Yesterday rumors surfaced that $NOVO B (+0.1%) had not paid the maintenance fee for its semaglutide patent in Canada, causing the patent to expire prematurely. This could pave the way for generic competition in Canada as early as 2026, years before the patent expires in other countries.

The article that first reported this was published six days ago. So far, no market reaction. Novo has not commented. It remains unconfirmed.

At first glance, it seems unlikely that Novo simply "forgot" to pay, but some have suggested that it may have been a deliberate strategy related to Canada's unique pricing rules.

In Canada, patented drugs are under the jurisdiction of the PMPRB, a pricing authority that limits the prices of patented drugs. However, if a drug is not patented, the PMPRB loses jurisdiction. So no patent means no price control (until generics come on the market).

When the patent expired, the PMPRB proposed stricter price regulations that could have led to a significant price reduction for drugs like Ozempic.

Novo may have compromised:

- Lose patent protection sooner

- In the meantime, avoid PMPRB price controls

- Maximize pricing while still enjoying de facto exclusivity (until generics come to market).

Interestingly, other Canadian patent applications for Ozempic have also been withdrawn, suggesting that this may not have been a one-off mistake but a deliberate IP strategy.

In a nutshell:

It may not be a case of incompetence/a mistake , but a choice between longer exclusivity under price caps and shorter exclusivity with freer pricing.

However, these are unconfirmed rumors and not official statements.

Here is also a report on this:

https://www.labiotech.eu/in-depth/novo-nordisk-semaglutide-patent-expiration-canada/

https://www.ncbi.nlm.nih.gov/books/NBK602920/table/t03/

Let's see how it goes on ✌️

BamBamInvest

@BamBamInvest

3D·

Novo Nordisk vergisst Patentverlängerung in Kanada 🤣

$NOVO B (+0.1%)
$NVO (+0.15%)

Novo Nordisk hat vergessen, das Patent für Semaglutid in Kanada zu erneuern, was bedeutet, dass das generische Ozempic im Jahr 2026 verfügbar sein wird.

Novo Nordisk hat das Patent für Semaglutid, den Wirkstoff von Ozempic, in Kanada aufgrund einer ausstehenden Gebühr von 450 US-Dollar nicht verlängert. Dies ermöglicht den Verkauf von Generika ab 2026 und dürfte die Kosten für Patienten mit Diabetes oder Übergewicht senken. Dies könnte zwar den Zugang verbessern, aber den Umsatz von Novo Nordisk verringern.

https://www.science.org/content/blog-post/novo-nordisk-s-canadian-mistake

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. 😂

This change is specific to Canada for now—patents for semaglutide in the US and Europe last until the early 2030s, so generics won’t show up there for several more years.

Novo Nordisk's annual report contains an interesting footnote on its key drug, Ozempic, which last year accounted for $19 billion of sales worldwide.

"For Ozempic in Canada, regulatory data protection applies until 2026," says the report from Novo Nordisk (DK:NOVO.B) (NVO), which last week reclaimed the mantle of being Europe's largest company by market capitalization.

Why that's the case was brought to light in a column in the publication Science, which picked up on an interview with the head of generics drug maker Sandoz (CH:SDZ), which has filed to make a generic version. (Hikma Pharmaceuticals (UK:HIK) and Aspen Pharmaceuticals (ZA:APN) are also doing so.)

The reason Novo Nordisk is losing patent protection is because it wouldn't pay a couple hundred bucks.

In 2019, the Canadian patent office sent a letter saying it hadn't received Novo Nordisk's annual $250 maintenance fee on time, but the company could maintain the patent by paying a total of $450.

"Once a patent has lapsed, it cannot be revived," the letter on May 1, 2019, warned. And that was the last of the correspondence on the Canadian patent for semaglutide, the medication in Ozempic.

How much of a loss is that? The Globe and Mail, citing data from Iqvia, said total sales of Ozempic were $2.5 billion through retail pharmacies last year, making it the number-one drug in Canada.

The real interesting footnote to the footnote comes in a discussion on whether a Canadian Ozempic generic could qualify for U.S. use under what's called the Section 804 importation program. Florida so far is the only state that so far has dialogue with the Food and Drug Administration about launching such a program.

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28 Comments

B. T.@Aktienhauptmeister

2D

You deliver faster than DHL allows 😂✌️

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