Articles

Article published on World Intellectual Property Review
Annual 2016.

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:

Practical Law – Life Sciences / 2015

Practical Law – Life Sciences / 2015

The Trademark Reporter© Vol. 104 – The Law Journal of the International Trademark Association (site da INTA)

Trade secrets are protected as a category of intellectual property rights. In Brazil, their protection resides in the legislation set forth against unfair competition (considered a crime under Brazil’s Industrial Property Law of 1996), in the TRIPS Agreement (the Agreement on Trade-Related Aspects of Intellectual Property Rights) and in other legal provisions such as the ‘inviolability of privacy’ clause of the Federal Constitution.

Trade secrets are thus protected by the statutory rules on fair competition, established in Articles 195(XI) and 195(XII) of the Industrial Property Law with civil and criminal effects, and by Article 842(g) of the Labour Law, according to which the breach of a trade secret by an employee is considered a valid reason for dismissal.

This paper gives an overview on legal, economic and cultural characteristics that are inherent to the Brazilian business scenario and how they affect the negotiation of know how licensing agreements. The Brazilian regulatory framework and the point of view of Brazilian companies can bring out significant issues not expected by their counterparts of other countries or regions. Experience demonstrates that understanding the concepts, reasons and dynamics of emerging economies from their perspective may help U.S. legal professionals to observe relevant factors and get insights to overcome obstacles in the practice of contractual law in a multinational or multicultural environment, in particular when negotiating know how licensing contracts.
 

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.