Skinny labels and patent infringement in Brazil: safe harbour or liability?

In 2023, the Brazilian Health Regulatory Agency (Anvisa) adopted a regulation permitting generic and similar medicines to omit patent-protected indications from their labels, a mechanism known as a skinny label or carve-out. This regulatory permission, however, raises a conflict with the statutory requirement that generic and similar medicines correspond to their reference products, including their therapeutic indications.

The new regulation could enable a generic manufacturer to omit a patented indication from its label while the product continues to be used for that indication. This raises the concern, already debated in jurisdictions where skinny labels are permitted, that a carve-out could be used to avoid the apparent scope of a patent while inducing or contributing to infringement. The question for Brazil is how that possibility should be assessed under its patent law.

Brazilian federal law requires that generic and similar medicines mirror the reference product not only in the label but also in essential features such as dosage, indications, and pharmaceutical form. That created a difficult position where a new indication was protected by a second medical use patent. Including the indication could expose the generic manufacturer to a patent infringement claim, while omitting it could breach regulatory requirements.

In 2023, Anvisa approved RDC 831/2023, which amended RDC 47/2009 and has been in force since February 2024, establishing that generic and similar medicines would be allowed to omit indications protected by patents or claimed in published patent applications. When they do so, their labels must state that information concerning patent-protected indications has been suppressed.

Anvisa was also careful about what the amendment does not do. During the regulatory process, the agency stated that removing a patented indication does not authorise advertising or other practices associating the product with an indication absent from its label. It also made clear that patent infringement falls outside Anvisa’s remit.

The carve-out therefore addresses a regulatory obstacle to marketing a generic for non-protected indications but does not resolve the statutory requirement that generic and similar medicines correspond to the reference product. Nor does it determine whether conduct involving that product may infringe the patent.

Allowing a skinny label for a generic implies authorisation to alter the uses of the drug under a generic approval. In practice, it does not hinder the use of the generic for the omitted indication.

The problem is that in Brazil, physicians are allowed to prescribe by the pharmaceutical ingredient name, and using the product for the carved-out indication would constitute off-label use in relation to that product, even if the same indication remains approved for the reference medicine. This does not mean that the indication lacks scientific or regulatory support. Rather, it is not an approved indication for that particular generic.

Where the omitted indication is covered by a valid second medical use patent, the infringement analysis cannot necessarily stop at the wording of the label and the distinction between direct and contributory infringement is relevant. Direct infringement concerns the unauthorised performance of acts reserved to the patent owner under Article 42 of the Brazilian Patent Law, assessed in light of the scope of the patent claims.

Brazilian law also expressly addresses contribution to infringement. Article 42, paragraph 1, gives patent owners the right to prevent third parties from contributing to the performance by others of the acts prohibited by Article 42.

Article 42, paragraph 1, may therefore become particularly relevant where a product is formally marketed only for non-protected indications but is in practice supplied or promoted in connection with the patented use.

The mere fact that a generic medicine is technically capable of being used for the carved-out indication does not, by itself, establish contributory infringement. However, the conclusion is different where there is evidence connecting the manufacturer, distributor, or supplier to exploitation of the patented use. Promotional materials, communications with healthcare professionals, participation in procurement specifically directed to the protected treatment, and other circumstances surrounding supply may therefore become relevant.

Brazilian courts have recognised contributory infringement outside the skinny-label context. In Appeal No. 1041797-53.2017.8.26.0224, decided in September 2023, the São Paulo Court of Appeals recognised protection against indirect, partial, and contributory infringement, relying on technical evidence concerning how the defendant’s conduct contributed to exploitation of the patented invention.

The same court has also made clear that contribution cannot simply be presumed. In Appeal No. 1125978-34.2018.8.26.0100, decided in March 2024, it rejected a contributory infringement claim where the evidence did not establish the necessary connection between the defendant’s individual conduct and the alleged infringement.

These decisions do not concern skinny labels, but they point to an important evidentiary question for future pharmaceutical disputes: what connects the supply of a product with the patented use?

Brazilian litigation concerning nintedanib provides an early example of the tension, although it does not settle the issue under the current regulatory framework.

Boehringer Ingelheim brought infringement proceedings against Sun Pharma and Ranbaxy concerning a second medical use patent covering nintedanib for idiopathic pulmonary fibrosis. In September 2023, the Rio de Janeiro trial court found infringement notwithstanding the defendants’ reliance on a skinny-label argument and restricted commercialisation of nintedanib in connection with the patented indication.

That decision preceded RDC 831/2023. The nintedanib litigation therefore cannot be read as deciding the effect of a skinny label under the rules now in force.

It does, however, show why the distinction matters. A carve-out can define the indications for which a generic is approved and marketed, but it cannot by itself determine how the product will ultimately be prescribed, offered, or supplied.

Skinny labels cannot be used as a safe harbour for patent infringement. Where a product reaches the patented use despite the carve-out, the infringement analysis will depend on the patent claims, the acts performed by each party, and, particularly for contributory infringement, the evidence connecting those acts to exploitation of the protected invention.