E-DRUG: Remdesivir in Argentina: new patent opposition filed by FGEP
intends to stop Gilead's abusive behaviour
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Fundacion GEP has filed a new opposition against a patent application that
Gilead has filed in Argentina. Remdesivir is the first drug approved
globally to treat people infected with COVID-19. If the National Institute
of Industrial Property (INPI) rejects the patent, Argentina will give a
step forward toward the access to this drug, because it would be possible
to manufacture it locally at a reduced price.
New pre- grant patent opposition
<http://fgep.org/en/argentina-fundacion-gep-opposed-gileads-patent-application-on-remdesivir/>
New pre-grant patent opposition against a patent application that Gilead has filed in order to be granted the right over the drug in Argentina.
Remdesivir is the first drug approved globally to treat people infected with COVID-19. As clinical trials are being developed globally, remdesivir already has the approval, for emergency use, of the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has approved its commercialization.
In Argentina, Gilead has filed at least five patent applications
before National Institute of Industrial Property <https://www.argentina.gob.ar/inpi>,
with the intention of having a monopoly over the manufacture and
commercialization of the drug in Argentina. The exclusive rights granted by
patents would allow the company to establish excessively high prices, as
they have already done with other products like sofosbuvir, a drug that
cures hepatitis C.
By filing these oppositions, Fundacion GEP claims it is necessary to
conduct a thorough revision of the content of the patent applications filed
by Gilead in Argentina. 'We had access to the patent applications and
were able to confirm that they do not meet the patentability requirements
in force in Argentina, so they should be rejected by INPI' said Lorena Di Giano. 'We have submitted before the patent office information proving that
Gilead's patent applications on remdesivir do not meet the legal conditions
of novelty or inventive step, because they claim treating methods,
pharmaceutical salts and compositions that are not new and which are
obvious, as well as it tries to claim combinations of already existing
active ingredients. And what is more, they lack the descriptive information
required by the National Patent Law', explains Di Giano.
Gilead set a price for that drug: $390 each application for the government
of the United States and developed countries. A value almost 400 times
higher than its manufacturing cost, which, according to a study by the
University of Liverpool, does not exceed one dollar per unit. Even the
price for private health insurance in the United States could be even
higher, at $520 per dose.
Patents allow companies to set exorbitant prices, remotely different from
their manufacturing cost. It goes without saying that prices become more
affordable when there is diversity of production and there is price
competition in the market. Particularly in the case of remdesivir, a month
ago Gilead has signed voluntary licensing agreements with pharmaceutical manufacturers based in India and Pakistan.
<https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir>
According to estimates from the Institute of Clinical and Economic Review (ICER), the price for the generic versions that are already being developed by two producers in India authorized by Gilead - Hetero Labs and Cipla - and will be accessible by the 127 LMIC, would not exceed $80 a dose.
'By signing voluntary licensing agreements, Gilead provides technology for
the generic manufacturing of remdesivir, but controls which countries can
buy these more affordable versions. Even we see $80 dollars a dose is
extremely expensive. Gilead deliberately leaves out many countries, as is
the case with most of countries in South America. Clearly, it is in the
excluded countries where Gilead intends to get the biggest profit.
Argentina is one of them, so we must pay special attention to the patent
applications filed as part of this strategy', warns Lorena Di Giano,
Executive Director of Fundacion GEP.
'Life is a supreme value is an incontestable truth, but, what happens
when a big pharma company is the absolute owner of a life-saving treatment?
Hedge funds are the main shareholders in these companies, and they are not
interested in saving lives; they only seek profit and, in any case, that
countries be forced to pay extortive prices so they can gain exorbitant
profit. COVID-19 has proved what a fatal mistake it was to make health an
object of market, and medicines a merchandise, instead of considering them
social goods. It might be the opportunity to transform the system and set
medical technologies free from the market', was the thought of José MarÃa
Di Bello, president of Fundacion GEP.
'INPI has to urgently examine and reject Gilead's patent applications on
remdesivir. Absence of monopoly on this drug or others that prove their
efficacy in treating COVID-19 will guarantee local manufacturing and
universal access to affordable generic versions for all the people that
might need them.'
MarÃa Lorena Di Giano
Directora Ejecutiva FGEP
Fundación Grupo Efecto Positivo
www.fgep.org
Buenos Aires- Mar del Plata- Argentina
Coordinadora General RedLAM
Red Latinoamericana por el Acceso a Medicamentos
Contact: lorenadigiano@gmail.com