The Brazilian pharmaceutical sector: a year in review


Otto Licks and Anderson Nascimento

Practitioners can take heart from recent developments in the Brazilian courts, say Otto Licks and Anderson Nascimento.

Brazil had no patent protection for pharmaceutical inventions until 1994. The TRIPs Agreement, incorporated in 1995 and the Patent Law, approved in 1996, provide patent protection for pharmaceutical inventions.

Despite this positive background and a strenuous patent examining procedure, the Brazilian Patent and Trademark Office (INPI) has a backlog of approximately 11 years, and there is uncertainty concerning INPI and the Brazilian Food and Drug Administration’s (ANVISA) roles in the prosecution of pharmaceutical patents. While the situation at INPI deteriorates, the courts have provided a means to obtain effective patent protection.

The courts are getting less intolerant and more welcoming to assess IP demands, and patent owners should seize the opportunity to look forward to future decisions applying the rule of law.

pharmaceuticals, ANVISA, TRIPS, INPI