Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
Novo Nordisk and Viatris subsidiary Mylan on Monday reached a settlement in their patent dispute over the blockbuster incretin therapy semaglutide.
According to a filing by Indian company Natco Pharma, the terms of the settlement are confidential, so the companies’ financial arrangements are unknown. It is also unclear when generic versions of semaglutide are allowed to enter the U.S. market. Natco is partnered with Mylan on the development of these generics.
In accordance with the settlement, Novo and Viatris on Monday also submitted a joint filing to the U.S. Patent and Trademark Office (PTO) asking it to terminate all proceedings and pending motions related to the patent dispute.
Novo sued Mylan in 2022 claiming patent infringement. According to the lawsuit, filed in the District Court for the Northern District of West Virginia, Mylan had filed an abbreviated New Drug Application (ANDA) for a generic version of Ozempic, the brand of semaglutide indicated for type 2 diabetes.
Novo argues that in filing its ANDA, Mylan signified its intention to “sell, offer to sell, use, and/or engage in the commercial manufacture” of an Ozempic generic that would violate nearly 20 of its patents that have yet to expire. In particular, Mylan’s generic uses protected technology related to the structure of the GLP-1 drug itself, the overall formulation of the medication and the injection device, among other characteristics.
The pharma at the time asked the court to prevent Mylan from manufacturing and selling its generic version, pending approval, before the expiration of any of the patents under contention, including extensions.
Novo has since filed other lawsuits against Mylan, including one in July 2024 that focused on two patents—concerning the pharmaceutical composition and specific use of semaglutide in type 2 diabetes—that Mylan’s ANDA allegedly violated.
Mylan, meanwhile, has challenged the validity of Novo’s patents. According to Monday’s joint document to the U.S. PTO, Mylan filed for an inter partes review in March 2023. The PTO Board started its review a few months later, in October 2023.
Ozempic works by mimicking the GLP-1 hormone and activating its corresponding receptor. Through this mechanism of action, Ozempic promotes the secretion of insulin from the pancreas in response to a rise in blood sugar levels. The drug also slows gastric emptying and helps suppress appetite. Ozempic’s sister brand Wegovy is indicated for chronic weight management.
Ozempic made around $14 billion in 2023, while Wegovy earned another $4.5 billion.
