In Viatris’ ambitious bid to be the first to introduce generic versions of Novo Nordisk’s blockbuster diabetes and obesity drugs, Ozempic and Wegovy, the company encountered a mix of favorable and unfavorable developments this week.
On Monday, the US Patent and Trademark Office (USPTO) tribunal delivered a setback by rejecting Viatris’ challenge to two of Novo’s patents covering the active ingredient, semaglutide, used in both drugs.
However, on Wednesday, a different twist emerged as the USPTO panel approved Viatris’ challenge to a third patent. This opens the door to an inter partes review, a process that offers a quicker and more cost-effective route compared to a full trial. Notably, this review process has faced criticism from branded drug manufacturers since its establishment in 2011.
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The patent under scrutiny is US Patent No. 10,335,462, which pertains to the “dosage regimes” employed in treating patients with semaglutide for diabetes and obesity. This patent, issued in 2019, offers protection in the market until 2033, as indicated in the FDA’s Orange Book, a repository of patents associated with approved drugs.
The tribunal’s decision acknowledged that Viatris demonstrated a “reasonable likelihood that it will prevail in establishing that at least one claim of the ‘462 patent is unpatentable.”
Oral arguments for this case are scheduled for July next year, with a decision expected in October.
For Novo Nordisk, safeguarding its diabetes and obesity medications is of paramount importance. Sales of Ozempic reached a substantial $3.2 billion in the second quarter, while revenue from Novo’s obesity treatments, Wegovy and Saxenda, amounted to $1.6 billion. These GLP-1 drugs represented a significant 61% of Novo’s $7.9 billion in quarterly revenues.
Also Read: Novo Nordisk And Eli Lilly Ride Obesity And Diabetes Drugs To The Forefront In Q2 Pharmaceutical Performance
In January of this year, Novo Nordisk initiated a lawsuit against Viatris in a federal court in Delaware, alleging patent infringement. This legal action came in response to Viatris’ submission of a new drug application for its proposed generic version of semaglutide.
The battle between these pharmaceutical giants continues, with significant implications for the future of diabetes and obesity treatments.
