Understand in 6 points the bill that breaks the Mounjaro patent in Brazil

The Chamber is analyzing a bill that facilitates the breaking of patents for two brands of weight-loss pens. The initiative, which has already been urgently approved and is now undergoing accelerated processing, makes the medicines Mounjaro and Zepbound of “public interest”.

The merits of the text still need to be voted on by the Chamber plenary and, if approved, it will be sent for analysis by senators. To be valid, the project also needs the sanction of the Presidency.

The text was authored by the leader of the PDT in the Chamber, Mario Heringer (MG), and has only three articles. The main point is to make both brands of medicine in the public interest.

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What does the project say?

When considering the two brands of public interest, the project cites a provision in the current patent law that provides for the granting of a compulsory license to exploit the patent when there is a public interest or national or international emergency.

After the license has been granted, if the patent owner is unwilling or unable to contest it, exploitation is granted within a period of one year.

There are two types of patents: invention patents, granted to solve specific technical problems, and utility model patents, applicable to improvements in objects of practical use.

In the case of an invention, which applies to weight loss pens, the patent lasts 20 years. In turn, the utility model patent lasts 15 years.

By law, it is possible to apply for a patent if “requirements of novelty, inventive activity and industrial application” are met.

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The person who regulates the granting of patents is the INPI (National Institute of Industrial Property), linked to the Ministry of Development, Industry and Services.

Brazilian patent law was created in 1996 and came into force two years after Brazil signed the TRIPS agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights), within the scope of the World Trade Organization (WTO). The agreement regulates standards of intellectual protection, copyright and patents.

In Brazil, patents protect the economic rights of those who created a medicine for 20 years, starting from the request to the INPI. When the deadline ends, other companies can copy substances that have already been developed and tested. By law, generics must be at least 35% cheaper than the reference.

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Although patents are expected to be broken due to public interest or emergencies, it is rare for drug patents to be broken. The breach occurred only once during the 30 years that the law has been in force, when a compulsory license was granted for the drug Efavirenz, used to treat HIV.

In 2021, Congress even approved the temporary breaking of patents for vaccines used against Covid-19. The initiative, however, was vetoed by the government.

When justifying the proposition related to weight-loss pens, congressman Mario Heringer, author of the text, says that they “constitute a safe, fast and much less invasive way than bariatric surgeries to combat obesity, high-risk overweight and the lipid, cardiovascular and metabolic diseases resulting from them”.

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Last Monday, when the urgency was approved, deputy Adriana Ventura (Novo-SP) criticized the initiative.

– The discussion is welcome, but in this way, it makes no sense. You are going against intellectual property rights, you are going against incentives for innovation and research.

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