Washington D.C., USA, July 2012www.aids2012.org Patent Oppositions in Argentina International AIDS Conference July 2012 M. Lorena Di Giano

Washington D.C., USA, July 2012www.aids2012.org Argentina has a population of (Population Census Oct 2010) people who live with HIV half of them are not aware if their HIV status (MoH and UNAIDS estimations, 2011) people under ARV treatment (AIDS Bulletin- Dec 2011)

Washington D.C., USA, 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 During the transition period, Argentina has developed its capacity to produce generic versions, particularly HIV first line drugs.

Washington D.C., USA, 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, 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 2 nd and 3 rd line) that are available at very high price.

Washington D.C., USA, 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, July 2012www.aids2012.org ARVs Procured by each sub health system

Washington D.C., USA, July 2012www.aids2012.org Prices Ministry of Health per 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, 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) EMCURE US$ 268 MATRIX US$ 250 EFAVIRENZ + EMTRICITABINA + TENOFOVIR DISOPROXIL (ATRIPLA) GADOR S.A. (Gilead licencee- packaging and distribution) PENDING CIPLA US$ 231 HETERO US$ 243 MATRIX US$ 219 EMTRICITABINA + TENOFOVIR DISOPROXIL (TRUVADA) GADOR S.A. (Gilead licencee- packaging and distribution) PENDING AUROBINDO US$ 140 CIPLA US$ 134 HETERO US$ 164 MATRIX US$ 116 RITONAVIR + LOPINAVIR (KALETRA) ABBOTT LABORATORIES ARGENTINA S.A. PENDING (tablets) AUROBINDO US$ 438 HETERO US$ 493 MATRIX US$ 402 CIPLA US$ 499

Washington D.C., USA, July 2012www.aids2012.org DRUG PUBLIC SECTOR SOCIAL SECURITY and PRIVATE SECTOR CHEAPEST INDIAN GENERIC VERSION ATAZANAVIR US$2912 Us$ US$ 250 LOPINAVIR+ RITONAVIR US$ 3955 Us$ US$ 402 TNF+FTC US$ 4160 US$11.215US$ 116 TNF+FTC+EFV X US$ US$ 219

Washington D.C., USA, 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, 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)

Washington D.C., USA, July 2012www.aids2012.org Thank you!