Did Novo Nordisk lose their Ozempic patent in Canada because they didn't pay a $450 fee?

Last week, Science magazine put out a story with the headline, “Novo Nordisk’s Canadian Mistake” stating that generic versions of semaglutide could come to Canada as early as next year after the Ozempic and Wegovy maker failed to pay the $450 renewal fee for its Canadian patent, resulting in its expiry.Science cited records from the Canadian Patent Database, which do indeed show that Danish drugmaker did indeed fail to pay a $450 fee back in 2019, and that the patent is now expired. The $450 that Novo Nordisk neglected to pay is the annual patent maintenance fee of $250 in addition to a $200 late fee. On March 20, 2019, the Canadian Intellectual Property Office sent a reminder letter to the drugmaker. Read: Could blockbuster weight-loss medications help prevent cancer?“In order to prevent the patent from lapsing, the amount listed above . . . must be paid within the one-year period of grace following the filing date anniversary. Once a patent has lapse it cannot be revived,” the office said in its letter.Science also cited an interview that biopharma publication Endpoints News conducted with Richard Saynor, CEO of biosimilar drugmaker Sandoz.“Canada, we filed and are waiting for approval once the data exclusivity expires sometime in Q1 next year,” Saynor said in the interview. “Interesting market. Novo never filed a patent in Canada. Never know why. I’m sure someone’s lost their job, but never mind. It’s the second-largest semaglutide market in the world.”Other news outlets followed suit. Outlets like Quartz and MarketWatch reported that Novo Nordisk could lose “billions” because they forgot to pay a tiny $450 filing fee and accidentally let their patent lapse.But how true are those claims?In Canada, patents only last up to a maximum of 20 years after the initial filing date, provided that the patent holder pays the annual maintenance fee. But patents aren’t the only way drugmakers can protect their intellectual property. For drugmakers who introduce an innovative drug, Health Canada can grant market exclusivity for that drug for up to eight years.Novo Nordisk still has market exclusivity for its GLP-1s until Jan. 4, 2026. Given that the company first filed its semaglutide patent in Canada in 2006, the patent would have still expired in 2026 even if the company continued to pay its annual maintenance fee“In Canada, the main protection for semaglutide is set to expire on January 4, 2026. This may have been the main impetus of Novo’s decision not to make the payment and allow the particular patent to lapse, likely not an oversight,” patent lawyer Steven Shape told biotech website Labiotech.Read: Healthcare providers should consider medical interventions to manage obesity in children: new guidelines“While oversights happen in IP services and third-party fee payment entities, oversights in fee payments are very rare . . . In this situation, it is more likely that the realization that this patent was expiring in January of 2026 and Novo was not giving up much by deciding not to pay this fee.”Novo Nordisk, for its part, denied that there was any mistake in its not paying patent maintenance fee in Canada. “All intellectual property decisions are carefully considered at a global level,” the company told Fortune. “Periods of exclusivity for pharmaceutical products end as part of their normal life cycle, and generic treatments may become available over time.”Novo Nordisk’s Ozempic and Wegovy patents are set to expire in the U.S. in 2032 and in Japan and Europe in 2031, according to its annual report. In China, the patents are set to expire in 2026.In addition to Sandoz, Canadian generic drugmaker Apotex has also filed a submission to Health Canada for a generic semaglutide.

Did Novo Nordisk lose their Ozempic patent in Canada because they didn't pay a $450 fee?

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