Viatris Scores Victory in Semaglutide Patent Dispute with Novo Nordisk

Viatris, the pharmaceutical company formed by the merger of Mylan and Upjohn, has secured a significant legal win against Novo Nordisk in a patent dispute over semaglutide, the active ingredient in the popular weight loss drug Wegovy. This development marks a crucial step forward in Viatris' efforts to bring a generic version of the blockbuster obesity treatment to market.

Court Ruling Favors Viatris

A federal district court in Delaware has ruled in favor of Mylan, now part of Viatris, in a patent litigation case concerning a proposed generic version of Wegovy. The court rejected Novo Nordisk's argument that Mylan's FDA application for its generic would encourage doctors and patients to infringe on a patent held by the Danish drugmaker.

The dispute centered on Novo Nordisk's #003 patent, which covers treatment methods using semaglutide. Novo's legal team argued that Mylan's proposed generic label could prompt the use of the medication in a way that would infringe on this patent. However, the court found that Mylan's label "does not state, imply, or suggest in any way that Mylan's semaglutide product should be administered without any other therapeutic agent to reduce weight loss or to treat diabetes or hypertension."

This ruling effectively removes the #003 patent from consideration in the upcoming patent trial scheduled for March 2026, clearing a significant hurdle for Viatris in its pursuit of a Wegovy generic.

Implications for the Pharmaceutical Industry

The court's decision has far-reaching implications for the pharmaceutical industry, particularly in the rapidly growing market for GLP-1 receptor agonists used in diabetes and obesity treatment. Wegovy, Novo Nordisk's branded semaglutide product, has been a commercial success since its approval, with U.S. patent protection currently set to expire in 2032.

Viatris' potential entry into the market with a generic version could significantly impact the accessibility and affordability of semaglutide-based treatments. However, it's important to note that Viatris' generic to Wegovy has yet to secure FDA approval, and the company still faces other patent challenges from Novo Nordisk.

This latest development follows a settlement reached between Novo Nordisk and Mylan in October regarding a proposed generic for Ozempic, another semaglutide-based drug used for type 2 diabetes treatment. The terms of that settlement remain undisclosed.

Ongoing Legal Battles in the Semaglutide Market

The semaglutide patent landscape remains complex, with Novo Nordisk engaged in multiple legal battles to protect its intellectual property. The company has pursued litigation against various entities, including telehealth firms, med spas, pharmacies, and weight loss clinics, for selling compounded semaglutide products. Novo Nordisk argues that these products potentially violate U.S. compounding laws and may pose safety risks.

As the demand for effective weight loss and diabetes treatments continues to grow, the outcome of these legal disputes will likely shape the future of the GLP-1 receptor agonist market. The pharmaceutical industry and healthcare providers will be closely watching for further developments in this ongoing saga.