Drug price regulation in Brazil: Roche faces IP rights abuse claims

02-08-2016

Anderson Ribeiro and Ricardo Campello

Drug price regulation in Brazil: Roche faces IP rights abuse claims

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The Brazilian Federal Prosecutor’s Office has taken court action against Roche for allegedly abusing IP rights in its sales of Herceptin to state governments. Anderson Ribeiro and Ricardo Campello of Provedel Advogados analyse the case.

The increasing price of medicines is a controversial and challenging issue worldwide. Countries adopt mechanisms to regulate such prices, generating an assumption that sales within regulated limits are legitimate.

However, on June 7 the Brazilian Federal Prosecutor’s Office (MPF) filed a class action against Roche’s Brazilian subsidiary arguing that its sales of Herceptin (trastuzumab) to state governments involves an alleged abuse of IP rights, even though they are compliant with the price regulatory framework. The abuse, according to the MPF, results from higher prices charged to states in named patient sales in order to comply with court orders, compared to sales to the Ministry of Health (MoH).

This case is of unparalleled relevance for the Brazilian pharmaceutical sector as it challenges a common belief that complying with the requirements of price regulation suffices.


Anderson Ribeiro, Ricardo Campello, Provedel Advogados, MPF, CMED, IP rights abuse claims, MoH, patent, trademark, copyright, Roche,

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