10 ms·

Novo Nordisk's Canadian Mistake

423 points by jbm 1y ago

theturtle 1y ago
[dead]
paulpauper 1y ago
So would it be possible to buy the drug in Canada and ship to US?
- jasongill 1y ago
  not legally, but anything is possible
  - OutOfHere 1y ago
    There is nothing illegal about it. People get medicines from abroad all the time that are not generic domestically. It's not a controlled substance. One might have to go through unofficial channels though. In fact, I know people domestically who already get it cheaply from elsewhere abroad.
    - js2 1y ago
      > In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S. https://www.fda.gov/industry/import-basics/personal-importation https://www.fda.gov/industry/import-basics/personal-importat...
      - OutOfHere 1y ago
        There are a million laws on the books that not only are not enforced, but aren't even self consistent with each other. It is enforcement that determines what one actually can or can't do. The enforcement exists for controlled substances, for resale, and for a supply of over 90 days. For personal non-commercial use of a non-controlled medicine for under 90 days, the law is not enforced, and for good reason. People would die if the law were to be enforced too strictly.
        tredre3 1y ago
        > There are a million laws on the books that not only are not enforced, but aren't even self consistent with each other. It is enforcement that determines what one actually can or can't do. 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.
        OutOfHere 1y ago
        It's not about getting caught. It's done in the open with full awareness of everyone. It's not like anyone is hiding it. 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.
        kelnos 1y ago
        You seem to be missing the point. You said, "there is nothing illegal about it". 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.
        OutOfHere 1y ago
        When the diversity of laws are not even logically self-consistent, with one law denying a right and the other permitting it, what defines what is legal and what isn't? Enforcement does. Additionally, some laws are not even written clearly, and in fact are intentionally written vaguely.
- rootusrootus 1y ago
  I think you may need to drive it across, not ship it, and the quantity limit is a 90 day supply. For people who live close enough to the border, it might be worth it.
- Hilift 1y ago
  Possible, but considering that US Ozempic revenue is $10 billion per year between only Medicaid and Medicare, that would attract customs attention. The US market was projected to increase to $58 billion by 2035.
- dlcarrier 1y ago
  Smuggling aside, they generally won't make it through customs: https://www.help.cbp.gov/s/article/Article-1815?language=en_US https://www.help.cbp.gov/s/article/Article-1815?language=en_...
- deleted 1y ago
  [deleted]
pedalpete 1y ago
I thought I had a decent handle on patent law, but maybe I'm missing something here. 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. :)
- rootusrootus 1y ago
  As Derek mentions, Canada is the second largest market. There may be a lot coming into the US already, legal or not.
- maximus_01 1y ago
  Not that small. High income and roughly the same population as California, which isn't too small for companies to bother selling into. Ozempic did about US$2bn of revenue in 2024 in Canada.
- deleted 1y ago
  [deleted]
- killingtime74 1y ago
  Don't worry about the law think about the practical impact. It's now completely legal to ignore the patent in Canada so the price in Canada will plummet. 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.
jzebedee 1y 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."
- ChrisMarshallNY 1y 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.
- eulgro 1y 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.
  - deleted 1y ago
    [deleted]
  - Vinnl 1y ago
    Maybe they'd even do it in exchange for just low-cost general availability in Canada!
bstsb 1y ago
looking at the filing, they had their patent deadline extended due to COVID-19 eighteen times! https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2601784/summary.html https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/26...
choffman 1y ago
There's about to be a lot of skinny people in Canada bordering states. :)
rahimnathwani 1y ago
AIUI, because they let the patent expire, the drug was not subject to price regulation by the government. So they could charge whatever. 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.
- Emphere 1y ago
  Thanks, can you point to where you found this info?
  - rahimnathwani 1y ago
    Sorry, pieced together from different sources. I am not an expert. Here's one about the price control on patented drugs: https://www.torys.com/our-latest-thinking/publications/2024/12/the-latest-on-pmprb https://www.torys.com/our-latest-thinking/publications/2024/...
  - malshe 1y ago
    See the comments on that article where a few people have pointed this out.
- chronos00 1y ago
  Seems like a plausible explanation, the government should reform the price regulation laws to avoid this endrun around price controls.
- dghlsakjg 1y ago
  The price in Canada is ~$175 USD month for name brand Ozempic where I am with no coupons, or other discounts. I see prices in the US around $800+/month. 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.
TMWNN 1y ago
Quoting myself <https://np.reddit.com/r/MapPorn/comments/1md4wde/the_most_valuable_companies_in_major_eu_economies/n6135h6/?context=3 https://np.reddit.com/r/MapPorn/comments/1md4wde/the_most_va...>: >Novo Nordisk did not file for a renewal because of a mistake, or someone going on vacation, or anything like that. >Novo Nordisk decided that the additional years of patent protection were not worth it compared to the advantage of the drug no longer being under the jurisdiction of the PMPRB <https://en.wikipedia.org/wiki/Patented_Medicine_Prices_Review_Board https://en.wikipedia.org/wiki/Patented_Medicine_Prices_Revie...>. Whether that decision was financially correct in light of GLP-1's subsequent application to weight loss, I do not know. However, again, it was not a silly mistake on Novo Nordisk's part.
- mmooss 1y ago
  An interesting citation! But you are not an authority on the issue (?) and so not much of a cite. What is yourself's claim based on?
0cf8612b2e1e 1y ago
I had never considered it-what makes a drug prescription vs OTC? Every substance has safety concerns(dose makes the poison), so with a lot of the financial gone, will the GLPs ever not require a prescription?
- dlcarrier 1y ago
  In the US, prescription and OTC are theoretically completely unrelated, but in practice patent holders want their drugs to be prescription, where end users aren't involved in the process of selecting or paying for the drug, whereas generic manufacturers want the drugs to be OTC, where end users are choosing the product in a competitive market. See, for example, Prilosec (Omeprazole) switching from prescription to OTC.
- apike 1y ago
  The FDA (or equivalent in the relevant country) regulates whether an approved drug requires a prescription based on the safety profile. To be approved for OTC, there is a much higher bar in terms of ease of misuse, side effects, and so on.
- petesergeant 1y ago
  They don’t require one in the UAE (in practice, anyway), which has a well-regulated med scene.
vitorgrs 1y ago
In Brazil it will expire in July 2026. It's pretty relevant as it's kinda already announced they will put the generics on the public health care (SUS) for free... Which is big deal as an Ozempic shot costs almost the same as the minimum wage. This year they already did an analysis to include Ozempic, but it was denied, probably because of the cost difference... But they were trying on justice to extend the patent...
- 1oooqooq 1y ago
  being free means taxpayers will pay. and being on the public system means it will be prescribed only for health risk, just like plastic surgery already is. you don't see people getting nose jobs just because.
  - aardvarkr 1y ago
    Generics are so cheap and easy to make that they can reasonably justify that it will save the government money by making the population healthier. Just think about how much less heart disease and cancer and every other obesity-affected disease costs the taxpayer.
    - 1oooqooq 1y ago
      totally agree. was pointing out things left out from the previous comment which was kinda of impling gov would be paying all uses of the sliming drugs, even if on generics price. ... because those drugs make profit not because of it's health benefits.
  - UltraSane 1y ago
    Why wouldn't it be prescribed to morbidly obese people?
    - matheusmoreira 1y ago
      It is prescribed to the morbidly obese. It's just that patients almost always opt for cheaper options when I inform them of the costs of the treatment. Even if our public health care system starts offering semaglutide, it is extremely likely that it will impose requirements and require "justification" for the use of the medicine. You know, the usual soulless kafkaesque bureaucracy. It can frustrate people so much they give up. I've seen it.
glp1guide 1y ago
Not only that, there is a legitimate raft of companies lining up to make generics. There’s one wrinkle though, legally importing prescription drugs from Canada isn’t really allowed in the US/UK AFAIK. HIMS is probably feverishly figuring out how to do that right now. Shameless plug: https://glp1guide.substack.com/p/another-glp1-generic-launch-indias https://glp1guide.substack.com/p/another-glp1-generic-launch... Also somewhat separately, injectable GLP1s are about to be upstaged by oral variants — orfoglipron for Eli Lilly and the Wegovy Pill for Novo.
- ChrisMarshallNY 1y ago
  > Also somewhat separately, injectable GLP1s are about to be upstaged by oral variants — orfoglipron for Eli Lilly and the Wegovy Pill for Novo. I believe that this gets a new patent, and will probably be a huge seller.
  - glp1guide 1y ago
    Absolutely -- certainly in their biggest markets they'll be able to protect those patents. Both companies have thus far been unable to really stop compounding pharmacies and/or gray market suppliers from replicating though, and price negotiation with the government is definitely going to happen (Trump recently announced wanting $150 GLP1s, Novo's lawsuit against medicare price negotiation failed)... I do not have much faith in their ability to protect their pricing power for very long, which unfortunate for them is probably what's best for humanity and is very well known at this point.
  - BurningFrog 1y ago
    I suspect a lot of the anti-vaxx movement is subconsciously motivated by fear of needles. So yeah, I expect the pill form to be a huge seller!
    - kridsdale3 1y ago
      This was made abundantly clear to me in 2020. It's a mass hysteria fueled by trypanophobia in a vast population of people who aren't very interested in self-analysis and understanding how their own behavior and thought patterns are driven by the amygdala. One bit of evidence for this: SARMS are huge in the bodybuilding as "gateway steroids". They don't work, they have bad side effects, but hey, they're oral.
alister 1y ago
> Interviewer at Endpoints: You plan to potentially launch a generic GLP-1 in Canada and Brazil in 2026. Looking at the original interview on Endpoints, Sandoz CEO Richard Saynor says this about Brazil: In Brazil, the biggest prescribers are dentists. Everyone says, “Why dentists?” They do aesthetic work, and then you have your Botox, and then you want a bikini body. It’s behaving like an OTC consumer brand. Imagine selling this, rather than $300, at $50. Anybody over the age of 40 in Brazil will probably want to be on that. But he doesn't explain how they got around the patents. Another comment on HN says they expire in July 2026, but can anyone explain why the patents expire so soon in Brazil?
- abirch 1y ago
  1. In the USA people use compounding companies to get around patents. 2. https://www.reuters.com/business/healthcare-pharmaceuticals/brazils-hypera-launch-an-ozempic-generic-2026-ceo-says-2025-03-21/ https://www.reuters.com/business/healthcare-pharmaceuticals/...
  - giarc 1y ago
    I think that loophole has closed. If I recall correctly, compounding pharmacies were only allowed to do that as the US gov put the drug on a special list due to shortages. I believe they have removed it from this list (or will do shortly) and that pipeline will stop.
- vitorgrs 1y ago
  In Brazil, medicines lose patent protection 20 years after the original filing date. The filing date was in 2006, so the patent expires in 2026. But note that the patent was only granted in 2019, it took 13 years. They went to court last year, but the justice (as far as I know) has continued to follow the precedent that the original filing date applies. So they went to the federal government to try to change the law, but the government has refused so far. The INPI (Brazilian Patent Office) used to take a VERY long time to register/grant patents. It's faster now (about 4 years on average), but it's still slow. But I'm seeing here that in the US it was 2017. So not that different from 2019 anyway. PS: Brazil also have several local labs focused on generics, and besides this, there's also state-owned lab, Fiocruz, who makes vaccines and medicines as well, several of them, to distribute though SUS. In Brazil by the constitution, everyone has the right of health, so if the public health care (SUS) don't distribute, you can sue the governament and get the medicine. So there's a big incentive for the governament to make patents expire as soon as possible to have generics and include on SUS. e.g Fiocruz manufacture PrEP, and started now PrEP injection (Cabotegravir).
pogue 1y ago
It sounds like people will be flocking to Canada to fill their ozempic prescriptions. However, the WP just posted this article about how ordering rx meds from Canada has become unaffordable due to tariffs. Many seniors get cheaper medicine from Canada. That might become harder https://www.washingtonpost.com/business/2025/10/18/deminimis-prescription-drugs-tariffs/ https://www.washingtonpost.com/business/2025/10/18/deminimis... No paywall: https://archive.ph/nT0Jl https://archive.ph/nT0Jl
tavavex 1y ago
The whole story seems utterly insane to me. The fact that Novo Nordisk went back to ask for a refund of $250 they paid for the patent in 2017 shows that there was active intent behind this, this wasn't just some internal disconnect between payment systems that prevented the money from being sent to the government. Who at NN thought that saving, what, ~$1000 total was justified for this? I thought companies of this scale didn't even think on the scale of thousands of dollars anymore. Oh well, at least we in Canada get more generic drug variants. Thanks!
- tempestn 1y ago
  Insane to the point that it doesn't seem believable. Even if the patent was worthless it wouldn't have been worth their time to pursue that refund just for the $250. Another comment here mentioned that patents in Canada come with strings on pricing. So it's possible there was an actual trade-off that was considered here.
- HDThoreaun 1y ago
  Apparently they can get around the government price controls by getting off the patent. I guess they figured it was better to keep prices high so americans didnt border hop but lose the exclusivity sooner
dmix 1y ago
This is great news for Canadian public/private healthcare insurance. Not only do the drugs cost less but people get healthier and use less services
enslavedrobot 1y ago
Fun fact: Novo Nordisk's first success was selling insulin, which was discovered in Canada and licensed by the Scientists who's discovered it for free to the danish company in exchange for a promise to use the revenues "for good purposes". Hopefully this patent SNAFU makes up for 1% of that monumental screw job.
- nl 1y ago
  Insulin is cheap everywhere in the world except the US, and it's been around since the 1920s. The price has nothing to do with Novo Nordisk's distribution of it last century. https://pmc.ncbi.nlm.nih.gov/articles/PMC8597930/ https://pmc.ncbi.nlm.nih.gov/articles/PMC8597930/
- simongray 1y ago
  > in exchange for a promise to use the revenues "for good purposes". They still do an enormous amount of charity, though activities of the foundation are probably highly localised to Denmark: https://en.wikipedia.org/wiki/Novo_Nordisk_Foundation https://en.wikipedia.org/wiki/Novo_Nordisk_Foundation
- BurningFrog 1y ago
  There are many different kinds of insulin now, and almost nobody uses the original version, because it's tricky to get timing and dosage right. All with their own patent situation, of course.
  - lotsofpulp 1y ago
    Insulin is so easy to make clickbait and ragebait with due to people not knowing, or willfully ignoring, that “insulin” is not one specific medicine. Kind of crazy considering how many people have diabetes.
  - enslavedrobot 1y ago
    I should how so, considering the discovery I'm talking about happened in 1921.
danielovichdk 1y ago
Eat healthy. Do sports. Sleep well. Repeat.
- metabagel 1y ago
  Also, meditate, fast intermittently, get therapy, and develop healthy ways of handling stress and dissatisfaction. Everyone’s path is a little different. What is only a little difficult for some might be downright impossible for others (or feel that way).
  - philipallstar 1y ago
    No, those things aren't nearly as important. Handling stress and therapy can also be replaced by some physical activity as well. General advice that would work for 95% of people shouldn't be criticised because it doesn't address the other 5%. If people did it then there'd be far more money in the system to pay for usefully targetted specialist treatment for those people.
    - devjab 1y ago
      Since we are pulling numbers out of our asses can you tell me what good advice that 95% of the people aren't capable of following is? It's great that our national health institutes advices us, but can you explain how the advice isn't completely useless in this particular context? To me it comes off as arrogant and rude.
      - philipallstar 1y ago
        I didn't say 95% of people aren't capable of following some advice. That would be bad advice. I'm saying this is good advice, because 95% of people can follow it.
    - metabagel 1y ago
      If we are talking about overweight people, then I think your 95% figure is backwards. Maybe 5% can stick to that regimen without addressing what’s going on between their ears. Likely, your perspective is skewed by the crowd you hang out with or from seeing other people at the gym. That’s not a representative cross-section of the population, particularly with respect to people who are overweight. The emotional/psychological side is important, because the person must make long term changes in their lifestyle. People tend to over-eat for a reason, and typically it is a reaction to stress or some emotional/psychological need which isn’t being met.
p0w3n3d 1y ago
Does it mean that Sandoz can start production of a generic in Canada and sell it e.g. in Europe?
- progbits 1y ago
  The protection (racket) is about selling, not manufacture. Otherwise everyone would just manufacture in china and sell anywhere they like.
bluecalm 1y ago
What's shocking here is that it costs several hundred dollars per year to have a big country enforcing a monopoly for you. I mean at least taking % of the revenue would make sense (and preferably for others to buy out underutilized patents). As it is it's just corporate welfare - enforcing lucrative market monopoly for an equivalent of a steak dinner for two.

423 points by jbm 1y ago

theturtle 1y ago

[dead]

paulpauper 1y ago

So would it be possible to buy the drug in Canada and ship to US?

jasongill 1y ago
not legally, but anything is possible
- OutOfHere 1y ago
  There is nothing illegal about it. People get medicines from abroad all the time that are not generic domestically. It's not a controlled substance. One might have to go through unofficial channels though. In fact, I know people domestically who already get it cheaply from elsewhere abroad.
  - js2 1y ago
    > In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S. https://www.fda.gov/industry/import-basics/personal-importation https://www.fda.gov/industry/import-basics/personal-importat...
    - OutOfHere 1y ago
      There are a million laws on the books that not only are not enforced, but aren't even self consistent with each other. It is enforcement that determines what one actually can or can't do. The enforcement exists for controlled substances, for resale, and for a supply of over 90 days. For personal non-commercial use of a non-controlled medicine for under 90 days, the law is not enforced, and for good reason. People would die if the law were to be enforced too strictly.
      - tredre3 1y ago
        > There are a million laws on the books that not only are not enforced, but aren't even self consistent with each other. It is enforcement that determines what one actually can or can't do. 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.
        OutOfHere 1y ago
        It's not about getting caught. It's done in the open with full awareness of everyone. It's not like anyone is hiding it. 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.
        kelnos 1y ago
        You seem to be missing the point. You said, "there is nothing illegal about it". 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.
        OutOfHere 1y ago
        When the diversity of laws are not even logically self-consistent, with one law denying a right and the other permitting it, what defines what is legal and what isn't? Enforcement does. Additionally, some laws are not even written clearly, and in fact are intentionally written vaguely.
rootusrootus 1y ago
I think you may need to drive it across, not ship it, and the quantity limit is a 90 day supply. For people who live close enough to the border, it might be worth it.
Hilift 1y ago
Possible, but considering that US Ozempic revenue is $10 billion per year between only Medicaid and Medicare, that would attract customs attention. The US market was projected to increase to $58 billion by 2035.
dlcarrier 1y ago
Smuggling aside, they generally won't make it through customs: https://www.help.cbp.gov/s/article/Article-1815?language=en_US https://www.help.cbp.gov/s/article/Article-1815?language=en_...
deleted 1y ago
[deleted]

pedalpete 1y ago

I thought I had a decent handle on patent law, but maybe I'm missing something here. 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. :)

rootusrootus 1y ago
As Derek mentions, Canada is the second largest market. There may be a lot coming into the US already, legal or not.
maximus_01 1y ago
Not that small. High income and roughly the same population as California, which isn't too small for companies to bother selling into. Ozempic did about US$2bn of revenue in 2024 in Canada.
deleted 1y ago
[deleted]
killingtime74 1y ago
Don't worry about the law think about the practical impact. It's now completely legal to ignore the patent in Canada so the price in Canada will plummet. 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.

jzebedee 1y 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."

ChrisMarshallNY 1y 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.
eulgro 1y 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.
- deleted 1y ago
  [deleted]
- Vinnl 1y ago
  Maybe they'd even do it in exchange for just low-cost general availability in Canada!

bstsb 1y ago

looking at the filing, they had their patent deadline extended due to COVID-19 eighteen times! https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2601784/summary.html https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/26...

choffman 1y ago

There's about to be a lot of skinny people in Canada bordering states. :)

rahimnathwani 1y ago

AIUI, because they let the patent expire, the drug was not subject to price regulation by the government. So they could charge whatever. 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.

Emphere 1y ago
Thanks, can you point to where you found this info?
- rahimnathwani 1y ago
  Sorry, pieced together from different sources. I am not an expert. Here's one about the price control on patented drugs: https://www.torys.com/our-latest-thinking/publications/2024/12/the-latest-on-pmprb https://www.torys.com/our-latest-thinking/publications/2024/...
- malshe 1y ago
  See the comments on that article where a few people have pointed this out.
chronos00 1y ago
Seems like a plausible explanation, the government should reform the price regulation laws to avoid this endrun around price controls.
dghlsakjg 1y ago
The price in Canada is ~$175 USD month for name brand Ozempic where I am with no coupons, or other discounts. I see prices in the US around $800+/month. 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.

TMWNN 1y ago

Quoting myself <https://np.reddit.com/r/MapPorn/comments/1md4wde/the_most_valuable_companies_in_major_eu_economies/n6135h6/?context=3 https://np.reddit.com/r/MapPorn/comments/1md4wde/the_most_va...>: >Novo Nordisk did not file for a renewal because of a mistake, or someone going on vacation, or anything like that. >Novo Nordisk decided that the additional years of patent protection were not worth it compared to the advantage of the drug no longer being under the jurisdiction of the PMPRB <https://en.wikipedia.org/wiki/Patented_Medicine_Prices_Review_Board https://en.wikipedia.org/wiki/Patented_Medicine_Prices_Revie...>. Whether that decision was financially correct in light of GLP-1's subsequent application to weight loss, I do not know. However, again, it was not a silly mistake on Novo Nordisk's part.

mmooss 1y ago
An interesting citation! But you are not an authority on the issue (?) and so not much of a cite. What is yourself's claim based on?

0cf8612b2e1e 1y ago

I had never considered it-what makes a drug prescription vs OTC? Every substance has safety concerns(dose makes the poison), so with a lot of the financial gone, will the GLPs ever not require a prescription?

dlcarrier 1y ago
In the US, prescription and OTC are theoretically completely unrelated, but in practice patent holders want their drugs to be prescription, where end users aren't involved in the process of selecting or paying for the drug, whereas generic manufacturers want the drugs to be OTC, where end users are choosing the product in a competitive market. See, for example, Prilosec (Omeprazole) switching from prescription to OTC.
apike 1y ago
The FDA (or equivalent in the relevant country) regulates whether an approved drug requires a prescription based on the safety profile. To be approved for OTC, there is a much higher bar in terms of ease of misuse, side effects, and so on.
petesergeant 1y ago
They don’t require one in the UAE (in practice, anyway), which has a well-regulated med scene.

vitorgrs 1y ago

In Brazil it will expire in July 2026. It's pretty relevant as it's kinda already announced they will put the generics on the public health care (SUS) for free... Which is big deal as an Ozempic shot costs almost the same as the minimum wage. This year they already did an analysis to include Ozempic, but it was denied, probably because of the cost difference... But they were trying on justice to extend the patent...

1oooqooq 1y ago
being free means taxpayers will pay. and being on the public system means it will be prescribed only for health risk, just like plastic surgery already is. you don't see people getting nose jobs just because.
- aardvarkr 1y ago
  Generics are so cheap and easy to make that they can reasonably justify that it will save the government money by making the population healthier. Just think about how much less heart disease and cancer and every other obesity-affected disease costs the taxpayer.
  - 1oooqooq 1y ago
    totally agree. was pointing out things left out from the previous comment which was kinda of impling gov would be paying all uses of the sliming drugs, even if on generics price. ... because those drugs make profit not because of it's health benefits.
- UltraSane 1y ago
  Why wouldn't it be prescribed to morbidly obese people?
  - matheusmoreira 1y ago
    It is prescribed to the morbidly obese. It's just that patients almost always opt for cheaper options when I inform them of the costs of the treatment. Even if our public health care system starts offering semaglutide, it is extremely likely that it will impose requirements and require "justification" for the use of the medicine. You know, the usual soulless kafkaesque bureaucracy. It can frustrate people so much they give up. I've seen it.

glp1guide 1y ago

Not only that, there is a legitimate raft of companies lining up to make generics. There’s one wrinkle though, legally importing prescription drugs from Canada isn’t really allowed in the US/UK AFAIK. HIMS is probably feverishly figuring out how to do that right now. Shameless plug: https://glp1guide.substack.com/p/another-glp1-generic-launch-indias https://glp1guide.substack.com/p/another-glp1-generic-launch... Also somewhat separately, injectable GLP1s are about to be upstaged by oral variants — orfoglipron for Eli Lilly and the Wegovy Pill for Novo.

ChrisMarshallNY 1y ago
> Also somewhat separately, injectable GLP1s are about to be upstaged by oral variants — orfoglipron for Eli Lilly and the Wegovy Pill for Novo. I believe that this gets a new patent, and will probably be a huge seller.
- glp1guide 1y ago
  Absolutely -- certainly in their biggest markets they'll be able to protect those patents. Both companies have thus far been unable to really stop compounding pharmacies and/or gray market suppliers from replicating though, and price negotiation with the government is definitely going to happen (Trump recently announced wanting $150 GLP1s, Novo's lawsuit against medicare price negotiation failed)... I do not have much faith in their ability to protect their pricing power for very long, which unfortunate for them is probably what's best for humanity and is very well known at this point.
- BurningFrog 1y ago
  I suspect a lot of the anti-vaxx movement is subconsciously motivated by fear of needles. So yeah, I expect the pill form to be a huge seller!
  - kridsdale3 1y ago
    This was made abundantly clear to me in 2020. It's a mass hysteria fueled by trypanophobia in a vast population of people who aren't very interested in self-analysis and understanding how their own behavior and thought patterns are driven by the amygdala. One bit of evidence for this: SARMS are huge in the bodybuilding as "gateway steroids". They don't work, they have bad side effects, but hey, they're oral.

alister 1y ago

> Interviewer at Endpoints: You plan to potentially launch a generic GLP-1 in Canada and Brazil in 2026. Looking at the original interview on Endpoints, Sandoz CEO Richard Saynor says this about Brazil: In Brazil, the biggest prescribers are dentists. Everyone says, “Why dentists?” They do aesthetic work, and then you have your Botox, and then you want a bikini body. It’s behaving like an OTC consumer brand. Imagine selling this, rather than $300, at $50. Anybody over the age of 40 in Brazil will probably want to be on that. But he doesn't explain how they got around the patents. Another comment on HN says they expire in July 2026, but can anyone explain why the patents expire so soon in Brazil?

abirch 1y ago
1. In the USA people use compounding companies to get around patents. 2. https://www.reuters.com/business/healthcare-pharmaceuticals/brazils-hypera-launch-an-ozempic-generic-2026-ceo-says-2025-03-21/ https://www.reuters.com/business/healthcare-pharmaceuticals/...
- giarc 1y ago
  I think that loophole has closed. If I recall correctly, compounding pharmacies were only allowed to do that as the US gov put the drug on a special list due to shortages. I believe they have removed it from this list (or will do shortly) and that pipeline will stop.
vitorgrs 1y ago
In Brazil, medicines lose patent protection 20 years after the original filing date. The filing date was in 2006, so the patent expires in 2026. But note that the patent was only granted in 2019, it took 13 years. They went to court last year, but the justice (as far as I know) has continued to follow the precedent that the original filing date applies. So they went to the federal government to try to change the law, but the government has refused so far. The INPI (Brazilian Patent Office) used to take a VERY long time to register/grant patents. It's faster now (about 4 years on average), but it's still slow. But I'm seeing here that in the US it was 2017. So not that different from 2019 anyway. PS: Brazil also have several local labs focused on generics, and besides this, there's also state-owned lab, Fiocruz, who makes vaccines and medicines as well, several of them, to distribute though SUS. In Brazil by the constitution, everyone has the right of health, so if the public health care (SUS) don't distribute, you can sue the governament and get the medicine. So there's a big incentive for the governament to make patents expire as soon as possible to have generics and include on SUS. e.g Fiocruz manufacture PrEP, and started now PrEP injection (Cabotegravir).

pogue 1y ago

It sounds like people will be flocking to Canada to fill their ozempic prescriptions. However, the WP just posted this article about how ordering rx meds from Canada has become unaffordable due to tariffs. Many seniors get cheaper medicine from Canada. That might become harder https://www.washingtonpost.com/business/2025/10/18/deminimis-prescription-drugs-tariffs/ https://www.washingtonpost.com/business/2025/10/18/deminimis... No paywall: https://archive.ph/nT0Jl https://archive.ph/nT0Jl

tavavex 1y ago

The whole story seems utterly insane to me. The fact that Novo Nordisk went back to ask for a refund of $250 they paid for the patent in 2017 shows that there was active intent behind this, this wasn't just some internal disconnect between payment systems that prevented the money from being sent to the government. Who at NN thought that saving, what, ~$1000 total was justified for this? I thought companies of this scale didn't even think on the scale of thousands of dollars anymore. Oh well, at least we in Canada get more generic drug variants. Thanks!

tempestn 1y ago
Insane to the point that it doesn't seem believable. Even if the patent was worthless it wouldn't have been worth their time to pursue that refund just for the $250. Another comment here mentioned that patents in Canada come with strings on pricing. So it's possible there was an actual trade-off that was considered here.
HDThoreaun 1y ago
Apparently they can get around the government price controls by getting off the patent. I guess they figured it was better to keep prices high so americans didnt border hop but lose the exclusivity sooner

dmix 1y ago

This is great news for Canadian public/private healthcare insurance. Not only do the drugs cost less but people get healthier and use less services

enslavedrobot 1y ago

Fun fact: Novo Nordisk's first success was selling insulin, which was discovered in Canada and licensed by the Scientists who's discovered it for free to the danish company in exchange for a promise to use the revenues "for good purposes". Hopefully this patent SNAFU makes up for 1% of that monumental screw job.

nl 1y ago
Insulin is cheap everywhere in the world except the US, and it's been around since the 1920s. The price has nothing to do with Novo Nordisk's distribution of it last century. https://pmc.ncbi.nlm.nih.gov/articles/PMC8597930/ https://pmc.ncbi.nlm.nih.gov/articles/PMC8597930/
simongray 1y ago
> in exchange for a promise to use the revenues "for good purposes". They still do an enormous amount of charity, though activities of the foundation are probably highly localised to Denmark: https://en.wikipedia.org/wiki/Novo_Nordisk_Foundation https://en.wikipedia.org/wiki/Novo_Nordisk_Foundation
BurningFrog 1y ago
There are many different kinds of insulin now, and almost nobody uses the original version, because it's tricky to get timing and dosage right. All with their own patent situation, of course.
- lotsofpulp 1y ago
  Insulin is so easy to make clickbait and ragebait with due to people not knowing, or willfully ignoring, that “insulin” is not one specific medicine. Kind of crazy considering how many people have diabetes.
- enslavedrobot 1y ago
  I should how so, considering the discovery I'm talking about happened in 1921.

danielovichdk 1y ago

Eat healthy. Do sports. Sleep well. Repeat.

metabagel 1y ago
Also, meditate, fast intermittently, get therapy, and develop healthy ways of handling stress and dissatisfaction. Everyone’s path is a little different. What is only a little difficult for some might be downright impossible for others (or feel that way).
- philipallstar 1y ago
  No, those things aren't nearly as important. Handling stress and therapy can also be replaced by some physical activity as well. General advice that would work for 95% of people shouldn't be criticised because it doesn't address the other 5%. If people did it then there'd be far more money in the system to pay for usefully targetted specialist treatment for those people.
  - devjab 1y ago
    Since we are pulling numbers out of our asses can you tell me what good advice that 95% of the people aren't capable of following is? It's great that our national health institutes advices us, but can you explain how the advice isn't completely useless in this particular context? To me it comes off as arrogant and rude.
    - philipallstar 1y ago
      I didn't say 95% of people aren't capable of following some advice. That would be bad advice. I'm saying this is good advice, because 95% of people can follow it.
  - metabagel 1y ago
    If we are talking about overweight people, then I think your 95% figure is backwards. Maybe 5% can stick to that regimen without addressing what’s going on between their ears. Likely, your perspective is skewed by the crowd you hang out with or from seeing other people at the gym. That’s not a representative cross-section of the population, particularly with respect to people who are overweight. The emotional/psychological side is important, because the person must make long term changes in their lifestyle. People tend to over-eat for a reason, and typically it is a reaction to stress or some emotional/psychological need which isn’t being met.

p0w3n3d 1y ago

Does it mean that Sandoz can start production of a generic in Canada and sell it e.g. in Europe?

progbits 1y ago
The protection (racket) is about selling, not manufacture. Otherwise everyone would just manufacture in china and sell anywhere they like.

bluecalm 1y ago

What's shocking here is that it costs several hundred dollars per year to have a big country enforcing a monopoly for you. I mean at least taking % of the revenue would make sense (and preferably for others to buy out underutilized patents). As it is it's just corporate welfare - enforcing lucrative market monopoly for an equivalent of a steak dinner for two.