Tirzepatide and semaglutide have established themselves as two of the most relevant therapeutic advances in recent years for the treatment of obesity and diabetes, which has driven growing demand for these medications and transformed them into high-value commercial assets in the pharmaceutical market.

However, the economic success of these medications also attracts the interest of organized crime, which reproduces the products’ formula to distribute them through social media and clinics – in addition to encouraging the irregular entry into Brazil of units manufactured in foreign countries, such as Paraguay.

But why Paraguay? Well, this is mainly due to the principle of territoriality applicable to patents. In countries where the patent is not applied for, the medication is free to be commercially exploited legally, since the patent holder has no exclusivity over that innovation.

Thus, in order for a patent not to be legally reproduced anywhere in the world, it is necessary to protect the patent in all territories. There is no patent with worldwide validity, and such global protection may be impractical. Therefore, companies strategically choose to protect their inventions through patents in territories that represent a relevant market for the production and commercialization of their medications.

The manufacture and commercialization of products containing tirzepatide or semaglutide in Paraguay does not, therefore, constitute an infringement of the patents granted to their respective holders – Eli Lilly in the case of tirzepatide, and Novo Nordisk in the case of semaglutide – in the countries where these inventions have been protected.

Upon crossing the border, however, the situation changes. What was previously produced and commercially exploited lawfully in Paraguay becomes a smuggled product in Brazilian territory, where the companies have duly protected their assets before the Brazilian Patent and Trademark Office (BPTO), and may also be classified as a crime against public health.

What this means for society is that this unofficial production in Paraguay – often carried out by manufacturers who do not have sufficient knowledge of the complexity and instability of these molecules – reaches the market without the same standard of sanitary control required of the original products, posing a real risk to the health of consumers, who are predominantly Brazilian.

Among the most critical risks to consumers are the lack of control over the quality and therapeutic efficacy of the product, inaccurate dosages (present in approximately 95% of products compounded irregularly), and the possibility of contamination by microbiological or chemical agents. Taken together, these factors place even greater pressure on the Brazilian healthcare system.

This uncontrolled consumption is largely driven by the sales channels themselves, such as social media and digital influencers, who, whether aware or unaware of the risks involved, rarely advise consumers to seek specialized medical supervision. This factor contributes to the spread of irregular channels and products without any production control, with potentially serious consequences for those who consume them.

Last but not least, products smuggled into Brazil make use of organized crime logistics channels which, attracted by the substantial financial gains in comparison with the minor penalties imposed in cases involving the smuggling of such products, generate a series of related crimes. Alongside other types of illegal markets, such as piracy, customs evasion, and counterfeiting, annual losses amounted to BRL 468 billion in 2024 (1.7% of GDP), in addition to causing indirect losses related to tax evasion and unemployment.

To address this problem, coordinated action among different sectors is essential: the productive sector, health regulatory agencies, law enforcement authorities, organizations involved in intellectual property, and the Judiciary, combined with ongoing efforts to raise consumer awareness of the risks they face to their own health.

The Green Patents Program was created to encourage the development of sustainable technologies by accelerating the examination of certain patent applications. However, eligibility for the Program is not automatic. To be admitted, the application must meet the requirements established by Brazilian Patent and Trademark Office (BPTO)’s Ordinance No. 79/2022 and be the subject of a request for participation in the Program.  

Understanding these requirements is essential for inventors, companies, and research institutions to assess, from the outset, the feasibility of submitting such a request. 

Who may apply?

The Green Patents Program covers both Invention Patents (PI) and Utility Models (MU). In addition, the patent application must have already been published in the Industrial Property Gazette (RPI) or be accompanied by a request for early publication. It is also necessary that the request for substantive examination has already been filed and that the examination has not yet commenced before the BPTO. 

The applicable regulation also establishes a limit of fifteen claims, of which up to three may be independent, and requires that the technology be classified under one of the categories covered by the International Patent Classification (IPC) Green Inventory, which includes fields such as alternative energy, transportation, energy conservation, waste management, and sustainable agriculture. Where the applicant is domiciled abroad, a Brazilian representative must also be appointed to act on its behalf before the BPTO.

How does the procedure work?

Applications for admission are submitted electronically through the BPTO’s e-Patentes system. 

After the patent application has been filed and published, and once the request for substantive examination has been submitted, the applicant may request participation in the Green Patents Program by completing the appropriate form and paying the applicable official fee. If the request is accepted, the application will proceed under a priority examination until the conclusion of the substantive examination. 

What are the benefits? 

The main benefit of the Program is the shorter time required to obtain a decision from the BPTO.

However, the benefits extend beyond administrative efficiency. A patent granted more quickly may strengthen a company’s intellectual property strategy, provide greater legal certainty for investments, facilitate licensing and technology transfer negotiations, and enhance the value of the organization’s intangible assets. 

For companies operating in innovation-intensive sectors, obtaining a patent more quickly may also represent a significant competitive advantage, particularly in industries where time to market is a strategic consideration. Before requesting qualification under the Green Patents Program, it is advisable to assess whether the technology effectively meets the criteria established by the BPTO and whether this strategy is aligned with the company’s business objectives.

Innovation plays an increasingly important role in the search for solutions capable of reducing environmental impacts and promoting the more efficient use of natural resources. From clean energy generation to the development of new industrial processes, sustainable technologies are transforming various sectors of the economy and creating opportunities for companies, universities, and research institutions

In this context, intellectual property becomes an essential instrument for protecting these innovations and encouraging further investment. With this objective, the Brazilian Patent and Trademark Office (BPTO) established the Green Patents Program, a mechanism that grants priority examination to certain patent applications related to environmentally sustainable technologies.

While a patent application usually takes several years to be examined, qualifying for the Green Patents Program may significantly reduce this timeframe, allowing the technology to be protected and commercially exploited more rapidly. 

What is a green patent?

Although the term is widely used, there is no specific category of “green patent” under Brazilian industrial property law. In practice, it refers to a patent application that, by meeting the criteria established by the BPTO, becomes eligible for a prioritized examination. The legal requirements for obtaining a patent remain exactly the same: the invention must be novel, involve an inventive step, and be capable of industrial application.

The distinguishing feature of the program lies exclusively in the priority granted to the substantive examination, reducing the time required for the patent application to be examined. The initiative is aligned with the United Nations (UN) Sustainable Development Goals (SDGs) and is based on the International Patent Classification (IPC) Green Inventory, developed by the World Intellectual Property Organization (WIPO).

Which technologies may qualify?

The Green Patents Program covers different areas of innovation aimed at sustainability. Eligible technologies may include solutions related to renewable energy generation, such as solar energy, wind energy, biomass, green hydrogen, and biofuels. The program may also encompass inventions related to sustainable transportation, including electric vehicles, hybrid systems, and technologies designed to reduce greenhouse gas emissions.

The program also covers solutions focused on energy efficiency, such as industrial processes with lower energy consumption, thermal insulation materials, and more efficient buildings, as well as technologies related to waste management, recycling, wastewater treatment, environmental sanitation, and the restoration of degraded areas. In agriculture, eligible technologies may include, for example, intelligent irrigation systems, reforestation techniques, and other solutions intended to promote the more sustainable use of natural resources.

However, the mere existence of an environmental benefit does not automatically qualify a technology for the program. Each application is individually examined by the BPTO to verify whether it meets the criteria established under the program.

Why is priority examination important?

In an increasingly competitive business environment, the time required to obtain a patent can have a direct impact on a company’s innovation strategy.

Obtaining a patent more quickly provides greater legal certainty for investments, facilitates licensing and technology transfer negotiations, strengthens the organization’s portfolio of intangible assets, and may represent an important competitive advantage in the marketplace. For companies developing sustainable technologies, the Green Patents Program therefore constitutes an important instrument for accelerating the protection of innovation and expanding opportunities for the commercial exploitation of the technology.

In the next article, we will explain the requirements for participating in the program, how to request priority examination before the BPTO, and the benefits that may be obtained through this procedure.