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

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

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

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Agenda Introduction –Justification –Objective Methodology –Patents search –Sanitary registration search Results Discussion Policy Recommendations

Agenda Introduction –Justification –Objective Methodology –Patents search –Sanitary registration search Results Discussion Policy Recommendations

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

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

Agenda Introduction –Justification –Objective Methodology –Patents search –Sanitary registration search Results Discussion Policy Recommendations

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

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

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 1.By the American patent number 2.By the Priority number

By the American patent number 1.Find in trough the “Number search”, the INPADOC patent family and 2.Look for the Brazilian application 3.Go to the Brazilian patent office (INPI) website and find the number, through simple search

By the priority number 1.To find the original patent document in USPTO 2.To survey the priority numbers of the American patents (Foreing Application Data ou Appl. No.) 3.To search on the INPI “Advanced Search”

Patent Search Summary Orange Book American Patent BRXXXXXXX PIXXXXXXX-X Priority Number INPI website – Advanced Search INPADOC Family INPI search

Other sources I-mak report –Combinations Patent pool database –To check the results found

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

Agenda Introduction –Justification –Objective Methodology –Patents search –Sanitary registration search Results Discussion Policy Recommendations

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

Results – Each medicine patentary status

Results – Protection expansion

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

Policy Recommendations 1.Integration of development policies of national pharmaceutical-chemical industry: widespread use of the Bolar Exception and high standards of examination of the patent applications 2.Strengthen Pre and post grant opposition

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

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