> Prof. Michael Hoffman from Toronto put me on to the Canadian Patent Database, where you can find that Novo did file a patent there for semaglutide. . .but the last time they paid the annual maintenance fee on it was 2018!
> 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."
I always wonder-in this case of such an epic company fuck up, does anyone ever get fired? Or is responsibility so diffuse that nobody is ultimately responsible?
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?
Typically when people get fired for something like this they are just the scapegoat.
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'm having trouble understanding the argument outlined in the legal.io link:
> 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?
It depends what the “simultaneous filing of the CSP” was simultaneous with. If it was simultaneous with letting the patent expire that makes no sense. If it was simultaneous with the original filing of the patent that does make sense.
Based on the gov website it sounds like it has to be filed within 120 days of filing the patent, so i guess its the latter.
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 think it's interpreted as meaning that the company is generally committed to patent protection, and so if they let it lapse in this case despite several warning letters that it's more likely it was a conscious decision for commercial reasons. Which is what they claim. I don't think it's a particularly strong argument.
Ah yes, the ole', it can't be a mistake because companies don't make mistakes therefor it must have been intentional.
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.
Back in 2018, it wasn't widely known that Ozempic would become a blockbuster weight loss drug. So it was possible they made the business decision based on its more limited use as a diabetes drug.
Just FYI, this isn't "by Science", it's by Derek Lowe, this is his blog, which is hosted on Science>Commentary>Blogs. In its description, Lowe says it is "editorially independent".
Yeah, Lowe doesn't work for Science -- he is a pharmaceutical chemist who has worked for various companies -- his "In the Pipeline" blog is interesting because while academic scientists often blog, industrial ones rarely do (perhaps for legal/IP reasons).
You just described how the general public should view opinion pieces but acts like the previous comment and assumes it is "news". (To add: this is very human to do)
Then they'd be better off removing this section if "editorially independent" means "we will take things that even in their headline may not be true at all".
It's a blog. It references an interview. The post is also four month old.
"In the Pipeline" is generally a fantastic resource on the pharma industry and chemistry news.
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).
> Derek Lowe’s commentary on drug discovery and the pharma industry. An editorially independent blog, all content is Derek’s own, and he does not in any way speak for his employer.
The top of the sidebar describes what "In the Pipeline" is.
> 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.
I wasn’t casting aspersions on NN, but jumping off from the allusion that was made by the user who I replied to.
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.
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.
Even at large corps, it's fairly common to outsource IP work to law firms that specialize in IP - and if you're Danish, it might make sense to outsource to a Danish law firm that has its own worldwide IP contacts (rather than getting your own worldwide branch offices to handle local IP laws everywhere). One of said contacts might then pawn off the work onto a junior, who then has their assistant handle all communiques from CIPO. Said assistant could then entirely drop the ball.
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.
That may be true if IP is not your core business but it is basically the core business of pharmaceutical companies. I don't speak from experience but it would seem surprising to me that any major pharma would outsource IP protection in a major market to contractors they can't sue for billions if they mess up.
It seems much more likely to me that they did it on purpose, as they claim to have.
> 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.
Saying pharma companies are just holders of ‘expensive, time-limited IP’ is not only wrong, it’s offensive to those of us who actually do the science. We spend years designing, testing, and validating drugs, not scheming to hike prices. We’re not all Shkrelis out here.
I was a bench scientist (proteomics) in pharma for over a decade. There is plenty of sweat and blood going into the pipeline, but a company is ultimately defined by the strength of its (patent) portfolio. Which is why a patent cliff drives their valuations.
I've read a little about Novo Nordisk's history and it is a pretty interesting story about aligning financial success with human flourishing. The pharmaco is a subsidiary of a anti-diabetes foundation started from proceeds from getting permission to produce insulin.
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]
A drug is almost never acquired that can then be put directly to patients and sold.
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”
Having seen AstraZeneca inside, this is not the case. There's quite a lot of development going on. It is all non-fundamental though, the focus is heavily on late stage. No identification of disease mechanisms and such.
> Or is responsibility so diffuse that nobody is ultimately responsible
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.
It could be something as simple as answering the phone. Or checking if the default image for a product on an ecommerce website exists. If you answer the phone or write a quick script to check if the default image exists, now you sort of become the person who is "expected" to do this task.
after working in many companies for decades I can guarantee that the person responsible is some middle manager, who will just blame one of her/his workers who had that piece of work "deprioritised" to instead focus on the styling of a spreadsheet. The paper trail will point to the manager, who will just claim it was allocated to a problem character.
The cartharsis comes in knowing that them firing the innocent just keeps them repeating the mistake.
In your typical large company, there's always enough nebulous process as to minimize personal accountability for any decision that is made. There might be a decision maker in practice, but there will be enough wide meetings and committees so that the groups as a whole can make bad decision, or a very immoral decisions, with minimal risk of consequences for anyone involved. Raising tough questions in those rooms is a good way to not make friends, and end up isolated in an unimportant position after the next semi-anual reorg.
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.
Uh, Novo is having an absolutely massive firing round; the CEO got axed first and Denmark now has a glut of qualified unemployed which we're all doing our best to hire ASAP :D (we just had the lowest unemployment rate in our history)
(Novo hired _way_ too many people because 'infinite money')
If you're going to go for a two year supply, it's probably better to just risk shipping it. You're not going to come home with that much without it getting confiscated, and you're way more likely to be searched individually than a typical package is.
> With de minimis for US-bound packages suspended I suspect way more packages are inspected than used to be
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.)
At least for wine, furniture, cheese, olive oil, art, kitchen equipment and medicine, at least from Italy and Germany and India and Taiwan, in the last six months, allegedly.
> got themselves a military base being built on American land now too
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 those downvoting: we sell fighter jets to many countries, including the UAE. They send pilots here to train on flying these jets. Those pilots need a place to stay.
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.
Not an American but there’s only very limited circumstances you can travel across the border home to the USA with foreign prescription drugs, right? And this scenario wouldn’t cover it. Unless you just meant they won’t get caught or maybe not fined or confiscated in practice? :)
That's mainly for visitors. If you're a US resident, you can't just buy medicines abroad, unless of course we are talking about the "they won’t get caught" scenario.
US residents can buy medicines abroad the FDA link says personal importation is allowed as long as the medicines are FDA approved and are not being imported for commercial purposes. Now in the context of the original post maybe generic versions of Ozempic won't technically be FDA approved yet if the company that produces it has to wait for the US patent to expire.
Of course you can buy medicine abroad and legally bring 90 day doses.
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.
I bet many Americans would travel to Canada to buy it there
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.
While I'm all for saving costs, I would be shocked if mixing your own inject-able medicine either weekly (with the chance of making a mistake in dosage or sterility) or too such a high degree of sterility that you can confidentally store several doses is not worth the $200 return flight every two years. Maybe I'm overestimating the risks but it still seems like a small saving for it.
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).
Its remarkably straightforward. Not fool-proof, but easy. Bacteriostatic water, single use needles/syringes, and self healing injection port vials makes it simple to maintain sterility throughout the process.
Multiple doses can be mixed and stored in the fridge for 4-6 weeks.
it's extremely common. everyone i know that's on a glp-1 does it this way. that way you can buy it in bulk for a discount. i buy mine roughly 35 weeks worth of doses at a time.
So cocaine from the south, ozempic from the north, fetanyl from the west and the meth is homegrown. So USA just need some powder from europe to close the circle.
I guess you get more shelf life, but it's an injectable drug.
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.
Bacteriostatic water is widely available and you hydrate it in the container it comes in. Its pretty easy. I promise you you probably know someone on a glp-1 that is already doing this.
I found it in a mainstream site here. 30ml for $300, with free shipping for next Wednesday. It has classified as a "nutricional supplement" for bodybuilders. I didn't purchase it, but I guess now I'm in yet another list.
There are places to get it WAY cheaper than that. I started off buying single vials for big money until I found group buys. Once my wife started using them too it was going to be too damn expensive to buy single vials. You can get kits (packs of 10 vials) for a lot less money. Been doing this 2 years now!
This sounds like something the current SCOTUS should be more than happy to shoot down, no? If you're bringing medication for yourself from abroad that you obtained legally, why should the FDA's concerns for your own safety trump (no pun intended) your freedom?
Remember that back in the dim antiquity of 2017, semaglutide was an experimental drug for type 2 diabetes. The sales explosion only happened a few years later when it started being prescribed for weight loss.
Don't be so quick to assume it was a failure not intentional. One of the comments in the article suggests it could have been to avoid PMPRB which is price control for patented drugs.
The company said it was intentional, probably because of the reason you mentioned: “In a statement to Fortune, Novo Nordisk said there was no mistake regarding its patent maintenance fee in Canada.”
I have an acquaintance working big law. They said the billing was "more offensive thank you could possibly imagine" ... but they took the money of course.
To be honest, given the efficiency of the drug and the huge benefit it could be to society, I feel like if I had been the employee in charge of filing patents I would've more than ready to lose my job in exchange for low cost general availability in the US via (illegal maybe, whatever) cross-border market. It's a nice loop hole and a great thing that once the delay expired they can't file ever again.
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.
> 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."