On April 7, the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/Rebrip), filed an amicus curiae to the Federal Court to assist the judge deciding on a case brought by Interfarma.
Our partner, the Brazilian Interdisciplinary Association of AIDS (ABIA), coordinated the action. Legal and technical arguments were provided to advise the court, and to disagree with Interfarma’s proposal to change how monopolies on medicines are authorized in the country.
Interfarma is an association that brings together the largest multinational pharmaceutical companies. It lobbies in Brazil for rules that allow a larger number of, and longer, monopolies on medicines. This latest initiative would further weaken the patent system to make this easier to achieve.
A request for low quality patents
Interfarma is requesting the removal of Anvisa (Brazil’s National Health Surveillance Agency) from the analysis of pharmaceutical patent applications. Since 2001, Anvisa’s participation has been a role known as ‘prior consent’. It carries out a merit analysis which is considered a preventative measure for patent abuse, by making the examination more rigorous by denying the approval of low quality patents. Patent applications that do not contain relevant innovation, and are designed purely to retain a monopoly and block the entry of cheaper generic drugs, would be refused.
In March, the Federal Public Ministry concluded Interfarma’s action to be “unfounded”. In addition, it emphasized that it must be preferable for Anvisa to continue to “evaluate not only the harmfulness of the medicines, but also the risks of restricting access to medicines by the granting of patents”.
However, several other court decisions have supported Interfarma’s arguments. This current impasse prevents the use of generic medicines as well as the associated savings for the Brazilian health system.
According to Pedro Villardi, GTPI coordinator: “Some specific cases highlight the significance of Anvisa’s contribution, and the value of them if its decisions are upheld. Recently, Anvisa denied the patent for sofosbuvir, the medicine that cures Hepatitis C. If Anvisa’s decision was followed through, Brazil could access the drug at prices almost 1/8 of what is paid today. That would mean being able to treat thousands of people who currently have to wait until they are at the most advance stages of the disease. However, because Interfarma is attempting to invalidate Anvisa’s participation, no-one can benefit from this stalled decision.”
Attacked from two angles
In addition to the dispute in the courts, an agreement is also being negotiated between Anvisa and Brazil’s patent office, the National Institute of Industrial Property (INPI). Such agreement would weaken Anvisa’s powers to reject patents, making the agency merely advisory body. “We consider any agreement to illegitimate as it is not as a result of any debate or consultation with society,” says Villardi. “We cannot give up the participation of Anvisa, especially at a time when the patent system is malfunctioning, bringing incalculable damage to public health”.
In a survey conducted by GTPI, it was identified that Anvisa’s rejection of the docetaxel medicines patent, used in the treatment of cancer, saved Brazil more than R $6 million in 2013 (approx $2 million USD). In addition, in 2010 a patent was denied on the antiepileptic medicine, pregabalin, due to Anvisa’s participation, and today Brazil has access to generic versions at prices almost 22 times lower.
However, there are also cases in which Anvisa’s contribution has been blocked by INPI. One example is of the cancer drug, afatinib. In October 2014, Anvisa sent INPI it’s opinion but still INPI has not published the decision. That means that the patent application still pending and the company that applied for the patent can continue to market the medicines in a monopoly situation, as while it’s ‘pending’ it is the only company that has registration of the medicine in the country. Sofosbuvir is now another example that is left hanging in the air, while tactics to attempt to allow corporations free reign in Brazil are decided upon.