Managing the Hydra: Dimensions of Intellectual Property and Access to Medicines

1. Managing the Hydra: Dimensions of Intellectual Property and Access to Medicines Pipeline Patents as an obstacle to access to AIDS treatment in Brazil Marcela Vieira Francisco Viegas Neves da Silva Renata Reis Veriano Terto Jr. Maria Cristina Pimenta

2. Pipeline patents • 1996 – Brazil changed its IP law to become TRIPS compliant • Before1996 – Brazil did not grant patents for pharmaceutical products • TRIPS-plus provision: pipeline patents

3. Pipeline patents • allowed patent applications for technological fields that Brazil did not recognize during the previous legislation (medication and foods) • The Brazilian patent office only “revalidated” patents granted in other countries. They were not submitted to the technical examination of the patentability requirements in Brazil • pipeline provision resulted in monopolies being granted for inventions that were already in the public domain

4. Pipeline patents • 1182 patentsfiled - 745 medicines - 5 ARVs (efavirenz, lopinavir/ritonavir, abacavir, nelfinavir, amprenavir) • Pipeline patents had a negative impact on local production and in the sustainability of universal access to treatment

5. Impact on access to treatment • Brazil is one of the few countries in the world to provide universal and free access to ARV therapy • (190.000 people on ART in 2008) • Universal access was based on the local production of ARV at prices much lower than those practiced in international market by the patent holders

6. Impact on access to treatment • pipeline patents anticipated the negative impact of patent protection on prices • Without pipeline patents Brazil could have produced other ARVs that were unnecessarily protected • Universal access is under threat due to price increase

7. Impact on access to treatment • An economic study coordinated by Dr. LiaHasenclever (UFRJ) estimated the damage caused by the adoption of the pipeline mechanism in Brazil • Brazil spent between US$420 million and US$ 519 million more in the purchase of 5 ARV between 2001 and 2007 • That is about 6 times more than Brazil spent in R&D in 2003

8. Estimated losses Comparison with WHO prices – US$ 420 million

9. Estimated losses Comparison with MSF prices – US$ 519 million

10. Estimated losses • Considering that approximately 1.200 patents have been granted by the pipeline mechanism and that their protection periods are much longer than the 7-year period analyzed in the study, it is nearly impossible to calculate the exact amount of the government’s financial losses. • The authors of the study estimated this amount to be in the billions of US dollars.

11. Comparative prices – high cost medicines

12. Comparative prices – high cost medicines

13. WorkingGrouponIntellectualProperty (GTPI) • ABIA (coordination), HIV/Aids organization and fora from different regions of Brazil, local consumer’s rights NGO (Idec), human rights NGO (Conectas), National Federation of Pharmacists (FENAFAR), MSF, researchers and experts • Aims to monitor and try to minimize the negative impact of patent system on access to medicines in Brazil

14. GTPI’s iniciatives • 2007: GTPI petition to the General Attorney challenging the constitucionality of the pipeline provision • 2009: the General Attorney presented a Direct Action of Unconstitucionality before the Supreme Court • Amicus curiae briefs: - 5 in favor of unconstitucionality • 3 against the unconstitucionality

15. GTPI’s iniciatives www.patentes.org.br

16. LESSONS LEARNED • NGOs role: - denouncing negative impact - proposing measures to overcome obstacles • Social mobilization and community participation are important strategies to achieve fairer medicine legislations

17. CONCLUSION • It is urgent that the Supreme Court judges immediately the case!! • That would return to the public domain about 475 medicines that could be freely imported or locally produced

18. THANK YOU! • marcela@conectas.org • www.patentes.org.br