Novo Nordisk opens new front with patent suit over Hims’ Wegovy copies

By Blake Brittain

Feb 10 (Reuters) - Novo Nordisk's U.S. patent suit against Hims & Hers, filed connected Monday, marks a caller beforehand successful the Danish pharmaceutical drugmaker's run against companies selling compounded versions of its blockbuster weight-loss cause Wegovy.

The case, Novo's archetypal U.S. patent infringement suit against a ​compounder implicit Wegovy, comes arsenic ample telehealth companies person expanded rapidly into the weight-loss cause market, and aft the U.S. Food and Drug Administration ‌determined that the drug's progressive constituent semaglutide is nary longer successful abbreviated supply.

That shift, experts say, has reduced concerns that enforcing patents could trigger a nationalist backlash by attempting to bounds entree to ‌a scarce drug.

Novo's suit follows Hims' motorboat connected Thursday of a $49 compounded mentation of Wegovy, and past a speedy retreat, aft the FDA announced it would instrumentality enactment against the institution connected Friday.

In a statement, Hims said the suit "attacks much than conscionable 1 medicine oregon institution – it straight assaults a well-established, captious constituent of US pharmacy signifier that has improved diligent attraction for everything from obesity to infertility to cancer."

Novo's ailment did not specify however overmuch the institution was seeking successful damages, but Novo's wide counsel John ⁠Kuckelman told Reuters it was a "very important amount."

RAPID SCALE-UP

The ‌San Francisco-based telehealth institution has grown quickly. It said successful November that it expected its full 2025 gross to beryllium much than $2.3 billion, and has targeted $6.5 cardinal successful gross by 2030.

"The erstwhile presumption quo was that pharmaceutical companies were not suing compounding pharmacies for ‍these individualized doses due to the fact that they were considered to beryllium minor, but the companies person intelligibly scaled up," said Sarah Rajec, a prof astatine William & Mary Law School.

U.S. regulations let compounding pharmacies to marque and merchantability immoderate brand-name medicines if they are successful abbreviated supply. Without a shortage, however, compounding is mostly permitted lone erstwhile a cause is customized for a peculiar ​patient.

The FDA archetypal listed semaglutide arsenic successful abbreviated proviso successful 2022, which allowed compounding to proliferate. The bureau declared the shortage was implicit successful February 2025, but Hims ‌continued to merchantability what it calls "personalized" doses of semaglutide, arguing that specified income are lawful erstwhile patients necessitate doses Novo does not offer.

LEGAL FIGHT ESCALATES

Novo had antecedently sued respective smaller compounding pharmacies for allegedly selling unsafe oregon falsely advertised Wegovy "knockoffs" that interruption its trademark rights. Those cases focused connected the information of the compounded products and alleged misconduct during a play erstwhile the semaglutide shortage heightened sensitivity astir entree to the drug.