Just over a year ago, commentary emerged on the patent defenses safeguarding Novo Nordisk and Eli Lilly’s substantial diabetes and weight-loss medications, namely Ozempic/Wegovy and Mounjaro/Zepbound (Above the Law, 2023). These drugs are credited with notable physical transformations among users, and demand for them has driven the valuations of their respective companies sky high.
Surrounding these highly profitable products are inevitable patent battles. Specifically, Novo Nordisk’s patent 8,536,122 is the focal point. This patent, which shields their semaglutide-based weight-loss drug Wegovy, is representative of the industry’s compound patents, set to expire in March 2026. Novo has been actively defending this and other related patents against various generic challengers. The denial of Mylan’s IPR petition by the PTAB marked a significant, although temporary, win for Novo.
With IPR challenges momentarily staved off, the onus has shifted back to the district courts. The ongoing multi-district litigation (MDL) before Delaware’s Chief Judge Colm Connolly, initiated in late 2023, is pivotal. The MDL consolidated six cases, primarily centralized in Delaware, and anticipates a trial by end of this calendar year. However, a clear resolution on the market entry of generics is projected for after a Federal Circuit decision, likely no sooner than 2026, pending potential settlements.
The rising demand for semaglutide has resulted in compounded versions appearing due to the drug’s presence on the FDA’s Drug Shortages list since May 2023. Compounders, adhering to certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, have seized this opportunity to offer semaglutide at a fraction of the branded price. This has prompted Novo to engage aggressively through trademark and false advertising claims against particular providers, though such legal maneuvers have, so far, produced more headlines than tangible shutdowns.
Moreover, conflicts between Novo and compounders, along with Eli Lilly’s related disputes (Reuters), are just secondary skirmishes. The primary focus remains on the larger-scale clashes with generics eyeing a share of this lucrative weight-loss market. Eyes remain on Delaware and the eventual CAFC decisions, with the direction of the landscape for these generally favored weight-loss treatments hanging in the balance.