Novo Nordisk and Viatris have reached a settlement in their patent dispute over the popular weight-loss medications Ozempic and Wegovy. The resolution, announced on October 7, 2024, encompasses both the case at the U.S. Patent and Trademark Office (USPTO) and the federal court lawsuit.
The dispute centered on a Novo Nordisk patent covering specific dosages of semaglutide, the active ingredient in Ozempic and Wegovy, for treating type 2 diabetes and obesity. Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, first approved for diabetes treatment in 2005. These medications work by mimicking a hormone that regulates appetite, making them effective for weight management.
Viatris, through its subsidiary Mylan Pharmaceuticals, had challenged the validity of Novo Nordisk's patents at the USPTO last year. The Patent Trial and Appeal Board (PTAB) agreed to review one of the patents in October 2023, after rejecting requests to examine two others. The USPTO, which issues over 300,000 patents annually, was set to make a final decision on the patent's validity this month but has extended the deadline to January 2025.
The obesity treatment market, valued at $5.4 billion in 2022, is projected to exceed $100 billion by 2034. This growth is largely attributed to the success of drugs like Wegovy, which contains a higher dose of semaglutide than Ozempic. The booming sales of these medications have significantly boosted Novo Nordisk's market value, making it one of Europe's most valuable companies.
Founded in 1923, Novo Nordisk has a long history in diabetes care and now employs over 50,000 people across 80 countries. The company's headquarters are located in Bagsværd, Denmark. On the other hand, Viatris, formed in 2020 through the merger of Mylan and Upjohn, is based in Canonsburg, Pennsylvania.
The settlement terms remain confidential, as confirmed by a Novo Nordisk spokesperson. This resolution comes at a time when the global health community is grappling with the increasing prevalence of obesity and type 2 diabetes, which affects approximately 462 million people worldwide.
The patent dispute resolution process utilized various legal mechanisms, including inter partes review (IPR) at the USPTO and federal court litigation. The Delaware Court, known for handling numerous corporate and patent disputes, was involved in the federal case. On average, the patent granting process in the US takes about 23 months, highlighting the complexity of intellectual property matters in the pharmaceutical industry.
As the obesity treatment landscape continues to evolve, the settlement between Novo Nordisk and Viatris marks a significant development in the field. It remains to be seen how this resolution will impact the future of weight-loss drug development and accessibility.