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19 February 2014Gabriel di Blasi

Tackling the patent backlog in Brazil

The Brazilian Patent Office (INPI) has been facing a huge backlog of patent applications, which has led to an average waiting time for examination of about 10 years, an extremely long period compared with other countries. The delays apply for both patent and utility model (UM) applications, with the examination of UM applications being slightly less, around eight years.

According to the INPI, the number of patent applications pending examination, mainly in the biotech, pharmaceutical, electronic and telecommunication industries, has been increasing every year, and is estimated to reach nearly 200,000 by 2015.

The initial cause for the backlog was a change from the Brazilian Industrial Code (CPI) to the Brazilian Industrial Property Law (LPI), finally recognising patent rights for pharma, agriculture and biotech. This allowance caused an overwhelming surge in patent applications in Brazil. For example, in 1995 the number of patent applications filed was about 16,000 per year. In 2013, this number reached approximately 34,000 patent applications.

Several other factors have contributed to the backlog. The INPI did not have sufficient infrastructure, especially examiners, to support such an increased demand, and its workers were frequently on strike with demands for wage increases, better working conditions, and the hiring of new examiners.

Additional delay for the examination of applications in biotech and pharma is caused by the double patent examination performed by the Brazilian Health Surveillance Agency (ANVISA). In 2001, in order to promote and develop generic drugs in Brazil, the Brazilian government established a special provision for patent examination in these technical areas.

"The INPI needs to move swiftly to enact the changes it has set to address rhe massive backlog and reduce the examination time for patent applications in Brazil."

Originally, the government provision regarding ANVISA's review of pharma patent applications applied only to ‘pipeline’ cases, which allowed for applications by owners of existing patent applications in these areas between May 15, 1996 and May 15, 1997.

It was later expanded to include all new, regular pharma applications as well as biotech applications. This causes several problems for granting patent rights in both sectors and creates legal uncertainty for overseas pharmaceutical companies.

The effects caused by the backlog have been tremendous. Aside from the legal uncertainty, because there is no guarantee as to when the patent rights will be granted, such delays in protection can have a spiralling effect on manufacturing costs, as the owners do not have the patent rights to prevent third parties from using their technologies, incurring a higher cost for bringing their products to market. These effects weaken the Brazilian IP system as a whole.

LPI provisions

Although Brazil has been plagued with this backlog, the LPI has some provisions to expedite the examination of patent applications, as well as to reduce the backlog. A resolution allows for expedited examination:

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