/DAP/94.21, at 1 (Jan. 1995), available at http://whqlibdoc.who.int/hq/1994/WHO_DAP_94.21.pdf [hereinafter WHO Certification Scheme]. The WHO Certification Scheme attempted to provide quality assurance for imported medicines by means of standard forms confirming the registration of the product in the country of manufacture (Certificate of Pharmaceutical Product), approval of GMP manufacturing conditions based on inspections, and quality analysis of the product. Id. at V. Based on these assurances, developing countries were expected to be able to promptly register and/or procure products of assured quality. See id. at 2. The above-referenced study found that after 20 years of the existence, the WHO Certification Scheme was not being widely used. Id. at 2.

40 In 2001, the WHO established its Prequalification Programme to provide UN procurement agencies and other procurers with a reliable, non-regulatory mechanism for ensuring the safety, efficacy, and quality of medicines used to treat HIV/AIDS, tuberculosis, and malaria. WHO, Key Facts About The WHO Prequalification Project (2006), available at http://www.who.int/3by5prequal/en/. The Prequalification Programme requires manufacturers who wish to be listed to provide a product dossier including details about the finished product, the purity of ingredients, stability studies, and in vivo bioequivalence studies. Id. After an initial assessment, the product is sent for testing by stringent laboratories and manufacturing sites are inspected for compliance with WHO GMP. Id. Only then is the product added to the list of WHO prequalified drugs. As of January 4, 2008, WHO had prequalified 171 HIV/AIDS medicines. WHO, WHO List of Prequalified Medicines, http://healthtech.who.int/pq/status/ProductRegistry.aspx?list=ha (last visited Jan. 4, 2008).

41 WHO, The World Medicines Situation 93-112 (2004), available at http://www.who.int/medicinedocs/collect/medicinedocs/pdf.s6160e/s6160e.pdf; WHO, WHO Medicines Strategy: Countries at the Core 94-110 (2004), available at http://whqlibdoc.who.int/hq/2004/WHO_EDM_2004.5.pdf.

42 WHO, Measuring Transparency in Medicines Registration, Selection and Procurement: Four Country Assessment Studies 1 (2006), available at http://www.who.int/medicines/areas/policy/goodgovernance/Transparency4CountryStudy.pdf. The combination of inefficiency, incapacity, and corruption has resulted in a very high proportion of sub-standard and counterfeit drugs on the market in developing countries. WHO, Fact Sheet No. 275: Substandard and Counterfeit Medicines (2003), available at http://www.who.int/mediacentre/factsheets/2003/fs275/en/ (estimating that up to 25% of drugs consumed in developing countries are counterfeit or substandard). In 2006, the WHO set up a special task force on drug counterfeiting. Zarocostas, John, WHO to Set up International Task Force on Counterfeit Drugs, 332 Brit. Med. J. 444 (2006)Google Scholar.

43 There are numerous important AIDS medicines that are still not registered in many developing countries, including atazanavir, tenofovir, emtricitabine, lopinavir, ritnavir, and Atripla. Baker, Brook K., Drug Registration Barriers & Logjams, in Missing the Target #5: Improving AIDS Drug Access and Advancing Health Care for All 49, 50–52 (2007)Google Scholar, available at http://www.aidstreatmentaccess.org/itpc5th.pdf. On the plus side, a separate study by the WHO found that the vast majority of ARVs in use in sub-Saharan Africa were registered and of good quality. WHO, Survey of the Quality of Antiretroviral Medicines Circulating in Selected African Countries, at iii (2007), available at http://www.who.int/medicines/publications/ARV_survey.pdf. 44 Baker, supra note 43, at 52-53.

45 Id. at 53-54.

46 Id. at 54; see WHO Certification Scheme, supra note 39.

47 The typical registration fee in the United States is $500,000 to which one must add attorney's fees and dossier preparation costs; registration fees in developing countries are ordinarily much cheaper, ranging from $100 in Malaysia to $4300 in South Africa. Sauwakon Ratanawijitrasin & Eshetu Wondemagegnehu, Effective Drug Regulation: A Multicountry Study 80-81 (2002), available at whqlibdoc.who.int/hq/200 2/9241562064.pdf; Medicines Control Council, Fees Payable to the Registrar (March 2004) available at http://www.mccza.com/showdocument.asp?Cat=23&Desc=Fees%20payable%20to%20the%20Registrar; see Carlos María Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement 6 (2002), available at http://www.southcentre.org/publications/protection/protection.pdf (discussing generic producers) [hereinafter Correa, Protection of Data].

48 There are substantial costs arising from differing requirements for registration dossiers, attorney's fees, and translation costs. These costs are problematic even in rich country markets. See E.C., Better Regulation of Pharmaceuticals: Towards a Simpler, Clearer and more Flexible Framework on Variations (2007), available at http://ec.europa.eu/enterprise/pharmaceuticals/varreg/variations_consultation_paper_codecision_20070710.pdf (discussing the complexity of harmonizing regulation of post-registration variations).

49 Baker, supra note 43, at 54.

50 For a discussion of the lower prices of generic AIDS medicines compared to originator medicines, see Médecins Sans Frontières (MSF), Untangling the Web of Price Reductions: A Pricing Guide for the Purchase of ARVs for Developing Countries 5-11 (10th ed. 2007), available at http://www.accessmed-msf.org/fileadmin/user_upload/diseases/hiv-aids/Untangling_the_Web/UTW10_RSep_horizontal.pdf. Clinton Foundation Antiretroviral (ARV) Price List (2007), available at http://www.clintonfoundation.org/pdf.chai-arvprice-list-050807.pdf.

51 Cook, Trevor M., The Protection of Regulatory Data in the Pharmaceutical and Other Sectors 105-15 (2000)Google Scholar; Correa, Protection of Data, supra note 47, at 11; Correa, Carlos María, Unfair Competition under the TRIPS Agreement: Protection of Data Submitted for the Registration of Pharmaceuticals, 3 Chi. J. Int’l L. 69, 71–72 (2002)Google Scholar [hereinafter Correa, Unfair Competition]. A 2001 study by the U.K. Commission on Intellectual Property Protections found that only 10% of developing countries studied had data exclusivity provisions, whereas another 75% had unclear law or no law on point and the final 15% clearly permit regulatory reliance on previously submitted data or the fact of prior registration. Phil Thorpe, Study on the Implementation of the TRIPS Agreement by Developing Countries (2001), available at http://www.iprcommission.org/papers/pdf./study_papers/sp7_thorpe_study.pdf.

52 As an alternative strategy for raising the registration bar, the U.S., E.U., and major pharmaceutical companies are promoting international harmonization of registration standards at a “platinum” level. In 1990, industry and regulatory participants from the U.S., Europe, and Japan initiated the International Conference on Harmonization (ICH), designed initially to harmonize drug registration submissions for 17 rich countries. The ICH has produced 26 guidelines pertaining to technical issues for establishing drug efficacy and safety thereby enabling mutual acceptance of registration data across all ICH countries. ICH originally focused on new chemical entities and bio-tech products, but the ICH has begun to try to influence requirements for non-ICH developing countries and for generic products. Unfortunately, harmonizing drug registration at an over-high standard that only proprietary companies are prepared to meet will prevent dynamic competition from generic producers who produce drugs of assured quality. See WHO, The Impact of Implementation of ICH Guidelines in Non-ICH Countries: Report of a WHO Meeting, Geneva, 13-15 September 2001 (2002), available at http://www.who.int/medicinedocs/collect/medicinedocs/pdf.h2993e/h2993e.pdf.

53 Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C, art. 8(1), Apr. 15, 1994, 33 I.L.M. 81, available at http://www.wto.org/english/docs_e/legal_e/27-trips.pdf. (Marrakesh Agreement Establishing the World Trade Organization) [hereinafter the TRIPS Agreement].

54 World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/2, 41 I.L.M. 746 (2002), available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm [hereinafter the Doha Declaration].

55 Press Release, House Comm. On Ways & Means, New Trade Policy for America, (May 11, 2007), available at http://www.bilaterals.org/IMG/pdf.07_05_10_New_Trade_Policy_Outline.pdf [hereinafter New Trade Policy].

56 Although individual companies played instrumental roles in pushing the global IPR agenda, national and international trade associations also played a key role. The main U.S. trade association for research-based drug companies is PhRMA (the Pharmaceutical Research and Manufacturers of America). See PhRMA.org, http://www.phrma.org (last visited Mar. 27, 2008). The international pharmaceutical lobby group is called the International Federation of Pharmaceutical Manufacturers Association (hereinafter IFPMA). See IFPMA, http://www.ifpa.org (last visited Mar. 14 2008).

57 See Peter Drahos & John Braithwaite, Information Feudalism: Who Owns the Knowledge Economy? (2003) (detailed history of the political and strategic genesis of the TRIPS agreement as engineered by U.S. knowledge industries). For an in-depth technical analysis of the background and main policy issues of TRIPS, see UNCTAD-ICTSD, Project on IPRs and Sustainable Development: Resource Book on TRIPS and Development (2005), available at http://www.iprsonline.org/unctadictsd/ResourceBookIndex.htm. For a discussion of the flexibilities available to developing countries with respect to TRIPScompliant implementation, see Brook K. Baker, Processes and Issues for Improving Access to Medicines: Willingness and Flexibilities to Utilise TRIPS Flexibilities in Non-Producing Countries (2004), available at http://www.dfid.gov.uk/pubs/files/dfidbrookbakertrips.pdf. Carlos Correa, Integrating Public Health Concerns into Patent Legislation in Developing Countries (2000), available at http://www.southcentre.org/publications/publichealth/toc.htm; Sisule F. Musungu & Cecelia Oh, The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? (2006), available at http://www.southcentre.org/publications/SouthPerspectiveSeries/TheUseOfFlexibilitiesInTripsFinal.pdf.

58 See generally WIPO.int, About WIPO, http://www.wipo.int/about-wipo/en/overview.html. (last visited Mar. 14, 2008).

59 See generally CIESIN Thematic Guides: General Agreement on Tariffs and Trade, http://www.ciesin.org/TG/PI/TRADE/gatt.html. (last visited Apr. 4, 2008).

60 The main tool that the United States used in splitting the incipient developingcountry alliance was Special 301 Watch List and threats of trade sanctions under 19 U.S.C. § 2242 (2006), which was amended in the Omnibus Trade and Competitiveness Act of 1988 to include close surveillance of IPRs. For a history of this use of bilateral threats during the negotiation of TRIPS, see generally Drahos & Braithwaite, supra note 57, at 85-107.

61 The TRIPS Agreement, supra note 53, art. 28.

62 See id. art. 33.

63 See id. art. 27.1.

64 “A study published by the United Nations in 1975 found that many developing and developed countries excluded pharmaceutical products as patentable inventions. At that time, the list covered most of the developing world as well as the Soviet Union and the former socialist countries in Eastern Europe. Austria, Canada, Italy, Japan and Switzerland were also in the same category…” See Roffe, Pedro, Spennemann, Christoph & Braun, Johanna von, From Paris to Doha: The WTO Doha Declaration on the TRIPS Agreement and Public Health, in Negotiating Health: Intellectual Property and Access to Medicines 9, 13 (Roffe, Pedro, Tansey, Geoff & Vivas-Eugui, David eds., 2006)Google Scholar (citing United Nations, The Role of the Patent System in the Transfer of Technology to Developing Countries (1975)) [hereinafter Negotiating Health].

65 See the TRIPS Agreement, supra note 53, art. 27.1.

66 See id.

67 Id. art. 39.3.

68 Correa, Unfair Competition, supra note 51, at 73.

69 Id. at 74-75.

70 Id. at 73-74.

71 Id. at 75-76.

72 For an extended discussion of options concerning appropriate use of undisclosed data, see Correa, Protectioin of Data, supra note 47. The ability of generic producers to compare generic drugs against previously registered medicines to establish bio-equivalent and comparable bio-availability is crucial to avoid cost-prohibitive, time consuming, and wasteful duplication of clinical trials.

73 Fellmeth, Aaron X., Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of Marketing Approval Data under the TRIPS Agreement, 45 Harv. Int’l L.J. 443, 455 (2004)Google Scholar; see Correa, Protection of Data, supra note 47, at 53-56.

74 Fellmeth, supra note 73, at 455, 458.

75 See Lee Skillington, G. & Solovy, Eric M., The Protection of Test and Other Data Required by Art. 39.3 of the TRIPS Agreement, 24 Nw. J. Int’l L. & Bus. 1, 29–35 (2003)Google Scholar. Fellmeth takes a more nuanced position, arguing that Art. 39.3 requires at least some “some form of protection against the naked exploitation of the marketing approval data.” Fellmeth, supra note 73, at 460. Fellmeth makes a pragmatic argument that drug companies will not undertake the cost of registration in some markets if they are not guaranteed a temporary monopoly during which they can recoup the costs of registration (plus presumably manufacturing and marketing costs). Id. at 471.

76 See Fellmeth, supra note 73, at 459-60.

77 Fellmeth ended up supporting an adjustable compensation system for reliance on regulatory data. Id. at 482-99. Cf. Sanjuan et al., supra note 10 (also arguing for a compensation system and offering several alternatives).

78 See Bayer, Inc. v. Canada, (Attorney Gen.), [1999] 87 C.P.R.3d 293; Correa, Unfair Competition, supra note 51, at 76-82; U.K. Comm’n on Intell. Prop. Rights, Integrating Intellectual Property rights and Development policy: Report of the Commission on Intellectual Property Right 50 (2002), available at http://www.iprcommission.org/papers/pdf./final_report/CIPRfullfinal.pdf [hereinafter U.K. Comm’n on IPRs]; Jerome H. Reichman, The International Legal Status of Undisclosed Clinical Trial Data: From Private to Public Goods, in NegotiatingHealth, supra note 64, at 133, 142.

79 See the TRIPS Agreement, supra note 53, art. 27.2, 27.3.

80 Id. art. 27.1 (“[P]atents shall be available for any invention, whether products or processes, … provided that they are new, involve an inventive step and are capable of industrial application.”).

81 Id. art. 6.

82 Id. art. 31.

83 Id. art. 30.

84 Id. art. 39.3.

85 Estimates of increased cost vary greatly, but an early estimate for TRIPS-related price increases totaled $20 billion. Lybbert, Travis J., On Assessing the Costs of TRIPS Implementation, 1 World Trade Rev. 309, 310 (2002)Google Scholar (critiquing estimate as too high).

86 Efforts by the Thai Government Pharmaceutical Organization to produce the antiretroviral drug didanosine under the compulsory licensing provision of TRIPS was thwarted because of the fear of trade pressure from the U.S. government, but an active civil society movement eventually succeeded in forcing Bristol Myers-Squibb to abandon its patent in Thailand. Weeraboon Wisartsakul, Civil Society Movement to Revoke the Thai Patent on ddI 3-5, 40 (Nusuara Grant, trans., MSF ed. 2004).

87 See, e.g., Omnibus Consolidated and Emergency Supplemental Appropriations Act, Pub. L. No. 105-277, 112 Stat. 2681 (1999).

Id. According to U.S. State Department documents and statements at the time, “[multiple federal agencies] have been engaged in an assiduous, concerted campaign to persuade the Government of South Africa (SAG) to withdraw or modify the provisions of Article 15(C)” that the U.S. believed violated the TRIPS Agreement. Patricia D. Siplon, AIDS and the Policy Struggle in the United States 120-21 (2002). For a discussion of early pro-pharma U.S. trade policy in South Africa, see Bond, Patrick, Globalization, Pharmaceutical Pricing and South African Health Policy: Managing Confrontation with U.S. Firms and Politicians, 29 Int’l J. Health Serv. 765, 768 (1999)Google Scholar.

88 Brook K. Baker, A Brief History of U.S. Trade Threats against India 2 (unpublished manuscript on file with the author).

89 In 1999, the U.S. filed a WTO dispute settlement case against Argentina challenging, among other things, its failure to provide data exclusivity for pharmaceutical products. Although the U.S. and Argentina partially settled the overall dispute in April of 2002, the U.S. retained its right to seek resolution on the data exclusivity issue under the WTO dispute settlement mechanism. Dispute Settlement, Argentina — Patent Protection for Pharmaceuticals and Test Data Protection for Agricultural Chemicals, WT/DS171 (June 20, 2002), available at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds171_e.htm.

90 For a brief history of the U.S. WTO complaint against Brazil, see t’Hoen, Ellen, TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha, 3 Chi. J. Int’l L. 27, 32–33 (2002)Google Scholar.

91 Siplon, supra note 87, at 121.

92 For a description of the lawsuit see t’Hoen, supra note 90, at 30-31. The lawsuit was unconditionally dismissed in April 2001 following “strong international public outrage.” Id. at 31 The challenged amendments were designed to permit parallel importation, generic substitution in filling prescriptions of off-patent medicines, and greater price transparency. Id. at 30.

93 Siplon, supra note 87, at 123-26. Of particular note is the Clinton Executive Order of May 10, 2000, Exec. Order No. 13,155, 3 C.F.R. 268 (2000), which in relevant part, reads:

94 For a detailed account of this collaboration, see Abbott, Frederick M., The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO, 5 J. Int’l Econ. L. 469, 480-90 (2002)Google Scholar. Developing countries rejected the theory that differential pricing would meet their needs.

95 U.S. Statement at TRIPS Council Meeting, (June 20, 2001), available at http://lists.essential.org/pipermail/pharm-policy/2001-June/001175.html.

96 Council for Trade-Related Aspects of Intellectual Property Rights, Communication from the European Communities and Their Member States, IP/C/W/280 (June 12, 2001), available at http://www.wto.org/english/tratop_e/trips_e/paper_eu_w280_e.htm.

97 See Council Discussion on Access to Medicine, Developing Country Group's Paper: TRIPS and Public Health, IP/C/W/296 (June 29, 2001), available at http://www.wto.org/english/tratop_e/trips_e/paper_develop_w296_e.htm; Council for Trade-Related Aspects of Intellectual Property Rights, Draft Ministerial Declaration – Proposal from a Group of Developing Countries, IP/C/W/312 (Oct. 4, 2001), available at http://www.wto.org/english/tratop_e/trips_e/mindecdraft_w312_e.htm.

98 In making this argument, the United States relied heavily an early version of a study published in the fall of 2001, which reported that antiretrovitals were not widely patented in sub-Saharan Africa. Attaran, Amir & Gillespie-White, Lee, Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?, 286 JAMA 1886, 1888 (2001)Google Scholar. Although the study was technically true, it neglected to address the fact that there was patenting in larger markets and in those few countries with manufacturing capacity. A subsequent analysis revealed that key patents blocked preferred, first-line regimens for sixty-eight percent of HIV positive persons in sub-Saharan Africa. Consumer Project on Technology et al., Comment on the Attaran/Gillespie-White and PhRMA Surveys of Patents on Antiretroviral Drugs in Africa (Oct. 16, 2001), http://lists.essential.org/pipermail/ip-health/2001-October/002097.html; see Flynn, Sean, Legal Strategies for Expanding Access to Medicines, 17 Emory Int’l L. Rev. 535, 538-39 (2003)Google Scholar.

99 Council for Trade Related Aspects of Intellectual Property Rights, Draft Ministerial Declaration—Proposal from a Group of Developed Countries, IP/C/W/313 (Oct. 4, 2001), available at http://www.wto.org/english/tratop_e/trips_e/mindecdraft_w313_e.htm; Non-Paper, Contribution from Canada, the Czech Republic, Japan, New Zealand, Switzerland and the United States, available at http://lists.essential.org/pipermail/ip-health/2001-September/001899.html; WTO Pursues Discussion on IPRs and Access to Medicines, Bridges Weekly Trade News Digest (Sept. 25, 2001) available at http://ictsd.org/weekly/01-09-25/story1.htm.

100 U.K. Secretary of State for International Development, White Paper on International Development, Eliminating World Poverty: Making Globalization Work for the Poor (Dec. 2000), ¶ 142-49, available at http://www.dfid.gov.uk/pubs/files/whitepaper2000.pdf.

101 United Nations Development Programme, Human Development Report 2001: Making New Technologies Work for Human Development 104 (2001), available at http://hdr.undp.org/en/media/completenew1.pdf.

102 The World Bank, Global Economic Prospects and the Developing Countries 2002: Making Trade Work for the World's Poor 129-50 (2001), available at http://siteresources.worldbank.org/INTGEP2002/Resources/gep2002complete.pdf.

103 The Secretariat of the United Nations Conference on Trade and Development (UNCTAD) & International Centre for Trade and Sustainable Development (ICTSC), Policy Discussion Paper by the UNCTAD-ICTSD, Project on IPRs and Sustainable Development, Intellectual Property Rights: Implications for Development, at 93-104 (2003) available at http://www.ictsd.org/pubs/ictsd_series/iprs/pp/pp_1intro.pdf.

104 WTO Secretariat & WHO, WTO Agreements & Public Health: A Joint Study by the WHO and the WTO Secretariat, at 144-49 (2002), available at http://www.wto.org/english/res_e/booksp_e/who_wto_e.pdf.

105 The Doha Declaration, supra note 54.

106 Id. ¶ 1. “We recognize the gravity of public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.” Id.

107 Id. ¶ 4. “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.” Id.

108 Id. ¶ 4-5:

109 Id. ¶ 6. “We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.” Id.

110 Id. ¶ 7. “We also agree that the least-developed country members will not be obligated, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016 … .” Id.

The proposed Paragraph 7 waiver and another waiver affecting exclusive market exclusivity rights were adopted by the General Council in the summer of 2002. Decision by the General Council for TRIPS, IP/C/25 (July 1, 2002), available at http://www.wto.org/english/tratop_e/trips_e/art66_1_e.htm; Least-Developed Country Members – Obligations under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products, WT/L/478 (July 12, 2002), available at http://www.wto.org/english/tratop_e/trips_e/art70_9_e.htm. Pursuant to these waivers, countries could suspend the future operation of their medicines patent and market exclusivity schemes even where they had prematurely and improvidently granted such protections before the expiration of their January 1, 2006, transition period. However, being freed from the threat of TRIPS sanctions does not relieve least-developed countries from any pre-existing, vested rights of patent holders. Moreover, many least developed countries have failed to take advantage of waiver rights by amending or suspending the patent and data protection legislation adopted in the colonial era.

111 Decision by the General Council for TRIPS, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540 (Aug. 30, 2003), available at http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm.

112 Statement of the Chairperson of the General Council for TRIPs, Excerpt from the Minutes of the General Council Meeting 30 August 2003 (paragraph 29), WT/GC/M/82 (Aug. 30, 2003), available at http://www.wto.org/english/tratop_e/trips_e/gc_stat_30aug03_e.htm. The legal significance of the Chairperson's Statement is quite debatable – at best, it might be used for interpretive guidance.

113 See Communication from Nigeria on behalf of the African Group, Implementation of Paragraph 11 of the 30 August 2003 Decision, IP/C/W/437 (Dec. 10, 2004), available at http://www.tas.gov.eg/NR/rdonlyres/51863A10-730C-4BF2-9DDD-E6E8B1A6A038/0/AfricanGroupproposedamendmenttoArticle31.doc; Communication from Nigeria on behalf of the African Group, Implementation of Paragraph 11 of the 30 August 2003 Decision Revision, IP/C/W/437/Rev.1 (Mar. 23, 2005), available at http://www.cptech.org/ip/wto/africagroup03232005.doc; Communication from Rwanda on behalf of the African Group, Legal Arguments to Support the African Group Proposal on the Implementation of Paragraph 11 of the 30 August 2003 Decision, IP/C/W/440 (Mar. 1, 2005), available at http://www.cc.nctu.edu.tw/∼kjni/files/WTO/TRIPs%20and%20Public%20Health/WTO%20doc/W440.doc; Communication from Rwanda on behalf of the African Group, The TRIPS Agreement and Public Health, IP/C/W/445 (Apr. 6, 2005), available at http://www.cc.nctu.edu.tw/kjni/files/WTO/TRIPs%20and%20Public%20Health/WTO%20doc/W445.doc; cf. Communication from the Delegation of Barbados, Report on the Workshop on WTO Decision on Access to Medicines at Affordable Prices for Countries with no or Insufficient Manufacturing Capacities, Organized by the Commonwealth Secretariat in Cooperation with the ACP Geneva Office and the Agency for International Trade Information and Cooperation (AITIC) (Geneva 12-14 October 2004), IP/C/W/439 (Feb. 23, 2005), available at http://www.cc.nctu.edu.tw/kjni/files/WTO/TRIPs%20and%20Public%20Health/WTO%20doc/W439.doc (communication from Barbados supporting improvements to the Paragraph 6 Decision). Contra Communication from the United States, Comments on Implementation of 30 August 2003 Agreement (Solution) on the TRIPS Agreement and Public Health, IP/C/W/444 (Mar. 18, 2005), available at http://www.wtocenter.org.tw/SmartKMS/fileviewer?id=61901 (communication from the U.S. insisting on exact replication of the August 30 Decision). The Africa Group Proposal was better than the original August 30 Decision in several regards:

• a. It avoided all of the quantity-restriction provisions of Paragraph 2 of the Aug. 30 Decision. This meant that the importing and exporting countries could avoid the prospect of issuing successive licenses as new quantity needs became apparent.

• b. It avoided the obligation of the importing country needing to document its incapacity in its pharmaceutical sector as described in Paragraph 2 of the Aug. 30 Decision and in the Annex.

• c. It eliminated Paragraph 4 of the Aug. 30 Decision which required not just effective legal means against re-exportation but also other “reasonable measures within their means to prevent re-exportation.”

• d. It eliminated the reference to the territorial nature of patents in the clause authorizing re-exportation/importation in certain regional trade groups. By its language, the clause would eliminate the need for regionally coordinated licenses and would instead allow one import-licensee to become the re-exporter for the entire region.

• e. It eliminated any reference whatsoever to the Chairman's Statement.

There was no doubt whatsoever in the text of the Aug. 30 Decision, ¶ 11, that any eventual amendment need not track the earlier Decision exactly: “amendment will be based, where appropriate on [the Aug. 30] Decision.” Statement of the Chairperson of the General Council for TRIPs, supra note 112. The “where appropriate” language gave ample latitude to permit changes, including significant changes. See id. Moreover, the WTO is a body with sovereign decision-making power and it could choose to amend, modify, or overrule earlier decisions. Nonetheless the Africa Group improvements were rejected.

114 Decision by General Council for TRIPS, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 6, 2005), available at http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm.

115 Statement by the Chairperson to the General Council for TRIPS (Dec. 6, 2005), available at http://www.wto.org/english/news_e/news05_e/trips_319_e.htm.

116 As of December 12, 2007, only 13 countries and the European Communities had accepted Art. 31bis. The timetable for notifications has been extended from December 1, 2007 to December 31, 2009. See WTO, Members Accepting Amendment of the TRIPS Agreement (Jan. 17, 2008), http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm.

117 Abbott, Frederick M., The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health, 99 Am. J. Int’l L. 317, 330 (2005)Google Scholar; Baker, Brook K., Arthritic Flexibilities for Accessing Medicines: Analysis of WTO Action Regarding Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, 14 Ind. Int’l & Comp. L. Rev. 613, 633-72 (2004)Google Scholar.

118 The Canada-Rwanda compulsory license process dramatically illustrates both the defects in Canada's implementing legislation and in the Paragraph 6 System itself. Canada was the first country to introduce domestic legislation designed to implement the August 30 Decision to enable production and export of specified quantities of specific medicines to countries with limited pharmaceutical capacity. An Act to Amend the Patent Act and the Food and Drugs Act, 2004 S.C., c.23 (Can.). Although the Canadian legislation was quick off the mark, it contained numerous defects including prior negotiation in all cases, a specified list of eligible products, a requirement of Canadian drug regulatory approval, and a two year limit on compulsory licenses. See Elliott, Richard, Pledges and Pitfalls: Canada's Legislation on Compulsory Licensing of Pharmaceuticals for Export, 1 Int’l J. Intell. Prop. Mgmt. 94–112 (2006)CrossRefGoogle Scholar. It took over three years for the first license to be issued to Apotex Inc. for the manufacture and export to Rwanda of 15,600,000 tablets containing a fixed-dose combination of lamivudine/nevirapine/zidovudine. See South Centre & the Center for International Environmental Law (CIEL), Rwanda and Canada: Leading the Implementation of the August 2003 Decision for Import/Export of Pharmaceuticals Produced under Compulsory License, Intell. Prop. Q. Update , Third Quarter 2007, at 4-8. Rwanda notified the WTO of its decision to import the product in the summer of 2007. Communication from Rwanda's Government Centre for the Treatement & Research on AIDS (TRAC), Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/9/RWA/1 (July 19, 2007), available at http://docsonline.wto.org/DDFDocuments/t/IP/N/9RWA1.doc. Apotex had taken until June 2006 to obtain regulatory approval from the Canadian government and first had to seek an amendment of the schedule of eligible products. South Centre & CIEL, supra note 118, at 5. Thereafter, Apotex was unable to secure unequivocal voluntary licenses from the patent holders, Glaxo Group Limited, Welcome Foundation Limited, Shire Biochem, Inc., and Boehringer Ingelheim Pharmaceuticals, Inc., though each of them signaled assent to Apotex's humanitarian, no-profit initiative. Id. Canada finally granted a license on September 29, 2007, whereafter it too filed a required notice to the TRIPS Council on October 5, 2007. Communication from the Delegation of Canada, Notification Under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/10/CAN/1 (Oct. 5, 2007), available at http://www.wto.org/english/news_e/news07_e/canada_notification_oct_e.doc. If Apotex and Rwanda want to increase quantities or extend the term beyond two years, they will need to start the post-regulatory approval process all over again. Id.; Communication from Rwanda's Government Centre for the Treatment & Research on AIDS (TRAC), supra note 118, at 1.

119 The Pharmaceutical Research & Manufacturing Group of America (PhRMA), PhRMA “Special 301” Submission 185 (2005), available at http://members.phrma.org/international/PhRMA_2005_Special_301.pdf (arguing that CAFTA “does not permit exceptions to data exclusivity”); Letter from Martin Terberger, Head of Consumer Goods (Pharmaceuticals) Unit, European Commission on Enterprise and Industry Directorate-General, to Greg Perry, European Generic Medicines Association (Feb. 20, 2006), available at http://www.cptech.org/ip/health/dataexcl/ec-de-tamiflu.pdf. (“The European pharmaceutical legislation does not foresee any exception to the above-mentioned periods of 8 year data exclusivity and 10 years marketing protection in case of emergency situations or in case a compulsory patent licence [sic] has been granted by an EU Member State”)

120 19. U.S.C. § 2242 (2006). U.S. power to act unilaterally is not unlimited. According to a WTO Dispute Settlement Panel, WTO Member States are prohibited from taking retaliatory measures under national law with respect to alleged TRIPS violations without first having exhausted all actions permissible under TRIPS rules. Panel Report, United States-Sections 301-310 of the Trade Act of 1974, WT/DS152/R (Dec. 22, 1999), available at http://docsonline.wto.org/GEN_viewerwindow.asp?docsonline.wto.org:80/DDFDocuments/t/WT/DS/152R.DOC. Paradoxically, however, the Panel decision does not preclude unilateral action under Section 301 to try to obtain rights greater than those codified within TRIPS. Yu, Peter K., The International Enclosure Movement, 82 Ind. L.J. 827, 869 (2007)Google Scholar.

121 Off. of U.S. Trade Representative, 2002 Special 301 Report, at 5 (2002), available at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2002/2002_Special_301_Report/asset_upload_file567_6367.pdf. (placing China, Argentina, Colombia, Dominican Republic, Hungary, India, and Israel all on its priority watch list, and placing Canada, Chile, Greece, Korea, Lithuania, Poland, Slovak Republic, Turkey, and Venezuela on its watch list).

122 This escalation is dramatically illustrated in General Accounting Office, Intellectual property: U.S. Trade Policy Guidance on WTO Declaration on Access to Medicines May Need Clarification 52, Figure 5 (2007) [hereinafter GAO Report], available at http://oversight.house.gov/documents/20071030125409.pdf (analyzing U.S. trade policy guidance on medicine access).

123 Off. of U.S. Trade Representative, supra note 121, at 20.

124 Off. of U.S. Trade Representative, 2003 Special 301 Report (2003), available at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2003/2003_Special_301_Report/asset_upload_file665_6124.pdf:

125 Priority watch list countries criticized on these issues included Argentina, India, the Philippines, and Poland; watch list countries included Bolivia, Canada, Chile, Ecuador, Israel, Mexico, Pakistan, Peru, Slovak Republic, Turkey, and Venezuela. Id.

126 Reading U.S. complaints about failed intellectual property protections for drug registration data in the 2004 Special 301 Report is a lot like reading a shortened version of PhRMA's 2004 Submission to the U.S. Trade Representative for the Special 301 Report (2004). Every country on the U.S. 301 Watch List is discussed at length in the PhRMA submission except the Philippines. In each and every one of these country submissions, PhRMA expressly targeted registration issues, sometimes for pages at a time. This focus is no surprise because in Appendix B, PhRMA expressly stated that it:

Id.

This focus by PhRMA was matched by its international counterpart, the International Federation of Pharmaceutical Manufacturers Associations, IFPMA, which in 2003 issued a 20-page report on data exclusivity. IFPMA, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity (2003), available at http://www.ifpma.org/documents/NR83/DataExclusivity.pdf.

PhRMA's 2004 focus on data exclusivity issues was replicated in its 2005 Submission to the U.S. Trade Representative for the Special 301 Report, supra note 119. In its 2005 Report, data exclusivity and patent-registration linkage remained a top-tier objective – data exclusivity was mentioned in 34 out of 41 country reports and linkage in 17 out 41. PhRMA has made it increasingly clear that it wants data exclusivity: (1) to extend to disclosed data as well as undisclosed data, (2) to be granted on pharmaceutical products beyond those involving “new chemical entities” (including new uses, dosages, indications, and formulations), (3) to be granted for at least but preferably more than 5 years, especially in EU accession countries, (4) to be based only on an in-country filing, not based on an earlier filing elsewhere, and (5) to permit no exception, even presumably when compulsory licenses are granted. PhRMA, supra note 119.

127 Off. of U.S. Trade Representative, 2004 Special 301 Report (2004), available at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2004/2004_Special_301/asset_upload_file16_5995.pdf.

128 The twelve countries were Argentina, Brazil, Egypt, India, Korea, Lebanon, Pakistan, Republic of the Philippines, Russia, Taiwan, and Turkey. Id.

129 The nineteen countries were Canada, Chile, Colombia, Costa Rica, Croatia, the Dominican Republic, Ecuador, Guatemala, Hungary, Israel, Malaysia, Peru, Poland, Romania, Saudi Arabia, Slovak Republic, Thailand, Uruguay, and Venezuela. Id.

130 Off. of U.S. Trade Representative, 2005 Special 301 Report, available at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2005/2005_Special_301/asset_upload_file195_7636.pdf. Paraguay is a Section 306 country and the priority watch list countries include China, Argentina, Egypt, India, Israel, Lebanon, Pakistan, Russia, Turkey, and Venezuela. The watch list countries include Canada, Chile, Costa Rica, Croatia, Ecuador, Korea, Malaysia, Mexico, Peru, Slovakia, Thailand, Uruguay, and Vietnam.

131 PhRMA's 2006 “Special 301” Submission also prioritized price controls. See PhRMA, PhRMA Special 301 Submission, 7-11 (2006), available at http://members.phrma.org/international/PhRMA_2005_Special_301.pdf.

132 Off. of U.S. Trade Representative, 2006 Special 301 Report (2006), available at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2006/2006_Special_301_Review/asset_upload_file473_9336.pdf. With respect to the priority watch list, the USTR mentioned the failure to adequately protect pharmaceutical data by China, Russia, and eight of the other eleven countries: Argentina (Data Exclusivity (DE) & linkage), Brazil (DE), Egypt (DE and linkage), India (DE), Israel (DE), Lebanon (DE and linkage), Turkey (DE and linkage), and Venezuela (DE and linkage). Thirty-four trading partners are placed on the lower level watch list. Pharmaceutical-related data exclusivity and/or linkage criticisms were made in 15 of these countries as follows: Bulgaria (DE), Canada (DE), Chile (DE), Costa Rica (DE), Croatia (linkage), Dominican Republic (DE), Ecuador (DE & linkage), Guatemala (DE), Hungary (linkage), Kuwait (DE), Pakistan (DE), Peru (linkage), Poland (DE), the Republic of Korea (linkage), and Thailand (DE).

133 Off. of U.S. Trade Representative, 2007 Special 301 Report (2007), available at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2007/2007_Special_301_Review/asset_upload_file230_11122.pdf. (criticizing every priority watch country: China, Russia, Argentina, Chile, Egypt, India, Israel, Lebanon, Thailand, Turkey, and Venezuela, but praising Ukraine for having amended its law; also criticizing watch list countries: Brazil, Ecuador, Indonesia, Malaysia, Mexico, Pakistan, Poland, Costa Rica, and Guatemala, but praising Canada, Republic of Korea, and Vietnam for correcting their registration related deficiencies; and criticizing a Section 306 Country, Paraguay).

134 Yu, supra note 120, at 866-70; Rossi, supra, note 2; Musungu & Oh, supra note 57, at 101-10. This pursuit of heightened IPRs conforms to one of the mandates of the Trade Act of 2002:

19 U.S.C. § 3802(b)(4) (2002). Of course, the U.S. has largely ignored a parallel provision in the Trade Act that requires it to respect the principles of the Doha Declaration. § 3802(b)(4)(C). The GAO specifically found that that the USTR has paid virtually no attention to the Doha Declaration mandate with two exceptions, parallel importation and compulsory licensing. GAO Report, supra note 122, at 57. The GAO Report ultimately recommends that Congress should clarify its trade objectives for the USTR. Id. at 58.

135 In addition to the U.S., Europe, and Japan, the following countries had adopted some form of data exclusivity: Australia, Brazil, Bulgaria, Canada, China, Costa Rica, Czech Republic, Egypt, Estonia, Finland, Guatemala, Hungary, Iceland, Jordan, Korea, Latvia, Mexico, New Zealand, Norway, Panama, Poland, Romania, Singapore, Slovak Republic, Slovenia, Switzerland, and the Andean Community (Bolivia, Colombia, Ecuador, Peru, and Venezuela); other countries were required to do so pursuant to bilateral trade agreements: Albania, Cambodia, Mongolia, Sri Lanka, Vietnam and Chile (US bilateral agreements), Lithuania, Cyprus and Malta (E.U. accession countries). Lee Skillington, G. & Solovy, Eric M., The Protection of Test and Other Data Required by Art. 39.3 of the TRIPS Agreement, 24 Nw. J. Int’l L. & Bus. 1, 49–50 (2003)Google Scholar. For a more recent, but still partial listing of country provisions on data protection, see Musungu & Oh, supra note 57, at Annex I.

136 See United States-Panama Trade Promotion Agreement, U.S.-Pan., art. 15.10.2, Dec. 19, 2007, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Panama_FTA/Final_Text/asset_upload_file131_10350.pdf. [hereinafter U.S.-Panama FTA]; United States-Peru Trade Promotion Agreement, U.S.-Peru, art. 16.10.2, Dec. 14, 2007, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Peru_TPA/Final_Texts/asset_upload_file392_9546.pdf. [hereinafter U.S.-Peru FTA]; United States-Oman Free Trade Agreement, U.S.- Oman, art. 15.9.1, Sept. 26, 2006, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Oman_FTA/Final_Text/asset_upload_file715_8809.pdf. United States Bahrain Free Trade Agreement, U.S.-Bahr., art. 14.9.1, Sept, 2004, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Bahrain_FTA/final_texts/asset_upload_file211_6293.pdf. [hereinafter U.S.-Bahrain FTA]; United States-Morocco Free Trade Agreement, U.S.-Morocco, art. 15.10.1, June 15, 2004, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Morocco_FTA/FInal_Text/asset_upload_file797_3849.pdf. [hereinafter U.S.-Morocco FTA]; Central America-Dominican Republican Free Trade Agreement, art. 15.10.1, May 28, 2004, available at http://www.ustr.gov/assets/Trade_Agreements/Regional/CAFTA/CAFTA-DR_Final_Texts/asset_upload_file934_3935.pdf. [hereinafter DR-CAFTA]; United States-Australia Free Trade Agreement, U.S.-Austl., art. 17.10.1, May 18, 2004, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Australia_FTA/Final_Text/asset_upload_file469_5141.pdf. [hereinafter U.S.-Australia FTA]; United States-Chile Free Trade Agreement, U.S.-Chile, art. 17.10.1, Jan. 1, 2004, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Chile_FTA/Final_Texts/asset_upload_file912_4011.pdf. [hereinafter U.S.-Chile FTA]; United States-Singapore Free Trade Agreement, U.S.-Sing., art. 16.8.1-.2, May 6, 2003, available at http://www.ustr.gov/Trade_Agreements/Bilateral/Singapore_FTA/Final_Texts/Section_Index.html. [hereinafter U.S.- Singapore FTA]; United Sates-Jordan Free Trade Agreement, U.S.-Jordan, art.4.22, Oct. 24, 2000, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Jordan/asset_upload_file250_5112.pdf. [hereinafter U.S.-Jordan FTA]; North American Free Trade Agreement, U.S.- Can.-Mex., art.1711, Dec. 17, 1992, 32 I.L.M. 289 (1993), available at http://www.nafta-secalena.org/DefaultSite/index_e.aspx?DetailID=168 [hereinafter NAFTA].

137 United States-Colombia Free Trade Agreement, U.S.-Colom., art. 16.10.1, June 28, 2007, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Colombia_FTA/Final_Text/asset_upload_file776_10142.pdf. [hereinafter U.S.-Colombia FTA]; United States-Korea Free Trade Agreement, U.S.-S.Korea, art. 18.9.1, Apr. 4, 2007, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Republic_of_Korea_FTA/Final_Text/asset_upload_file273_12717.pdf. [hereinafter U.S-Korea FTA].

138 The U.S. is currently negotiating or has temporarily suspended free trade negotiations with Thailand, Malaysia, and the Southern Africa Custom Union, of which South Africa is a leading member. See Office of the United States Trade Representative, Thailand Free Trade Agreement, http://www.ustr.gov/Trade_Agreements/Bilateral/Thail_FTA/Section_Index.html?ht= (last visited Apr. 4, 2008); Office of the United States Trade Representative, Malaysia Free Trade Agreement, http://www.ustr.gov/Trade_Agreements/Bilateral/Malaysia_FTA/Section_Index.html. (last visited Apr. 4, 2008); Office of the United States Trade Representative, South African Customs Union Free Trade Agreement, http://www.ustr.gov/Trade_Agreements/Bilateral/Southern_Africa_FTA/Section_Index.html. (last visited Apr. 4, 2008).

139 This term appears in definitions of new pharmaceutical products in ten FTAs; U.S.-Australia FTA, supra note 136, art. 17.10.1(d), ; U.S.-Bahrain FTA, supra note 136, art. 14.9.1(c); U.S.-Chile FTA, supra note 136, art. 17.10.1; U.S.-Colombia FTA, supra note 137, art. 16.10.1(c); DR-CAFTA, supra note 136, art. 15.10.1(c); U.S.-Korea FTA, supra note 137, art. 18.9.1(c); U.S.-Morocco FTA, supra note 136, art. 15.10.1; U.S.-Oman FTA, supra note 136, art. 15.9.1(c); U.S.-Panama FTA, supra note 136, art. 15.10.2(d); U.S.-Peru FTA, supra note 136, art. 16.10.2(d);. Over time, the U.S. is making it increasingly clear that data exclusivity should apply to new pharmaceutical products, meaning “one that does not contain a chemical entity that has been previously approved in the territory of the Party for use in a pharmaceutical product.” See, e.g., U.S.-Oman FTA, supra note 136, art. 15.9.1(c). The U.S.- Singapore FTA is an exception in its use of the broader term “pharmaceutical product” and its requirement of at least five years of exclusivity for all pharmaceutical products, subject to footnote 16-14, which grandfathers in lesser periods for products not containing new chemical entities to safeguard U.S. practice. U.S.-Singapore FTA, supra note 136, art. 16.8.1.

140 All pre-2007 FTAs except with Jordan required at least five years of data exclusivity. The U.S.-Jordan FTA, supra note 136, art. 4.22 n.10, did not specifically reference a mandatory five-year term of data exclusivity, though it does reference an additional required period of three years for protecting new uses. One 2007 FTA did require a five year minimum term for data exclusivity. U.S.-Korea FTA, supra note 137, art. 18.9.1(a), . In its WTO accession agreement with China, the U.S. succeeded in obtaining six years of data exclusivity. WTO, Report of the Working Party on the Accession of China, WT/MIN(01)/3 (Nov. 10, 2001) available at http://www.wto.org/english/thewto_e/acc_e/completeacc_e.htm#chn. For three of the developing country trade agreements under consideration in 2007, however, five years may no longer be the minimum. See U.S.-Colombia FTA, supra note 137, art. 16.10 2(b); U.S.-Panama FTA, supra note 136, art. 15.10 2(b); U.S.-Peru FTA, supra note 136, art. 16.10 2(b) . In each of these FTAs, the reasonable period for data exclusivity “shall normally mean five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and person's efforts and expenditures in producing them.”

141 U.S.-Bahrain FTA, supra note 136, art. 14.9.1(a) (submission of information); U.S.- Oman FTA, supra note 136, art. 15.9.1 (submission of information); U.S.-Singapore FTA, supra note 136, art. 16.8.1 (submission of information); U.S.-Korea FTA, supra note 137, art. 18.9.1(a) (submission of information); U.S.-Morocco FTA, supra note 136, art. 15.10.1 (submission of safety and efficacy data). The failure to mention “undisclosed data” is important for two reasons. First, it is a direct departure from TRIPS Art. 39.3, which requires both that the data be non-disclosed. Second, it blocks registration of follow-on products not because of any lingering remnants of trade secret policy, which requires efforts to prevent disclosure, but purely as a means to prevent a generic company's reliance on prior data or the fact of prior registration. For a discussion of the origin of data protection rules in trade secret law, see Fellmeth, supra note 73. Part of the background to the U.S. dropping the term “undisclosed” may be growing regulatory effort to require drug companies to publish clinical trial results both on government and/or industry websites. See U.S.-Peru FTA Offers Tighter Protection than CAFTA for Clinical Data, Inside U.S. Trade, Jan. 13, 2006.

142 Multiple U.S. bilateral and regional FTAs have dropped the TRIPS Art. 39.3 requirement that the data collection required considerable effort – investment – in order to be entitled to data protection. U.S.-Australia FTA, supra note 136, art. 17.9.8; U.S.-Bahrain FTA, supra note 136 art. 14.9.1(a); U.S.-Chile FTA, supra note 136, art. 17.10.1; DR-CAFTA, supra note 136, art. 15.10.1(a),; U.S.-Morocco FTA, supra note 136, art. 15.10.1.1(a); U.S.-Oman FTA, supra note 136, art. 15.9.1(a); U.S.-Singapore FTA, supra note 136, art. 16.8 .

143 With the exception of the U.S.-Chile FTA, all U.S. FTAs provide for data exclusivity even if the registering authority relies on the fact of registration elsewhere. NAFTA, supra note 136, art. 1711.7; U.S.-Australia FTA, supra note 136, art. 17.10.1(c); U.S.-Bahrain FTA, supra note 136, art. 14.9.1(b); U.S.-Colombia FTA, supra note 137, art. 16.10.2(c); DR-CAFTA, supra note 136, art. 15.10.1(b); U.S.-Jordan FTA, supra note 136, art. 4.22; U.S.-Korea FTA, supra note 137, art. 18.9.1(b); U.S.-Morocco FTA, supra note 136, art. 15.10.1-.2; U.S.-Oman FTA, supra note 136, art. 15.9.1(b); U.S.-Panama FTA, supra note 136, art. 15.10.2(c); U.S.- Peru FTA, supra note 136, art. 16.10.2(c); U.S.-Singapore FTA, supra note 136, art. 16.8.2.

144 See U.S.-Australia FTA, supra note 136, art. 17.10.2; U.S.-Bahrain FTA, supra note 136, art. 14.9.2(a); U.S.-Jordan FTA, supra note 136, art. 4.22; U.S.-Korea FTA, supra note 137, art. 18.9.2(a); U.S.-Morocco FTA, supra note 136, 15.10.2(b), . In addition to these FTAs, which directly provide for evergreening data exclusivity, several other FTAs require or permit countries to continue granting exclusivity for new uses if they have done so in the past. U.S.- Chile FTA, supra note 136, art. 17.10 n.25; U.S.-Panama FTA, supra note 136, art. 15.10 n.17; U.S.-Singapore FTA, supra note 136, art. 16.8 nn.16-14.

145 New Trade Policy, supra note 55.

146 There are many other concerns about TRIPS-plus terms in U.S. FTAs including: (1) requirements that patent terms be extended to compensate for regulatory delays in issuing patents and registering medicines; (2) expansions of the definition of patentability to require new uses; (3) restrictions on compulsory licenses; (4) restrictions on parallel importation; (5) restrictions on mandatory use of generic names; (6) restrictions on pre-grant opposition; and (7) enhanced enforcement procedures. See, e.g., Rossi, supra note 2, at 159-66, 170, tbl. 1. Discussion of these concerns is beyond the scope of this Article.

147 DR-CAFTA, supra note 136, art. 15.10.2 (emphasis added). Patent/registration linkage is also provided in U.S.-Australia FTA, supra note 136, art. 17.10.4; U.S.-Bahrain FTA, supra note 136, art. 14.9.3; U.S.-Chile FTA, supra note 136, art. 17.10.2(c); DR-CAFTA, supra note 136, art. 15.10.2; U.S.-Korea FTA, supra note 137, art. 18.9.5; U.S.-Morocco FTA, supra note 136, art. 15.10.4; U.S.-Oman FTA, supra note 136, art. 15.9.4; U.S.-Singapore FTA, supra note 136, art. 16.8(4)(c). Several other agreements provide for notification and adequate judicial patent infringement procedures rather than linkage. U.S.-Colombia FTA, supra note 137, art. 16.10.3; U.S.-Panama FTA, supra note 136, art. 15.10.3; U.S.-Peru FTA, supra note 136, art. 16.10.3; U.S.-Jordan FTA, supra note 136, art.4.22. Despite not requiring patent/registration linkage, the three U.S.-Colombia, U.S.-Panama, and U.S.-Peru FTAs all suggest that parties may implement full linkage. U.S.-Colombia FTA, supra note 137, art. 16.10.4; U.S.-Panama FTA, supra note 136, art. 15.10.4; U.S.-Peru FTA, supra note 136, art. 16.10.4.

148 See 19 U.S.C. § 3802(b)(4)(C)(2000) (mandating that the United States Trade Representative respect the Doha Declaration).

149 DR-CAFTA, supra note 136; Office of the United States Trade Representative, Understanding Regarding Certain Public Health Measures (Aug. 5. 2004) available at http://www.ustr.gov/assets/Trade_Agreements/Regional/CAFTA/CAFTADR_Final_Texts/asset_upload_file697_3975.pdf. U.S.-Bahrain FTA, supra note 136; Side Letter on Public Health (Sept. 14, 2004), available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Bahrain_FTA/final_texts/asset_upload_file447_6296.pdf. U.S.-Morocco FTA, supra note 136;, Side Letter on Public Health (June 15, 2004), available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Morocco_FTA/FInal_Text/asset_upload_file258_3852.pdf. U.S.-Oman FTA, supra note 136;, Letter on Public Health (Jan. 19, 2006), available at http://www.ustr.gov/assets/Trade_Agreements/Biilateral/Oman_FTA/Final_Text/asset_upload_file44_8808.pdf. As discussed further below, the previous text of the side letters has now been added to the official text in the U.S.-Colombia FTA, supra note 136, art. 16.10.2(e), ; U.S.-Panama FTA, supra note 136, art. 15.10.2(e); U.S.-Peru FTA, supra note 136, art. 16.10.2(e); and U.S.-Korea FTA, supra note 137, art. 18.9.3.

150 DR-CAFTA, Understanding Regarding Certain Public Health Measures, supra note 149.

151 The extent to which side letters can influence the interpretation of contrary text in an FTA is uncertain at best. Correa, Carlos, Implications of Bilateral Free Trade Agreements on Access to Medicines, 84 WHO Bull. 399, 402 (2006)Google Scholar, available at http://www.who/int/bulletin/volumes/84/5/399.pdf. Carsten Fink & Patrick Reichenmiller, Tightening TRIPS: The Intellectual Property Provisions of Recent US Free Trade Agreements, Trade Note ( The World Bank Group) Feb. 7, 2005, at 98; cf. Gathi, James Thuo, The Legal Status of the Doha Declaration on TRIPS and Public Health Under the Vienna Convention on the Law of Treaties, 15 Harv. J.L. & Tech. 291, 314 (2002)Google Scholar.

152 See, e.g., DR-CAFTA, Understanding Regarding Certain Public Health Measures, supra note 149.

153 See Hyman, Cindy Joffe, Food for Thought: Defending the Organic Foods Production Act of 1990 Against Claims of Protectionism, 14 Emory Int’l L. Rev. 1719, 1746-56 (2000)Google Scholar.

154 See Fellmeth, supra note 73, at 450-52 (interpretations of “necessary” often require that no alternative to the measure exists). Several nations have successfully brought challenges before trade tribunals claiming that public health measures violate trade rights. In responding to these challenges, the burden of persuasion is placed on the nation attempting to implement the public health measure to prove that it was necessary pursuant to a two-tiered test: (1) the responding nation must show that the health measure is necessary, i.e., that it is effective, and that no less trade restrictive measures were available to achieve the same public health purpose; and (2) if proven to be necessary, the responding nation must also show that the proposed public health measure does not constitute a “disguised restriction on international trade” or “arbitrary or unjustifiable discrimination.” If an international trade tribunal determines that a measure in effect is discriminatory to trade, the measure may be found to be a violation of trade rules, even if the discrimination is unintended. Cf. WTO Analytical Index: GATT 1994 General Agreement on Tariffs and Trade 1994 available at http://www.wto.org/english/res_e/booksp_e/analytic_index_e/gatt1994_07_e.htm (interpreting “necessary” in the context of Emergency Action on Imports of Particular Products).

155 A discount pricing program launched by five drug companies in cooperation with the WHO in early 2001. See WHO, Accelerating Access Initiative: Widening Access and Support for People Living with HIV/AIDS – Progress Report (2002), available at http://whqlibdoc.who.int/publications/2002/9241210125.pdf; WHO, Accelerating Access – Fact Sheet (Dec. 31, 2005), http://www.who.int/hiv/AAI_fs_4Q2005.pdf.

156 Doha Declaration, supra note 54, ¶ 1-4 .

157 WHO, Preventing Chronic Disease: A Vital Investment 1-4 (2005), available at http://www.who.int/chp/chronic_disease_report/full_report.pdf. (reporting that four out of five chronic disease deaths worldwide are now in low- and middle-income countries).

158 DR-CAFTA, Understanding Regarding Certain Public Health Measures, supra note 149.

159 As previously stated, the Doha Declaration mandates that each nation “has the right to grant compulsory licences [sic] and the freedom to determine the grounds upon which such licences [sic] are granted.” The Doha Declaration, supra note 54, ¶ 5.

160 The TRIPS Agreement, supra note 53, art. 31(b).

161 Id. art. 31(b), (f).

162 Id. art. 31(k).

163 The right to parallel import might be negatively impacted by the difficulty of registering an imported version of an innovator's patented drug that was produced at a different location than the one already registered in-country. Id. art. 6; see the Doha Declaration, supra note 54, ¶ 5d.

164 See, e.g., CAFTA, supra note 136, art. 15.10.2.

165 Letter from John K. Veroneau to Rep. Sander M. Levin (July 19, 2004), in United States-Morocco Free Trade Agreement Implementation Act, USTRH.R. Rep. No 108-267, at 32-40 (2004).

166 Id. at 36.

167 “‘Chapter Fifteen does not prevent the effective utilization of the TRIPS/health solution’ reached in the WTO last year to ensure that developing countries that lack pharmaceutical manufacturing capacity may import drugs. Therefore, if circumstances ever arise in which a drug is produced under a compulsory license, and it is necessary to approve that drug to protect public health or effectively utilize the TRIPS/health solution, the data protection provisions in the FTA would not stand in the way.” Id. at 38.

168 Draft letter from Susan Schwab to Pablo De le Flor (Jan. 6, 2006), available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Peru_TPA/Final_Texts/asset_upload_file856_8710.pdf. This side letter has been replaced in the final text renegotiated in the summer of 2007 pursuant to the New Trade Policy. See U.S.-Peru FTA, supra note 136, art. 16.10.

169 The typical patent challenge lawsuit in the U.S. costs nearly $4 million. Executive Office of the President, Economic Report of the President 222 (Feb. 2006), available at http://www.gpoaccess.gov/eop/2006/2006_erp.pdf. The cost in developing countries might be less, but is still a significant deterrent.

170 Under investment clause provisions in free trade agreements, aggrieved investors, including pharmaceutical company investors, can take national, state, and local government to WTO-related dispute resolutions mechanisms asking for compensation for lost investments and lost investment opportunities where those losses result from violations of FTA provisions. Accordingly, not only can disgruntled MNCs sue in national courts under national law regimes, they can also resort to unreviewable adjudication before panels of WTO experts. This right to bring investment clause claims could greatly deter the willingness of developing countries to implement and then use TRIPS flexibilities. See Ermias T. Biadgleng, IP Rights Under Investment Agreements: The TRIPS-Plus Implications for Enforcement and Protection of Public Interest (2006), available at http://www.southcentre.org/publications/researchpapers/ResearchPapers8.pdf.

171 Thai-U.S. FTA Talks Left for Next Govt, Bangkok Post; July 13, 2006, available at http://www.bangkokpost.com/breaking_news/breakingnews.php?id=108780; Press Release, Office of the United States Trade Representative, U.S.-SACU Agree to Pursue Concrete Steps to Deepen Trade and Investment Relations (Apr. 18, 2006), available at http://www.ustr.gov/Document_Library/Press_Releases/2006/April/US-SACU_Agree_to_Pursue_Concrete_Steps_to_Deepen_Trade_Investment_Relations.html.

172 Sarah Hiddleston, An Important Win for Domestic Pharma Industry, The Hindu (India), June 4, 2007, available at http://www.thehindu.com/2007/06/04/stories/2007060401361300.htm.

173 Resolved, That it is the sense of the Senate that the United States should--

• (1) honor the commitments the United States made in the 2001 World Trade Organization Doha Declaration on the TRIPS Agreement and Public Health, which allows member states of the World Trade Organization to use `to the full’ the flexibilities in the Agreement on Trade-Related Aspect of Intellectual Property Rights (in this resolution referred to as the TRIPS Agreement’) `to protect public health and, in particular, to promote access to medicines for all,’ including the issuance of compulsory licenses on grounds determined by member states;

• (2) not place countries on the Special 301’ Priority Watch List under section 182 of the Trade Act of 1974 (19 U.S.C. 2242) for exercising the flexibilities on public health provided for in the TRIPS Agreement, such as issuing compulsory licenses to obtain access to generic medicines in accordance with the Doha Declaration;

• (3) not ask trading partners who are developing nations to adopt measures to protect intellectual property rights that relate to public health in excess of protections required in the TRIPS Agreement; and

• (4) support new global norms for promoting medical research and development that seek to provide a sustainable basis for a needs-driven essential health agenda.

S. Res. 241, 110th Cong. ( 2007), available at http://www.govtrack.us/congress/billtext.xpd?bill=sr110-241; H.R. Res. 525, 110th Cong. (2007), available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=110_cong_bills&docidf:hr525ih.txt.pdf.

174 The New Trade Policy for America, supra note 55. The New Trade Policy has been implemented most prominently in the U.S.-Colombia, U.S.-Panama, and U.S.-Peru FTAs. Portions of it have been implemented in the U.S.-Korea FTA, but it contains several New Trade Policy-plus provisions, including linkage, protection of disclosed data, and three-years of exclusivity for products with supported by new clinical information. U.S.-Korea FTA, supra note 137, art. 18.9.

175 U.S.-Colombia FTA, supra note 136 art. 16.10; U.S.-Panama FTA, supra note 136, art. 15.10; U.S.-Peru FTA, supra note 136, art. 16.10.

176 U.S.-Korea FTA, supra note 137, art. 18.9. The U.S. is less generous with Korea because it considers it a high-income country and thus not as entitled to public health flexibilities.

177 U.S.-Colombia FTA, supra note 137, art. 16.10; U.S.-Panama FTA, supra note 136, art. 15.10; U.S.-Peru FTA, supra note 136, art. 16.10; U.S.-Korea FTA, supra note 137, art. 18.9.

178 U.S.-Colombia FTA, supra note 137, art. 16.10.2(a); U.S.-Panama FTA, art. 15.10.2(a), supra note 136; U.S.-Peru FTA, supra note 136, art. 16.10.2(a); cf. U.S.-Korea FTA, supra note 137, art. 18.9.1(c) (adopting a slightly less stringent definition, “a new pharmaceutical product is one that does not contain a chemical entity that has been previously approved in the territory of the Party for use in a pharmaceutical product”).

179 U.S.-Singapore FTA, supra note 136, art. 16.8.1.

180 U.S.-Colombia FTA, supra note 137, art. 16.10.2(a); U.S.-Panama FTA, supra note 136, art. 15.10.2(a) ; U.S.-Peru FTA, supra note 136, art. 16.10.2(a); cf. U.S.-Korea FTA, supra note 137, art. 18.9.1 (protecting all information).

181 U.S.-Colombia FTA, supra note 137, art. 16.10.2(a); U.S.-Panama FTA, supra note 136, art. 15.10.2(a) ; U.S.-Peru FTA, supra note 136, art. 16.10.2(a) ; U.S.-Korea FTA, supra note 137, art. 18.9.1.

182 U.S.-Bahrain FTA, supra note 136, art. 14.9.1(a) (submission of information); U.S.- Oman FTA, supra note 136, art. 15.9.1 (same); U.S.-Singapore FTA, supra note 136, art. 16.8.1 (same); U.S.-Korea FTA, supra note 137, art. 18.9.1(a) (same); U.S.-Morocco FTA, supra note 136, art. 15.10.1(submission of safety and efficacy data).

183 See U.S.-Colombia FTA, supra note 137, art. 16.10; U.S.-Panama FTA, supra note 136, art. 15.10; U.S.-Peru FTA, supra note 136, art. 16.10. In each, the reasonable period for data exclusivity “shall normally mean five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and person's efforts and expenditures in producing them.” Cf. U.S.-Korea FTA, supra note 137, art. 18.9.1 (“for at least five years”). This is, in essence, a return to the earlier NAFTA standard: “a reasonable period shall normally mean not less than five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and the person's efforts and expenditures in producing them.” NAFTA, supra note 136, art. 1711.6 (difference italicized).

184 See Staff of H. Comm. on Ways and Means, 110th Cong., Peru and Panama FTA Changes, at ¶ III D(3) (Comm. Print 2007) (“The Parties … would … (3) include an exception to the data exclusivity obligation for measures to protect public health in accordance with the Doha Declaration and the subsequent protocols for implementation.”). Certain IPR activists had been urging the creation of an explicit exception to data exclusivity for some time. See, e.g., Weissman, Robert, Public Health-Friendly Options for Protecting Pharmaceutical Registration Data, Int’l J. Intell. Prop. Mgm't 113, 124-27 (2006)Google Scholar.

185 Understandings Regarding Certain Public Health Measures

1. The Parties affirm their commitment to the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2).

2. The Parties have reached the following understandings regarding this Chapter.

   • (a) The obligations of this Chapter do not and should not prevent a Party from taking measures to protect public health by promoting access to medicines for all, in particular concerning cases such as HIV/AIDS, tuberculosis, malaria, and other epidemics as well as circumstances of extreme urgency or national emergency. Accordingly, while reiterating their commitment to this Chapter, the Parties affirm that this Chapter can and should be interpreted and implemented in a manner supportive of each Party's right to protect public health and, in particular, to promote access to medicines for all.

   • (b) In recognition of the commitment to access to medicines that are supplied in accordance with the Decision of the General Council of 30 August 2003 on the Implementation of Paragraph Six of the Doha Declaration on the TRIPS Agreement and Public Health (WT/L/540) and the WTO General Council Chairman's statement accompanying the Decision (JOB(03)/177, WT/GC/M/82) (collectively, the “TRIPS/health solution”), this Chapter does not and should not prevent the effective utilization of the TRIPS/health solution.

   • (c) With respect to the aforementioned matters, if an amendment of the TRIPS Agreement enters into force with respect to the Parties and a Party's application of a measure in conformity with that amendment violates this Chapter, the Parties shall immediately consult in order to adapt this Chapter as appropriate in the light of the amendment.

U.S.-Colombia FTA, supra note 137, art. 16.13; U.S.-Panama FTA, supra note 136, art. 15.12; U.S.-Peru FTA, supra note 136, art. 16.13; U.S.-Korea FTA, supra note 137, art. 18.12. On the plus side, the new text removed a prior requirement in the earlier FTA side letters that the freedom to take measures to protect public health was limited to when such measures were “necessary.”

186 U.S.-Colombia FTA, supra note 137, art. 16.10.2(e); U.S.-Panama FTA, supra note 136, art. 15.10.2(e) ; U.S.-Peru FTA, supra note 136, art. 16.10.2(e).

U.S.-Peru FTA, supra note 136, art. 16.10.2(e). The comparable provision in the U.S.-Korea FTA is U.S.-Korea FTA, supra note 137, art. 18.9.3.

187 Office of the U.S. Trade Representative, Statement of Administration Action (2007), available at http://finance.senate.gov/sitepages/leg/LEG%202007/Leg%20110%20092007paperb.pdf.

188 NAFTA, supra note 136, art. 1711.7 (“Where a Party relies on a marketing approval granted by another Party, the reasonable period of exclusive use of the data submitted in connection with obtaining the approval relied on shall begin with the date of the first marketing approval relied on.”); DR-CAFTA, supra note 136, art. 15.10.1(b) (addressing only the most egregious cases of delay lasting longer than five years).

189 See, e.g. U.S.-Bahrain FTA, supra note 136, art. 17.10.1 (no incentives for early registration or even reference to timeline for registration).

190 U.S.-Colombia FTA, supra note 136, art. 16.10.2(c).

Id. U.S.-Panama FTA, supra note 136, art. 2(c); U.S.-Peru FTA, supra note 136, art. 16.10.2(c).

191 One objection to concurrency rules is that the originator can lose part of its period of data exclusivity through no fault of its own because of registration delay by the drug regulatory authority. It seems intuitively unfair for the incentive of early registration to be dissipated because of delays in the registration process. One solution is to allow a reasonable period for drug registration, but to “toll” or suspend the running of the exclusivity period if the regulatory delay is too long (so long as the delay is not attributable to the originator). An even more generous solution for the originator is to begin the exclusivity period at the time of first registration, but to toll it during the regulatory process (as long as the delay is not attributable to the originator) so that the originator always gets 5 years of exclusivity, less any period of its own pre-registration and registration-related delay.

192 Paris Convention for the Protection of Industrial Property, art. 4., cl.1, Mar. 20, 1883, 21 U.S.T. 1583, 828 U.N.T.S. 305 (last revised at Stockholm July 14, 1967), available at http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html.num;P83_6610 [hereinafter Paris Convention]. See Chile, Ley No. 19.996, VIII, art. 91(e) (2005) (in Spanish), available at http://sdi.bcn.cl/boletin/publicadores/normas_publicadas/archivos/19996.pdf.

193 U.S.-Colombia FTA, supra note 137, art. 16.10.4.

Id. (citations omitted); U.S.-Panama FTA, supra note 136, art. 15.10.4; U.S.-Peru FTA, supra note 136, art. 16.10.4.

194 U.S.-Colombia FTA, supra note 137, art. 16.10.3.

Each Party shall provide:

• (a) procedures, such as judicial or administrative proceedings, and remedies, such as preliminary injunctions or equivalent effective provisional measures, for the expeditious adjudication of disputes concerning the validity or infringement of a patent with respect to patent claims that cover an approved pharmaceutical product or its approved method of use;

• (b) a transparent system to provide notice to a patent holder that another person is seeking to market an approved pharmaceutical product during the term of a patent covering the product or its approved method of use; and

• (c) sufficient time and opportunity for a patent holder to seek, prior to the marketing of an allegedly infringing product, available remedies for an infringing product.

Id.; U.S.-Panama FTA, supra note 136, art. 15.10.3; U.S.-Peru FTA, supra note 136, art. 16.10.3.

195 Pedro Roffe, Ctr. for Int’l Envtl. Law (CIEL), Intellectual Property, Bilateral Agreements and Sustainable Development: The Challenges of Implementation, (2007), available at http://ciel.org/Publications/FTA_ImplementationPub_Jan07.pdf.

196 U.S.-Peru FTA, supra note 136, art. 16.1.7; U.S.-Colombia FTA, supra note 137, art. 16.1.7; cf. U.S.-Korea FTA, supra note 137, art. 18.1.5 (“A Party may provide more extensive protection for, and enforcement of, intellectual property rights under its law than this Chapter requires, provided that the more extensive protection does not contravene this Chapter.”).

197 This would in essence be a return to the NAFTA standard: “Where a Party relies on marketing approval granted by another party, the reasonable period of exclusive use of the data submitted in connection with obtaining the approval relied on shall begin with the date of the first marketing approval relied on.” NAFTA, supra note 136, art. 1711.7.

198 As a complement to this reliance registration measure, developing countries should have provisions in their law allowing for compulsory licenses for the failure of the patent holder to work its patent within three years of patent approval or four years after application, whichever is later. See Paris Convention, supra note 192. Since first registration almost always takes place years after patent filing, the waiting period should not be a problem.

199 For many years, Brazil threatened compulsory licenses on AIDS medicines only to pull back at the last moment because of promises of price concessions. Although multiple developing countries have issued compulsory licenses on AIDS medicines in the last several years, Thailand set an important precedent this past year by issuing two government use licenses on efavirenz and lopinavir/ritonavir, AIDS medicines, and another on clopidrogel, an anti-platlet; shortly thereafter Brazil followed suit and also issued a license for efavirenz. See Abbott, Fred & Reichman, Jerome, The Doha Round's Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions, 10 J. Int’l Econ. L. 921, 949-57 (2007)Google Scholar; Cahoy, Daniel R., Confronting Myths and Myopia on the Road from Doha, 42 Ga. L. Rev. 131 (2007)Google Scholar (presenting a highly critical, Pro-Big Pharma critique of the Thai and Brazil compulsory licenses).

200 See M. Asif Ismail, Ctr. for Pub, Integrity, Drug Lobby Second to None: How the Pharmaceutical Industry Gets its Way in Washington (July 7, 2005), available at http://www.publicintegrity.org/rx/report.aspx?aid=723; M. Asif Ismail, Ctr. for Pub. Integrity, Exporting Prices: Drug Makers’ Trade Group Makes the Industry'sPriorities U.S. Trade Policy (July 1, 2005), http://www.publicintegrity.org/rx/report.aspx?aid=718.