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Novo Nordisk's Canadian Mistake

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Re: Novo Nordisk's Canadian Mistake

#91

Post by crummy »

Rebelgecko wrote: post #89
0cf8612b2e1e wrote: post #14

Earlier quoted context omitted.

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…

Is this the patent equivalent of letting your website's cert expire?

More like letting the domain expire, and someone else snapping it up before you can renew.

Re: Novo Nordisk's Canadian Mistake

#92

Post by dghlsakjg »

rahimnathwani wrote: post #20

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…

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.

Re: Novo Nordisk's Canadian Mistake

#93

Post by digianarchist »

doubled112 wrote: post #81
eek2121 wrote: post #46

Earlier quoted context omitted.

I don't know about that, Canada is a beautiful country. If I were on the meds, I wouldn't hesitate to fly out for a day trip every 90 days. 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.

Detroit and Windsor are a single bridge crossing away from each other. Sarnia and Port Huron too. 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.

There's a tunnel between Detroit and Windsor. Faster than the bridge sometimes because no trucks.

Re: Novo Nordisk's Canadian Mistake

#94

Post by SecretDreams »

pedalpete wrote: post #3

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…

Canada's one of the bigger markets for this product. That aside, think of the percentage of Americans that live driving distance of a Canadian border - it's easy to envision from meaningful lost sales just from normal Americans who go to Canada to shop on the weekend.

Re: Novo Nordisk's Canadian Mistake

#95

Post by aspenmayer »

nextos wrote: post #85
aspenmayer wrote: post #83

Earlier quoted context omitted.

> 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://lega…

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.

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.

Re: Novo Nordisk's Canadian Mistake

#96

Post by SoftTalker »

choilive wrote: post #75
greycol wrote: post #71

Earlier quoted context omitted.

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 semiglu…

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.

This is commonly done for injectable fertility treatments, though in my experience they are hydrated just before use.

Re: Novo Nordisk's Canadian Mistake

#97

Post by bawolff »

nextos wrote: post #67
bawolff wrote: post #38

Earlier quoted context omitted.

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.

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…

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?

Re: Novo Nordisk's Canadian Mistake

#98

Post by glp1guide »

ChrisMarshallNY wrote: post #41
glp1guide wrote: post #35

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... Also somewhat separately, injectable GLP1s are about to be upstaged by o…

> 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.

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.

Re: Novo Nordisk's Canadian Mistake

#99

Post by jay_kyburz »

chronos00 wrote: post #78
valicord wrote: post #60

Earlier quoted context omitted.

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.

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?

Re: Novo Nordisk's Canadian Mistake

#100

Post by SoftTalker »

dghlsakjg wrote: post #92
rahimnathwani wrote: post #20

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…

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? Count…

Everyone I know taking these is buying generic compounded formulas. Insurance mostly doesn’t cover it so the go for the cheaper options.
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