A MATHEMATICAL SOLUTION TO THE SINE OF MADNESS THAT IS PHARMACEUTICAL COMPULSORY LICENSING UNDER THE TRIPS AGREEMENT AND THE DOHA DECLARATION.

• Author: Sperbeck, Ashley E.

INTRODUCTION I. INTERNATIONAL COMPULSORY LICENSING--AMBIGUITIES AND DEFICIENCIES A. The TRIPS Agreement 1. Enactment of the TRIPS Agreement 2. Chasms in the TRIPS Framework 3. Historical Basis for Compulsory Licensing 4. Article 31 B. The Doha Declaration 1. Paragraph 5 2. Paragraph 6 and the "Paragraph 6 Problem" 3. Proposed Solutions to the "Paragraph 6 Problem" C. Amendment to the TRIPS Agreement--Article 31bis II. PROPOSED SOLUTION A. Step One: Initial Inquiries into the Surrounding Circumstances 1. First Inquiry: Analysis of Emergency Situation 2. Second Inquiry: Developed Status of the State 3. Third Inquiry: Type of Pharmaceutical Sought 4. Fourth Inquiry: Ability to Produce Pharmaceuticals In-House B. Step Two: Mathematical Solution 1. Example Analyses (a) Tier One State (b) Tier Three State CONCLUSION APPENDIX Table 2. List OF Emergency Situations, Circumstances of Extreme Urgency, or Public Health Crises INTRODUCTION

States defined by their severe impediments to sustainable development are designated as "least developed countries" ("LDC") by the United Nations ("UN") (1) because they exhibit the lowest indicators of socio-economic development. (2) Socio-economic development is measured by a low-income criterion, (3) a human assets index ("HAI"), (4) and an economic vulnerability index ("EVI"). (5) Some of these States include Zambia, Liberia, Madagascar, Nepal, and the Republic of Tanzania. Based on these socio-economic factors, the LDCs are often powerless to provide medical assistance to their ailing citizens. (6) International patent agreements, which generally support private enterprises, coupled with a lack of manufacturing capabilities to produce pharmaceuticals within the LDC itself further exacerbates this problem. (7) As such, it is not surprising that more than half of all deaths in low-income countries in 2016 were caused by preventable and treatable conditions, such as communicable diseases, maternal causes, and nutritional deficiencies. (8)

While the estimated number of individuals between the ages of zero and forty-nine suffering from HIV/AIDS in the world was 33.2 million by the end of 2007, approximately one-third of those individuals are estimated to live in LDCs. (9) Furthermore, even though LDCs comprise approximately 80% of the world's population, these States represent approximately 20% of global pharmaceutical consumption. (10) Access to affordable medications could grossly reduce the proportion of the LDC populations hit hardest by these preventable and treatable conditions. (11)

A beautiful contradiction surrounds accessibility of these medications: the innovative vehicle used to create these pharmaceuticals is the very means that limits access to them. That is, promotion of innovation occurs by allowing a once-patented technology to enter the public domain and be openly used (12) but at the cost of granting a patent owner a limited duration monopoly (13) to exclude others from, "making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States" for a set time period. (14) When this rationale is expanded to the international level, humanitarian issues emerge.

In an attempt to remedy the humanitarian concerns posed by patent enforcement in the international sphere, the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS Agreement") was negotiated and established in 1995 as the "most comprehensive multilateral agreement on intellectual property" to date. (15) The TRIPS Agreement specifies a minimum set of substantive standards for procedural regulation of intellectual property between World Trade Organization ("WTO") Member States, (16) which allows for protection of inventions in all technological fields upon a finding that the inventions meet the minimal criteria for patentability. (17)

As a means to alleviate the suffering of those Members facing a public health crisis, compulsory licensing language was codified in Article 31 of the TRIPS Agreement. (18) Compulsory licensing enables WTO Members to use a patented technology by third parties without authorization from the patent holder, (19) thus decreasing the LDC's pharmaceutical drought by increasing its pharmaceutical accessibility. (20) However, Article 31(f) of the TRIPS Agreement restricts the availability of export drugs made under compulsory licenses causing problems for LDCs that lack domestic manufacturing capabilities but desire to import generic copies of pharmaceuticals manufactured in another country. (21)

While these public health concerns were placed on the agenda for the WTO's Third Ministerial Conference held in Seattle, Washington, in 1999, (22) partial resolution of these health issues did not occur until the WTO's Fourth Ministerial Conference held on November 14, 2001, in Doha, Qatar. (23) During the WTO's Fourth Ministerial Conference, WTO Members adopted a Declaration on TRIPS and Public Health ("Doha Declaration"), (24) seen by many, including James Love of the Consumer Project on Technology, as "the strongest and most important international statement yet on the need to refashion national patent laws to protect public health interests." (25) Recognizing the gravity of the public health issues plaguing the international sphere, (26) the Doha Declaration clarified some textual ambiguities of the TRIPS Agreement and affirmed both the inherent flexibility of the TRIPS Agreement and the right of Member States to take precautionary measures to protect public health. (27)

Despite these strides, the Doha Declaration did not adequately respond to the "Article 31(f) Problem" because it failed to provide a viable solution that would increase the availability of compulsory licensing for LDCs suffering from a public health crisis that lacked the ability to manufacture pharmaceuticals in-house. (28) As an attempt to address this issue, on December 6, 2005, an Amendment to the TRIPS Agreement, which introduced Article 31bis, was proposed. (29) It was not until January 23, 2017, that the Amendment was ratified by the two-thirds threshold of WTO Members needed to achieve formal approval. (30)

Introduction of Article 31bis (31) into the TRIPS Agreement made permanent the waiver that had been in force since 2003 to empower LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to seek generic pharmaceuticals from other countries under a compulsory licensing agreement. (32) However, a fog surrounded these concessions with regards to the remuneration costs bore by the LDC to the State exporting the generic pharmaceutical under a compulsory license. (33)

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete solution will drastically improve access to pharmaceuticals for the LDC's in dire need of them.

1. INTERNATIONAL COMPULSORY LICENSING--AMBIGUITIES AND DEFICIENCIES

   1. The TRIPS Agreement

      1. Enactment of the TRIPS Agreement

         On January 1, 1995, not only did the WTO commence as the largest international economic organization in the world (34) under the Marrakesh Agreement, (35) but the TRIPS Agreement was established with the aim of, "protecting] and enforce[ing] [] intellectual property rights[,] [while] [] promot[ing] [] technological innovation and [] the transfer and dissemination of technology." (36) Derived from existing intellectual property conventions, such as the Berne Convention for the Protection of Literary and Artistic Works adopted in 1886, (37) the TRIPS Agreement provides a similar framework to that guiding the U.S. patent law system. (38) For example, the TRIPS Agreement provides the patent owner a right to exclude other "parties not having the owner's consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product" (39) for a term of twenty years from the filing date of the patent application. (40) However, despite these substantive intellectual property protections, LDCs objected to the TRIPS Agreement for fear of more stringent pharmaceutical patent protection and the associated price increases of these pharmaceuticals. (41)

      2. Chasms in the TRIPS Framework

         WTO Member States have exposed chasms in the foundation of the TRIPS Agreement. These chasms include a lack of absoluteness associated with international patent rights, as well as patent right exemptions. (42) The TRIPS Agreement patent right exemptions include (1) a research exemption, which, despite any patent protection, allows research and testing in preparation for regulatory approval (e.g., Food and Drug Administration regulatory approval in the U.S.) prior to the expiration of the patent term; (43) (2) a compulsory licensing exemption; (44) (3) an anti-competitive exemption; (45) (4) an exhaustion of intellectual property rights exemption; (46) and (5) a public health exemption. (47)

      3. Historical Basis for Compulsory Licensing

         Arising in the nineteenth century, (48) compulsory licensing has been historically utilized, "[(1)] to deal with a situation in which a patent owner is unwilling to work his invention; [(2)] to satisfy an unmet demand from the public for a patented product; [and (3)] to introduce price-reducing competition for important but expensive products [(e.g...