E-DRUG: MSF launches resource for challenging unwarranted drug patents
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On 10-year anniversary of landmark Thai case, new ‘Patent Opposition
Database’ aims to boost access to medicines in countries increasingly hit by
high drug prices.
Geneva, 2 October 2012 – A new online resource for civil society and patient
groups in developing countries to challenge unwarranted drug patents was
launched today by Médecins Sans Frontières (MSF). The Patent Opposition
Database comes as many developing countries face dramatically high drug
prices because patents block the production of lower-cost generic versions.
MSF relies on affordable medicines for its medical work in more than 60
countries; in the case of HIV treatment, over 80 per cent of medicines used
in developing countries are generics. The Patent Opposition Database is
accessible at patentoppositions.org
“Drug companies routinely apply for patents or are granted monopolies on
medicines even when these aren’t actually deserved,” said Michelle Childs,
Director of Policy Advocacy for MSF’s Access Campaign. “It’s a myth that
every patent application that is filed is valid. When you look closely, a
patent application may fail one or more of the legal tests it needs to pass.
The idea behind this database is to help civil society and patient groups
stop unwarranted patents from blocking people’s access to more affordable
medicines.”
A ‘patent opposition’— a legal challenge to prevent or overturn the granting
of an unwarranted patent — is allowed under international trade rules as a
way to keep checks and balances on pharmaceutical patenting. In countries
where they are allowed, like Thailand, Brazil or India, patent oppositions
have successfully prevented undeserved patent monopolies from being granted
and allowed generic competition to bring the price of medicines down.
“Successful patent oppositions by civil society in India have enabled us to
use more affordable generic versions of key HIV medicines in our treatment
programs”, said Dr Esther C Casas, MSF HIV/TB Specialist for Zimbabwe.
"Due to the volume of applications, local patent examiners can miss
information and grant unjustified patents," explains Vikas Ahuja, President
of Delhi Network of Positive People. "Just putting two or three separate
pills into one, or using known industry practices to formulate a drug,
should not be considered innovative enough to warrant a new 20-year patent,
for example. By filing patent oppositions, we can highlight this
information and the possibility of invalid patents being granted is
reduced."
Successful examples include the opposition by Indian groups to
GlaxoSmithKline's patent application in India on the HIV
fixed-dose-combination zidovudine/lamivudine, on the grounds that it was not
a 'new invention', but simply the combination of two existing drugs. This
combination is now widely used in HIV treatment in developing countries. A
pre-grant opposition filed by the Cancer Patient Aid Association was also
the spur for the rejection of Novartis's patent application on the salt form
of imatinib, on the basis that the medicine was merely a new form of an old
medicine. The move – which is now the subject of a challenge before the
Supreme Court - opened up generic competition on the drug used in the
treatment chronic myeloid leukaemia and brought the price down by 92 per
cent from over US$2158 per month to $174 per month.
“An unwarranted patent not only delays the entry of price-lowering
competition, it also undermines the drive for genuine innovation,” said
Michelle Childs. “With very few innovative new drugs in their product
pipelines, pharmaceutical companies desperately want to stave off generic
competition by trying to get more patents on old molecules, or on processes
that are not new.”
The Patent Opposition Database aims to guide civil society groups through
the process of challenging an unjustified patent. It will allow
organisations to forge new alliances and share vital specialist knowledge,
as a patent application can often be challenged in different countries on
the same basis. It contains a searchable listing of 45 patent oppositions
relating to key medicines and over 200 other supporting documents that will
aid in the building of future patent oppositions. The resource will grow as
more data is added.
The launch of the database marks the ten-year anniversary of the first time
a patent opposition filed by a patient group - Thailand’s AIDS Access
Foundation - successfully overturned an unfair patent on the HIV drug
didanosine in the Thai courts.
“At the time, we didn’t have much of a choice but to try and oppose the
patent – unaffordable prices meant antiretroviral treatment in developing
countries was still scarce, so it was our lives on the line”, said Nimit
Tien U-dom, Director of the AIDS Access Foundation, speaking at a protest in
Bangkok to mark the tenth anniversary of the didanosine lawsuit.
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Shailly Gupta
Policy Advocacy Officer
Medecins Sans Frontieres
Access Campaign
C 236 Defence Colony
New Delhi, India
Tel: +91 11 46573730-31
Mob: +91 9899976108
shailly.17@gmail.com