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Analysis of Pharmaceutical Patents & Health Registration of ARV Drugs in Brazil

This study explores the implications of pharmaceutical patents and sanitary registrations of ARV drugs in Brazil on access to health. It involves an in-depth analysis of the patent status and sanitary registration of various ARV drugs, aiming to identify potential barriers to generic competition. The methodology includes a detailed patent search and examination of the sanitary registration status of selected drugs. The results reveal the presence of numerous patents covering ARV medications, as well as insights into the distribution of patents and sanitary registrations among different drugs. Policy recommendations emphasize the need for integrating development policies of the pharmaceutical-chemical industry and advocating for improved examination processes and opposition mechanisms. Overall, the research sheds light on key challenges and opportunities in the pharmaceutical sector in Brazil.

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Analysis of Pharmaceutical Patents & Health Registration of ARV Drugs in Brazil

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  1. Panorama of the pharmaceutical patenting and sanitary registration of ARVs drugs in Brazil: implications to access and to health industrial complex Pedro Villardi Session:The Future of Affordable ART: Trends in Patents and Price WDC - July 2012

  2. Brazilian Interdisciplinary AIDS Association - ABIA • Created in 1986 – 25-year old NGO • Objectives • Mobilize civil society • Monitor public policies in HIV and Health, education, prevention, sexuality and human rights

  3. Working Group on Intellectual Property - GTPI • Created in 2003 • Collective made of NGOs, unions, researchers and social movements. ABIA is its secretariat. Mission: monitor and mitigate the impacts of the IP system on public health policies and on access to medicines in Brazil and others developing countries

  4. Support

  5. Agenda • Introduction • Justification • Objective • Methodology • Patents search • Sanitary registration search • Results • Discussion • Policy Recommendations

  6. Agenda • Introduction • Justification • Objective • Methodology • Patents search • Sanitary registration search • Results • Discussion • Policy Recommendations

  7. Justification • No public database with compilation ARVs registered in Brazil. • Difficulty in finding patents and patents application from the INN • Several patents covering one medicine

  8. Objectives • To develop a search methodology for patents and patents applications in Brazil • To build a panorama of the ARVs patents status • To find the sanitary registration status of the selected ARVs • Also build a panorama of the sanitary registration • To analyze whether the patent applications impede the entrance of generic competitors • To develop policy recommendations from the data found

  9. Agenda • Introduction • Justification • Objective • Methodology • Patents search • Sanitary registration search • Results • Discussion • Policy Recommendations

  10. Methodology • Building the ARVs list • Interview with specialists • Juan Carlos Raxach • Eloan Pinheiro • Brazilian National Therapeutic Guidelines • OMS treatment guidelines

  11. Methodology I – Patent Search • Search was strictly conducted in public databases • Search methodology was designed to applied in Brazil • Can be adapted to other countries without Linkage

  12. Methodology I – Patent Search (2) • Starting at the Orange Book website • Search by INN • Collect all the American patents granted for each ARV • Limitations • Process patents not listed • Only granted patents listed • Two ways developed to search the Brazilian patents • By the American patent number • By the Priority number

  13. By the American patent number • Find in esp@cenet, trough the “Number search”, the INPADOC patent family and • Look for the Brazilian application • Go to the Brazilian patent office (INPI) website and find the number, through simple search

  14. By the priority number • To find the original patent document in USPTO • To survey the priority numbers of the American patents (Foreing Application Data ou Appl. No.) • To search onthe INPI “Advanced Search”

  15. Patent Search Summary INPADOCFamily INPADOCFamily esp@cenet BRXXXXXXX American Patent INPI search Orange Book American Patent PIXXXXXXX-X Priority Number INPI website – Advanced Search

  16. Other sources • I-mak report • Combinations • Patent pool database • To check the results found

  17. Methodology – Sanitary Registration Search • ANVISA search database • Only granted and not granted applications published

  18. Agenda • Introduction • Justification • Objective • Methodology • Patents search • Sanitary registration search • Results • Discussion • Policy Recommendations

  19. Results • 98 patents for 30 drugs • 8 combinations with 21 patents or patent applications • 22 drugs with 77 patents or patent applications • Distribution by status

  20. Results – Each medicine patentary status

  21. Results – Protection expansion

  22. Results II – sanitary registration • 11 drugs with more than one sanitary registration • ABC, ddI, EFV, d4T, IDV, 3TC, NPV, RTV, SQV, TDF, AZT+3TC • 11 drugs with only one sanitary registration • ATV, DRV, T20, Etravirine, FPV, MVC, Raltegravir, Tipranavir, ABC+3TC, ABC+AZT+3TC, Lop/r • No generic competition! • 8 Drugs without sanitary registration • EVG, FTC, Rilpivirine, FTC+3TC, FTC+TDF, EFV+FTC+TDF, DRV+RTV+TDF

  23. Policy Recommendations • Integration of development policies of national pharmaceutical-chemical industry: widespread use of the Bolar Exception and high standards of examination of the patent applications • Strengthen Pre and post grant opposition

  24. Policy Recommendations (2) 3. Problems regarding INPI website a. expiry of session b. no digitalization of patents and patent applications c. Claims of granted patents are no published 4. Possibility to overcome the opacity of the patent system in Brazil

  25. THANK YOU! PEDRO@ABIAIDS.ORG.BR WWW.DEOLHONASPATENTES.ORG.BR

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