Merck celebrates another win in Januvia patent battle against Viatris
Viatris has suffered its second stinging loss in as many weeks in its attempt to challenge Merck’s Januvia and Janumet patents.
A federal appeals court on Thursday upheld Merck’s patent rights related to the dihydrogen phosphate salt of sitagliptin — an active ingredient in the blockbuster diabetes drugs Januvia, Janumet and extended-release formulation Janumet XR — calling Viatris’ claims “unpersuasive.”
The latest ruling protects Merck’s patent through May 2027, including six months of pediatric exclusivity, according to the company.
Viatris had previously challenged the validity of the salt patent, dubbed No. 7,326,708 or ‘708 for short. When the US Patent Office sided with Merck in May 2021, the company took the case to a federal appeals court, which affirmed the Patent Office’s decision on Thursday.
It’s a tough blow for Viatris, which lost a separate patent suit against Merck’s sitagliptin just last week. Judge Irene Keeley of West Virginia upheld two key patents, including the salt patent and another one covering the co-formulation of sitagliptin and metformin in Janumet, which expires in 2029.
Januvia and Janumet are both oral drugs designed to lower patients’ blood sugar, but Janumet also contains metformin, which helps the body respond better to insulin. Together, they raked in $1.2 billion last quarter, up 3% from Q2 2021.
Viatris is looking to go to market with generics for both Januvia and Janumet. While the company has the option to appeal last week’s decision upholding the salt and metformin patents, it’s unclear if there are any plans to do so. The company has not responded to a request for comment as of press time.
Merck said in an email to Endpoints News on Friday that it is “pleased” with the appeals court decision, adding, “We look forward to continuing to provide these important products to patients who need them through 2027.”
Merck has settled with several other rivals who have agreed not to launch their own generics until 2026 “or earlier under certain circumstances,” the company said in a news release.