Key Summary
- Novo is seeking a ban on Hims from selling unapproved, compounded drugs that infringe their patents.
- The FDA has said that it would restrict GLP-1 ingredients used in compounded drugs.
- Analysts say the lawsuit and the unusually rapid FDA response could mark a crackdown on compounded GLP-1s.
Novo Nordisk sued Hims and Hers Health on Monday (9) over patent infringement after the US telehealth firm launched, then cancelled, a $49 copy of Novo's weight-loss pill Wegovy following a swift backlash from US authorities.
Shares of the Danish multinational and US rival Eli Lilly had tumbled last week after Hims introduced the cut-price pill, which had looked set to erode Novo's takings and jeopardise its shift towards a cash-pay consumer market.
The lawsuit, which covers Novo's weight-loss drug in pill and injectable forms, highlights the friction between obesity drugmakers and companies selling copies based on the same active ingredients, harming the earnings of the original drug manufacturers.
"There is now a growing chorus of parties that have said, 'Enough is enough on the compounding situation in the United States,'" Novo Nordisk's general counsel, John Kuckelman, told Reuters, adding that Hims' pill launch was a "tipping point."
The lawsuit, Hims said, was a "blatant attack" by Novo on "millions of Americans who rely on compounded medications for access to personalised care."
"Once again, Big Pharma is weaponising the U.S. judicial system to limit consumer choice," it said.
'War on GLP-1 compounders'
Analysts said the lawsuit and the unusually rapid US Food and Drug Administration response could mark a broader crackdown on compounded GLP-1s, potentially easing competition on the big manufacturers' patented weight-loss treatments.
"They are not only declaring war on Hims & Hers' Wegovy pill, but GLP-1 (compounders) in general," said Sydbank analyst Soren Lontoft Hansen.
Novo said it was "asking the court to permanently ban Hims from selling unapproved, compounded drugs that infringe our patents, and is seeking to recover damages."
US regulations allowed rival versions to enter the market when Novo's and Lilly's drugs were in shortage.
They then remained on the market after the shortages ended as the compounding industry leaned on US law allowing them to mix and sell ingredients in medicines that are personalised, such as in different doses than the branded version.
The lawsuit marks a shift in the Danish pharmaceutical giant's legal strategy against compounding pharmacies. Novo has sued several compounders for allegedly selling unsafe, falsely advertised Wegovy "knockoffs" that violate its trademark rights, but the Hims lawsuit is its first US patent case against a compounder.
“At minimum, Novo probably hopes this patent filing creates a deterrent effect against Hims and other compounders thinking about offering semaglutide products, while also giving Novo a shot at money damages for past and ongoing sales of those products,” said Gaston Kroub, a partner at intellectual property law firm K2K IP Law.
Novo, Lilly pricing deals with Trump
The FDA said on Friday it would restrict GLP-1 ingredients used in compounded drugs.
Hims, whose pill was based on semaglutide - the active ingredient in Novo Nordisk's blockbuster drugs Wegovy and Ozempic - said on Saturday (7) it would stop offering the treatment.
Novo and Lilly struck high-profile pricing deals with US president Donald Trump last year and their weight-loss drugs are prominent on the new TrumpRx discounted-drugs website.
