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Picture the scenario: your company invests in R&D, designs an innovative technology and files a patent application. While it waits years for the technical examination by Brazil’s Patent and Trademark Office (INPI), a competitor launches an identical product on the market. The sense of harm is immediate. But what does Brazilian law actually safeguard during that wait?

The recent expiration of the semaglutide patent, in March 2026, brought the debate over the INPI’s examination times back into the spotlight. This reality, however, affects companies across every technology sector, not only pharmaceuticals.

The term starts running before the patent is granted

In Brazil, the rule on patent life is strict. Article 40 of the Industrial Property Law (Law No. 9,279/1996) provides that an invention patent is valid for 20 years, and a utility model for 15 years, counted strictly from the filing date. This means that examination time consumes exclusivity time. If the INPI takes 8 years to analyze the application, only 12 years remain for exclusive commercial exploitation.

Since the Federal Supreme Court (STF) ruled on Direct Action of Unconstitutionality No. 5,529 (ADI 5,529), which eliminated the guaranteed minimum term of 10 years after grant, the 20-year cap from the filing date is absolute. The courts have already settled, including in recent decisions by the Superior Court of Justice (STJ) at the end of 2025, that it is not for the Judiciary to extend patent terms by judicial order.

It is also worth noting that examination time varies considerably depending on the technology. Data from the INPI itself indicate an average of around 6 years for biopharmaceuticals and 3.5 years for polymers and related products. This is why deciding when and how to file a patent application carries strategic weight, and is not merely a bureaucratic step.

Is the invention unprotected during examination?

Although the applicant does not hold the definitive title while the application is pending, it is not left without recourse. Article 44 of the Industrial Property Law grants the holder the right to obtain compensation for the undue exploitation of the subject matter of the patent, including for the period between publication of the application and its grant.

A competitor that chooses to copy the technology while examination is underway therefore takes on a significant financial liability. Once the patent is granted, the effects of protection reach back to the publication date of the application (which, as a rule, occurs 18 months after filing).

This makes the publication of the application a decisive milestone. It is from that point that the clock on compensation begins to run. It is also from that point that the content of the application becomes public, which means competitors gain access to the invention and the company acquires a concrete interest in monitoring what they do.

Grant as a precondition for collecting

As noted above, the protection exists, but it cannot be exercised at just any moment. While the application is pending, the applicant holds a mere expectation of a right, not a title. The Superior Court of Justice has held that grant by the INPI is a precondition for an infringement action seeking compensation, because before grant the right to be repaired does not yet exist.

Once the patent is granted, the right comes into being and extends not only across the years still ahead, but back to the publication of the application. For that reason, the patent holder may claim for the entire period during which the competitor exploited the invention without authorization, including the years when the application was still under examination.

There is a time limit to observe. Article 225 of the Industrial Property Law sets a five-year period for actions seeking compensation for harm caused to industrial property rights. Add to this the need to prove the undue exploitation and its economic extent, and it becomes clear why the wait for examination cannot be a period of inaction, but rather a period in which the company builds the evidence for what it will later claim.

What about the INPI?

Delay in examination, known in legal terminology as administrative delay (mora administrativa), is a structural problem, acknowledged by the Federal Court of Accounts (TCU), by the courts and by the INPI itself, which attributes the backlog to a combination of rising filing volumes, the growing complexity of technologies and limited technical staff.

Acknowledging the problem, however, is not the same as converting it into extra patent term. Until 2021, the sole paragraph of Article 40 of the Industrial Property Law contained a form of automatic compensation, guaranteeing a minimum term of ten years from grant. The Federal Supreme Court declared that provision unconstitutional in ADI 5,529, and it was repealed in the same year. Only the rule of 20 years from filing (or 15, for utility model patents) remained in force.

Since then, nearly a hundred lawsuits have been filed seeking to have the lost time returned in the form of additional patent life. In the higher courts, virtually all have been denied, and always on the same ground: there is no Brazilian statute establishing objective criteria for such an adjustment, and it is not for the Judiciary to create them. That was the unanimous holding of the Fourth Panel of the STJ in December 2025, in the case concerning the semaglutide patents.

A separate question, still without settled guidance in the courts, is whether the holder may seek monetary compensation from the State for the delay itself. What is already clear is the point that matters most to anyone facing the problem today: fault for the delay, whoever bears it, does not change what the company may demand from the competitor that moved first. These are two independent paths, and only one of them is expressly provided for in the law.

The debate in the legislative arena

Because the Judiciary has recognized that it is not its role to create objective criteria for the adjustment, bills are now moving through Congress to create an administrative mechanism for adjusting the term of protection in cases of delay not attributable to the holder, inspired by instruments that exist in other jurisdictions, such as Patent Term Adjustment. In parallel, the INPI has set up a working group to review the Industrial Property Law, which turns 30 in 2026, with a public consultation planned.

Nothing has been voted on or approved to date. Until a statute exists, the rule remains the same: 20 years counted from the filing date, with no compensation for examination time.

What to do in practice

The current landscape rewards those who treat the wait as an active phase of their intellectual property management strategy. A few measures make a concrete difference:

  • Monitor the publication of the application, because it is the milestone from which the right to compensation for undue exploitation arises.
  • Assess mechanisms to accelerate examination, such as priority examination programs, like the one for green patents, and the PPH (Patent Prosecution Highway), which can significantly shorten the time to grant.
  • Monitor competitors and document from publication onward, gathering evidence of launches, volumes, prices and channels, because this documentation is what supports the compensation claim later on.
  • Plan exploitation counting the years from the filing date, not from grant, adjusting return-on-investment projections to that real horizon.
  • Combine layers of protection, pairing the patent with a trademark, a trade secret and other assets, so that the strategy does not depend on a single title.
  • Keep your own deadlines in order, responding promptly to the INPI’s office actions, since delays attributable to the applicant weaken any future discussion about administrative delay.

The importance of proper legal guidance

Every case depends on specific variables: the sector, the publication date, the competitor’s conduct, the stage of examination and the extent of what was actually exploited. The assessment must be made individually, and the sooner the better, because the decisions taken during the pendency of the application determine what it will be possible to claim later.

The team at Ricci Intellectual Property has more than 35 years of experience protecting patents, trademarks and other intangible assets, following the evolution of this topic closely and advising companies, including foreign companies operating or planning to operate in Brazil, on shaping their strategies in the face of administrative delay. To discuss your case, get in touch with us.

Autor

  • Renata Sebalos

    Renata atua há mais de 12 anos na área de Propriedade Intelectual e integra o escritório desde 2024. Compõe o departamento de patentes, atuando principalmente nas áreas de biologia, química, farmácia e biotecnologia.

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