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The Brazilian government is keen to amend the country’s 1996 patent law and related legislation, although consensus remains elusive on a number of issues, said sources close to the matter.
“The government is braced for a battle in Congress,” said a Sao Paulo-based attorney close to the pharmaceutical industry who is familiar with numerous bills awaiting congressional approval. Diverse interests within the industry and disagreements within the government’s own coalition may be difficult to reconcile, the attorney said.
One of the key pending bills would forbid the granting of patent protection for second and further medical uses of a given drug, said the attorney. A second patent is requested when scientists or companies discover a new application to a given drug. Viagra is the classic example of this, but there are many others in the pharmaceutical sector, the attorney explained.
Another key pending bill would alter article 40 of the Brazilian patent law, reducing patent protections to 10 from 20 years in the country, the attorney said.
Both bills are supported by GTPI, an advocacy group that monitors intellectual property policymaking. There are 16 bills currently in Congress dealing with various aspects of Brazilian patent law, according to GTPI.
About 60% of all patent filings are for second-use patent protection, and corporations are sensitive to the issue, said Jorge Raimundo, a patent attorney based in Rio de Janeiro. “All countries bar Argentina” grant second-use patents and INPI (the Brazilian agency that grants patents), has issued them on a case-by-case basis because there is no provision in the law saying it should not, Raimundo said.
The bill forbidding second-use patents has been defeated in every congressional committee and is not favored by companies, Raimundo added.
Almost half of all patent requests come from the chemical or pharmaceutical industry, said an INPI source, who added that a patent application request has an average eight-year processing time. But the source could not confirm whether 60% of filings were for second-use patents.
Beyond the second-use patent debate, technological innovation has brought about new regulatory challenges for Brazil, the sources told PaRR.
For the generic drugs industry, which is changing in focus to developing biological drugs to increase profits, watching policy trends is crucial, the first attorney said. The reason is biologics are derived from living organisms, and aspects of Brazil’s patent law may possibly have to be adapted to accommodate those trends, the attorney said.
A generic version of a biological drug takes 10 years to develop, compared with two years for a non-biological generic pharmaceutical, said the lawyer.
In Brazil, genetically modified microorganisms may be subject to patentability under article 8 of the patent law, according to a report by law firm Demarest e Almeida. However, there is no patent protection for “isolated substances” found in nature or for stem cells, the INPI source told PaRR. Nor is there protection for methods of medical treatment, the same source said.
Article 10 of Brazil’s patent law deals with items which are not patentable, and reforms for it are inevitable given growing pressure from corporations and even government-run research centers, the INPI source also said.
When a company like Natura [NATU3:BZ] lobbies for the right to access so-called ‘Brazilian genetic assets’, “it means it is developing a product and wants to patent that product,” the INPI source said. He explained that a correlation exists between requesting the authorization to tap Brazil’s natural resources and patenting an invention that may arise from the related research.
According to the first attorney, amending Brazil’s patent law is one thing, while laying out the rules for companies and scientists to exploit Brazil’s genetic assets is another. These will probably be dealt with in different pieces of legislation, the attorney said.
After the enactment of a 2001 law dealing with the exploitation of Brazil’s genetic assets, CGen became the Brazilian agency responsible for issuing permits for research purposes. But CGen has been criticized for being too slow to grant these permits, while the law has been criticized for becoming outdated, according to remarks by a Brazilian government official.
“We have to change the intellectual property regime, which does not only concern patents, but also [the] permits [regime] to do biotechnology research,” Fernando Pimentel, ministry for Development, Industry and Trade, was quoted as saying in Valor Economico’s 15 March edition.
Brazil’s current regulations also “say nothing” with respect to how the indigenous populations that have “original knowledge” of a given isolated substance might be rewarded by an entity doing research based on their knowledge of that substance, the INPI source said.
This is another matter the new regulation is expected to address, the INPI source said, adding that the government discussions to refine these rules are complex and may take about a year. This week, INPI is holding a three-day symposium in Rio de Janeiro, but the only new development is the launch of a system that will allow parties to file for patent applications online, the INPI source said.