E-DRUG: Argentina: GILEAD forced to withdraw Truvada® patent application
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*The decision, for which the Fundación GEP contributed with/to
decisive arguments, paves the way to generic versions to facilitate access
to treatments.*
May 23, 2017 - In a resolution that means a step forward in safeguarding
the right to health, Argentina's patent office (the National Institute of
Industrial Property - INPI) forced Gilead withdrawal of the patent
application for the antiretroviral combination of drugs
tenofovir-emtricitabine (TDF+FTC) known by Its trade name Truvada. The
decision was taken in November 2016 but recently made public.
Fundación GEP participated in the case by an opposition to the patent application in April 2015 noting that the application does not meet legal requirements for the patent to be granted.
Likewise, GEP argued and proved that Gilead intended to
claim a combination of two known active ingredients that had already been
patented and that, according to the current legislation, is not patentable
as a combination. *The evidence filed by GEP is part of the justification
of the INPI's examiners report for rejecting Gilead's application*, which
in its words 'does not meet legal and regulatory requirements' to receive
a patent and 'violates Article 6e' of the Argentine Patent Law since 'Treatment methods are not considered an invention'.
With similar arguments, shortly after INPI's decision, the
patent on Truvada in Brazil was rejected in January of this year:
<http://abiaids.org.br/apos-argumentos-da-sociedade-civil-inpi-rejeita-pedido-de-patente-do-truvada-no-brasil/29776>\.
In Argentina's case 'the current patentability guidelines, globally
considered an example of public health safeguard due to its strict criteria
pro health and judicially questioned by the multinational pharmaceutical companies
prevented Gilead from obtaining an illegitimate monopoly at the expense of
people's health.*
*Truvada is a very important drug in the response to HIV and AIDS in
Argentina, where approximately 50% of people under treatment take this
combination of drugs as part of their ARV regime.
For this reason, according to 2015 research, Argentina invests an yearly sum of U$S12,054,528 in Truvada. That amount represents 23% of the annual budget of the National AIDS Office (DNSyETS), meaning a millionaire business for Gilead.
However, according to the publication 'Untangling the Web' of the international humanitarian organization Médecins Sans Frontières, the generic version of TDF + FTC is available in the international market at US$ 74 per person per year, which shows that the manufacturing cost of this drug is significantly low.
<http://www.msfaccess.org/content/untangling-web-antiretroviral-price-reductions>
In contrast, according to the last public purchase registered to Gador S.A. (Gilead's licensee in Argentina) *Argentina pays US $ 2797 per person per year buying from Gilead. According to this data, if the DNSyETS purchase the generic version produced in India, Argentina could save approximately US$ 11,246,000 per year.*
'The withdrawal of the patent application on Truvada means a
victory in favor of the health of our population. In GEP we are analyzing
other similar patent applications of ever-greening that Gilead seeks in the
country to claim undeserved monopolies on other tenofovir (TAF) and in the
combination TAF + emtricitabine.' stated Lorena Di Giano, Executive
Director of GEP.
Truvada and PrEP: opportunities and challenges
The chance of acquiring or manufacturing generic versions of Truvada
would also have a huge impact on preventive policies such as "PrEP"
(Pre-Exposure Prophylaxis) recommended by the World Health Organization
<http://apps.who.int/iris/bitstream/10665/186275/1/9789241509565_eng.pdf>
and by Unicef
<https://www.unicef.org/about/execboard/files/2017-EB2-Oral_report_HIV-AIDS-15Dec2016.pdf>
in their HIV and AIDS treatment guidelines, which recommends HIV-negative
people taking Truvada to reduce their risk of acquiring HIV. If this
policy were implemented in Argentina, as is strongly promoted by UN
agencies, the availability of medicines and the sustainability of public
budgets could benefit from the acquisition of low-cost generic versions
enabled by the absence of patent on these drugs.
*However, as stated by FGEP's Secretary José MarÃa Di Bello, the PrEP
strategy has been challenged by numerous civil society networks and
organizations since 'Scientific evidence is not questioned, although at
least two people using PrEP have contracted resistant HIV infection to one
of the components of Truvada, but the risk for the population is to
contract other sexually transmitted infections such as syphilis, whose
prevalence has increased in recent years. This strategy generates a false
belief of safety, discourages the use of condoms and means the
medicalization of HIV prevention'.
Fundación GEP celebrates the INPI's decision to force the withdrawal of
the patent on the tenofovir + emtricitabine combination (TDF + FTC )
against the abusive action of Gilead, which clearly tried to illegitimately
control access to medicines that as social goods should be in the service of
public health.
Contact information:
lorenadigiano@gmail.com
Argentina
*MarÃa Lorena Di Giano*
*Directora Ejecutiva FGEP*
*Fundación Grupo Efecto Positivo *
Buenos Aires- Mar del Plata- Argentina
*Coordinadora General RedLAM*
*Red Latinoamericana por el Acceso a Medicamentos*
www.redlam.org
"Lorena Di Giano" <lorenadigiano@gmail.com>