The Brazilian Patent Office (INPI) informed that will prioritize the examination of the patent application PI0413882-1, related to two HIV medicines. This application is related to the heat-stable versions of the drugs lopinavir / ritonavir and ritonavir, which are widely used to treat HIV / AIDS in Brazil. This notification means that the INPI will prioritize the examination of this request, anticipating the analysis that will decide whether to reject or grant the patent. It is important to remember that the INPI currently has a backlog of nearly 10 years on analyzing patents on drugs, and while there is no answer on the granting or rejection, it is unlikely that generic competitors enter the market to exploit the technology. Resolution No. 191/08 of the INPI, which rules the priority examination, does not set any specific deadline for the exam, but states that a commission must be set up to address the examination of the patent application.
On November 10, the Working Group on Intellectual Property (GTPI) of the Brazilian Network for the Integration of Peoples (REBRIP) presented at the INPI technical arguments to contest the patent application PI0413882-1, made by American pharmaceutical company Abbott in 2004. In this patent opposition, GTPI alleges that the claims made by Abbott do not meet requirements of the Brazilian industrial property law, such as novelty and inventive step. The group considers it essential that these arguments are taken into account by the INPI commission that will review the application under the priority process, so that the patent is denied. This patent opposition was part of an important collective action by civil society groups in a number of countries to increase access to lopinavir/ritonavir, the “global Kaletra campaign”.
What is at stake in this patent application is the extension of Abbott's monopoly on the drug lopinavir / ritonavir and the appropriation of the drug ritonavir. The company currently holds a monopoly on lopinavir / ritonavir because of a patent granted in 1997, which will only expire in 2017. If the patent application PI0413882-1 is granted, the patent will be extended until 2024. In addition, in the application PI0413882-1, the drug ritonavir, which is now free of patents, is also included in its isolated form. This means that in case of granting, ritonavir will also be under Abbott’s monopoly. It must be said that both drugs are essential in the treatment of HIV / AIDS and it is expected that more patients in Brazil will start using them in the future. The request for priority examination itself can also be seen as an evidence of the essentiality of these products.
According to GTPI, not only the extent of the monopoly on these drugs is improper, but the existence of the monopoly itself, caused by the patent granted in 1997 through the mechanism called "pipeline." In 2007, GTPI presented a Direct Action of Unconstitutionality (ADI 4234) contesting the "pipeline" mechanism, which since 2009 is pending in Supreme Court (STF). Therefore, GTPI considers that besides the denial of the patent application PI0413882-1, which can be fast-tracked through the priority examination process, it is essential that the ADI 4234 is judged so that the mechanism "pipeline" is ruled unconstitutional and the various patents that have been granted trhough it, including lopinavir / ritonavir, are canceled. Place the drugs lopinavir / ritonavir and ritonavir in a "patent free condition” can enhance the reduction of prices and, consequently, preserve the sustainability of the program of universal access to medicines for the treatment of HIV / AIDS, in which many Brazilians rely on to survive.