THE Federal Regional Court of the 1st Region (TRF1) published This Friday (19) decision authorizing third parties to produce liraglutide medicines. Among them are the “Pens” that fight obesity and type 2 diabetes.
According to the court, There is no right to extend the period of the substance patent (PI0410972-4), As the new company Nordisk wantedResponsible for the SAXENDA LINDING PEN.
THE measure meets the request of the National Institute of Industrial Property (INPI) to suspend first instance decision that had extended the duration of the patent.
According to INPI, the decision gains relevance amid concern for the shortages of drugs. Recently, the National Health Surveillance Agency (Anvisa) has opened a public notice for registration of semaglutado products, reinforcing the need to expand supply in the market.
According to the INPI, the understanding of TRF1 follows the Supreme Court (STF) line, which in 2021, in the Direct Unconstitutionality Action (ADI) No. 5,529, declared unconstitutional the automatic extension of patents and fixed the maximum term from the deposit.
For INPI, the decision reaffirms legal certainty and predictability in the industrial property system, ensuring the social function of the patent, free competition and the population’s access to more affordable drugs.
The report of Brazil agency contacted the new company Nordisk. The company sent the following note:
“It caused a strange Nordisk that INPI claimed to court, in its reasons of appeal, the recognition of the alleged right to free commercialization of products in favor of third parties, as well as having a statement on its official website about the alleged risk of shortage of GLP-1 drugs in the Brazilian market. Pro-Inovation Environment in the country. INPI is a technical organ, whose performance in patent examination must be attached to compliance with legal requirements, should not be guided by public policies of any specific industrial sector. “
