Pin for obesity: justice reverses a decision that has extended the liraglute patent

Pin for obesity: justice reverses a decision that has extended the liraglute patent


The injunction allows the Brazilian pharmacist IS to continue producing the national version of the drug, thus suspending the effects of the previous decision, in favor of the new Nordisk

A new decision of the Federal Court has suspended the extension of the period of validity of the patent of liraglutideActive ingredient present in the medicinal products of Victa and Saxenda, used in the treatment of diabetes Type 2 e obesity.

Last week, the new Danish pharmacist Nordisk, who had a patent, had obtained a favorable decision from the third federal civil court of the judicial section of the Federal District that recognized the right of the reconstruction company of the patent period Due to the “disproportionate and unjustified” delay of the National Institute of Industrial Property (INPI) to grant the patent.

THE New Nordisk He submitted an Ini registration request in 2004, but the cause was completed by the Institute only more than 13 years later, in 2018. In Brazil, patents in the last 20 years, but this deadline is not counted from the moment in which the patent is actually granted, but from the start date of the process. Therefore, the exclusivity of the patents of the liraglutado was in force until last year.

The first judge of request considered that, in the 13 years of procedure with the Inpi, there were two periods of inertia that amounted to about eight years and granted a recomposition of at least eight years within the patent, which would protect the liraglutide starting from 2032.

Last Saturday, 6, however, the EMSBrazilian pharmaceutical production that produces the first national version of liraglutide (oil and lirux), has obtained an injunction by overturning the decision of the first instance and thus guaranteeing the continuity of the production and the marketing of its products based on the liraglutide. The first national versions of the drug began to be sold in August.

It is still presented to the decision, but if no part has submitted another request, the injunction will be valid until the merit of the action is valid.



In the injunction, granted by the Federal Judge Flávio Jardim, of the Federal Regional Court of the 1st Region, the magistrate states that the first instance decision “violated the duties of maintaining a stable, full and coherent jurisprudence” Supreme Federal Court (STF) “It does not authorize the extension of the patent period.”

This is because the first decision was based on a position of the Supreme in the judgment of the action of direct unconstitutionality (ADI) 5529, in 2021

In the same decision, however, the Supreme would have recognized, according to judge Bruno Anderson Santos da Silva, the possibility of punctual adjustments in the patent period (mechanism known internationally as Adjustment of the patent term – PTA) In exceptional delay situations not attributable to the owner. The thesis, however, was refuted by the judge in the second instance injunction.

The judge also affirmed, in his argument, that the sentence that extended the patent of the liraglutide “” “ends up having a direct impact on the public policy of the marketing of generic drugs based on the liraglutide, maintaining the concentration of the market, the high price and causing collective economic damage. “

In his decision, he quoted the fact that, recently, the National Commission for the incorporation of Sus (Conitec) technologies they denied the incorporation of drugs drugs (liraglutide) and wegovy (semaglutida) in the public health system. The magistrate said he was used as topics for non-incorporation “the absence of cost-benefits” and “the high impact of the budget, given the price imposed during the period of patent protection”.

In a declaration, EMS declared that the decision “strengthens the full regularity of EMS, the only active registration company in Anvisa for Liraglutide medicines” and has declared that “he reiterates his commitment to guarantee safe access, at accessible prices to the Brazilian population, while investing in the innovation and development of high -complexity medicines, in line with the principles of free competition.

Novo Nordisk was also wanted on the afternoon of Monday 8, to comment on the new decision, but did not comment.

Previously, the company had already stated that “the central controversy of the action was not to extend the period of 20 years of protection, global standards, but rather on how this period is consumed by bureaucracy”. He also said he was looking for “legal certainty to continue investing and bringing the most modern treatments to the population in Brazil”.

Source: Terra

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