Semaglutide(Zhejiang Apeloa Kangyu)

Novo Nordisk on Monday said it is suing telehealth company Hims & Hers for allegedly infringing its patent on the weight loss medication semaglutide — not just for the pill version but also for the injectable form as well. The move comes after Hims , on Thursday, said it would launch a compounded version of the Danish drugmaker’s obesity pill Wegovy, before reversing course on Saturday. Novo’s lawsuit seeks to stop Hims from selling the compounded shots of semaglutide, and if the case is successful, it could have seismic repercussions for Novo’s — and Hims’ — top lines. Even if Hims has stepped back on the GLP-1 pills, it is still selling compounded versions of injected semaglutide, which is sold by Novo in the US as Ozempic for diabetes and Wegovy for obesity. Novo is not seeking only to have Hims permanently banned from selling all compounded semaglutide products, but also wants damages. These could add up to hundreds of millions of dollars, Novo’s group general counsel John Kuckelman told Endpoints News . “If we prevail, the minimum recovery is reasonable royalties,” he said. But Novo also intends to seek lost profits — redress for the sales of Wegovy and Ozempic that it has lost thanks to compounders undercutting the authentic drugs. “We believe that Hims’ unlawful and illicit sale of compounded semaglutide for sham personalization has cost us lost profits, and we will seek those and then we have to see how the case unfolds,” Kuckelman said. “But if the facts support that Hims’ conduct has been egregious, we could also seek a trebling of those damages.” Whether Novo can or will seek this trebling is yet to be decided, but it is “definitely on the table.” Asked what treble damages might mean in dollar terms, “I think it’s safe to say it’d be the hundreds of millions,” Kuckelman said. Novo filed the suit in the Delaware district court on Monday. The 28-page complaint alleges that Hims’ compounded forms of semaglutide infringe US Patent No 8,129,343, which was granted in March 2012. “The launch of the pill was an egregious step by Hims,” Kuckelman said. “There are patients who have been on the injectable because they started on that during the drug shortage, but there can be no justification for launching a compounded pill.” Hims began selling copycat semaglutide shots in 2024, when there was a shortage of Ozempic and Wegovy because Novo couldn’t make them fast enough to meet demand. When Novo upped its manufacturing and semaglutide was taken off the shortage list earlier this year, strictly speaking, Hims and other compounders should have stopped selling their versions. But they continued, arguing that compounding remained permissible on the grounds that it personalizes doses for patients. But the Wegovy pill has never been in shortage — Novo made huge efforts to stockpile the drug ahead of approval. “It is a sham mass personalization, and it was a tipping point, and so we have filed the patent infringement suit,” Kuckelman said. There has been some speculation that Novo might have avoided suing Hims over the injected versions before, as there is a risk that its patent might end up being invalidated. But Kuckelman does not believe this could happen. “We feel very confident in the strength of this patent,” he said. Asked if the risk of patent invalidation had put Novo off suing Hims in the past, Kuckelman said that there was “a complex set of factors that have weighed in on that” decision, adding that Novo “certainly have always had a consideration of our confidence in our patent.” The company might also add a claim to the lawsuit alleging deceptive marketing and promotional practices by Hims, Kuckelman said. A final judgment in the case might take a while to arrive. “Litigation is not a fast process,” Kuckelman said, adding that it could take a year or two to get to the final decision on damages — and even that could be subject to an appeal by Hims if it goes in Novo’s favor. However, as the case progresses, Novo might be able to ask the court to enjoin Hims from continuing to infringe Novo’s patent, meaning the compounder would have to stop selling the shots even though the case has not yet been definitively decided. Such a move could markedly boost Novo’s sales.