The Ministry of Health sent to the National Congress, in June 2026, a technical opinion with an unfavorable recommendation for PL 5810/2025, which establishes a mechanism for adjusting the term of validity of drug patents in case of delay in the processing of requests at the INPI. The study that supports the opinion was conducted by the General Coordination of Promotion and Regulation of the Economic-Industrial Health Complex (CGPR), and its numbers are significant: in a moderate scenario, the proposal could generate an additional impact of R$ 3.1 billion for the SUS and R$ 4.5 billion for supplementary health — considering only four medications.
Lígia Formenti’s article in JOTA, brought the details of the study to public.
The Regulatory Context
PL 5810/2025 is part of a debate that gained new momentum after the judgment of ADI 5.529 by the Federal Supreme Court, which declared the sole paragraph of art. 40 of the Industrial Property Law (LPI) unconstitutional. This provision ensured a minimum term of validity of ten years for patents, counted from the grant — which, in practice, extended the monopoly when the INPI took longer than expected to examine the application. The STF understood that this rule violated public interest by artificially delaying the entry of competitors into the market.
PL 5810/2025 seeks, in essence, to recreate this mechanism in a new guise: adjusting the patent term as a way to compensate the applicant for delays in processing — an approach internationally known as Patent Term Adjustment (PTA).
The Study Methodology
To project the impact, CGPR analyzed four high-cost medications: aflibercept, blinatumomab, nivolumab, and ofatumumab. The choice is not casual — these are drugs with patents nearing expiration, indicated for serious conditions (oncological and ophthalmological), and with a consolidated presence in the SUS incorporation lists.
The study considered two scenarios:
| Scenario | Premise | SUS Impact | Supplementary Health Impact |
|---|---|---|---|
| Conservative | Current prices maintained during extension | R$ 1.24 billion | R$ 1.81 billion |
| Moderate | Reduction of up to 60% (synthetic generics) and 50% (non-new biologics) | R$ 3.11 billion | R$ 4.52 billion |
The document highlights that even limited to four medications, the financial magnitude is already “relevant”. Projected for the total universe of medications with extension potential, the impact would be substantially greater.
Systemic Consequences
The document points out that PL 5810/2025, by artificially prolonging monopoly structures:
- Increases prices — by delaying the entry of generics and biosimilars, it maintains the original manufacturer’s price for longer
- Restricts competitive efficiency — the pharmaceutical market in Brazil already faces significant entry barriers; patent extension adds another obstacle
- Compromises public resource allocation — every real spent more on monopolized medications is a real that is no longer invested in the incorporation of new technologies, expansion of access, or other health policies
As the technical note states: “resources potentially directed towards the incorporation of new technologies” are diverted to maintain high prices for medications whose patents should have already expired.
In supplementary health, the effect is also concerning: the document warns that the persistent rise in prices “tends to pressure healthcare expenses, compromise the economic-financial sustainability of operators, and intensify cost pass-throughs to beneficiaries”.
Alignment with Industrial Policy
The CGPR’s technical opinion provides analytical depth to this position, with concrete data that allows Congress to evaluate the trade-off between the interests of patent holders and the public interest.
It is worth noting that the Economic-Industrial Health Complex is one of the central axes of the New Brazil Industry (NIB), which foresees investments and policies to reduce external dependence on pharmaceutical inputs. Patent extension, in this context, acts in the opposite direction — by prolonging monopolies of foreign manufacturers, it hinders the development of local productive capacity.
What to Expect in Congress
PL 5810/2025 is being processed under a priority regime and has strong support from the pharmaceutical industry, which argues that the INPI’s delay cannot penalize the applicant. The INPI, in fact, has a history of significant backlog — although it has reduced the stock of pending applications in recent years, as we have already analyzed in another article.
The Ministry of Health’s opinion, however, presents a piece of data that the Legislature will hardly ignore: the PTA’s bill is not abstract — it has a value, a recipient (the SUS), and specific medications. For a Congress that constantly discusses public health funding, the impact of R$ 3.1 billion on just four medications is a number difficult to circumvent.
Read also:
- The INPI backlog is over — but not for drug patents
- The INPI backlog is over — but not for drug patents
- The INPI backlog is over — but not for drug patents
You can get in touch to discuss this and other topics at the email [email protected]