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24 Gonz. J. Int'l L. 1 (2020-2021)

handle is hein.journals/gjil24 and id is 1 raw text is: TRIP-ING UP: THE FAILURE OF TRIPS ARTICLE 31BIS Nicholas G. Vincent, Ph.D.* I. IN TR O D U CTIO N ........................................................................................ 3 II.THE TRIPS AGREEMENT AND THE LEAD-UP TO ARTICLE 31BIS ............... 4 a. The TRIPS Agreement: General Provisions and Scope ......... 4 b. Part II, Section 5 of the TRIPS Agreement: Patents............... 7 c. The Unraveling of A rticle 31.................................................. 9 d. A Proposed Solution: Paragraph 6 of the Doha Declaration.... 11 III. A R TICLE 3 1BIS ..................................................................................... 13 a. Article 31bis: Structure and Contents................................... 13 b. The Annex and Appendix to Article 31bis............................ 16 c. Article 31bis in Practice: the Rwanda-Canada Case Study...... 19 IV. CRACKS IN THE FRAMEWORK: THE SHORTCOMINGS AND FAILINGS OF ARTICLE 31BIS .................................................................................. 21 a. The Administrative and Social Burdens of Article 3ibis......... 22 b. Pharmaceutical Challenges of Article 31bis.......................... 23 c. A rticle 31bis C onflicts........................................................... 27 d. Competing Views: Article 31bis as a Small Piece to a Larger P u zzle ................................................................................... . . 3 0 V.POTENTIAL SOLUTIONS AND ROADBLOCKS TO THE ARTICLE 3iBIS P R O B L EM ........................................................................................ 3 2 a. Regional Agreements and Economies of Scale..................... 33 b. Encouraging Infrastructure Development ............................ 33 c. Preventing Drug Sharing and Promoting Drug Compliance .... 35 d. D ata E xclusivity ................................................................... 36 VI. LESSONS AND CONCLUSIONS .............................................................. 37 * J.D., New York University School of Law, 2020; Ph.D. (Microbiology), Yale University 2017. I would like to thank Professor Rochelle C. Dreyfuss for her guidance on this research and for her helpful comments on the draft. I would also like to thank the members of the Spring 2019 International Intellectual Property class at New York University School of Law for providing constructive feedback on this project. Finally, I would like to thank Nicole Carloni, MPH for her helpful discussions on preventing drug sharing in the context of HITV/AIDS, and Christopher Guzman, PhD for helpful comments on addressing biologics-specific concerns of Article 31bis. 1

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