The first Over-the-Counter Continuous Glucose Monitor (CGM) ever cleared in the United Stated by the FDA was launched by Dexcom. The Stelo Glucose Biosensor System (commercial name) has been cleared for anyone 18 years or older who does not use insulin (such as individuals with diabetes treating their condition with oral medications, or those without…

The BRPTO published on August 28, 2024, Appeal Board Ordinance #4, a rule intended to provide internal guidelines for the examiners responsible for analyzing appeals of patent applications, the so called “second instance” in Brazil. This Ordinance brings structured and standardized procedures that the examiners shall observe when analyzing appeals briefs ensuring consistency, transparency and…

Prepared by Rob Rodrigues and Luiza Cotia The recent publication of the pharma tech-transfer guidelines (PDPs or partnership for productive developments) is bringing an interest for companies to monitor patent portfolios in Brazil. (https://patentblog.kluweriplaw.com/2024/06/25/brazil-pharma-pdps-and-challenges-for-ip-owners/). In view of this development, one of the questions arising is how third parties can influence patent examination of cases that…

Prepared by Rob Rodrigues, Brenno Telles and Dara Offrede On Friday June 21, 2024, the government formally introduced regulations addressing the new framework for Partnerships for Productive Development (PDP). The Ministry of Health published new guidelines (Ordinance #4,472/20241) as part of the government policy to foster the “National Strategy for the Development of the Economic-Industrial…

Divisional applications and pre-grant oppositions may be filed until the “end of the examination”. That is the wording of the Brazilian IP Statute (Law No. 9279/96, articles 26 and 31). Looks simple enough, but in the absence of a definition in the law of what constitutes the “end of the examination”, the BRPTO has been…

As of December 1st, 2023, Brazil is leading G20, wherein one of the three priorities to be addressed is tackling climate change, with a focus on energy transition, in addition to promoting sustainable development in its economic, social and environmental dimensions[1]. At this same date, the BRPTO launched a new commission, namely: sustainability and biotechnology…

On December 30, 2023, the Brazilian government, through Provisional Measure No. 1.205/2023, announced the national program “Mobilidade Verde e Inovação – Green Mobility and Innovation” (MOVER), with the objective of expanding the sustainability requirements for automobiles and stimulating the development of new technologies in the areas of mobility and logistics. The program, conceived by the…

With 1.5 billion chickens and 234.3 million cows, Brazil is an important market for the animal health industry. According to the National Syndicate of the Industry of Animal Health Products (SINDAN, in Portuguese), in 2022, 700 million doses of vaccine were manufactured in Brazil for herbivorous animals, and 21 billion for aviary. The Brazilian animal…

The Brazilian Patent and Trademark Office (BRPTO) has issued a new set of guidelines to clarify its recent regulations on amending patent claims during the appellate phase and help patent applicants adapt to the new policy. Last month, we published an article regarding the decision rendered by the President of the BRPTO on 12 December…

On February 20, 2024, a Brazilian Congressman introduced a bill to amend the national IP Statute (Law #9,279/96) and regulate the ownership of inventions generated by artificial intelligence systems. Bill #303/2024 proposes the addition of a paragraph to Article 6 of the IP Statute, which regulates ownership of inventions, with the following wording: “in the…