Novo Nordisk suffers loss over negative claim limitation in ongoing patent dispute over diabetes drug Wegovy

Context: Wegovy is a Novo Nordisk drug used for weight loss and the treatment of type 2 diabetes that generated global sales of approximately $2.7 billion in Q1 2025 (May 7, 2025 Novo Nordisk press release). Wegovy is less profitable than its sister product Ozempic (which generated $5.1 billion in global sales in Q1 2025 and uses the same semaglutide peptide molecule), but Novo Nordisk has nonetheless started enforcing patents around the product. In January 2023, it sued Viatris (a joint venture between Mylan and Upjohn, a legacy division of Pfizer) in the District of Delaware over five patents, shortly after Viatris filed an Abbreviated New Drug Application (ANDA) for approval to market its generic version of Wegovy with the FDA (January 27, 2023 complaint).

What’s new: Adjudicating a motion for the pleadings by which Viatris sought to narrow the case, Judge Colm F. Connolly has held that Viatris does not infringe Novo Nordisk’s U.S. Patent Nos. 9,764,003 (“Use of long-acting GLP-1 peptides”). After disposing of direct infringement, which the complaint did not allege, and contributory infringement, which Novo Nordisk effectively waived, the sole remaining theory was inducement, but the decision holds that the claim limitation “without another therapeutic agent” was not met because Viatris did not explicitly encourage it (July 22, 2025 opinion).

Direct impact: After settling an Ozempic dispute with Novo Nordisk in October 2024, this decision allows Viatris to clear another obstacle in the way of having its generic launched on the market (there are still four patents remaining). However, as the ‘003 patent is not due to expire until at least 2033, it is likely that Novo Nordisk will seek to get this decision overturned by the Federal Circuit.

Wider ramifications: Novo Nordisk apparently needed the disputed claim language (“without another therapeutic agent”) to have its patent granted by the USPTO. But the judge’s decision makes it almost impossible to prove infringement with such a claim limitation, unless Viatris’s label is worded slightly differently (“administer this one without any other therapeutic agent”, for example). Pharmaceutical companies in particular should take note of this claim limitation standard and its potential risks.