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Viatris Looks To Call It A Day In US Januvia, Janumet Patent Saga

ANDA Sponsor And Originator Merck Look To Settle Hatch-Waxman Case

 
• By Dean Rudge

Viatris and Merck have disclosed plans to settle litigation currently pending before the US Court of Appeals for the Federal Circuit over the ANDA sponsor’s generic versions of its sitagliptin-containing medicines, Januvia (sitagliptin) and Janumet (sitagliptin/metformin).

Settlement Law Legal Gavel
• Source: designer491 / Alamy Stock Photo

God loves a trier, as the old saying goes, and few could accuse Viatris Inc. of not digging deep in its lengthy bid to find a way around US patents shielding Merck & Co’s sitagliptin-containing medicines, Januvia (sitagliptin) and Janumet (sitagliptin/metformin).

After two bites at the cherry – the first a failed challenge to the validity of certain claims of Merck’s sitagliptin dihydrogen phosphate salt patent in an inter parties review before the US Patent Office and Trademark Office; the second a failed challenge against two patents in Hatch-Waxman proceedings – Viatris has alongside Merck notified

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