- The pharma giant will lose its patent protection on semaglutide, which is sold as Ozempic and Wegovy, in Canada after not paying a nominal maintenance fee years before it became a blockbuster drug for fighting diabetes and obesity, Science reported. Novo Nordisk generates billions of dollars in revenue from the drug in Canada, but patent protection is due to end next year.
Years before semaglutide became a blockbuster drug for Novo Nordisk, the Danish pharma giant had the chance to maintain its patent in Canada but didn’t pay a small fee to do so, according to a recent report in Science.
The drug, which is sold as Ozempic and Wegovy, has made so much money for Novo Nordisk after exploding in popularity in the past few years that it has even impacted Denmark’s currency and interest rates.
To keep the semaglutide patent in Canada, the company had to pay an annual fee of just 250 Canadian dollars (~$185 USD). While it paid that amount in 2018, Science reported that it didn’t the following year.
The Canadian government offered Novo Nordisk another chance to keep its patent, this time with an additional charge that brought the total to 450 Canadian dollars ($331 USD).
“In order to prevent the patent from lapsing, the amount listed above, which includes the required maintenance fee and the late payment fee, must be paid within the one-year period of grace following the filing date anniversary,” a letter from regulators said, putting the anniversary date at March 20, 2019. “Once a patent has lapsed it cannot be revived.”
Makers of generic drugs have taken notice, with Science pointing to recent comments from the company Sandoz that it has filed to launch a generic GLP-1 drug in Canada next year and expects approval sometime in the first quarter when exclusivity expires.
“Interesting market. Novo never filed a patent in Canada. Never know why,” Sandoz CEO Richard Saynor told Endpoints News earlier this month. “I’m sure someone’s lost their job, but never mind. It’s the second-largest semaglutide market in the world.”
In a statement to Coins2Day, Novo Nordisk said there was no mistake regarding its patent maintenance fee in Canada and declined to comment on other drug manufacturers’ plans.
“All intellectual property decisions are carefully considered at a global level,” the company added. “Periods of exclusivity for pharmaceutical products end as part of their normal life cycle, and generic treatments may become available over time.”
The company confirmed that protection for semaglutide regulatory submissions in Canada will expire in 2026.
Meanwhile, Ozempic patents expire several years later in other big markets like the U.S. (2032), Japan (2031), and Europe (2031), according to the company’s most recent annual report.
Last year, Novo Nordisk generated about $19 billion in global Ozempic sales and about $9 billion in Wegovy sales. In Canada, retail pharmacies there booked Ozempic sales of 2.5 billion Canadian dollars.