jzebedee
7 hours ago
> 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."
0cf8612b2e1e
7 hours ago
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?
bawolff
6 hours ago
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.
nextos
5 hours ago
Some people, including legal experts, claim it could have been intentional: https://www.legal.io/articles/5691258/Novo-Nordisk-Lets-Cana....
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.
nl
a minute ago
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?
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.
wasabi991011
3 hours ago
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".
bawolff
4 hours ago
Given how much of a blockbuster drug it is, wouldn't it be worth it for generics to rerun the trials in this specific case?
aspenmayer
4 hours ago
> If it is solely up to one person that is a failure in and of itself.
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...
nextos
4 hours ago
The process for the patent to lapse in Canada is quite long, and you get warning letters once deadlines are close.
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.
aspenmayer
4 hours ago
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.
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.
Marsymars
3 hours ago
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.
nijuashi
2 hours ago
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.
cperciva
2 minutes ago
I may be wrong, but aren't most drugs sold by large pharma companies actually developed elsewhere and then acquired?
0cf8612b2e1e
35 minutes ago
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.
foofoo12
5 hours ago
> 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.
userbinator
7 hours ago
Or is responsibility so diffuse that nobody is ultimately responsible?
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.
JumpCrisscross
6 hours ago
> 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.
ionwake
7 hours ago
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.
hibikir
2 hours ago
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.
Rebelgecko
4 hours ago
Is this the patent equivalent of letting your website's cert expire?
crummy
4 hours ago
More like letting the domain expire, and someone else snapping it up before you can renew.
benrawk
an hour ago
I mean the CEO got fired…
gpt5
7 hours ago
Canadian manufacturers (Sandoz and Apotex) are preparing to launch their own generic versions in early 2026.
I bet many Americans would travel to Canada to buy it there (despite the legality concerns). The medications lasts 2 years in a refrigerator.
rootusrootus
7 hours ago
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.
c2h5oh
6 hours ago
With de minimis for US-bound packages suspended I suspect way more packages are inspected than used to be.
JumpCrisscross
5 hours ago
> 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.)
CamperBob2
4 hours ago
You can import from UAE without paying any duties or fees?
JumpCrisscross
3 hours ago
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.
delfinom
3 hours ago
I mean that entire region has bought the president, even got themselves a military base being built on American land now too.
So why not.
bparsons
2 hours ago
Higher enforcement demands probably lead to more stuff slipping through.
themafia
7 hours ago
You should be able to travel with a 90 day supply without issue.
daniel_iversen
6 hours ago
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? :)
toomuchtodo
6 hours ago
valicord
5 hours ago
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.
chronos00
5 hours ago
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.
jay_kyburz
3 hours ago
The FDA approved version may be significantly cheaper to compete with the generic brands.
I also wonder if only the "active ingredients" need to be FDA approved, and the packaging is irrelevant?
Muromec
5 hours ago
Sounds like an opportunity for non-residents.
loeg
41 minutes ago
I think the biggest legality concern is having your shipment seized at the border. Maybe a risk but it’s not exactly a scheduled drug.
stevehawk
6 hours ago
the shelf life is probably longer than that if you buy it in dehydrated form and don't hydrate it (but i have no idea)
greycol
5 hours ago
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).
choilive
5 hours ago
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.
kimos
4 hours ago
While I agree and this all seems reasonable, I think you give the average person far too much credit.
stevehawk
3 hours ago
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.
SoftTalker
4 hours ago
This is commonly done for injectable fertility treatments, though in my experience they are hydrated just before use.
gus_massa
5 hours ago
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.
stevehawk
5 hours ago
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.
gus_massa
an hour ago
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.
ReptileMan
5 hours ago
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.
reaperducer
5 hours ago
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.
AnimalMuppet
7 hours ago
Um, what are the legality concerns? Is it illegal to bring medicine for your own use over the border? If not that, then what?
(Honest question. I don't know.)
jacobgorm
6 hours ago
Just don’t do it in a speed boat.
ano-ther
7 hours ago
dataflow
27 minutes ago
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?
ChrisMarshallNY
7 hours ago
I totally believe this happened.
If anyone has worked in a big, hidebound corporation, they are familiar with the "That's not my job" quandary.
general1465
6 hours ago
This is impressive feat of bean counting. To save few thousand dollars, they lost market of few billion dollars. Good job.
duxup
5 hours ago
That letter from lawyers probably cost more than 250 …
eulgro
7 hours ago
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.
Vinnl
7 hours ago
Maybe they'd even do it in exchange for just low-cost general availability in Canada!