Brazilian Lawmakers Propose Patent Break for Eli Lilly's Mounjaro as Ozempic Patent Expires
核心洞察
A Brazilian federal deputy has proposed legislation to unilaterally terminate Eli Lilly's patent for tirzepatide (Mounjaro), which doesn't expire until 2032, citing public interest concerns.
The bill received expedited processing with 337 votes in favor and only 19 against, raising industry concerns about legal certainty and future pharmaceutical investments in Brazil.
Meanwhile, Anvisa is analyzing three applications for semaglutide biosimilars as Novo Nordisk's Ozempic patent expires in March 2025, with EMS (搜索) positioned to launch first.
Brazilian lawmakers are advancing controversial legislation that would break Eli Lilly's patent for tirzepatide, the active ingredient in Mounjaro, eight years before its scheduled expiration in 2032. The proposal comes as Novo Nordisk's exclusive rights to semaglutide (Ozempic) are set to expire on March 20, 2025, opening the door for biosimilar competition in Brazil's rapidly expanding weight-loss medication market.
Legislative Action Targets Mounjaro Patent
Federal Deputy Mario Heringer (PDT-MG) introduced the bill seeking to unilaterally terminate Eli Lilly's tirzepatide patent, citing public interest justifications. The proposal received expedited processing approval with overwhelming support—337 votes in favor and only 19 against—just one week after submission, an unusually rapid pace for legislative proposals.
"I have no doubt that there is public interest [in breaking these patents]. And I also don't believe that this will be the end of Eli Lilly and large companies. They continue to have a lot of money. I want to acknowledge the merit of the laboratories in research, but in my mind the good of humanity comes first," Heringer told NeoFeed.
The orthopedic doctor and Mounjaro user emphasized his medical perspective, noting he sees many patients with joint problems resulting from severe obesity (搜索) cases. Heringer reported losing 12 kilograms in three months using Mounjaro.
Industry Pushback and Investment Concerns
Eli Lilly strongly opposed the proposal, warning of broader implications for pharmaceutical innovation in Brazil. "Lilly opposes the proposal that seeks to remove legitimate intellectual property rights. The measure violates technical standards, undermines legal certainty, and threatens the innovation that is responsible for bringing cutting-edge medicines to patients," the company stated.
The pharmaceutical giant invested R$ 760 million in clinical research in Brazil during 2025 alone, making the country one of its five largest operations worldwide. "The weakening of intellectual property protections will make Brazil less attractive for future investments in innovation and will delay patients' access to life-saving therapies," Eli Lilly added.
Industry associations echoed these concerns. Nelson Mussolini, president of the Pharmaceutical Products Industry Union (Sindusfarma), warned that "patent breaking has never proven to be a structural solution to public health challenges. On the contrary, where it has been used inappropriately, it has produced legal uncertainty, driven away capital, and discouraged clinical research."
Ozempic Patent Expiration Creates Market Opportunity
As the legislative battle unfolds, Anvisa is currently analyzing three applications for semaglutide biosimilars, with expectations that first authorizations will be issued by April 2025. EMS (搜索), owned by the Sanchez family, leads the queue with manufacturing infrastructure already in place at its Hortolândia facility.
"This will be our company's main market launch in 2026. We are preparing to begin the production process as soon as our application is reviewed and approved by Anvisa," said Marcus Sanchez, EMS (搜索) vice president.
EMS (搜索) projects its semaglutide version will generate revenue between R$ 350 million and R$ 400 million in the first 12 months, with plans to sell approximately 700,000 pens during that period. The company has secured pre-orders for raw materials and active pharmaceutical ingredients from Chinese suppliers, pending regulatory approval.
Market Projections and Growth Potential
The Brazilian GLP-1 (搜索) analog market represents substantial growth opportunities. According to Itaú analysts, the market reached R$ 10 billion in pen sales by 2025, including semaglutide, liraglutide, and tirzepatide, with potential to reach R$ 20 billion in 2026.
"Our estimate is that the LPG-1 market will reach at least US$9 billion (R$50 billion) in Brazil by 2030, compared to approximately US$1.8 billion (R$10 billion) currently, representing a compound annual growth rate of 40% over five years," the Itaú report stated.
This growth could significantly impact pharmaceutical retail chains, with GLP-1 (搜索) medications potentially representing around 20% of revenues for major players like RD Saúde, Pague Menos, and Panvel, compared to the current 8-9%.
Regulatory and Legal Challenges
Novo Nordisk has attempted to extend its semaglutide exclusivity period through legal channels, but the Superior Court of Justice denied the request in December 2025. The court upheld that patent terms in Brazil last 20 years from the application filing date, with semaglutide's protection ending in March 2025.
"Novo Nordisk applied for protection on March 20, 2006, the first patient to receive semaglutide in clinical trials was in 2013, and the patent was only granted on May 7, 2019," the company noted, highlighting delays in the patent approval process.
The National Commission for the Incorporation of Technologies (Conitec) previously denied incorporating semaglutide and liraglutide into Brazil's public healthcare system due to high costs, with potential five-year expenses reaching R$ 4.9 billion.
Security and Market Challenges
The growing market has created unexpected challenges, including increased theft of weight-loss pens. According to the Brazilian Association of Pharmacy and Drugstore Chains (Abrafarma), São Paulo alone experienced R$ 70 million in losses from the theft of nearly 60,000 pens.
"We recently met with the state's public security leadership to express our concern, especially regarding the increased quantity of these products on the shelves. It is necessary to guarantee the safety of people and the stock of pharmacies," said Sérgio Mena Barreto, Abrafarma president.
The patent-breaking proposal has raised concerns about potential diplomatic implications with the United States and possible impacts on the recently signed European Union-Mercosur agreement, as stakeholders worry about Brazil's commitment to intellectual property protections.