At Viatris' request, US agency will review Novo Nordisk patent on semaglutide

In Viatris' attempt to become the first company to reach the market with generic versions of Novo Nordisk’s diabetes and obesity juggernauts Ozempic and Wegovy, the company received good and bad news this week.

Monday, a U.S. Patent and Trademark Office (USPTO) tribunal rejected Viatris' challenge of two Novo patents on the active ingredient for both of the drugs—semaglutide.

But Wednesday, the USPTO panel signed off on Viatris’ questioning of a third patent.

A panel of USPTO experts will hold an inter partes review to determine whether the patent is valid. The inter partes review process is faster and cheaper than a trial but has been under fire from branded drugmakers since it was established in 2011.  

Under scrutiny is U.S. Patent No. 10,335,462, which relates to the “dosage regimes” used in treating diabetes and obesity patients with semaglutide. The patent was issued in 2019 and would provide market protection until 2033, according to the FDA’s Orange Book, a listing of patents for approved drugs.

In its decision, the tribunal wrote that Viatris showed a “reasonable likelihood that it will prevail in establishing that at least one claim of the ‘462 patent is unpatentable.”

Oral arguments in the case are set for July of next year, with a decision expected in October.

“Novo Nordisk will vigorously defend the company’s intellectual property on this matter,” a company spokesperson said in an email. “Since the dispute in ongoing, we cannot comment further.”

Novo has much at stake in defending its diabetes and obesity meds. Sales of Ozempic reached $3.2 billion in the second quarter, while revenue from Novo’s obesity treatments Wegovy and Saxenda came to $1.6 billion.

The GLP-1 drugs accounted for 61% of Novo’s $7.9 billion in revenues in the quarter.

In January of this year, Novo Nordisk filed suit against Viatris in federal court in Delaware, claiming patent infringement after the Pennsylvania drugmaker submitted a new drug application for its proposed generic version of semaglutide.