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The Ministry of Industry and Commerce (MDIC) and the Brazilian Patent and Trademark Office (INPI) have opened for Public Consultation a Proposal for a Resolution to regulate a simplified allowance procedure for patent applications in Brazil, aiming to deal in a swift manner with the ever increasing backlog of patent applications awaiting examination, currently exceeding the figure of 230.000.

The Brazilian Patent Office’s (BPO) “green patents” prioritized examination proceeding, which was initiated in April 2012 and has been yearly renovated for four consecutive years, has now been reissued on a permanent basis via Resolution No. 175 as per publication made in Brazilian Official Gazette No. 2396 of December 6, 2016.

Further to the ongoing discussion regarding ANVISA

(Brazilian FDA)'s role in the examination of pharmaceutical

patent applications, this is to briefly inform you that the

Attorney General's Office just recently issued the legal opinion number 0006-2015-AGU/PGF/PFE/INPI/COOPI-LBC-1.0 affecting Brazilian PTO's (BPTO) procedure on applications forward to ANVISA for purposes of prior consent approval.

1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

The distribution of medicinal products is regulated by the National Sanitary Surveillance Agency (ANVISA)

Pharmaceutical can be marketed and distributed if the following requirements are met:

The Convention on Biological Diversity, signed in Rio de Janeiro, Brazil, back in 1992, set out that the genetic resources should no longer be considered as a heritage of the Humanity, but rather that each country should have sovereign to its own resources.

Brazil has signed the Convention in 1992, such International Treaty having been ratified in Brazil by means of Decree No. 2,519 of March 16, 1998. Nevertheless, it was only in 2000 that a legislation regulating the access to Brazilian genetic resources and associated traditional knowledge was enacted.

In compliance with the Convention on Biological Diversity (CBD), more specifically, in its articles 1, 8, letter “j”, 10 letter “c”, 15 and 16 items 3 and 4, previous Provisional Ruling 2,186-16/01 was enacted to regulate the access to and use of genetic heritage and associated traditional knowledge (TK) in the Brazilian territory, fair and equitable benefit sharing and access and transfer of technology for the conservation and use of biological diversity. 

Practical Law – Life Sciences / 2015

Practical Law – Life Sciences / 2015

Written with Marielle Dejligbjerg, from HOIBERG A/S

Brazil is the world’s fifth largest country, both by area and population, and has the seventh largest economy measured by GDP. The country excels in the production and exportation of commodities like coffee, iron ore, soya, orange juice, tobacco, and cattle; and produces steel, automobiles & aircrafts, computers and petrochemicals. In the last decade a great portion of the population has become prosperous, and in a time where inflation rates are under control, this makes the Brazilian market attractive to foreign investments. In this article we describe peculiarities of the Brazilian patent system, which are of particular relevance for those who wish to enter the market.

A review od ANVISA's role in the prosecution of pharma patent applications and the latest developments reveals ongoing controversies, as Joao Luis Vianna and Maria Claudia Souza report.

Launched on April 2012, the Brazilian Patent Office’s pilot program that establishes prioritized examination for the so-called “green patents” has now been extended for a further year, being available up to April 16, 2015.

This program’s purpose is to prioritize the examination procedures of patent applications involving “green technologies”, reducing the current average time for concluding the examination of patent applications – which currently takes more than 10 years – to a promised lag time of about 2 years.

Until now, only Paris Convention filed applications, or Brazilian originated national applications, were eligible to enter into this special program.

The big novelty in extending the “green patents” program is that, in this new phase, also Brazilian national phases of PCT applications can benefit from this prioritized route. These can be either new patent applications, still to be filed, or pending patent applications, already filed at the Brazilian Patent Office. For

Brazilian PTO’s new Resolution No. 80 of March 19, 2013 sets forth rules for granting priority examination for patent applications related to pharmaceutical products and processes, and equipments and materials related to public health

The Brazilian PTO published Resolution No. 80, on March 19, 2013 in the Official Gazette, which establishes the proceedings for requesting priority examination of patent applications related to pharmaceutical products and processes, and equipments and materials related to public health. We are pleased to hereby enclose a complete English language version of the resolution for your review.

According to the new resolution, now in full force, priority for the examination of patent applications related to public health may be requested by:
(i) The Ministry of Health when the object of the patent is considered strategic to the policies within the National Public Health System (the SUS) — the possibility of having a

Regulatory Overview.