Could a Novo error set up early GLP-1 generics in Canada?

It has been reported that Novo Nordisk may have inadvertently allowed generics of its GLP-1 agonist semaglutide, the active ingredient in diabetes therapy Ozempic and obesity drug Wegovy, into the Canadian market early.

According to an article in Science, which references an Endpoints interview, the Danish drugmaker made a monumental error by failing to pay modest patent maintenance fees to the tune of a few hundred dollars to the Canadian patent office.

The result? Its main patent for semaglutide expired in 2020 and – while it still has protection for a few months under Canada's data exclusivity rules – it has been reported that generic drugmakers, including Sandoz and Apotex, are preparing to launch copycat versions as soon as January next year.

That is in stark contrast to the US, where Novo Nordisk is expecting to have patent protection until at least 2032. And while Canada may be a modest market for the drug in its own right, it is thought there is cross-border trade in semaglutide from Canada to the US that has a bearing on sales booked north of the border – and in fact makes Canada the second-largest semaglutide market in the world.

The Canadian patent office’s register shows that the last time that Novo Nordisk paid its annual maintenance fee was in 2018, the year when Ozempic launched in Canada.

Novo Nordisk made more than $24 billion from Ozempic and Wegovy, with another $3 billion from Rybelsus, an oral semaglutide product for diabetes, which means that the drug accounted for almost two-thirds of its total group revenues.

The company is already facing strong competition from rival therapies, including Eli Lilly's tirzepatide medicines for diabetes (Mounjaro) and obesity (Zepbound), that could also be affected if low-cost generics launch in Canada.

But was it actually an error? According to some commentators on this illuminating thread on LinkedIn, Novo Nordisk may have made a calculation that its patent and data exclusivity were both due to end in 2026, and simply decided not to extend the protection on the patent.

Another possibility is that it sacrificed the patent to ensure that Canada – with a public health system, price controls, and mechanisms that allow medicines to be excluded from the market if deemed too expensive – would continue to support use of semaglutide at a reasonable, profitable price.

Photo by Jason Hafso on Unsplash