In March 2018, Argentine NGO, the Fundación Grupo Efecto Positivo (FGEP), requested that the country’s National Institute of Industrial Property (INPI) deny Gilead Sciences Inc’s patent request for an antiretroviral drug.
NGO urges HIV drug patent application to be denied in Argentina
Generics/General
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Posted 06/04/2018
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The drug, TAF (Tenofovir Alafenamide fumarate), has been used to treat approximately half of those infected with HIV (approximately 45,000 people), and has been used for almost a decade. TAF is currently produced by an Argentine laboratory and the NGO is concerned that, if a patent were to be granted, its cost could rise by up to 1,000%. This would make an affordable drug much harder for patients to access.
The FGEP has stated that the drug in the patent application falls short of the inventiveness, novelty and industrial application required by Argentine patent law. They accuse US pharmaceutical company Gilead of only making a small modification to the molecule so that they can have another 20 years of exclusivity. Gilead made the same patent request in Brazil and this was rejected in 2017.
The company has also requested to patent a compound in Argentina that acts against hepatitis C. However, the foundation has expressed concerns that this will likely affect three Argentine companies that supply the national market and that such uncertainty over patents discourages the local manufacturing of generic drugs. One such patent request was already rejected in 2017, with the aid of opposition from the FGEP [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. India and Argentina call for hepatitis C generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www:gabionline.net/Policies-Legislation/India-and-Argentina-call-for-hepatitis-C-generics
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Posted 27/05/2018 by k v narale
NGO
First posted 27/5/2018 ---
FDA REGULATORY NOT SUPPORTED TO NGO
Multinational Never support to NGO
same Regulators also not want to reduce cost indicate
Sorry NGO urges HIV drug patent application to be denied in Argentina
Regulators Government Official political force may do not want such activity
Finally PM should understand need for society then health office will allow to approve such type NGO activity
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