The complaint
The case is Mylan Pharmaceuticals Inc. v. Novo Nordisk Inc. and Novo Nordisk A/S, No. 1:26-cv-01192 (D. Del.), filed September 23, 2026, ECF No. 1 (12 pages). Mylan seeks declaratory judgments of noninfringement and invalidity of U.S. Patent 12,551,536 in connection with its ANDA No. 217705 for semaglutide prefilled single-dose pens.
What the patent covers
U.S. Patent 12,551,536, titled Semaglutide in Medical Therapy, issued February 17, 2026. Claim 1 covers a method for reducing the body weight of a subject in need by administering semaglutide subcutaneously in an amount of 2.0 to 10.0 mg weekly. The complaint says the patent is listed in the Orange Book for Wegovy (semaglutide) injection, 2.4 mg/0.75 mL prefilled pens, under NDA No. 215256, but not for the lower-dose pens that Mylan's ANDA also covers. (U.S. Patent 12,551,536 claim 1; Compl. paras. 28 to 32.)
What the lawsuit alleges
Mylan alleges that on June 17, 2026 it certified to the FDA that no valid claim of the '536 Patent will be infringed by its proposed ANDA products and/or that the patent is invalid, and sent Novo Nordisk a notice letter, which it says was delivered June 18 and 19, 2026. It alleges that because the patent is listed in the Orange Book, Novo Nordisk's failure to sue within 45 days may impair Mylan's ability to market its products. It alleges, on information and belief, that Novo Nordisk A/S owns the patent, and it points to the co-pending case Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc., C.A. No. 23-101 (D. Del.), in which Novo Nordisk asserts U.S. Patent 12,029,779 from the same family. Count One seeks a declaration of noninfringement and Count Two a declaration of invalidity. (Compl. paras. 1 to 7, 28 to 44; Counts One and Two.)
What to watch next
Watch for Novo Nordisk's response, any counterclaim for infringement, and any coordination with C.A. No. 23-101.