Mylan, seeking to market Victoza generic, convinces panel to start up patent review

Mylan, coming off a big patent win against Biogen, aims to launch a copycat version of Novo Nordisk's diabetes drug Victoza. Now, a U.S. patent office panel says there's a "reasonable likelihood" that Mylan could successfully nix a Victoza patent that covers the blockbuster med through early 2026.

The U.S. Patent Trial and Appeal Board instituted an inter partes review on patent No. 8,114,833, which covers Victoza's formulation and methods for producing it effectively. Mylan claims the patent is invalid because it covers an obvious invention.

After hearing initial arguments over the patent, the board found a “reasonable likelihood” Mylan would win the case. The review process is set to play out through late 2020 and early 2021, according to a scheduling order.

Victoza's U.S. active ingredient patent expires in 2023, according to the company's annual report. Novo has already inked a patent settlement (PDF) with generics giant Teva that allows the Israeli drugmaker to launch a copycat late that year.

But Teva is the only copycat maker who's made a deal with Novo, and the Danish drugmaker has other patents protecting Victoza's use for years after that—including the '833 patent, whose protection runs out in February 2026, according to the FDA Orange Book. Novo sued Mylan last year in Delaware federal court for patent infringement and that lawsuit is ongoing.

RELATED: Novo preps for Rybelsus 'strike mode' as Ozempic hits blockbuster heights

As Victoza nears the end of its exclusive hold on the market, Novo is working to grow sales for Rybelsus, its new oral diabetes med carrying big expectations. A Victoza follow-up that uses the same active ingredient as Novo’s injectable Ozempic, Rybelsus could earn peak sales of $2 billion to $5 billion, analysts say.

The patent board’s Victoza decision comes right on the heels of a win for Mylan against Biogen on multiple sclerosis blockbuster Tecfidera. Biogen previously prevailed in an inter partes review challenge, but last week, a judge invalidated key Tecfidera patent claims. Biogen has pledged to appeal, and another patent lawsuit against other generics companies is ongoing.