Brazil Challenges Pharmaceutical Giants: The “Glamorized” Injection Widely Used for Weight Loss Will Lose Patent Protection in Brazil in the Coming Months

The recent decision of the Federal Regional Court of the 1st Region (TRF-1) to deny the extension of patents in Brazil for medications containing the active substance semaglutide, particularly the products Ozempic®, Wegovy®, and Rybelsus®, reverberated throughout the pharmaceutical sector. The Danish giant Novo Nordisk, which sought to extend the patent validity period and consequently the territorial marketing exclusivity of these medications, faced a significant setback.

In this article, we will explore the main aspects of this decision, highlighting the pros and cons, as well as the relevance of patents in the globalized scenario.

Understanding the Semaglutide Case

1. Context and Scope Semaglutide is an analog of the human glucagon 1 hormone/peptide (GLP-1), primarily intended for the treatment of type 2 diabetes and has been a crucial source of revenue for the pharmaceutical company Novo Nordisk.

The company requested an extension of the patent validity period by at least 12 (twelve) years for Ozempic® (injection/pen) and by at least 7 (seven) years for Rybelsus® (oral formulation). However, the TRF-1 rejected this request, maintaining the original validity dates of the respective patents.

2. Revenue Impact and Generic Competition The court’s decision has significant implications for the pharmaceutical industry: • Threatened Revenue: Revenue prospects for semaglutide will be harmed in Brazil. Wegovy® and Ozempic®, subcutaneous formulations of semaglutide, will now face generic competitors in just three years; • Off-Label Use: While Wegovy® is specifically indicated for obesity, Ozempic® and Rybelsus® are increasingly used off-label for weight loss.
3. Novo Nordisk’s Argument and Supreme Court Decision Novo Nordisk claimed it sought a “restitution” of the periods of exclusivity its patents would have enjoyed if not for delays in evaluation by the National Institute of Industrial Property (INPI). However, the court based its decision on the recent and controversial decision of the Federal Supreme Court│STF, in DIRECT ACTION OF UNCONSTITUTIONALITY (ADI) 5529, which resulted in the loss of deadline extensions granted based on the sole paragraph of art. 40 of the Industrial Property Law.

Balancing Innovation and Accessibility While the TRF-1 decision is based on competition protection and accessibility of medications, it raises questions about continuous innovation.

Patents incentivize companies to invest in research, development, and innovation, creating solutions for health problems. Extending these periods of exclusivity could be seen as a fair reward for these efforts.

In a world where health is a global priority, it is crucial to find a balance between protecting intellectual property rights and access to essential medications. The decision on semaglutide underscores the importance of timely patent assessments to ensure patient accessibility and health, as well as points to some lessons to be learned, namely:

• Do we really need to wait for a patent to be granted by INPI to start commercializing it? What is the concept of “right expectation” within intellectual property?
• Can different scopes of protection of one or more patents on the same subject be strategically drafted to minimize such validity setbacks?
• Do Brazilian pharmaceutical industries have “fine chemical” technology to develop new patentable pharmaceutical technologies or only the capacity to reproduce “copies,” resulting in generics and/or similars?
• Could a study and technical-commercial evaluation between a reference medicine in the public domain (at a fair cost for social programs) and a generic medicine (without the same efficacy, despite the regulatory need for bioavailability and bioequivalence) provide better accessibility to better meet societal needs?
• Does the strategy of using the current patent system collaborate with the prevention of crimes such as piracy, crimes against property, unfair competition, among others?

It is time to continue debating and finding solutions that serve the common good. The decision on semaglutide underscores the importance of timely patent assessments to ensure patient accessibility and health.

In this context, it is essential to consider both the interests of pharmaceutical companies in protecting their investments in research and development and the need to ensure that essential medications are accessible to all who need them.

ELVAS IP, as a strategic partner, is committed to contributing to this debate and offering solutions that promote both innovation and fair access to medications. Contact us to discuss how we can help your company navigate this challenging landscape and continue to drive significant advancements in healthcare. We are available to collaborate and find the best solutions for your business.