Novo Nordisk's Canadian Mistake
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Novo Nordisk's failure to maintain a Canadian patent for semaglutide (Ozempic) has sparked discussion about generic production and international drug pricing, with some seeing it as a business blunder and others as an opportunity for more affordable healthcare.
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https://www.fda.gov/industry/import-basics/personal-importat...
Okay but your statement was that there's "nothing illegal about it". You now agree that it's illegal, you're just unlikely to get caught. And if you are, you'll just lose that purchase and not face any legal consequences.
Afaik, people hide it only for some controlled substances.
Next time you play a random music video on YouTube, please look at the number of federal copyright laws you're violating. Also, if you ever drive from one state to another, check if you have any plant food with you because crossing state lines with any plant material may be illegal. And I need not remind of marijuana which we know remains highly illegal at the federal level.
That's false: it is entirely illegal.
Whether or not you can get away with it due to lax enforcement, or whether or not there are any real penalties for getting caught... that's a separate issue that has nothing to do with what you said.
Additionally, some laws are not even written clearly, and in fact are intentionally written vaguely.
Yes, the patent won't be valid for Canada, but you can't import a product into the US which would infringe on a US patent.
So, though there may be a small amount that would slip through the cracks, it isn't as if anyone in the US can now manufacture Semaglutide and distribute it.
Canada is such a small market, that many companies don't bother. Though, for the cost, it seems ridiculous a company as big as Novo didn't pay the $500...that may even have been in Canadian dollars. :)
Canadian pharmacies can legally sell it and Americans (and all other foreigners for that matter) traveling there can legally buy it.
Unlike the criminal law, Novo nordisk would have to go after every single person individually and make the case that they are infringing the American patent. This is all without the help of the police or customs, as a private civil matter.
Obviously this would be uneconomic for Novo Nordisk. You can't search anyone as you don't have any warrants, as it's not a crime and then even if you could, you need to prove that the drugs they have on them were purchased in Canada.
Foreigners who currently pay a huge amount of money would only have to make one trip to Canada in however long period it takes for the drugs to expire. I know I would certainly make a day trip if I was using this drug.
Intellectual property law firms offer services to renew and watch registrations like this worldwide and it would have been very simple to have a contract with one of them.
Well, about that... Aren't all variants of medications like these prescription-only? And in Canada you can't fill a foreign prescription without having a local doctor sign off on it, as far as I know.
This is how medical tourism typically works.
I don't think that's quite right. One of the things that CBP does is inspect incoming shipments, and confiscate IP-infringing things.
Think about the recent Apple Watch SpO2 sensor patent shenanigans: The threat was to have CBP confiscate any infringing devices at the port of entry. I also remember that multimeters infringing on Fluke's ~~design patent~~ trademark have been blocked at the port of entry:
https://hackaday.com/2014/03/19/multimeters-without-a-countr...
US consumers would have to travel to Canada for injections which isn't practical unless you live on a border town.
It's unlikely to meet the bar for personal importation as you say.
That probably won't stop people from trying. There's already a huge market for illegal compounds and GPL-1 drugs are available alongside the usual testosterone and other steroids.
> There's already a huge market for illegal compounds and GPL-1 drugs are available alongside the usual testosterone and other steroids.
The peptide and oils markets are both big, but largely separate -- the peptides folks don't seem to want to be associated with oils. Within peptides, GLP1s definitely dominate, though the other options are pretty popular. In my experience it seems like GLP1s are kind of a "gateway peptide" -- a lot of folks start with a GLP1 on the gray market, and then start to branch out and try the other options available.
Also, let's be real, anyone in the northeast could be there in a few hours driving. New York City is about 7 hours away from Ottawa, for example.
I’ve ended up at the border crossing from Niagara Falls to Buffalo by accident before. I was glad when they let me make a U-turn.
As a Canadian national in the US I wouldn't even attempt doing this in the current political climate.
[0] https://www.fda.gov/industry/import-basics/personal-importat...
Ozempic did about US$2bn of revenue in 2024 in Canada.
Probably depends on enforcement, price delta, and various other variables.
e.g. something like a quarter of smartphones sold in Brazil are smuggled in, more than a small amount slipping through the cracks.
Technically true, but in practice you can often get it across the border in personal-dose-level quantities without getting caught.
> You can even find a letter where their lawyers send a refund request for the 2017 maintenance fee ($250) because Novo apparently wanted some more time to see if they wanted to pay it.
> On the same date in 2019, the office sent a letter saying that “The fee payable to maintain the rights accorded by the above patent was not received by the prescribed due date. . .”
> By that time it was $450 with the late fee added, but that was apparently too much for Novo. They had a one year grace period to make it up, and apparently never did, so their patent lapsed in Canada. And as the Canadian authorities remind them, “Once a patent has lapsed it cannot be revived”.
Impressive failure for "the second-largest semaglutide market in the world."
One's got to find ways to feel like the good guy when working for Big Pharma . That's probably not what happened but it's nice imagining it.
Pharma companies are really nothing more than holders of time-limited, expensive, exclusive IP. The number one priority should be to maintain those protections as long as possible. How could any patent be allowed to lapse, even if there was limited commercial value, let alone, a blockbuster drug making billions?
That's exactly how things like this happen. No one has responsibility, thinking it's someone else's problem, so no one bothers to do the needful.
Or it’s in someone’s political interest to let the fuckup play out.
A failure like this isn't just one dude forgetting, its a system failure where policies and checks failed. If it is solely up to one person that is a failure in and of itself.
I was surprised Science didn't discuss this option. However, reader comments in Science do comment on this possibility.
The idea is that letting the patent lapse would avoid getting regulated by the Patented Medicine Prices Review Board.
I know several people working at NN, and it's quite chaotic and political, so I wouldn't rule out an internal oversight.
Not really. It doesn't look like a blog, and it's not a person/org's specific blog post. It's just called "blog" in a breadcrumb somewhere, which most people won't read. It's actual a guest editorial, but still - doesn't really look like one.
Yeah, it really is, even if what's linked to is one post rather than the entire blog.
His stuff pops up here often enough. He really does blog at Science. Has for years and years.
If you have a background in chemistry, it's fairly accessible (i.e., he very rarely talks about anything in a depth that an undergrad chem major would have trouble understanding - which, given that most chemists start branching off very quickly in grad school, is roughly the appropriate depth for writing intended for a general chemistry audience, since it's the last common knowledge level).
The top of the sidebar describes what "In the Pipeline" is.
> Nordisk has rejected any suggestion that the loss of its Canadian semaglutide patent was a simple mistake. In a statement cited by Fortune, the company stressed that its intellectual property strategy is “carefully considered at a global level,” indicating intentionality rather than a blunder.
> Legal analysts believe the decision was deliberate. Steven Shape, IP Chair at Omnus Law, noted that the annual $250–$450 fee was negligible compared to the looming expiration of both data exclusivity and patent protection in January 2026. Shape argued the lapse was likely “a clear decision by Novo,” not an error.
> That interpretation is bolstered by the company’s simultaneous filing of a Certificate of Supplementary Protection (CSP) in Canada, suggesting Novo valued extended market exclusivity beyond the patent’s life. But because the underlying patent lapsed early, the CSP cannot take effect.
If the interpretation is bolstered by the company’s filing for CSP, but they were ineligible for CSP because they let the patent expire doesn't that imply it was an error?
I'd never heard of CSPs before, but https://en.wikipedia.org/wiki/Supplementary_protection_certi... has some details. They seem to be a patent extension in all but name.
It might not be as nonsensical as the alternative, but I still dont understand how the CSP filing makes it any less likely letting the patent lapse was a mistake.
I know you're not the one making the argument but it really is rediculously silly to argue that it must be an intentional action to not do something because in the past the company wanted to do the thing. While duh, a mistake by definition is something you dont want to do.
I would agree. The so-called bus factor has been common knowledge in the industries in question for literal decades now.
https://en.wikipedia.org/wiki/Bus_factor
> An early instance of this sort of query was when Michael McLay publicly asked, in 1994, what would happen to the Python language if Guido van Rossum were to be hit by a bus.
http://legacy.python.org/search/hypermail/python-1994q2/1040...
There is also a possibility of a paying a late fee and, finally, there is also a reinstatement process.
NN could have missed all these, but they would have to be a really dysfunctional organization. Definitely not a low bus-factor situation.
I don’t know what kind of sequence of events could lead to this outcome at NN, but perhaps they were hoist by their own petard. I’m reminded of the “money on the ground” joke involving two economists, which is semi-famous in these parts.
To wit:
> Economist 1: Look, there’s $20 on the ground!
> Economist 2: No there isn’t. If there were, someone would have picked it up already.
https://slatestarcodex.com/2014/06/19/money-on-the-ground/
https://news.ycombinator.com/item?id=28029044
Perhaps the folks at NN are so busy picking up (billions of) dollars that they neglect the dimes on the ground that it would cost to comply with these seemingly trivial, even menial functional requirements of keeping their money printer running.
I’m honestly as befuddled by this brouhaha as anyone. This is a monumental failure of multiple entire business units to perform the core competencies of their jobs. That said, I could honestly believe that the number of people whose job it is (or perhaps was) to worry about the patent expiry at all, let alone be aware of the repeated communiques from the Canadian patent office, is quite low. I would further believe that the accountability dodging has only just begun behind closed doors, if the internal game of megacorporate musical chairs hasn’t already concluded well before this news broke and reached the shores of HN.
I've zero idea about anything specific to Novo Nordisk, but have enough exposure to IP in Canada to envision the above happening in other cases.
It seems much more likely to me that they did it on purpose, as they claim to have.
This isn't what that joke means.
It doesn't take a very large company for this to happen. I've seen it in a sub 50 person company. There is a task to be done but no one can do it because everyone involved is waiting for someone else to do something. It's like a Mexican standoff.
Boggles my mind.
The foundation has an objective of providing support for scientific, humanitarian and social purposes. . . . In 2024, the foundation distributed a total of DKK 10.1 billion (approx. $1.39 billion) and paid out DKK 6.9 billion ($1.08 billion) in grants. [0]
0. https://en.wikipedia.org/wiki/Novo_Nordisk_Foundation
Large pharma makes strategic bets on several drugs, some initiated in house, others acquired, but they all just go through further optimization and testing before it is approved.
Huge RnD is required even if drug is “simply acquired”
(Novo hired _way_ too many people because 'infinite money')
The cartharsis comes in knowing that them firing the innocent just keeps them repeating the mistake.
Even in companies with a strong CEO who is, in fact, lording over everyone, mechanisms will be built to make sure said CEO's bad decisions were group decisions, and that most of the people around him agreed.
I bet many Americans would travel to Canada to buy it there (despite the legality concerns). The medications lasts 2 years in a refrigerator.
I also wonder if only the "active ingredients" need to be FDA approved, and the packaging is irrelevant?
More over, you can order and ship medicine, including ozempic and zepbound, using American prescription from Canadian online pharmacies. For some drugs it’s quite cheaper than paying American prices.
But a smaller fraction.
If you’re paranoid, route it via the UAE. All my European and Indian shippers are doing that for tariff-free pricing. (Personal stuff. I’ll pay a customs duty if I get it, of course.)
So why not.
As a European I'm as critical of the US government as can be and their president has definitely been bought, but there are already several countries that have some training facilities and military personnel in the US.
Calling it a foreign military base is really unnecessarily hyperbolic. And given the amount of military bases that the US have on foreign land, the outrage also seems a bit misplaced.
For their own security protocols, among other reasons, many partner nations prefer to have a small area set up, think of it like a consulate, where their people stay within their own jurisdiction, rather than a hotel. The UAE is setting up such a place for its pilots.
That is all.
This isn’t a force-projection military base on US soil.
(Honest question. I don't know.)
You probably have to disolve it in very clean water in a very clean container. Do you have to match the salinity and pH with the proprties of the blood? How much time must you stir it to ensure it's completely disolved? Do you have to add something to increase/reduce viscosity? Some alcohol in case there are a few bacterias or improve solubility? How long does the small homemade batch last in the fridge?
IIUC there is another version in pills, they may have a longer shelf life, or not. But ask a medical doctor before taking a ramdom medicine.
Realistically the cost of semiglutide in generic form means you could fly return every 90 days (personal import restriction for perscription meds) and still save $1000 every 3 months (3x$500 monthly - return flight - generic cost).
Multiple doses can be mixed and stored in the fridge for 4-6 weeks.
Why travel? There are thousands of ads on TV, radio, and the internet each day for Canadian pharmacies that promise to ship whatever you need to the U.S.
I guess they think some other production patent will let them maintain exclusivity without it being a patent on the drug itself?
If anyone has worked in a big, hidebound corporation, they are familiar with the "That's not my job" quandary.
And during most of that time, they were still protected by 'data exclusivity' which means that any generic producer could not get approved without doing their own clinical trials, until 8 years had passed.
So they gave up some period of exclusivity in return for being able to charge a higher price when they still had a monopoly.
I am not an expert.
Here's one about the price control on patented drugs: https://www.torys.com/our-latest-thinking/publications/2024/...
That is significantly cheaper than the US, and cheaper than other GLP-1 class drugs up here, arguably reasonable. Is the supposition that they would have been forced to charge even less? If so, why are their competitors who kept their patents not charging more?
Counterpoint: Mounjaro/Tirzepatide did keep their patent protection. They are able to, and do, charge significantly more.
Compounding isn't allowed in Canada, currently, so I assume you are talking about the US? Compounding Ozempic in the US wasn't a thing in 2018 when this patent was released in Canada, so not sure what one has to do with the other.
What are you getting at in reference to the argument that the patent was released intentionally in order to charge a higher price?
How does this work? Why/when would compounding not be allowed?
I'm not sure why you think that, compounding is allowed, I live right be a compounding pharmacy. And confirmed it's legal through google.
It's also relatively common for toddlers who need special doses, or for people who can't swallow pills and need liquid formulations.
Compounding is normal.
I was making no judgement on compounding generally.
https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/26...
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