A key Ozempic patent lapses in Canada: Deliberate or a mistake?
By Reddie & Grose
It is impossible to escape the headlines on GLP-1 agonists such as Ozempic and Wegovy. Therefore, it seems reasonable to assume that the innovator behind these blockbuster drugs has robust, fail-safe strategies to protect their intellectual property worldwide.
However, inaction by Danish company Novo Nordisk, who manufactures Ozempic and Wegovy, has allowed a critical Canadian patent to lapse – was this deliberate or a mistake?
The active ingredient in both Ozempic and Wegovy is the GLP-1 agonist semaglutide, which works by mimicking the natural hormone GLP-1 that contributes to the regulation of blood sugar and appetite.
Ozempic is prescribed for the treatment of type 2 diabetes, whilst Wegovy is prescribed for weight loss.
Novo Nordisk is the market leader, with reportedly a 63 per cent share of the global GLP-1 agonist market in 2024.[1]
As part of its IP strategy to protect Ozempic and Wegovy, Novo Nordisk has a patent family directed to the active ingredient semaglutide.
It filed a PCT application, WO2006/097537, and from this, has obtained protection in numerous jurisdictions worldwide. However, the granted Canadian patent in this family, CA 2601784, was allowed to lapse.[2]
In 2019 Novo Nordisk failed to pay a $250 CAD maintenance fee. Novo Nordisk was given the opportunity to correct this omission.
It was notified of the missed maintenance fee by the Canadian Intellectual Property Office and had the opportunity to pay the missed fee with an additional late fee for a further year.
As Novo Nordisk failed to remedy the situation and did not pay the missed fee and late fee (totalling only $450 CAD), the patent lapsed.
The Canadian Intellectual Property Office clearly informed Novo Nordisk that “[O]nce a patent has lapsed it cannot be revived”.
Currently, semaglutide generics are unable to enter the Canadian market.
Whilst there is no patent protection, Novo Nordisk has data exclusivity in Canada which prevents generics entering the market.
Data exclusivity protects the clinical trial data submitted to regulatory agencies when seeking approval for a new drug.
The protection afforded by data exclusivity in Canada is due to expire in 2026. Following this, it is expected that there will be an influx of generics onto the Canadian market. It is noted that generics company Sandoz has already announced their intention to launch a semaglutide generic in Canada in 2026.[3]
The lapse of Canadian patent CA 2601784 first came to the public’s attention in June 2025 when reported by Science magazine columnist Derek Lowe3.
Many of the commentaries on this issue have indicated this is a big blunder by Novo Nordisk, not least as Canada is the world’s second largest semaglutide market.
Arguments that the lapse was unintentional include consideration of the term of protection afforded by the patent.
Canadian patent CA 2601784 was due to expire in 2026, which is when the data exclusivity is also due to expire. However, it is incorrect to conclude that by allowing the patent to lapse, the term of protection is unaffected.
This is because a Canadian certificate of supplementary protection (CSP) – a form of patent term extension – was issued for semaglutide.[4]
CSPs are legal mechanisms that enable the extension of the effective protection of patented active ingredients by up to two years. The semaglutide CSP was linked to the Canadian patent CA 2601784 and would have extended protection to 2028.
However, the CSP is now ineffective as the underlying patent has lapsed. Therefore, it seems that Novo Nordisk has lost two years of protection by allowing its patent to lapse.
Novo Nordisk has told a different story, indicating that there was no mistake regarding missed payment of the maintenance fee.
Novo Nordisk reportedly said in a statement to Fortune that “All intellectual property decisions are carefully considered at a global level”.[5]
It is not possible to deduce Novo Nordisk’s strategy from these vague statements, which may be interpreted by some to amount to reputational damage limitation if the missed payment was an error.
However, some commentators believe it is more likely that the lapse was intentional.
These commentators think that an intentional lapse is a more plausible explanation of events as accidental omission of paying maintenance fees is rare, especially for large pharmaceutical companies, which have robust systems in place to prevent such errors.
Canada has a Patented Medicine Prices Review Board (PMPRB) that reviews the prices of patented medicines sold in Canada.
The PMPRB caps the prices that innovators are able to charge for new pharmaceuticals, to ensure that they are not excessive.
Allowing the Canadian patent to lapse means that Novo Nordisk’s pricing of Ozempic and Wegovy no longer needs to be regulated by the PMPRB.
Perhaps Novo Nordisk considered that the benefit of unregulated pricing was strategically better, and likely to lead to more revenue than an additional two years of market exclusivity afforded by the patent and associated CSP?
A definite conclusion on whether the Canadian patent lapse was deliberate or a mistake cannot be made at present.
However, it appears that there are convincing commercial reasons for allowing the patent to lapse.
This situation is a reminder that patents and other forms of intellectual property rights do not exist in a vacuum, rather they are a commercial tool in a larger toolkit.
In certain situations, maximising the duration of market exclusivity achieved by patents and patent term extensions may not be best strategy for innovators.
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