INTRODUCTION
Access to medicines goes hand in hand with the protection of intellectual property rights. At a time when the United States is undertaking large-scale reforms in both the intellectual property and healthcare arenas, it is worth thinking more deeply and broadly about the connections between the two. In March 2010, Congress enacted the Patient Protection and Affordable Care Act[1] and the Health Care and Education Reconciliation Act of 2010.[2] The passage of these highly controversial statutes led to a constitutional challenge to the first statute before the United States Supreme Court. In the 5–4 decision of National Federation of Independent Business v. Sebelius, Chief Justice John Roberts upheld the statute’s individual mandate while striking down its Medicaid expansion provisions.[3]
In the intellectual property arena, Congress enacted the Leahy-Smith America Invents Act[4] in September 2011, providing a complete overhaul of the U.S. patent system. The next year, high-stakes patent trials resulted in three eye-popping verdicts, each exceeding $1 billion.[5] By the end of the 2012 Term, the United States Supreme Court has reviewed an unusually large number of patent cases.[6] As Timothy Holbrook reminded us:
Starting in around 2000, the Supreme Court became active, if not even hyperactive, in patent law. . . . Additionally, the Supreme Court’s intervention is no longer on the periphery of patent law. The cases they have decided go right to the substance of patent law: the doctrine of equivalents and prosecution history estoppel, subject matter eligibility, induced infringement, the statutory experimental use defense, to name but a few.[7]
Of great interest in the 2012 Term was Association for Molecular Pathology v. Myriad Genetics, Inc.[8] Lying at the intersection of intellectual property and public health, this case concerned the patentability of composition and method claims covering two isolated human genes associated with breast and ovarian cancers as well as their alterations and mutations. In a surprisingly short decision, Justice Clarence Thomas held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [synthetically created DNA segment known as complementary DNA] is patent eligible because it is not naturally occurring.”[9] He further noted that the case did not involve patent claims in “an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes,” “patents on new applications of knowledge about the BRCA1 and BRCA2 genes,” and “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”[10] Although it is too early to assess the full implications of this narrowly written decision, it is not hard to appreciate the decision’s potential impact on U.S. biotechnology and life science industries. Myriad Genetics will also raise important questions about the appropriate level of patent protection in relation to the development of biologics[11] and diagnostic kits.[12]
At the international level, there has been a decade-long, but still vibrant, debate about the major impediments the Agreement on Trade-Related Aspects of Intellectual Property Rights[13] (“TRIPS Agreement”) has generated to access to essential medicines in less developed countries—a term used collectively to cover both developed and least developed countries as identified within the World Trade Organization (“WTO”).[14] Since the TRIPS Agreement entered into force in January 1995, it not only has taken away the wide policy space less developed countries once enjoyed at the international level,[15] but it has also resulted in needless deaths and suffering to patients that have acquired either the human immunodeficiency virus (“HIV”) or the Acquired Immune Deficiency Syndrome (“AIDS”).[16] The pandemic caused by HIV/AIDS, malaria, and tuberculosis has also greatly reduced the productivity of many countries in sub-Saharan Africa.[17]
In December 2013, WTO member states met in the Ninth Ministerial Conference in Bali, with the hope of reviving the Doha Development Round of Trade Negotiations (“Doha Round”).[18] This ministerial conference was held a few months after WTO members agreed at the Council for Trade-Related Aspects of Intellectual Property Rights (“TRIPS Council”) to extend the transition period for least developed countries.[19] Article 66 of the TRIPS Agreement initially set the period at ten years.[20] In November 2005, shortly before the Sixth Ministerial Conference in Hong Kong, WTO members agreed to extend the period for seven-and-a-half years until July 1, 2013, as long as the extension-seeking country has not yet met the TRIPS requirements or has not already offered protection in excess of those requirements.[21] Building on Haiti’s formal request for another extension on behalf of the Least Developed Countries Group,[22] the June 2013 TRIPS Council decision further extended the transition period for eight years until July 1, 2021 without the earlier “non-rollback” commitment.[23]
Notwithstanding this recent extension for least developed countries, there remains another deadline that is highly important to the global access to medicines debate. This deadline concerns the ratification of the protocol to amend the TRIPS Agreement, which WTO member states adopted also shortly before the Hong Kong Ministerial.[24] If ratified by two-thirds of the WTO membership, the new Article 31bis would allow countries with insufficient or no manufacturing capacity to import generic versions of patented pharmaceuticals. Although the initial deadline for ratification was December 1, 2007, that deadline has since been extended four times to December 31, 2015. As of this writing, slightly less than a third of the 159 WTO member states have ratified the proposed amendment.[25] If the amendment fails to attain the requisite ratifications by the new deadline, this deadline will have to be extended again.[26]
Sadly, with all the interrelated developments in the intellectual property and public health arenas both within and outside the United States, the domestic debate remains surprisingly disconnected from the international debate. Because of this disconnect, the laws and policies Congress and the administration adopt often do not synchronize with developments abroad. To help bridge this disconnect, this Article discusses the interrelationship between intellectual property and public health in the context of communicable diseases. This type of disease is intentionally picked to highlight how developments abroad could easily affect what happens at home, and vice versa.
Parts I to III of this Article recount three distinct “virostories”—stories about viruses responsible for AIDS, the Severe Acute Respiratory Syndrome (“SARS”),[27] and the avian influenza.[28] Part I discusses the ongoing developments within the WTO concerning efforts to address the access-to-medicines problems in relation to HIV/AIDS and other pandemics. Part II documents the unusual race among research and health institutions in Canada, Hong Kong, and the United States to patent technologies involving the isolated gene sequences of the SARS coronavirus. This Part also explores the use of patenting as a defensive measure and the development of patent pools as a solution to prevent the creation of a patent thicket. Part III examines the recent efforts by Indonesia, India, and other members of the Non-Aligned Movement to claim sovereignty over viruses found within their jurisdictions. This Part focuses on the H5N1 strain of the avian influenza virus in Indonesia.
To help illustrate the need to take a global, holistic, multidisciplinary socio-legal approach, which will be the focus of the second half of this Article, Parts I to III embrace the narrative technique. Such a technique enables the stories to be told in a way that would be meaningful to those participating in both the intellectual property and public health debates. The thick descriptions the article provides also highlight related issues on cross- border trade, global governance, human development, North-South relations, international sovereignty, human rights protection, and medical and biological ethics. With a wide range of characters, openings, plot twists, and endings, these virostories provide insight into the different facets of the international patent debate. By bringing together HIV/AIDS, SARS, and H5N1, this Article will further remind policymakers that the discussion on the TRIPS Agreement should not focus so much on the HIV/AIDS crisis in the less developed world to the point that they ignore other similar problems created by an out-of-balance intellectual property system.[29]
Part IV draws seven important lessons from the three earlier narratives to advance a new, integrated approach to setting international intellectual property norms. This new approach takes account of both the existing problems concerning the TRIPS Agreement and the new problems precipitated by the negotiation of the Anti-Counterfeiting Trade Agreement (“ACTA”),[30] the Trans-Pacific Partnership (“TPP”) Agreement,[31] and other nonmultilateral trade and investment agreements.[32] Tying domestic laws and policies to the international debate, this Part focuses on three sets of issues that often come up in the international intellectual property norm- setting process: negotiation gains, the negotiation process, and negotiated outcomes.
By bringing together both the descriptive and the prescriptive, this Article seeks to drive home the message that the international intellectual property and public health debates could easily spill over into the domestic debates, and vice versa. Just as viruses do not recognize national boundaries[33]—as health professionals have repeatedly warned us— policymakers and commentators should also think more holistically and globally about the connections between the domestic and international debates and between developments in the intellectual property and public health arenas. After all, there are non-altruistic reasons for developed countries to promote access to essential medicines in the less developed world.
Featured here is the Introduction of a paper by Peter K. Yu, IP Osgoode Research Affiliate, Kern Family Chair in Intellectual Property Law and Founding Director of the Intellectual Property Law Center at Drake University Law School. Born and raised in Hong Kong, Professor Yu is a leading expert in international intellectual property and communications law. He also writes and lectures extensively on international trade, international and comparative law, and the transition of the legal systems in China and Hong Kong. The full article was published in 45 Ariz.St. L. J. 1564 (2013) and can also be found here.
[1] Pub. L. No. 111-148, 124 Stat. 119 (2010).
[2] Pub. L. No. 111-152, 124 Stat. 1029 (2010).
[3] Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, 2608 (2012).
[4] Pub. L. No. 112-29, 125 Stat. 284 (2011).
[5] See Amanda Bronstad, IP Awards Dominate, NAT’L L.J., Mar. 4, 2013, http://www.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1202590587509&slreturn=20131006195123 (reporting the verdicts from the lawsuit Carnegie Mellon University filed against Marvell Technology, the lawsuit Apple filed against Samsung Electronics, and the lawsuit Monsanto filed against DuPont).
[6] For a discussion of the Court’s growing interest, see generally Timothy R. Holbrook, Explaining the Supreme Court’s Interest in Patent Law, 3 IP THEORY 62 (2013).
[7] Id. at 63–64 (footnotes omitted). 8. 133 S. Ct. 2107 (2013).
[8] 133 S. Ct. 2107 (2013).
[9] Id. at 2111.
[10] Id. at 2119–20.
[11] For discussions of intellectual property issues in relation to biologics, see generally Donna M. Gitter, Innovators and Imitators: An Analysis of Proposed Legislation Implementing an Abbreviated Approval Pathway for Follow-on Biologics in the United States, 35 FLA. ST. U. L. REV. 555 (2008); Christopher M. Holman, Maintaining Incentives for Healthcare Innovation: A Response to the FTC’s Report on Follow-on Biologics, 11 MINN. J.L. SCI. & TECH. 755 (2010); Gregory N. Mandel, The Generic Biologics Debate: Industry’s Unintended Admission that Biotech Patents Fail Enablement, 11 VA. J.L. & TECH. 8 (2006); Symposium, Follow-on Biologics: Implementation Challenges and Opportunities, 41 SETON HALL L. REV. 501 (2011).
[12] See, e.g., EDSON BEAS RODRIGUES JR., THE GENERAL EXCEPTION CLAUSES OF THE TRIPS AGREEMENT: PROMOTING SUSTAINABLE DEVELOPMENT 168–69 (2012) (discussing the impact of gene patents on the development of diagnostic kits); Rochelle C. Dreyfuss & James P. Evans, From Bilski Back to Benson: Preemption, Inventing Around, and the Case of Genetic Diagnostics, 63 STAN. L. REV. 1349, 1361–70 (2011) (providing a case study of patent-related issues arising in genetic diagnostics).
[13] Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh AgreementEstablishing the World Trade Organization, Annex 1C, 108 Stat. 4809, 869 U.N.T.S. 299 [hereinafter TRIPS Agreement].
[14] See Peter K. Yu, The International Enclosure Movement, 82 IND. L.J. 827, 858–62 (2007) (discussing these deleterious impacts). For book-length discussions of access-to- medicines problems in relation to the TRIPS Agreement, see generally SUDIP CHAUDHURI, THE WTO AND INDIA’S PHARMACEUTICALS INDUSTRY: PATENT PROTECTION, TRIPS, AND DEVELOPING COUNTRIES (2005); HOLGER HESTERMEYER, HUMAN RIGHTS AND THE WTO: THE CASE OF PATENTS AND ACCESS TO MEDICINES (2008); CYNTHIA M. HO, ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS (2011); INTELLECTUAL PROPERTY, PHARMACEUTICALS, AND PUBLIC HEALTH: ACCESS TO DRUGS IN DEVELOPING COUNTRIES (Kenneth C. Shadlen et al. eds., 2012); VALBONA MUZAKA, THE POLITICS OF INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO MEDICINES (2011); NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES (Pedro Roffe et al. eds., 2006) [hereinafter NEGOTIATING HEALTH].
[15] See generally Yu, The International Enclosure Movement, supra note 14, at 855–72 (discussing the growing enclosure of the policy space of less developed countries at the international level).
[16] For discussions of access-to-medicines problems in relation to HIV/AIDS, see generally THE GLOBAL GOVERNANCE OF HIV/AIDS: INTELLECTUAL PROPERTY AND ACCESS TO ESSENTIAL MEDICINES (Obijiofor Aginam, John Harrington & Peter K. Yu eds., 2013) [hereinafter GLOBAL GOVERNANCE OF HIV/AIDS]; THE POLITICAL ECONOMY OF HIV/AIDS IN DEVELOPING COUNTRIES: TRIPS, PUBLIC HEALTH SYSTEMS AND FREE ACCESS (Benjamin Coriat ed., 2008) [hereinafter POLITICAL ECONOMY OF HIV/AIDS].
[17] See FRANKLYN LISK, GLOBAL INSTITUTIONS AND THE HIV/AIDS EPIDEMIC: RESPONDING TO AN INTERNATIONAL CRISIS 82–92 (2009) (discussing the impact of HIV/AIDS on human resource capacity); Wolfgang Hein et al., Introduction: Globalization, HIV/AIDS and the Rise of Global Health Governance, in GLOBAL HEALTH GOVERNANCE AND THE FIGHT AGAINST HIV/AIDS 1, 7 (Wolfgang Hein et al., eds., 2007) [hereinafter FIGHT AGAINST HIV/AIDS] (“HIV/AIDS and infectious diseases strike hardest at the productive parts of the population, at the pool of experienced individuals that would qualify for leading positions in society, leading to economic decline.”); Colin McInnes, National Security and Global Health Governance, in GLOBAL HEALTH GOVERNANCE: CRISIS, INSTITUTIONS AND POLITICAL ECONOMY 42, 48 (Adrian Kay & Owain David Williams eds., 2009) [hereinafter GLOBAL HEALTH GOVERNANCE] (noting the “disproportionate impact [of HIV/AIDS] upon workers in what should be the most productive period of their lives”); Geoff Tansey, Introduction: Legal Fictions and Public Health, in NEGOTIATING HEALTH, supra note 14, at 1, 2 (noting that, in rural Africa, “HIV/AIDS is devastating farming families and undermining their ability to farm”); Srividhya Ragavan, The Jekyll and Hyde Story of International Trade: The Supreme Court in PhRMA v. Walsh and the TRIPS Agreement, 38 U. RICH. L. REV. 777, 821 (2004) [hereinafter Ragavan, Jekyll and Hyde] (“An epidemic increase of AIDS reduced life expectancy and affected labor and economic output, as the younger casualties increase. Consequently, national productivity declined in several developing nations since the loss of labor from the loss of each life affected a proportionate value of output.” (footnotes omitted)); Yu, The International Enclosure Movement, supra note 14, at 855 (“At the macro level, health problems could also lower the productivity of a country—to the point that it will fall behind its trading partners in terms of economic development, technological innovation, industrial progress, and national competitiveness.”).
[18] Press Release, World Trade Org. [WTO], Bali Ministerial to Be Held 3–6 December 2013 (Dec. 11, 2012), http://www.wto.org/english/news_e/news12_e/gc_11dec12_e.htm.
[19] Press Release, WTO, The Least Developed Get Eight Years More Leeway on Protecting Intellectual Property (June 11, 2013), http://www.wto.org/english/news_e/ news13_e/trip_11jun13_e.htm.
[20] TRIPS Agreement art. 66.
[21] Press Release, WTO, Poorest Countries Given More Time to Apply Intellectual Property Rules (Nov. 29, 2005), http://www.wto.org/english/news_e/pres05_e/pr424_e.htm.
[22] Communication from Haiti on Behalf of the LDC Group, Request for an Extension of the Transitional Period Under Article 66.1 of the TRIPS Agreement, IP/C/W/583 (Nov. 5, 2012). Haiti initially proposed to extend the transition period “for as long as the WTO Member remains a least developed country.” That proposal, though eventually failed, earned the support of the Joint United Nations Programme on HIV/AIDS (UNAIDS), the United Nations Development Programme (UNDP), and more than 300 civil society organizations. See UNAIDS & UNDP, TRIPS Transition Period Extensions for Least-developed Countries 6 (UNAIDS, Issue Brief, 2013), http://www.unaids.org/en/media/unaids/contentassets/documents/ unaidspublication/2013/JC2474_TRIPS-transition-period-extensions_en.pdf [hereinafter UNAIDS/UNDP Issue Brief] (calling on the WTO members to give “close and immediate attention” to the extension request from least developed countries); Catherine Saez, WTO: LDCs to Press for Extension for TRIPS, Plain Packaging Back, INTELL. PROP. WATCH (Feb. 26, 2013, 2:15 PM), http://www.ip-watch.org/2013/02/26/wto-ldcs-to-press-for-extension-for-trips-plain- packaging-back (reporting the support least developed countries received from UNAIDS, UNDP, and civil society organizations).
[23] Council for Trade-Related Aspects of Intellectual Property [TRIPS Council], Extension of the Transition Period Under Article 66.1 for Least Developed Country Members: Decision of the Council for TRIPS of 11 June 2013, IP/C/64 (June 11, 2013). For discussions of this extension, see generally Frederick M. Abbott, Technical Note: The LDC TRIPS Transition Extension and the Question of Rollback (ICTSD Programme on Innovation, Technology and Intellectual Property, Policy Brief No. 15, 2013), available at http://ictsd.org/ downloads/2013/05/the-ldc-trips-transition-extension-and-the-question-of-rollback.pdf; Arno Hold & Bryan Christopher Mercurio, After the Second Extension of the Transition Period for LDCs: How Can the WTO Gradually Integrate the Poorest Countries into TRIPS? (NCCR Trade Regulation, World Trade Institute, University of Bern, Working Paper No. 2013/42, 2013), available at http://ssrn.com/abstract=2302335.
[24] General Council, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 8, 2005) [hereinafter TRIPS Amendment], available at http://www.wto.org/english/ tratop_e/trips_e/wtl641_e.htm; see also Yu, The International Enclosure Movement, supra note 14, at 872–86 (tracing the development of Article 31bis of the TRIPS Agreement).
[25] Members Accepting Amendment of the TRIPS Agreement, WTO, http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm (last updated Oct. 21, 2013) [hereinafter Members Accepting Amendment].
[26] See General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, ¶ 11, WT/L/540 (Sept. 1, 2003), 43 I.L.M. 509 (2004) [hereinafter August 30 Decision] (stating that the waivers granted in this decision “shall terminate for each Member on the date on which an amendment to the TRIPS Agreement replacing its provisions takes effect for that Member”).
[27] For discussions of SARS, see generally THOMAS ABRAHAM, TWENTY-FIRST CENTURY PLAGUE: THE STORY OF SARS (2007); TIM BROOKES, BEHIND THE MASK: HOW THE WORLD SURVIVED SARS, THE FIRST EPIDEMIC OF THE 21ST CENTURY (2004); DAVID P. FIDLER, SARS, GOVERNANCE AND THE GLOBALIZATION OF DISEASE (2004); KARL TARO GREENFELD, CHINA SYNDROME: THE TRUE STORY OF THE 21ST CENTURY’S FIRST GREAT EPIDEMIC (2006); WORLD HEALTH ORG. [WHO], SARS: HOW A GLOBAL EPIDEMIC WAS STOPPED (2006) [hereinafter HOW A GLOBAL EPIDEMIC WAS STOPPED].
[28] See generally AVIAN INFLUENZA: SCIENCE, POLICY AND POLITICS (Ian Scoones ed., 2010) [hereinafter AVIAN INFLUENZA] (discussing avian influenza).
[29] As the U.K. Commission on Intellectual Property Rights reminded us:
It is particularly important not to allow the debate in [the intellectual property] area to be influenced unduly by the HIV/AIDS experience, dramatic though it is. Apart from HIV/AIDS, which is the biggest single cause of mortality in developing countries, TB and malaria claim almost as many lives. Together all three diseases claimed nearly six million lives [in 2001], and led to debilitating illness for millions more. In addition, there are a number of less common diseases which are collectively important. These include, for instance, measles, sleeping sickness, leishmaniasis and Chagas disease.
COMM’N ON INTELLECTUAL PROP. RIGHTS, INTEGRATING INTELLECTUAL PROPERTY RIGHTS AND
DEVELOPMENT POLICY: REPORT OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS 30
(2002) [hereinafter IPR COMMISSION REPORT] (footnote omitted).
[30] Anti-Counterfeiting Trade Agreement, opened for signature May 1, 2011, 50 I.L.M. 243 (2011) [hereinafter ACTA].
[31] See Trans-Pacific Partnership, OFFICE OF THE U.S. TRADE REP., http://www.ustr.gov/tpp (last visited Nov. 7, 2013) (providing up-to-date information about the TPP).
[32] See, e.g., Central America–Dominican Republic–United States Free Trade Agreement, May 28, 2004 [hereinafter CAFTA-DR], available at http://www.ustr.gov/trade- agreements/free-trade-agreements/cafta-dr-dominican-republic-central-america-fta/final-text; United States–Australia Free Trade Agreement, U.S.-Austl., May 18, 2004 [hereinafter AUSFTA], available at http://www.ustr.gov/trade-agreements/free-trade-agreements/australian- fta/final-text; United States–Singapore Free Trade Agreement, U.S.-Sing., May 6, 2003 [hereinafter SUSFTA], available at http://www.ustr.gov/sites/default/files/ uploads/agreements/fta/singapore/asset_upload_file708_4036.pdf. For discussions of bilateral, plurilateral, and regional trade agreements, see sources cited in Peter K. Yu, Intellectual Property and Human Rights in the Nonmultilateral Era, 64 FLA. L. REV. 1045, 1046 n.1 (2012). For a discussion of intellectual property provisions in international investment agreements, see generally Bryan Mercurio, Awakening the Sleeping Giant: Intellectual Property Rights in International Investment Agreements, 15 J. INT’L ECON. L. 871 (2012).
[33] As Colin McInnes observed:
Health threats, the provision of health care services and the market for pharmaceuticals are increasingly transborder in nature. In terms of health security, this makes defence ‘at the border’ a near impossibility despite efforts by states to do just that. The state can no longer function as a self- contained vessel for health provision (and indeed health security), rather it has become permeable. This is most obliviously the case with infectious disease where the processes of globalization have enabled disease to spread more quickly.
McInnes, supra note 17, at 44 (citation omitted); accord FIDLER, supra note 27, at 13–16 (discussing the “germs do not recognize borders” mantra of public health); MARK W. ZACHER & TANIA J. KEEFE, THE POLITICS OF GLOBAL HEALTH GOVERNANCE: UNITED BY CONTAGION 1 (2008) (“[T]he world is becoming an ever smaller place, and microbes that cause devastating diseases do not stop for border guards.”).