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by apo 2777 days ago
Glybera was never sold in North America and was available in Europe for just two years, beginning in 2015

The patent will expire within a few years, setting the stage for generic manufacturers to step in, but the article doesn't mention it.

In the US, patent protection extends for 20 years after the earliest filing date for the application on which the grant is based. There can be adjustments to the term if the grant was delayed.

https://en.wikipedia.org/wiki/Term_of_patent

The article is fuzzy about the timeline of events, bu has this quote:

The stunning results of the mouse experiments were featured on the cover of the journal Human Gene Therapy in September 2004. The cover image showed how, week by week, the mouse blood changed from milky white to a clear, transparent red, illustrating just how effectively the gene therapy was working.

So it seems like a good first guess to put the patent filing at or before 2004.

If so, then the Glybera patent would expire sometime after 2024. At that point, generic manufacturers can step in to sell their version of the product, assuming regulatory approval.

1 comments

As you can see from the lack of biosimilars in the US, manufacturing a biological is a hell of a lot more complex and expensive than doing it for a small molecule.

And in fact, since this is version 1.0, I’ll bet a better version comes out before any generic company launches.

If they come out with a new version, they must be expecting it to sell in a quantity that makes the investment worth it. So maybe the pricing worry is just a temporary concern.