Context: Novo Nordisk sued Mylan (a Viatris unit) in the United States District Court for the District of Delaware in January 2023 over five Wegovy patents, after Mylan filed an Abbreviated New Drug Application (ANDA) for a generic version of the weight loss drug. That case, C.A. No. 23-101-CFC, has been narrowing gradually: last year, Judge Colm F. Connolly ruled that Mylan’s proposed label does not induce infringement of Novo Nordisk’s U.S. Patent No. 9,764,003 (“Use of long-acting GLP-1 peptides”), since the label does not instruct doctors to administer semaglutide “without another therapeutic agent” (July 25, 2025 ip fray article). Under the Hatch-Waxman Act, once a generic maker sends a Paragraph IV notice contesting a newly Orange Book-listed patent, the patent owner has 45 days to sue for infringement, after which the generic maker may itself seek a declaratory judgment that the patent is invalid or not infringed.
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Counsel
Novo Nordisk is being represented by Morris, Nichols, Arsht & Tunnell’s Jack B. Blumenfeld, Brian P. Egan, and Travis J. Murray, as well as Groombridge, Wu, Baughman & Stone LLP’s Daniel J. Klein, Ananya Pillutla, Jenny C. Wu, Josephine Young, Joshua D. Reich, Michael F. Milea, Naz Erdeniz Wehrli, Nicholas P. Groombridge, Peter H. Sandel, Philip S. May, and Scott Miller.
Meanwhile, Mylan Pharmaceuticals and Viatris are being represented by Stamoulis & Weinblatt LLC’s Stamatios Stamoulis and Richard C. Weinblat, and Ashurst Perkins Coie’s Brandon M. White, Bryan D. Beel, David L. Anstaett, Emily J. Greb, Aaron E. Schindler, Rodney Swartz, and Shannon M. Bloodworth.