tdf patent case

8/10/2019 Tdf Patent Case

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The Case of TDF

Drug in Brazil


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Tenofovir disoproxil fumarate (TDF) - Drug used in treatmentof 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.


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The decision to oppose the TDF patent application stemmed from

the high prices charged by Gilead, the originator company, which

threatened the sustainability of Brazilsuniversal 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 and

encouraged other oppositions on ARV patents in Brazil.


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The pharmaceutical company Gilead filed a patent applicationfor 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 thegovernment 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.
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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 preventthe patent from being granted and then to encourage competition

that would reduce the price of the drug.
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GTPI was created in 2003 to address the negative impact of the

patent system on access to medicines in Brazil. It advocated for therights 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.

r


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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 wouldnot 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.
http://www.aalhadpune.org/http://www.aalhadpune.org/http://www.aalhadpune.org/http://www.aalhadpune.org/http://www.aalhadpune.org/http://www.aalhadpune.org/


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But finally, in August 2008, the patent office in Brazil rejected the

patent application on TDF on the grounds that it lackedinventiveness. 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 accessto 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 localproduction 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.


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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


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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 aninformation, 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

Viddato 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 GTPsopposition of the HIV drug TDF


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The United States and India are currently involved in a biopiracydispute 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.


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The movement around the issue of the neem tree and trade-related

aspects of intellectual property rights (TRIPS) represents a challengeto the developing countries.

According to Patent law , this case comes under the Section 3(p)


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The villager supplier of neem products ranging from pesticides to

formulations for creams to cure skin disorders, Raju, was not the firstin 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 peoplein 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.


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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.


15/19

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 livingorganisms,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.


16/19

The European Patent office ( EPO ) delivered a favourable interim

judgement on the challenge of a European patent on the fungicidaleffects 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 officeto 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 andhence no other company can patent its properties. The EPO

accepted the argument.


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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 May2000,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 aresupposed to satisfy three criteria of novelty, non-obviousness and

utility.


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1. http://patentoppositions.org/case_studies/4f106d0504a7f92f5b000003

2. http://www1.american.edu/ted/neemtree.htm


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