The Case of TDF

Drug in Brazil

 Tenofovir disoproxil fumarate (TDF) - Drug used in treatment

of HIV in Brazil.
The medicine was incorporated into the countrys treatment
guidelines in 2003 but with numerous disputes over price.
According to Patent law , this comes under Section 3(i)
Today, TDF is produced through a partnership between two
Brazilian manufacturers and its price has been greatly reduced.
But this was only made possible due to opposition on patent of
the drug by fiocruz, the Brazilian government laboratory for drug
manufacturing and development, and civil society groups.

 The decision to oppose the TDF patent application stemmed from

the high prices charged by Gilead, the originator company, which
threatened the sustainability of Brazils universal access to free HIV
treatment for its citizens.
The opposition also helped raise a debate over the need to reject
undeserved patent applications to protect public health.
The successful pre-grant opposition is emblematic. It was the first
time a patent related to an antiretroviral (ARV) medicine was rejected
as a result of civil society pressure.
The outcome inspired confidence amongst patients
encouraged other oppositions on ARV patents in Brazil.

and

 The pharmaceutical company Gilead filed a patent application

for TDF in Brazil in 1998.
In 2003, the lack of competitors in Brazil allowed Gilead to
charge US$3,300 per person per year (ppy).
Due to the high price of this and other ARVs, the Brazilian
government started to negotiate prices with originator companies.
The threat of a compulsory licence, which would allow the
government to override the patent in the interest of public health
and produce ARVs, as well as public laboratories with the capacity
to produce them, helped to achieve some price reductions.

 In 2006, the first generic versions of TDF produced in India

became available on the international market.
This placed pressure on Gilead, which ultimately agreed to
halve the price of its TDF from $2,766 in 2004 to $1,380 per
patient per year in 2006 in Brazil.
In 2006, Working Group on Intellectual Property from the
Brazilian Network for the Integration of Peoples
(GTPI/REBRIP) decided to use a pre-grant opposition to prevent
the patent from being granted and then to encourage competition
that would reduce the price of the drug.

 GTPI was created in 2003 to address the negative impact of the

patent systemr on access to medicines in Brazil. It advocated for the
rights of people living with HIV (PLHIV) and pushed for the use of
flexibilities allowed for within the framework of international trade
rules, but had no experience with patent oppositions before 2006.
The group's ability to build a patent opposition relied on
collaboration with other parties. After presenting the opposition,
GTPI publicly called on the Brazilian government to take action,
because the country was paying $1,380 per patient per year, more
than 10 times the best generic price offered at that time.
In 2008, after GTPI had spent two years claiming the TDF patent
application was undeserved and should be rejected, the government
declared TDF to be of public interest.

 A wealth of confusion surrounded the announcement, with some

media mistakenly claiming it was a move towards a compulsory
license. But this was not the case as the patent had not even been
granted yet.

In an unprecedented move, ABIA also filed a patent opposition in

India together with the Indian NGO SAHARA (Centre for
Residential Care and Rehabilitation), because a patent in India would
not only restrict generic competition in India, but would also directly
impact Brazil being able to import and access affordable generic
versions of the drug.
The Brazilian activists were aware that, should the patent be
rejected, local production would take some time to start. During this
delay, if no other source were available, Brazil would still have to pay
monopoly prices for a short time.

 But finally, in August 2008, the patent office in Brazil rejected the
patent application on TDF on the grounds that it lacked
inventiveness. The activists and PLHIV were delighted. However,
just a few months later, in March 2009, Gilead appealed the decision
and also requested a divisional patent.
GTPI again opposed the patents and, in another victory for access
to medicines, they were successfully rejected on the basis of lack of
an inventive step in May 2011.
The Brazilian government has since announced the start of local
production of TDF through a partnership between public and private
manufacturers in Brazil. Gilead is still appealing its patent application
[number PI9811045], in the Brazilian courts.

 Most of the patent oppositions were achieved by the collaboration

& solidarity between Brazilian and Indian activists.

It took five years for the patent opposition to result in the first

batch of locally-produced TDF for Brazilian HIV patients

The patent opposition has helped support the right to free

treatment in Brazil
The success of the patent opposition also represents the 30-year

fight to preserve the principles of equality and universality which

underlie the Brazilian response to the AIDS epidemic.
The GTPI & ABIA have been working on patent oppositions for

other drugs & they intend to keep using this strategy since it has
proven to be effective to improve the access to medicines

GTPIs efforts to learn new strategies such as patent oppositions

were made on behalf of all those people living with HIV.
One such person is Mara Moreira, who coordinates an
information, communication and education programme at Pela
Vidda, a member organisation of GTPI which provides legal and
psychological support to PLHIV.

She was infected with HIV at the age of 18, & joined Pela
Vidda to share her experiences with other HIV-positive people.
she worked with various such groups and took keen interest in
clinical trials on medicines & learned more about patent oppositions
Mara believes there should be more focus on work to oppose
patents, such as GTPs opposition of the HIV drug TDF

 The United States and India are currently involved in a biopiracy

dispute over the rights to the neem tree.

The neem tree has been used in India for over 2000 years for

various purposes such as pesticides, spermicides and toothbrushes

etc
A US company has been suing Indian companies for producing the

emulsion because they have a patent on the process

The dispute is over the rights of companies to conduct research and

development by using patents against the interest of the people who

live at the source of the resource.

 The movement around the issue of the neem tree and trade-related
aspects of intellectual property rights (TRIPS) represents a challenge
to the developing countries.
According to Patent law , this case comes under the Section 3(p)

 The villager supplier of neem products ranging from pesticides to

formulations for creams to cure skin disorders, Raju, was not the first
in his family to use the "blessed tree" for as many purposes as
possible. His family revered and know all of the tree's sacred
qualities. While Raju did not know the exact word for the extract of
the neem seed, Azadirachtin, he did know that it helped all the people
in his village in one way or another.

One day his life changed drastically. An American company called

W.R.Grace patented the natural insecticide that had been used for
generations by Indian farmers. The company was allowed to patent
the process of making the insecticide because the Indian government
did not patent agricultural or pharmeceutical products.

 Raju often asks, how is it possible for American companies to

come into our country, steal our knowledge and make money out
of it? He was also concerend why the Indian government did not
protect the neem emulsion through patents themselves. This is a
question that many intellectual property disputes have to answer.

 The controversy over who has the rights to the Neem tree raised

many questions.
India claims that what the US companies are calling discoveries
are the actual stealing and pirating of the indigenous practices and
knowledge of its people.
The Indians and members of the Green Party in the European
union oppose big businesses owning the rights to living
organisms,because they believe that the rights of poor farmers in
developing countries will be harmed.
The United States,on the other hand,states that what they are
doing will help the Indian economy.
Another issue is whether the neem tree is patentable, since it is a
product of nature.
The problem is that W.R. Grace does not have a patent on the tree
itself, but rather on the process of making the emulsion.

 The European Patent office ( EPO ) delivered a favourable interim

judgement on the challenge of a European patent on the fungicidal

effects of neem oil (Patent no. 436257 B1) owned by W.R.Grace
& Co.
The European patents office accepted the arguments offered by
Indian scientists and rejected the order of the U.S. Patents office
to award the patent to W.R. Grace, US- based company, at the last
hearing of the case.
The Indian scientists argued that the people of India have known
the medicinal properties of neem for thousands of years and
hence no other company can patent its properties. The EPO
accepted the argument.

 The victory is a result of four years- long effort by the Research

Foundation for Science, technology and Environment. Professor U P
Singh, an agricultural scientist at the Banaras Hindu University
represented the Indian side.

The European Patent Office agreed to withdraw the patent in May

2000,the patent was revoked however.
The US also needs to change its patent laws which allow
biopiracy by non-recognition of foreign prior art. Patents are
supposed to satisfy three criteria of novelty, non-obviousness and
utility.

1. http://patentoppositions.org/case_studies/4f106d0504a7f92f5b00
0003
2. http://www1.american.edu/ted/neemtree.htm