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In 2020, Novo Nordisk’s Canadian patent for semaglutide, the lively ingredient in its blockbuster GLP-1 medication Ozempic and Wegovy, quietly expired. The explanation? A small missed upkeep payment, reportedly round 1,200 Canadian {dollars}. The lapse went largely unnoticed till it was lately highlighted by Derek Lowe in Science, the place he described it as an eyebrow-raising second for an organization with a lot at stake.
With no different semaglutide-related patents listed in Canada’s Patent Register, the trail now seems clear for generic and biosimilar rivals to enter the market as early as January 2026. And that is what sparked Lowe’s consideration as Sandoz’s chief government officer (CEO), Richard Saynor, informed Endpoint Information that the corporate was planning to launch a GLP-1 generic in Canada as quickly as governmental safety of semaglutide expires in 2026, as a result of, in line with him, Novo didn’t have the patent to guard it additional.
For a drug projected to generate tens of billions in annual income globally, that form of publicity, even in a single market, carries actual penalties. The case raises broader questions on how firms handle mental property throughout jurisdictions, and what biotech companies of any dimension can be taught from this slip.
GLP-1 patent expiration: Mistake or strategic resolution from Novo Nordisk?
This raises the important thing query: Was the lapse a real oversight or a calculated transfer based mostly on patent timelines?
On one hand, Steven Form, companion and mental property (IP) Chair at Omnus Regulation, famous: “I’m stunned that Novo didn’t pay the comparatively insignificant upkeep payment to maintain its issued Canadian patent alive… In Canada, the principle safety for semaglutide is about to run out on January 4, 2026. This will likely have been the principle impetus of Novo’s resolution to not make the fee and permit the actual patent to lapse, possible not an oversight.”
On this view, letting the patent lapse might need merely been a low-cost calculation, particularly if Novo believed their core IP safety was set to run out quickly.
Form confirmed this was possible not a mistake however a transparent resolution by Novo. “Whereas oversights occur in IP companies and third-party payment fee entities, oversights in payment funds are very uncommon… On this scenario, it’s extra possible that the belief that this patent was expiring in January of 2026 and Novo was not giving up a lot by deciding to not pay this payment.”
To simplify, consider Novo’s medication as being protected by two locks in Canada. The primary is information exclusivity, a governmental rule that forestalls anybody from even attempting to repeat the drug for eight years following the drug’s approval. This primary lock began to be efficient in 2018 and can naturally finish in 2026.
The second is the patent that Novo both neglected or determined to not keep. If maintained correctly, this patent would have expired in March 2026, but it surely expired in 2020 as an alternative.
At first look, it seems to be just like the patent was pointless since semaglutide was already protected by information exclusivity, and each had been ending in early 2026. Nonetheless, when information exclusivity ends, it ends for good, which isn’t essentially the case for the patent. In lots of jurisdictions, together with Canada, the safety of a patent will be prolonged by a certificates of supplementary safety (CSP). The extension granted by a sound CSP begins when the patent it’s tied to expires, if it was adequately maintained.
What’s shocking is that Novo did file a CSP for the semaglutide patent, and it was even granted by the Canadian authorities. It’s nonetheless within the Canadian CSP register, scheduled to take impact in March 2026 and final till March 2028.
However right here’s the twist: the CSP is tied to the very patent Novo let expire in 2020, that means the CSP could be invalid. “The CSP is just enforceable if the underlying patent is legitimate and in pressure on the time the CSP is about to take impact. If the patent lapses earlier than the CSP’s begin date, as a consequence of non-payment of upkeep charges or different causes, the CSP can not legally take impact or be enforced”, defined Form
That is the place the choice feels odd. Even when the choice wasn’t unintended, most massive pharma firms wouldn’t let a patent lapse so quietly in Canada, one in every of Novo’s largest semaglutide markets, over a comparatively small quantity. Novo clearly noticed some worth in post-2026 safety; why else file the CSP? So, why abandon the underlying patent over a small payment?
If the CSP is invalid, it makes Novo’s resolution to not keep the patent questionable, to say the least, as it’s dropping two extra years of exclusivity on the Canadian market.
And in line with Form, the CSP is certainly as invalid because the Novo GLP-1 patent. “The Canadian CSP Register might record a CSP even when the underlying patent has lapsed, however this doesn’t imply it’s enforceable. Well being Canada’s registers might not at all times be up to date in real-time to replicate patent standing adjustments.”
“If firms like Sandoz usually are not appearing as if the CSP is enforceable, it’s possible as a result of they’re conscious the underlying patent has lapsed and thus the CSP is invalid. Novo’s resolution to not keep the patent certainly forfeits the extra two years of exclusivity the CSP would have offered had the patent remained in pressure,” mentioned Form
I reached out to Canada Well being to verify whether or not the CSP was invalid, however I’m nonetheless ready for a solution. In any case, 2026 will come very quickly, and will probably be very fascinating to see how the scenario unfolds. Will it’s the start of a brand new IP struggle for Novo, just like the one it’s at present combating on the Indian market?
What Novo Nordisk stands to lose in Canada and past
The expiry of Novo Nordisk’s semaglutide patent in Canada would possibly look small on paper, however the penalties could possibly be substantial. “There isn’t any query that generic producers are making ready for launch as quickly because the Novo information exclusivity expires in January 2026. As soon as the safety expires, Novo Nordisk will lose its unique rights to promote semaglutide-based medication in Canada, together with Ozempic and Wegovy. This can open the market to generic and biosimilar rivals, possible driving costs down and rising affected person entry,” mentioned Form.
As quickly as January 2026, firms like Sandoz and Apotex are anticipated to launch generic variations of semaglutide in Canada, the place protections from information exclusivity will come to an finish. Sandoz has been particularly vocal: its CEO Richard Saynor informed Bloomberg the corporate would use Canada as a launchpad, citing the absence of a sound Novo GLP-1 patent as a transparent inexperienced gentle.
The monetary implications for Novo could possibly be vital. “I’m conscious that analysts anticipate costs of Ozempic and Wegovy to drop by as a lot as 50 to 80% in comparison with the brand-name variations. Novo’s market shares will possible decline as healthcare suppliers and sufferers shift towards extra inexpensive generic options. Novo might concentrate on differentiating its merchandise, equivalent to with new formulations or mixtures, however the core semaglutide market will face elevated competitors,” defined Form.
For a drug that generates tens of billions yearly, even partial lack of market share in a single nation will be painful, and Canada occurs to be Novo’s second-largest marketplace for semaglutide. As soon as generics hit, public techniques are more likely to pivot rapidly, switching sufferers to cheaper variations.
The scenario might not cease at Canada’s borders. “These points usually are not distinctive to Canada. Related waves of generic filings are anticipated or already underway in different nations the place semaglutide patents are expiring, equivalent to China, India, and Brazil,” defined Form.
Nonetheless, Novo might need a couple of tips up its sleeve, as its experimental weight problems drug Amycretin may doubtlessly surpass Wegovy and is about to begin section 3 trials in 2026.
Lesson discovered from the Novo Nordisk IP case?
Whereas we don’t know for certain if this GLP-1 patent lapse was a deliberate resolution from Novo or a mistake, the case does make clear the complexity of coping with a number of jurisdictions.
“Submitting and sustaining patents in a number of nations is dear. Charges for utility, examination, grant, and annual upkeep can rapidly add up, particularly for firms with massive portfolios. The executive burden of monitoring deadlines, payment funds, and compliance necessities throughout dozens or tons of of patents is critical and requires strong mental property and doc administration techniques,” mentioned Form.
For giant companies, these techniques exist, and but even they’ll slip. For smaller biotech firms, the stakes are greater. A single missed deadline or pointless submitting in a low-value jurisdiction can drain sources or create authorized vulnerabilities.
So what’s the smarter path ahead for leaner IP groups or biotechs with no IP groups in any respect?
Based on Form, key methods for managing world IP upkeep prices embody:
- Submitting and sustaining rights solely in jurisdictions the place they provide a strategic or industrial benefit
- Often reassessing the worth of every proper and abandoning those who now not align with enterprise targets
- Implementing a tiered upkeep technique based mostly on enterprise significance
- Utilizing analytics to evaluate market potential, competitor exercise, and income influence
- Permitting rights to lapse in areas the place they now not present worth
The GLP-1 patent case might or might not replicate a expensive mistake on Novo’s half, but it surely’s a reminder that IP isn’t static. For firms chasing world enlargement or making ready for partnerships or acquisitions, clear, well-prioritized IP portfolios could make or break a deal. And in a world the place even billion-dollar medication can see their safety questioned over a missed payment, the lesson is obvious: monitor and query all the pieces.
