Novo Nordisk and Mylan Pharmaceuticals, a unit of Viatris, have agreed to settle a patent dispute and validity challenge concerning the former’s weight-loss drugs, Ozempic and Wegovy.
In a joint filing with the US Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (PTAB), Novo Nordisk and Mylan Pharmaceuticals announced their settlement.
Denmark-based Novo Nordisk accused Mylan Pharmaceuticals of patent infringement while developing a generic version of Ozempic.
PTAB was reviewing a challenge to a Novo Nordisk patent related to specific dosages of these drugs for treating type 2 diabetes and obesity.
The Dutch drugmaker has filed separate lawsuits in federal court against Viatris and other companies for patent infringement, aiming to block proposed generics of its drugs.
Last week, Novo Nordisk and Viatris informed a Delaware judge that they had settled the former’s lawsuit regarding the latter’s proposed generic version of Ozempic.
Wegovy is said to be the first drug in a new class of weight-loss drugs to hit the market. Its sales have contributed significantly to Novo Nordisk’s growth.
In 2022, Novo Nordisk sued Viatris’s unit in a federal court in West Virginia, part of a series of lawsuits against generic drugmakers for allegedly copying its profitable drugs. The case was later moved and merged with others in Delaware federal court.
Last year, Mylan Pharmaceuticals filed a petition with the PTAB to cancel three of Novo Nordisk’s asserted patents. The board declined to review two of them but agreed in October 2023 to consider Mylan Pharmaceuticals’ challenge to the third patent.
In July, Novo Nordisk urged the PTAB to sanction Pharmaceuticals for what it described as harassing and duplicative litigation regarding that patent. However, Novo Nordisk later withdrew that motion as part of the agreement to terminate the proceeding.
The USPTO was set to issue a final ruling on the patent’s validity this month but pushed the decision deadline to January 2025.
In June, Reuters reported that Novo Nordisk may face the generic challenge to Ozempic and Wegovy in China.
The publication said the Chinese drugmakers are developing around 15 generic versions of Ozempic and Wegovy.
