Delaware Court Finds No Induced Infringement in Wegovy® Patent Dispute at Pleading Stage

In a decision issued on July 22, 2025, Chief Judge Colm F. Connolly of the U.S. District Court for the District of Delaware held that Mylan Pharmaceuticals Inc. does not induce infringement of U.S. Patent No. 9,764,003 in connection with its proposed generic version of Wegovy®. The ruling was made at the Rule 12(c) stage, prior to expert discovery, and relied solely on the pleadings and Mylan’s proposed drug label.

The ’003 patent, owned by Novo Nordisk, claims a method for reducing body weight through the administration of semaglutide “without another therapeutic agent.” Novo argued that Mylan’s proposed label for its generic semaglutide product would encourage physicians and patients to perform the patented method and therefore constituted induced infringement under 35 U.S.C. § 271(b).  The court disagreed. Applying its prior claim construction, Judge Connolly found that Mylan’s label did not instruct, promote, or encourage administering semaglutide without any other therapeutic agents for weight loss or treatment of diabetes or hypertension. Instead, the Court found that the label included multiple references to the expected coadministration of semaglutide with other therapeutic agents, such as insulin and antihypertensives, undermining Novo’s theory that the label promoted the patented method.  

The Court emphasized that the determinative question in Hatch-Waxman induced infringement claims is whether the proposed label would cause physicians or patients to perform the patented method.  It concluded that the absence of a directive to avoid other therapeutic agents—coupled with language anticipating their use—meant Mylan’s label did not induce infringement.

Novo argued that Mylan’s motion should be denied because of “material factual issues that would need to be resolved, including any expert physician testimony on what the label encourages.”  The Court rejected Novo’s contention that expert physician testimony was necessary to interpret the impact of Mylan’s proposed label in this case.  Judge Connolly distinguished this case from post-approval infringement actions—such as the one addressed in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.—where courts may consider additional factual evidence like marketing materials and real-world usage.  In contrast, Judge Connolly found no ambiguity in the label requiring expert clarification and held that the inducement analysis could be resolved as a matter of law without further factual development. 

Because all asserted claims of the ’003 patent depended on the claim language at issue, the court found no induced infringement as a matter of law and granted Mylan’s motion for judgment on the pleadings under Rule 12(c).

Given courts’ increasing willingness to consider disposing of induced infringement claims based solely on the labeling, even at the pleading stage, applicants should be mindful of the evolving case law and ensure that when drafting method-of-treatment claims, those claims are aligned with the instructions and information set forth in the product’s labeling.  Patentees should also identify specific factual disputes pertaining to the labeling that would benefit from expert input when opposing such motions, as it may have been the case that the general nature of Novo’s arguments was ultimately unpersuasive to the Court.