Hi @bedgerthanks for your note on Judge Bernal's ruling.. The...

Hi @bedger

thanks for your note on Judge Bernal's ruling.. The California Federal (District) Court decision is important, especially for the FDA.

However, I don't see the reasoning in the case as indicating that Mesoblast Ltd may have fewer or lower hurdles to jump in obtaining marketing approval or getting to market in some other manner (by hook or by crook, so to speak). Nor do I think the USA is going to allow this bundle of issues to go quietly through to the keeper.

Conversely, I don't see it as any kind of problem for MSB's 'moat', and I do see it as providing yet another reason why Mesoblast's continuing 'good faith' collaboration with the FDA on its primary BLA/ IND should be recognised, valued & responded to by those very same FDA bureaucratic administrators who so value citizens' adherence to proper administrative process, over and above just about everything else.

You'll recall the judge in the injunction case stated, in his reasons for declining to give the FDA the injunction it was seeking, that: " ..As a threshold matter, the cells involved in the Expanded MSC Surgical Procedure are not drugs. They are human cells removed from patients and then reintroduced into those same patients. They are not fungible goods that can be sold, mass produced, or patented.. " .

This thought weighed very heavily on the judge. It's apparent throughout his reasons & I don't see any particular value in getting into the detail here. But the key takeaway for us IMO is set out in a couple of different references in the evidence, including this:





The decision can, and IMO should, be quite reasonably seen as being confined to the potential uses of MSCs etc in autologous treatments, and the extent of the FDA's proper regulatory jurisdiction there.

For MSB, as I see it, its IP-protected allogeneic treatments are readily distinguishable, and not under threat of devaluation. But for those who've been focussing on autologous therapies, there'll be some sleepless nights for their IP lawyers.

Cheers