USA — Rival drugmakers Merck and Viatris have reached an agreement in their patent dispute over diabetes drugs Januvia and Janumet, pending approval from a judge.
Attorneys for both companies have requested that the district court in West Virginia enter a final judgment in the case, following an appeal to the United States Court of Appeals for the Federal Circuit.
The attorneys in the Merck and Viatris patent dispute have requested that the district court modify an existing amended judgment, prohibiting Mylan affiliates from manufacturing, using, or selling any drug products subject to a Mylan ANDA until two of Merck’s patents expire.
Entering the final judgment would enable a settlement agreement to proceed and allow Mylan to voluntarily dismiss its appeal.
The attorneys believe that approving the settlement will save resources and prevent further proceedings in this court.
The attorneys claim that approving the settlement agreement and modified judgment will conserve the resources of the parties and the courts, and end the possibility of further proceedings.
This would allow a settlement agreement to go forward and would also enable Mylan to voluntarily dismiss its appeal.
The dispute began in 2019 when Merck sued then-Mylan for patent infringement and resulted in a win for Merck last year after an appeals court ruled that it has patent rights until 2027 on the dihydrogen phosphate salt of sitagliptin, a key ingredient in Januvia, Janumet, and Janumet XR.
The terms of the settlement remain confidential, and neither company has responded to requests for comment.
Merck’s patents for the dihydrogen phosphate salt of sitagliptin and the co-formulation of sitagliptin and metformin found in Janumet provide intellectual property protection until 2027 and 2029, respectively.
These patents cover blockbuster diabetes drugs Januvia and Janumet, which generated approximately US$5.3 billion in sales for Merck in 2021.
Viatris, like other generic drugmakers, is looking to market generic versions of these drugs in the U.S. market.
Merck had previously announced that Januvia’s U.S. exclusivity was set to expire in January 2023. But, if the “salt/polymorph patent” holds up in court, it would prevent generic manufacturers from producing sitagliptin phosphate salt and polymorphic forms until 2027.
With the recent court decision, Merck could potentially enjoy several more years of exclusive sales for the drugs, subject to any appeals.
Merck expects a significant drop in sales when the drugs lose exclusivity, and the company has already signed at least 21 settlements with generic drug manufacturers, allowing them to launch in May 2026 or earlier under specific circumstances.
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