After inking a related patent settlement last year, Viatris has cleared another obstacle in its quest to launch generic versions of Novo Nordisk’s lucrative semaglutide drugs for diabetes and obesity.
On Tuesday, a federal district court in Delaware took the side (PDF) of Mylan—now part of Viatris—in a patent litigation case over a proposed generic to the GLP-1 obesity blockbuster Wegovy. The court disputed Novo’s argument that Mylan’s FDA application for its generic encourages doctors and patients to infringe a patent held by the Danish drugmaker.
Novo has accused Mylan of running afoul of five of its patents overall, though this week's decision focused on a single patent, known as the #003 patent, which covers treatment methods using the drug.
Novo’s legal team was careful not to directly accuse Mylan of infringing the #003 patent, according to court documents posted earlier this week. Instead, the company argued that the proposed generic’s label could prompt doctors and patients to use the medication in a way that would infringe the patent.
The #003 patent concerns the administration of semaglutide independent of other therapeutic agents as a treatment for obesity, diabetes or hypertension, according to the legal filing.
Mylan’s proposed label, in turn, states that its semaglutide generic “should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonists.”
Because the instructions only exclude a specific set of drugs, 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.”
“To the contrary, the label makes clear that Mylan expects that physicians will at times administer its semaglutide with therapeutic agents other than semaglutide-containing products and GLP-1 receptor agonists,” the decision continued.
The court ultimately ruled that Mylan’s application does not encourage infringement of the “administered without another therapeutic agent" limitation of Novo’s #003 patent.
"As this case is ongoing, we cannot provide any further comment," a Novo Nordisk spokesperson told Fierce Pharma when asked for comment.
Viatris is “pleased with the District Court’s favorable decision finding non-infringement of the ‘003 patent related to Wegovy, which removes it from the patent trial scheduled to begin in March 2026,” a Viatris spokesperson told Fierce Pharma.
Viatris’ generic to Wegovy has yet to secure FDA approval. Branded Wegovy, for its part, could lose U.S. patent protection in 2032, according to Novo’s 2024 annual report (PDF).
The latest update in the semaglutide feud comes after Novo and Mylan inked an undisclosed settlement over the latter company’s proposed Ozempic generic in October. Both Ozempic and Wegovy leverage the same semaglutide peptide molecule but are approved at different doses in separate obesity and type 2 diabetes indications.
Novo first sued Viatris over its generic semaglutide plans in January 2023, shortly after Viatris filed its generic semaglutide application with the FDA.
Viatris retaliated by challenging the Novo patents in question at the U.S. Patent and Trademark Office (USPTO), with mixed results.
Elsewhere, Novo has been engaged in a litigation crusade against a slew of telehealth firms, med spas, pharmacies and weight loss clinics for selling compounded semaglutide products, which the Danish company has argued are potentially unsafe and violate U.S. compounding laws.