Merck, Viatris Close in on Settlement in Long-Running Januvia Patent Case

In a filing, Merck and Viatris told an appeals court they need until mid-May to finalize their Januvia patent settlement. (Photo credit should read TOM MIHALEK/AFP via Getty Images)

After years of battling over the patents on blockbuster diabetes drug Januvia, Merck and its generic rival Viatris are ready to put the case to rest.

In a recent filing with the U.S. District Court for the Northern District of West Virginia, the companies said they have reached a settlement after the court last year ruled in favor of Merck and Viatris' appeal. They're asking the court to enter a new judgment that would allow their proposed deal to become a reality.

The exact terms of the settlement are confidential, the companies said in a joint motion. Under the deal, Viatris would be granted a license to settle its generic "on specific dates prior to the expiration of the relevant patents-in-suit," the filing said.

That's where the deal clashes with the established judgment. Last fall, the court ruled in favor of Merck, finding Viatris liable for infringing certain Januvia patents that are set to expire later this decade. The court also rejected the generics maker's challenge to the patents and stipulated that Viatris must not sell its generics before the patents expire.

Now, the companies are asking the court to amend its ruling so that Viatris can sell its generics with the license from Merck before the patent expirations.

In addition to the filing in West Virginia federal court, the companies asked a federal appeals court to stay its proceedings for two months while they work to finalize the deal.

The motions come after years of legal back and forth. In 2019, Merck sued Mylan to initiate the litigation. In November 2020, Mylan merged with Pfizer's Upjohn unit to form Viatris.

Meanwhile, Januvia continues to be a reliable revenue contributor for Merck. The drug and its sister product Janumet, which combines Januvia's active ingredient sitagliptin with the older anti-diabetic drug metformin, generated $4.5 billion in 2022.

While that revenue haul placed the drug among Merck's four biggest-selling medicines last year, it did represent a 15% decline from 2021. In Merck's fourth-quarter results announcement, the company attributed the decline to generic pressure in Europe and Asian markets plus lower demand and prices in the U.S.

Source: fiercepharma.com-Eric Sagonowsky

Editor: IPR Daily-Ann