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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.


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