Pharma companies attempt to overturn Brazilian Supreme Court’s historic decision on patents

Pharmaceutical companies are trying to undermine a decision of the Brazilian Supreme Court from 2021 which puts health ahead of private profit

December 15, 2022 by Felipe Carvalho Borges da Fonseca, Susana Rodrigues Cavalcanti Van Der Ploeg, Maria Clara Pfeiffer Noronha, Alan Rossi Silva
Health activists during action for access to medicines. Photo: GTPI/ABIA

The barriers that certain intellectual property rules can generate – preventing the fair distribution of vaccines and medicines – are a recurring theme in debates on global health. Traumatic experiences such as the HIV/AIDS treatment access crisis in the 90s, the global rationing of hepatitis C treatment in 2014, and the unfair distribution of COVID-19 vaccines are concrete examples of the right to health being systematically violated when monopolies over medical technologies are established and exercised arbitrarily.

It is urgent to recognize, expose and confront the abuses that are committed in the patent system that result in death and suffering for millions of people. In Brazil, we are currently experiencing a situation of triple abuse, which threatens the populations’ access to dozens of essential medicines.

On May 12th 2021, in the scope of the Direct Action of Unconstitutionality (ADI) no. 5.529/DF, the Brazilian Supreme Court declared that one part of the Brazilian Industrial Property Law was unconstitutional. With this important decision, the Supreme Court ruled out the possibility of extending, under any pretext, the term of patents in Brazil, putting an end to an injustice that lasted more than two decades.

The order meant that from then on, every granted patent in Brazil would have a term of 20 years at most, counted from the patent application filing date. Considering the essential nature of the right to health, and the challenges imposed by the COVID-19 pandemic, the judges also established that this decision would have retroactive effects on all patents related to pharmaceutical products and processes, as well as healthcare equipment and/or materials.

A victory for the Brazilian people threatened by Big Pharma

This meant that thousands of health-related patents expired immediately or had their terms significantly shortened. In practice, it paved the way for an increase in the supply of generic medicines, saving billions of reais in public resources, and strengthening public health policies. It was a great victory for the Brazilian people, no doubt.

As expected, however, a group of transnational pharmaceutical companies and their lobbyists were not satisfied at all with this result. For them, the two-decade monopoly over life-saving technologies was not enough. To make even more money, it would be necessary to subvert the Supreme Court decision to recover the possibility of extending patent terms in Brazil.

When they recognized the impossibility of appealing against a Supreme Court decision, these companies mobilized their substantial financial resources and resorted to an unbelievable subterfuge. Without any legal basis, they filed dozens of lawsuits in the lower courts, and asked the judiciary to extend the term of specific patents, case by case. That was what they started calling Patent Term Adjustment (PTA) — an instrument that does not exist in the Brazilian legal system.

The arguments presented by them were so fragile that from the beginning, there was no doubt that these actions were unconstitutional and directly challenged the Supreme Court’s authority. In a perverse trial-and-error game, the companies that sponsor these actions are trying to abuse the complexity of the legal system and are investing loads of money to advance their arguments, no matter how outrageous they are.

Having been an amicus curiae in the ADI no. 5.529/DF, the Brazilian Interdisciplinary AIDS Association (ABIA) has warned about the absurdity of these actions from the beginning. In addition to participating in interviews, events and opinion articles, ABIA has already filed two amicus curiae briefs in the case that tried to extend the term of a patent related to palbociclib, an essential medicine in fighting against advanced or metastatic breast cancer.

In this case, the pharmaceutical company Warner-Lambert Company LLC., part of the Pfizer group, wants to extend the patent on this medication. The patent for the drug was initially extended, but this was ruled as unconstitutional by the Supreme Court. But despite this, the company is trying to get a patent extension of almost 10 years, which would be longer than the one already declared unconstitutional.

A triple abuse situation

Considering this absurd scenario, more recently, ABIA and other 18 civil society organizations formulated an inquiry to the former Supreme Court Justice, Professor Eros Roberto Grau. The Justice drew up a pro bono legal opinion, in which he is emphatic: the proposition of these legal actions is triply abusive! According to Justice Grau, by contradicting article 40 of the Brazilian Industrial Property Law, these actions abuse the patent right. They also abuse the right to petition by aiming for compensation without the evidence of any damage. Finally, they abuse the patent system by trying to hide their own strategic silence during the examination of the patent applications. Pharma companies remained silent during the examination of the patent application, not taking any effective measure about the time it was taking. Now, they want to be granted an extension on the basis that the Brazilian Patent Office was too slow in processing their initial applications.

The Brazilian legal system needs to give a strong response to these cases and stop, once and for all, the abusive conduct of these transnational companies. The right to health of our population and the integrity of the Federal Constitution are at stake in these actions. In doing so, Brazil can serve as an international example on this matter, rejecting and fighting this triple abuse situation.

It is certain that the ADI no. 5.529/DF was a great victory and needs to be widely celebrated by those who defend the public interest. From a historical perspective, it can be included in the same winning streak that goes back to the inclusion of the right to health in the Brazilian Constitution of 1988, the creation of the Unified Health System (SUS), and to the institution of universal and free access to treatment and preventive methods programs. The attempts of overthrowing the spirit of the decision taken within the scope of this case constitute an affront to all of these social achievements.

If ignored, the three abuses pointed out by Justice Eros Grau will tend to spread, leaving a trail of setbacks. If fought now, the economic actors that aim to obtain even more market power through the tortuous road of unconstitutionality will receive a clear response that, in Brazil, the right to health is taken seriously.

Felipe Carvalho Borges da Fonseca holds a Master in International Political Economy from the Federal University of Rio de Janeiro (UFRJ) and is coordinator of the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/Rebrip).

Susana Rodrigues Cavalcanti Van Der Ploeg is a PhD student in Law at the State University of Rio de Janeiro (UERJ) and staff attorney at the Brazilian Interdisciplinary AIDS Association (ABIA).

Maria Clara Pfeiffer Noronha is a Master’s student in Public Policies, Strategies and Development at the Federal University of Rio de Janeiro (UFRJ) and project assistant at the Brazilian Interdisciplinary AIDS Association (ABIA).

Alan Rossi Silva is a PhD candidate in Law at the State University of Rio de Janeiro (UERJ) and staff attorney at the Brazilian Interdisciplinary AIDS Association (ABIA).

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