[Ip-health] Pipelines and IFPMA - Brazil

[Renata Reis]

Full Title: SCRIP - World Pharmaceutical News - http://www.scripnews.com
FILED 6 February 2008 COPYRIGHT Informa UK Ltd 2008

Brazilian patent challenge berated by industry


The International Federation of Pharmaceutical Manufacturers and
Associations,
the IFPMA, has slammed an attempt in Brazil to have pipeline patents
declared
unconstitutional, labelling it "symptomatic of a certain schizophrenia in
Brazilian public life".

At the end of 2007, the national federation of pharmacists (Fenafar) -
representing a number of NGOs - presented a case to Brazil's attorney
general,
Antonio Fernando Barros e Silva e Souza, arguing that pipeline patents
should
be declared unconstitutional.


These patents were set up under new legislation when Brazil signed up to
the
TRIPS agreement in 1996. Articles 230 and 231 of the industrial property law
said that pipeline patents could be granted in Brazil, and given the
priority
date of the first foreign filing, for pharmaceuticals and other products if
a
patent already existed in a country that had  treaties with Brazil. There
were
two conditions: that the patented product or process had not yet been
introduced in "any market", and that a third
party had not made "serious and effective" attempts to exploit the
technology
in Brazil. Filings had to be made within a year of the publication of the
law.

Therefore, patents were granted in Brazil even though their subject matter
had
been rendered non-novel by the publication of patents elsewhere.

"The new legislation went further than the obligations demanded by the TRIPS
agreement," Celia Chaves, president of Fenafar, told Scrip. A similar
mechanism
had originally been proposed by the US during the TRIPS negotiations but was
rejected, she said.


"This type of protection clearly favours foreign interests over domestic
ones
and it does not serve the objectives of the constitution because it goes
against Brazil's economic and technological development ... it also removes
information that is relevant to everyone from the public domain, and this
goes
against society's interests," she said.


Over 1,000 of these patents were filed, many of them for essential
medicines. "The impact of these patents has been enormous: millions of
Brazilians cannot get the medicines that they need, and the government has
been
obliged to spend vast amounts of money on these treatments," said Ms
Chaves.


Several antiretrovirals used in the government's HIV/AIDS programme are
protected by pipeline patents, including GlaxoSmithKline's Ziagen
(abacavir),
Roche's Viracept (nelfinavir), Vertex's Agenerase  (amprenavir), Abbott's
Kaletra (lopinavir plus ritonavir) and Merck & Co's Stocrin (efavirenz).
Between 1996 and 1997 the amount spent on antiretrovirals jumped from R$34.5
million ($19.8 million) to R$241.8
million and by 2005, the cost had risen to R$986 million, said Ms Chaves.


Last May, the Brazilian government issued a compulsory licence for Stocrin,
and
had it threatened to do the same for Kaletra in 2005.  According to Ms
Chaves,
these actions illustrate the negative consequences of medicine monopolies
and
how they compromise the supply of medicines.


The IFPMA is critical of the move to declare pipeline patents
unconstitutional.
It told Scrip that in Brazil there was an "outward-looking political
community
that aspires to take Brazil into the ranks of the developed countries. It is
keen to encourage the realisation of Brazil's considerable potential to
deliver
world-class innovation in
many fields, including healthcare. This faction understands that this cannot
be
achieved without strong intellectual property rights that approach or match
developed country standards.


"However, there is also a less confident, inward-looking faction wedded to
reactive, protectionist policies that seem designed to perpetuate Brazil's
position as a developing country. This group seeks to weaken intellectual
property protection, and attaches more importance to cheap access to novel
products and techniques developed abroad than it does to encouraging
innovation
at home. Needless to say, the move by Fenafar bears all the hallmarks of the
protectionist, introvert camp."


Various NGOs from other parts of the world have written to the attorney
general
in support of Fenafar's action, including the Thai NGO Coalition on AIDS and
a
Colombian NGO alliance, comprising the Colombian branch of  Health Action
International, the IFARMA Foundation and the mission health
foundation.

In addition Kevin Outterson, associate professor at the Boston University
School of Law, wrote declaring that some pipeline patents would be invalid
under US and patent treaty law.


If the attorney general decides that the patents are unconstitutional, the
Advocacia Geral da Uniao, which defends the constitutionality of the law,
will
hear the case. It may then be subject to a public hearing in the STF, the
superior federal tribunal. francesca.bruce@informa.com


Full Title: SCRIP - World Pharmaceutical News - http://www.scripnews.com
FILED 6 February 2008 COPYRIGHT Informa UK Ltd 2008


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