This was an interesting interview with Richard Saynor, the head of Sandoz (which is now an independent generics company). That’s a part of the industry that I don’t cover as much, partly because I’ve never worked in it and partly because it can be a very different world than the new-drug-discovery-oriented pharma one that I know. Generic competition can be extremely fierce (and can come down to price, which is much more rare among patented drugs). There are also a lot of interesting IP and regulatory issues about when you can start making and selling a generic version of a drug that’s coming off-patent, and these can also be country-specific. As you're about to see.
As Saynor himself puts it, pharma companies tend to be “lousy” at running a generics business, and part of that is because the generics mindset is to be a “patent destroyer”. These firms are always looking for ways to invalidate protection on patented drugs or to shorten the term of that protection so they can get into the market, and that brings on a whole different mindset (and a whole different attitude towards timelines for decisions!) As you can imagine, the more lucrative the patented drug, the bigger the fight over taking it generic. I was particularly struck by this exchange over semaglutide (Ozempic/Wegovy):
Dunn (interviewer at Endpoints): You plan to potentially launch a generic GLP-1 in Canada and Brazil in 2026. What do you expect for the biosimilar market, both there and eventually in the US?
Saynor: Canada, we filed and are waiting for approval once the data exclusivity expires sometime in Q1 next year. Interesting market. Novo never filed a patent in Canada. Never know why. I’m sure someone’s lost their job, but never mind. It’s the second-largest semaglutide market in the world.
Dunn: That’s pretty remarkable.
Saynor: You gotta ask why. I don’t think Canadians are disproportionately large. There’s clearly a dynamic, like insulin, with cross-border business. It’s going to be interesting to see how that evolves. . .
I posted this on my BlueSky account and a follower there (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”.
Meanwhile in the US it’s going to be at least 2032 before we start talking about semaglutide’s patent protection lapsing. But as Saynor alludes to, that huge Canadian market has to reflect what he calls “cross-border demand”, and Novo will have to decide how to deal with that starting next year. I’m sure it would have been cheaper to pay that fee, you know?
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