Wegovy® (semaglutide)
Case Name: Novo Nordisk, Inc. v. Mylan Pharms. Inc., Civ. No. 23-101-CFC, 2025 WL 2051441 (D. Del. July 22, 2025) (Connolly, J.)
Drug Product and Patent(s)-in-Suit: Wegovy® (semaglutide); U.S. Patent No. 9,764,003 (“the ’003 patent”)
Nature of the Case and Issue(s) Presented: Novo makes and sells Wegovy. Novo sued Mylan asserting patent infringement of five patents that are listed, or Novo intends to list, in FDA’s Orange Book. In its complaint, Novo alleged that Mylan’s submission to FDA of its ANDA for approval to market its generic semaglutide product constituted infringement of the asserted patents pursuant to § 271(e)(2)(A) of the Patent Act. Mylan responded to the complaint by filing a Fed. R. Civ. P. 12(c) motion for an order of judgment on the pleadings that it did not infringe the ’003 patent. The court granted Mylan’s motion.
Why Mylan Prevailed: Mylan argued that because the asserted claims were method-of-treatment claims, and Mylan is a pharmaceutical company that does not treat or administer drugs to patients, it could not directly infringe the asserted claims under 35 U.S.C. § 271(a) as a matter of law. While the factual allegations in Novo’s complaint do not imply in any way that Mylan itself would directly infringe the ’003 patent were it to market its ANDA product, the complaint included “conclusory legal allegation[s that Mylan] will infringe one or more claims of the Asserted Patents under 35 U.S.C. § 271(a) ....” Therefore, the court found that its opinion was required and granted the motion as unopposed with respect to direct infringement by Mylan.
The court also granted as unopposed Mylan’s in seeking judgment of no contributory infringement of the ’003 patent under § 271(c). Novo stated that it had proposed to Mylan that the parties stipulate to entry of partial judgment of no contributory infringement of the ’003 patent, so the court formalized that agreement and entered a stipulated judgment.
Next, Mylan argued that it was entitled to a judgment of no induced infringement of the ’003 patent under Section 271(b) based on the court’s construction of the term “administered without another therapeutic agent” in claim 1 of the patent. The court construed the term to mean “administered without another therapeutic agent as part of the method for reducing body weight, or for treating the conditions of diabetes or hypertension.” Mylan argued that its proposed label did not instruct users to administer its semaglutide product without another therapeutic agent as part of a method for reducing body weight or for treating the conditions of diabetes or hypertension, and that therefore it could not as a matter of law infringe. The court agreed, finding that although “Mylan’s label instructs that its semaglutide product should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist, the label does not state, imply, or suggest in any way that Mylan’s semaglutide product should be administered without any other therapeutic agent to reduce weight loss or to treat diabetes or hypertension.” Rather, the label made clear that Mylan expected doctors to administer its semaglutide with therapeutic agents other than semaglutide-containing products and GLP-1 receptor agonists as part of a method for reducing body weight or for treating the conditions of diabetes or hypertension. Most notably, the label also instructed physicians to “consider reducing [(i.e., not eliminating)] the dose of concomitantly administered insulin secretagogue ... or insulin to reduce the risk of hypoglycemia.”
