Anvisa approves skinny labeling practice in Brazil

Starting February 6, 2024, generic and branded-generic (“similar”) drugs will be allowed to have different labels than their respective standard labels with respect to indications protected by patents or claimed in published patent applications. This is a radical change in the position of the Brazilian National Health Surveillance Agency (ANVISA), which until then did not allow the practice of skinny labeling or carve out in Brazil.

Although Federal Law 6.830/1976 does not allow the removal of patented uses from labels, the Brazilian National Health Surveillance Agency (ANVISA)’s Collegiate Board (DICOL) approved the modification of Article 14 of RDC No. 47/2009, which prohibited generic and similar drug labels from being different from the respective standard label. Such labels should list all the therapeutic indications of the reference drug, whether or not they are protected by patents.

Based on the understanding endorsed by its Federal Attorney, that the Agency has the power to regulate the text of labels in order to expand access to medicines for the population and that, therefore, there would be no violation of federal regulations, on December 6, 2023, ANVISA’s Collegiate Board approved the modification.

The President of ANVISA, Antonio Barra Torres, pointed out that the removal of the patent-protected therapeutic indication from the label, accompanied by the reason why the indication was suppressed, brings transparency to doctors and patients, making it clear that the removal has no relation to the interchangeability of the product, but only makes it clear that the marketing of the product in question does not infringe the patent rights of third parties.

ANVISA’s President also stressed that ANVISA does not exercise any oversight with regard to patent violations or purchases of medicines for uses other than the therapeutic indications listed on the label, and thus, the new guideline would not encourage any patent violation, off-label prescription (for unproven scientific uses) and/or of therapeutic indications not listed on the label.

In labels that are different from the standard labels, it is now mandatory to include the phrase “The information referring to the patented indications of the drug has been suppressed” in bold in the section “1. WHAT IS THIS MEDICINE INDICATED FOR?” in the patient label and “1. INDICATIONS” in the professional label.”

Although the recent modification, published in the Federal Official Gazette of December 11, 2023, through RDC No. 831, of December 6, 2023, and which will come into force on February 6, 2024, is positive for manufacturers of generic and similar drugs that want to market drugs with other therapeutic indications beyond those protected by patents, the permission of the practice of skinny labeling in Brazil causes concern to patent holders, as it can impact the enforcement of use patents in Brazil.

Currently, there is already ongoing litigation pertaining to skinny labeling, in which it has been verified that, in practice, it is not possible to avoid infringement to patent rights in Brazil. We believe the new regulation may lead to an increase in lawsuits in Brazil.

The regulatory and litigation teams from our firm have been closely monitoring the issue since the beginning of the discussions and are available to clarify any questions. Please do not hesitate to contact us at the email address: regulatorio@kasznarleonardos.com.