On December 6, 2023, the Board Resolution (RDC) No. 831 was published, amending RDC No. 47 of September 8, 2009, which establishes rules for the elaboration, harmonization, updating, publication, and availability of medicament labels for patients and healthcare professionals.
RDC No. 831 modifies the prior resolution with regard to the requirement that labels for generic and similar (branded generic) medicaments must contain the same therapeutic indications as those in the labels of reference medicaments. This modification will allow the labels for these medicines to differ from the Standard Labels, by suppressing the therapeutic indications protected by patents or claimed in published patent applications.
The Resolution provides that labels different from the Standard ones must include the sentence: “Information referring to indications of the medicament protected by patent has been omitted,” in bold, in the section “1. FOR WHAT THIS MEDICAMENT IS INDICATED?” in the patient’s label and “1. INDICATIONS” in the healthcare professional’s label. Upon expiration of the patent or rejection of the patent application, the labels of generic and similar medicaments should then incorporate the suppressed indications, and the above-mentioned sentence must be removed.
RDC No. 831 will enter into force on February 6, 2024, and will allow generic and similar medicaments containing active ingredients and formulas already in the public domain (but still protected by patents for second medical uses) to be marketed in Brazil without infringing, through their labels, existing patents or pending patent applications covering these novel therapeutic uses. The purpose of the regulation is to increase the availability of generic and similar medicaments in the country and reduce their costs. The practice of skinny labeling is not exclusive to Brazil, and is already being adopted by the regulatory agencies from the USA (Food and Drug Administration) and Europe (European Medicines Agency), for example.
This new rule may be seen with concern by patent holders in Brazil, as it could impose challenges in the enforcement of their patents in the country, raising questions within the judiciary related to a potential patent infringement.
Furthermore, the legality of this Resolution may be questioned as Law No. 6.360/76 sets forth that similar and generic medications must contain the same active principles, concentration, pharmaceutical form, route of administration, dosage, as well as therapeutic indications as of the reference medicaments.
RDC No. 831/2023 (in Portuguese) can be read in this link.
We will closely monitor the developments of the implementation of skinny labeling and its implications for intellectual property protection in Brazil. In the meantime, we are available for further clarification via email at firstname.lastname@example.org.