Brazil Supreme Court suspends drug patent extensions

Brazil’s highest court has suspended extensions of drug patents due to the public health emergency caused by COVID-19.

Brazilliian Supreme Court judge Justice Dias Toffoli cited the “exceptional situation” of the COVID-19 crisis in the preliminary ruling on Wednesday, April 7.

The decision suspends the sole paragraph of Article 40 of the Brazilian IP Statute—an article that ensures a minimum ten-year term of patent protection for inventions from the grant date.

Wednesday’s order, which will be submitted for a plenary referendum, aims to protect generic drug manufacturers from IP litigation when manufacturing treatments against the coronavirus and reduce costs for COVID-19 drugs across the country.

The ruling resulted from a lawsuit first filed in 2016 to petition the Supreme Court to reconsider its patent protection laws, claiming that the laws offer protection for an “excessive time period”.

According to Reuters, Augusto Aras, Brazil’s prosecutor general, asked the Supreme Court for an urgent ruling on the litigation in February to allow the development of more generic drugs to tackle the COVID-19 pandemic.

The Attorney General’s office, acting as plaintiff in the lawsuit, argued that the article allowed for an “indefinite period for the validity of invention patents”, which violates item XXIX of the Brazilian constitution.

The constitutional challenge was scheduled for a decision yesterday, April 7, before a full panel at the Supreme Court. In view of another judgment, the case was postponed until next Wednesday.

However, Justice Dias Toffoli, decided yesterday to grant a preliminary injunction.

“The pressure on health systems has increased globally, increasing the demand for inputs throughout the service chain, such as pulmonary respirators, personal protective equipment, drugs to alleviate the symptoms of the disease and to treat its complications, substances intended for sedation of intubated patients, just to name a few examples,” said Toffoli.

IP rights and COVID

Joaquim Eugenio Goulart, a partner at Danneman Siemsen, said: “Hon Dias Toffoli’s opinion on the merits establishes that the ten-year patent term provision is unconstitutional. However, he understood that all patents—but the pharmaceutical ones—should keep the ten-year term (only new patents would be granted without applying the ten-year term from the granting date).

"So, on the merits, the reporting justice (Toffoil) states that pharmaceutical patents with a ten-year term would have to be reduced to 20 years from filing date.”

Goulart added: “However, we need to check the next steps and also how the full panel of the Supreme Court will decide the merits of the case.”

There have been calls from many human rights groups and governments to waive certain IP rights related to COVID-19 treatments in order to lower costs of drugs, allow the production of generics, and make treatments more widely available.

The World Trade Organisation (WTO) is under pressure to waive Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreements related to COVID vaccines.

Most recently, a group of global charities, including Oxfam, Amnesty International and Trócaire have called on the Government of Ireland to support the waiving of these rights to ensure equitable access to COVID-19 vaccines across the globe.

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