On December 6, 2023, the Brazilian Health Regulatory Agency (ANVISA) unanimously decided to permit an exemption allowing generics and branded generics (also called “similar” drugs) to remove indications covered by patented uses from drug labels, a practice known as “skinny labeling”.
ANVISA’s Collegiate Board (DICOL) submitted for public consultation a proposal to change RDC Rule #47 of 2009, which regulates the marketing authorization for generics, specifically, their package inserts. The proposal recommended amending a portion of this rule to read: “[…] the package leaflets of generic and similar medicines may differ from their respective Standard Package Leaflets with respect to patented therapeutic indications or indications claimed in published patent applications”.
During a vote on the proposal on December 6, 2023, the director president of ANVISA, Mr. André Barra Torres, stated that the new wording of Rule #47 was in line with the “real” objective of Brazil’s national generics public policy, namely, to guarantee access to healthcare. Mr. Torres stated that the removal of a patent protected indication from a label, accompanied by the reason why the indication was removed, made it clear that the removal was not related to the interchangeability of a drug but was the result of the indication being patent protected. According to Mr. Torres, allowing removal of a patented indication would solidify the patent owner’s rights, as it would reinforce the patentee’s right to exclude others from using the patented invention.
A copy of the regulation approved by ANVISA is provided below.
BRAZILIAN FOOD AN DRUGS AGENCY
DRAFT RESOLUTON OF THE COLLEGIATE BOARD OF DIRECTORS
RESOLUTON OF THE COLLEGIATE BOARD OF DIRECTORS –
RDC No, [o], of [Month], [Day], [Year]
Amends Collegiate Board Resolution (RDC) No 47, September 8th, 2009, which establishes rules for preparation, harmonization, updating, publication, and availability of drug labels for patients and health professionals
The Collegiate Board of Directors of the Brazilian Food and Drug Agency (BFDA), exercising the powers conferred by articles 7, item III, and 15, items III and IV, of Law Nº 9,782, of January 26th , 1999, and considering the provisions of article 187, item VI and paragraph 1º, of the Internal Regiment, approved by Resolution of the Collegiate Board of Directors (RDC) Nº. 581, of December 10th, 2021, resolves to adopt the following Resolution of the Collegiate Board of Directors. 187, item VI and paragraph 1º, of the Internal Regulations, approved by Resolution of the Collegiate Board of Directors – RDC Nº 585, of December 10th, 2021, resolves to adopt the following Resolution of the Collegiate Board of Directors, as deliberated at a meeting held on XX, XXXX, 2023, and I, the Director-President, order its publication:
Art. 1. Art. 14 of Collegiate Board Resolution – RDC No. 47, of September 8, 2009, is hereby amended as follows:
“Art. 14. ……………………………..
§1 The labels of generic and similar drugs may differ from their respective Standard Package Labels in the specific information for each product, which must be in accordance with the pharmacotechnical characteristics approved in the registration, as contained in the parts:
…………………………………………..
§3 In addition to the provisions of Paragraphs 1 and 2 of this article, labels of generics and branded generics may differ from their Standard Label with respect to patented therapeutic indications or indications claimed in published patent applications.
§4 In the package labels of generic and similar drugs that differ from their respective Standard Package Label in relation to patent-protected therapeutic indications or indications claimed in published patent applications, the sentence “The information referring to the patent-protected indications of the drug has been suppressed.”, in bold, must be inserted in the section “1. WHAT IS THIS MEDICINE FOR?” in the patient’s package label and “1. INDICATIONS” in the healthcare professional’s package label.”
§5 If the patent application is denied or the validity period of the patent letter expires, the package leaflets of generic and similar drugs must: I – include the indications referred to in §3; and II – remove the sentence referred to in §4.
§6 In the case of §5 of this article, the new labels texts must be notified electronically within 90 (ninety) days of the publication of the denial of the patent application or at the term of the patent and the deadline for starting the manufacture of the drug with the new label text material will be up to 180 (one hundred and eighty) days from the date of the notification request, which must be implemented regardless of prior manifestation by BFDA and this being the time foreseen for the stock of obsolete label text material to be exhausted.” (NR)
Art. 2. Art. 16 of Collegiate Board Resolution – RDC No. 47, of September 8, 2009, is hereby amended as follows:
“Art. 16. ……………………………………….
VI – to the Legal Sayings, regarding the corporate name of international companies;
VII – to the Legal Sayings, regarding the corporate name of national companies, after BFDA’s approval of the change of corporate name, and;
VIII – indications protected by patent or claimed in published patent applications, regarding the application of the provisions of §4º of art. 14 of this Resolution.
………………………………………………..” (NR)
Art. 3 This Resolution comes into force on mmmm dd of yyyy. [in accordance with Decree 10.139/19, art. 4º, items I and II]
This post was written by Lisa Mueller and Rob Rodrigues and Bruno Telles of Licks Attorneys.