Multinationals Challenge Brazil Patent Approvals System

Multinational drugmakers, including Swiss pharmaceuticals major Roche, have strongly criticised Brazil's intellectual property approvals system. The complaints have focused on ambiguities in Law 10.196/01, under which drug regulator Anvisa has the final say on the validity of patents registered with the country's National Industrial Property Institute (INPI).

Local producers' association Febrafarma has added to the criticism, as the Swiss drugmaker and others currently take legal action to challenge the bipartite system, which is unique to Brazil. Some local industry professionals claim that the system's duplication of patent eligibility assessments is deliberate and allows the government greater control in ensuring that patents do not obstruct widespread access to medicines. Many now believe that there is potential for a conflict of interest as long as the country's drug regulator is also finally responsible for protecting patents.

In an attempt to fend off the criticism, INPI and Anvisa have pledged to improve their mutual co-operation, although the regulator continues to defend the existing system. Anvisa claims that current arrangements allow the two bodies to pool information, and that it has overturned only 29 of the 619 of the patent recommendations put forward by INPI since March 2001. Officials have also agreed a framework whereby INPI will issue its opinion only after Anvisa has previously announced a position on each patent. Nevertheless, that is unlikely to impress the multinational sector, which has already highlighted resourcing problems at INPI, as well as the fact that patents are outside the regulator's proper area of competence.