Washington D.C., USA, 22-27 July 2012 Patent Oppositions in Argentina International AIDS Conference...
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Washington D.C., USA, 22-27 July 2012 www.aids2012.org Patent Oppositions in Argentina International AIDS Conference 22-27 July 2012 M. Lorena Di Giano
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Transcript of Washington D.C., USA, 22-27 July 2012 Patent Oppositions in Argentina International AIDS Conference...
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Patent Oppositions in Argentina
International AIDS Conference
22-27 July 2012
M. Lorena Di Giano
Washington D.C., USA, 22-27 July 2012www.aids2012.org
• Argentina has a population of 40.091.359 (Population Census Oct 2010)
• 130.000 people who live with HIV half of them are not aware if their HIV status
(MoH and UNAIDS estimations, 2011)
• 43.000 people under ARV treatment (AIDS Bulletin- Dec 2011)
Washington D.C., USA, 22-27 July 2012www.aids2012.org
• Argentina is a MIC which has enacted its national Patent Law in the year 1995 to comply with TRIPS agreement.
• Argentina made use of the transition period and medicines were not patentable until the year 2000.
• During the transition period, Argentina has developed its capacity to produce generic versions, particularly HIV first line drugs.
Washington D.C., USA, 22-27 July 2012www.aids2012.org
The local production has contributed to market competition improving access and Argentina’s
sovereignty to maintain a public policy of universal access to medicines.
Washington D.C., USA, 22-27 July 2012www.aids2012.org
• The entry into force of patent protection for medicines, brought about a number of patent applications for essential medicines which are currently under patent protection or under a pending decision (which creates “a factual protection”).
• These facts generated monopolies on ARVs drugs (particularly for 2nd and 3rd line) that are available at very high price.
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Argentina's Health Care System
Composed of three principal elements:• Public sector (publicly funded and maintained);
• Compulsory social security sector (“obras sociales” insurance plans); and
• Private sector (funded by voluntary prepaid insurance plans)
Washington D.C., USA, 22-27 July 2012www.aids2012.org
ARVs Procured by eachsub health system
69%
26%
5%
public sector
social security sector
private sector
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Prices Ministry of Healthper Patient per Year
• Atazanavir (Reyataz) US$2912 (May 2012)
• TDF+ FTC (Truvada) US$ 4160 (May 2012)
• Lopinavir + Ritonavir (Kaletra) US$ 3955 (May 2012)
• EFV+ TDF+ FTC (Atripla)
Washington D.C., USA, 22-27 July 2012www.aids2012.org
DRUG
COMPANY (which registered product
in Argentina)
PATENT STATUS
PRICE SOCIAL SECURITY AND PRIVATE
SECTOR(ARGENTINA)
US$ YEAR/PERSON
PRICE GENERIC VERSION
UNTANGLING THE WEB MSF
US$ YEAR/PERSON
ATAZANAVIR
NOVARTIS
BRISTOL MYERS SQUIBB ARGENTINA S.R.L.
GRANTED
PENDING (process)
10.524
EMCUREUS$ 268
MATRIXUS$ 250
EFAVIRENZ + EMTRICITABINA + TENOFOVIR DISOPROXIL(ATRIPLA)
GADOR S.A.(Gilead licencee- packaging and distribution)
PENDING
15.408
CIPLAUS$ 231
HETEROUS$ 243
MATRIXUS$ 219
EMTRICITABINA + TENOFOVIR DISOPROXIL(TRUVADA)
GADOR S.A.(Gilead licencee- packaging and distribution)
PENDING
11.215
AUROBINDOUS$ 140
CIPLAUS$ 134
HETEROUS$ 164
MATRIXUS$ 116
RITONAVIR + LOPINAVIR(KALETRA)
ABBOTT LABORATORIES ARGENTINA S.A.
PENDING (tablets)
11.040
AUROBINDOUS$ 438
HETEROUS$ 493
MATRIXUS$ 402
CIPLAUS$ 499
Washington D.C., USA, 22-27 July 2012www.aids2012.org
DRUG
PUBLIC SECTOR
SOCIAL SECURITY
and PRIVATE SECTOR
CHEAPEST
INDIAN GENERIC VERSION
ATAZANAVIR
US$2912
Us$ 10.524
US$ 250
LOPINAVIR+ RITONAVIR
US$ 3955
Us$ 11.040
US$ 402
TNF+FTC
US$ 4160
US$11.215 US$ 116
TNF+FTC+EFV
X
US$15.408
US$ 219
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Oppositions
• Pre grant (art. 28 Patent Law)- limitations
• Post grant (art. 59 and concordants of Patent Law)
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Challenges
• Cost of Post grant opposition- judiciary process
• Cost of translations- it should be an official public translation
• Funding avaliable to do this work (pre- and post grant oppositions)
