Judge rules Mylan's proposed generic semaglutide does not infringe one Novo Nordisk patent

A federal judge in Delaware ruled on July 22, 2025 that Mylan's proposed generic version of semaglutide does not infringe one of the five Novo Nordisk patents at issue in a lawsuit over the drug Wegovy ^[1].

The case is Novo Nordisk, Inc. v. Mylan Pharms. Inc., Civ. No. 23-101-CFC, in the U.S. District Court for the District of Delaware ^[1]. Novo makes and sells Wegovy, which contains semaglutide. Novo sued Mylan asserting infringement of five patents that are listed, or that Novo intends to list, in the FDA's Orange Book ^[1]. Novo argued that Mylan's submission of an abbreviated new drug application, or ANDA, seeking FDA approval to market a generic semaglutide product infringed those patents under a provision of the Patent Act, § 271(e)(2)(A), that treats a generic drug application as a hypothetical act of infringement ^[1].

The ruling by Judge Connolly addressed only one of the five patents, U.S. Patent No. 9,764,003, referred to in the decision as the '003 patent ^[1]. Mylan asked the court for judgment on the pleadings that it did not infringe that patent, and the court granted the motion ^[1].

The court considered three theories of infringement. On direct infringement, Mylan argued that the patent's claims cover methods of treatment and that Mylan, as a pharmaceutical company, does not treat or administer drugs to patients ^[1]. The court granted judgment for Mylan on that point as unopposed ^[1]. On contributory infringement under § 271(c), the court entered a stipulated judgment of no infringement after Novo said it had proposed that the parties stipulate to that result, which the court formalized ^[1].

The third theory, induced infringement under § 271(b), turned on how the court read the phrase "administered without another therapeutic agent" in claim 1 of the '003 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" ^[1].

Mylan argued that its proposed label does not instruct users to do that, and therefore could not infringe as a matter of law, and the court agreed ^[1]. The court found that although Mylan's label instructs that its semaglutide product should not be used with other semaglutide-containing products or any other GLP-1 receptor agonist, the label does not state, imply or suggest that the product should be administered without any other therapeutic agent to reduce weight or treat diabetes or hypertension ^[1]. The label also instructs physicians to "consider reducing [i.e., not eliminating] the dose of concomitantly administered insulin secretagogue ... or insulin to reduce the risk of hypoglycemia" ^[1].

Why it matters for patients

Generic competition is one of the main forces that can lower the price of a prescription drug in the United States, and the timing of any generic semaglutide depends on litigation like this one. The July 22, 2025 decision resolves one patent of five in this case; how the remaining patents will be decided has not been reported ^[1].

The ruling also does not mean a generic is available. An ANDA is a request for FDA approval, not an approval, and the decision does not address whether FDA has acted on Mylan's application ^[1]. Nothing in the ruling changes what is on pharmacy shelves now, and the decision concerns patent infringement, not the safety or effectiveness of either Wegovy or a proposed generic.

What happens next

The '003 patent claims were resolved by the July 22, 2025 order ^[1]. The status of Novo's other four asserted patents, and any trial date or further schedule in the case, has not been reported ^[1].