Snapshot: Cristàlia, a Brazilian pharmaceutical company that produces a generic version of lop/r, a drug used in the treatment of HIV, brought a lawsuit against Abbott Laboratories seeking to annul its patent on lopinavir. In 2012, a Brazilian court granted Cristália’s request to annul Abbott’s patent on the grounds that the ‘pipeline’ process by which the patent was granted was unconstitutional.

Factual Background

Abbott Laboratories holds the patent for lopinavir (marketed under the brand name ‘Kaletra’), an important drug used in the treatment of HIV.  Brazilian NGOs have criticised this patent because its existence meant the Brazilian Government could only purchase Abbott’s patented, more expensive version of lop/r for use in its public HIV/AIDS treatment programme.

Legal Argument

In July 2009, Cristália, a Brazilian pharmaceutical company that produces a generic version of lop/r, brought a lawsuit against Abbott Laboratories seeking to annul its patent on lopinavir.  Cristália argued that the patent was granted under the “pipeline mechanism”, which allowed revalidation of patents granted in other countries (in this case the US) while Brazil’s patent legislation was being amended.  This mechanism facilitated the extension of pharmaceutical patent monopolies already obtained outside Brazil without having to go through that country’s patent application process. Cristália also claimed that the World Health Organization (WHO) had validated the quality of the generic version and that the generic version facilitates access to HIV treatment due to its lower price.  

Legal Proceedings

On 7 March 2012, the Federal Court of Rio de Janeiro granted Cristália’s request to annul Abbott’s patent on the grounds that the pipeline process was unconstitutional.  This decision thus allows other companies to manufacture a generic lop/r combination, such as the drug produced by Cristália, which costs 47% less than Abbott’s drug.

Latest Legal News

Abbott filed an appeal and requested an injunction to prevent the enforcement of the court’s ruling.  On 23 March 2012, the Federal Regional Court of the second circuit of Rio rejected Abbott’s request for an injunction.  The appeal is pending before the Federal Regional Court.  If the annullment ruling is upheld, other patents granted to drugs through the pipeline process may also be invalidated.

News Items

• TRF2 pode retomar julgamento esta semana sobre produção de remédio contra Aids, O Globo Brasil, 14 Nov 2013
• Another Boost For Generics: Brazilian Judge Annuls Patent On Key AIDS Drug, techdirt.com, 23 Mar 2012
• Decisão da Justiça anula patente de droga anti-Aids, Folha de S. Paulo, 9 Mar 2012
• Brazil HIV Drug Patent Ruling Allows Generics, Sends Pipeline Process Into Doubt, Intellectual Property Watch, 21 Mar 2012

Documents from NGOs

• GTPI  supports  judicial  decision  annulling  the  patent  for  a  HIV/AIDS  medicine, Working Group on Intellectual Property, 26 Mar 2012

Legal/Court Documents

• Cristália: [PO] “TRF2 pode retomar julgamento esta semana sobre produção de remédio contra Aids”, André de Souza, 14 novembro de 2013
  
• [PO] [PDF] “Ação de Cristália Produtos Químicos Famacêuticos contra Abbott laboratories”, 23 fevereiro de 2012 [Decision of Federal Court of Rio de Janeiro annulling patent for HIV/AIDS medicine, 23 Feb 2012]