Once a patent expires, other companies may begin to exploit an innovation that was previously protected and has now entered the public domain. However, those who choose to do so must take care not to infringe other types of intellectual property associated with the product. The expiration of a patent does not mean that the name, packaging and appearance of the original product may also be freely used.

Take, for example, the so-called “weight-loss pens”, the popular name in Brazil for semaglutide injection pens, which are generally indicated for diabetes or weight management, depending on the product. The semaglutide patent expired in Brazil in March 2026, and other pharmaceutical companies may now develop drugs containing the substance, provided they obtain marketing authorization from Anvisa (Brazil’s National Health Surveillance Agency). Everything else, however, is less straightforward: the injection mechanism and the visual identity may be subject to other types of protection that remain in force.

These competing versions are often referred to as “generics”. In legal terms, however, a generic drug in Brazil is one that is interchangeable with the reference drug and identified solely by the name of its active substance, without a brand of its own. When a competitor has its own name and visual identity, trademark and trade dress issues become even more significant. For this reason, both companies already on the market and those planning to launch a competing product must ask what can be reproduced and what must be respected.

The main types of protection for an injection pen

To answer this question, it is important to understand that a single product may combine different types of protection, each with its own purpose, requirements and duration. Some of them are outlined below.

Invention patent

Invention patents protect new technical solutions, such as a chemical compound, a mechanism or a process, provided they involve an inventive step and are capable of industrial application. Protection lasts 20 years from the filing date, and a single product may be related to several patents expiring on different dates. In the case of weight-loss pens, for example, patents covering the dose-setting mechanism may remain in force after the patent on the active ingredient has expired.

Utility model patent

A utility model protects functional improvements to objects of practical use, such as a new shape or arrangement that makes the object easier to use or manufacture. Unlike an industrial design, which protects appearance, a utility model protects a shape that improves functionality. In an injection pen, it might cover, for example, a grip that makes the injection easier. The inventive threshold is lower than for an invention patent, and protection lasts 15 years from the filing date.

Industrial design

Industrial design registration protects the new and original ornamental appearance of an object. Registrations are granted by the INPI (Brazilian Patent and Trademark Office) and may last up to 25 years, including the extensions provided for by law. Ideally, the application should be filed before any public disclosure, not merely before the commercial launch. Brazilian law provides a 180-day grace period for certain disclosures, including those made by the designer, provided the legal conditions are met. Outside these conditions, disclosing the design may prevent a valid registration.

Trademark

Trademark registration protects signs that identify the origin of a product or service, such as names and logos, and, under certain conditions, its shape, as a three-dimensional mark. Registrations are granted by the INPI and may be renewed for successive ten-year periods, provided the legal requirements are met.

Trade dress

Trade dress, known in Brazil as conjunto-imagem, is perhaps the least understood type of protection outside legal circles. It refers to the overall presentation of a product or service to the public, such as the combination of colors, shapes, packaging, labeling and layout, and may also include sensory elements such as fragrances. It does not depend on registration and has no fixed term, but its protection is subject to specific requirements, discussed below.

These instruments complement each other, and the expiration of a patent does not automatically end the protection of a product’s identity. At the same time, that identity cannot be used to extend exclusivity over a technical solution.

Pharmaceutical trade dress: protection without registration, but with requirements

In the pharmaceutical sector, trade dress may cover the box, the label and the drug delivery device itself.

In Brazil, there is no specific registration for trade dress. Its protection derives from the rules against unfair competition set out in Articles 195(III) and 209 of the Industrial Property Law (Law No. 9,279/1996). These rules make it possible to act against imitations capable of causing confusion or undue association between competitors and to seek compensation for the resulting damages.

According to case law, including that of the Superior Court of Justice (STJ), Brazil’s highest court for non-constitutional matters, it is not enough to show that a company uses a particular visual presentation. As a rule, the following must be demonstrated:

• prior use;
• inherent or acquired distinctiveness;
• the non-functional nature of the elements; and
• likelihood of confusion among consumers.

In other words, similarity is not synonymous with unfair competition. Features that are common in the sector or necessary for the product to function do not become exclusive merely because a company uses them. The party seeking protection must prove the requirements on which its claim is based.

Functionality, color and the limits of protection

Appearance cannot serve as a shortcut to indefinitely prevent the use of a technical solution. For this reason, Brazilian law excludes from trademark registration shapes that are necessary, common or inseparable from a technical effect, and prohibits the registration as industrial designs of shapes determined essentially by their function.

In an injection pen, the elongated body, the dose selector, the dose window and the protective cap may respond to usability, ergonomic and safety requirements. When these solutions meet the legal requirements, they may be protected by an invention patent or a utility model, for a limited term, but they do not become exclusive through their appearance. This does not prevent the protection of specific ornamental choices, provided the requirements of each instrument are met.

Color calls for similar caution. Colors and their names, on their own, cannot be registered as trademarks unless they are arranged or combined in a peculiar and distinctive manner. In trade dress cases, the assessment considers the presentation as a whole, not merely the coincidence of a color or the use of a particular color combination.

Evidence that the public has come to associate a given presentation with a company may strengthen its protection. This is known as acquired distinctiveness, or secondary meaning. Since November 2025, the INPI has had a specific procedure to recognize it in trademark registration (INPI Ordinance No. 15/2025). This procedure, however, does not override the statutory prohibition on registering a single color as a trademark.

Is it possible to obtain a preliminary injunction in trade dress disputes?

Yes. The Brazilian Code of Civil Procedure (Article 300) and the Industrial Property Law itself (Article 209, paragraph 1) allow judges to order the provisional suspension of a conduct before the final judgment. To do so, however, there must be evidence indicating the likelihood of the right claimed and a risk of harm or of jeopardizing the outcome of the proceedings.

In trade dress disputes, the difficulty may lie in demonstrating these requirements at the outset. It is therefore advisable to support the request with documents showing that the trade dress meets the requirements for protection and that there is a likelihood of confusion, such as legal opinions, technical reports and opinions, semiotic studies and consumer perception surveys.

In addition, the likelihood of confusion must be assessed in the context of the market, taking into account the presentation of the products, their sales channels and their target audience.

The STJ has held that whether unfair competition by confusion exists, for the purpose of protecting trade dress, is a question of fact to be determined through a technical expert examination (Special Appeal REsp 1.591.294/PR, Reporting Justice Marco Aurélio Bellizze, Third Panel, judged on March 6, 2018). This does not mean that every injunction must await the completion of a court-appointed expert examination: the decision depends on the evidence available and the particular circumstances of the case.

For this reason, it is advisable to gather documents, images, usage history and technical evidence before filing suit, especially when seeking urgent relief. It is not necessary to have all the evidence ready before the proceedings begin, but the better supported the initial complaint, the greater the chances of obtaining urgent relief in the form of a preliminary injunction. Other evidence, including the expert examination, may be produced during the proceedings.

Likewise, the denial of a preliminary injunction does not, in itself, mean that the challenged use is lawful. The finding on whether an infringement exists may differ once the case has been fully examined.

What to do before a dispute arises

For companies developing or already marketing the product

• Separate function from identity: identify, from the design stage, which features stem from how the product works and which are visual choices capable of distinguishing it.
• Combine the available types of protection: consider invention patents or utility models for technical solutions, industrial designs for ornamental appearance and trademarks for distinctive signs. Whenever possible, plan filings before any public disclosure.
• Document use and recognition: keep versions of packaging, advertising materials, launch dates and recognition surveys. These records can help demonstrate prior use and the distinctiveness of the trade dress.
• Monitor the market: track product launches and registration applications to identify conflicts and assess administrative or judicial measures within the applicable deadlines.

Para quem pretende lançar um produto concorrente

• Check freedom to operate: confirming that the patent on the active ingredient has expired is not enough. It is necessary to assess whether other patents still in force may cover the device, the formulation or the manufacturing process to be used.
• Assess the name and visual identity: the analysis should consider trademarks, industrial designs and the trade dress of established products. Developing a distinctive presentation helps reduce the risk of confusion.
• Distinguish regulatory approval from trademark protection: Anvisa grants marketing authorization for the drug and reviews its name from a health and safety perspective, while the INPI grants trademark registrations. Regulatory approval does not replace an intellectual property analysis, nor does it, in itself, rule out a potential unfair competition claim.
• Record the creative process: documenting how the name, colors and other visual elements were chosen helps demonstrate the independent development of the presentation, but does not replace an analysis of third-party rights.
• Protect your own identity: file trademark and industrial design applications for the new product before any public disclosure.

Ricci Propriedade Intelectual advises Brazilian and foreign companies on the protection of patents, industrial designs, trademarks and trade dress in Brazil, from launch planning to unfair competition disputes. If your company operates in or plans to enter the Brazilian market and needs to assess the protection of a product or the safety of a new visual identity, contact our team.