@otherperspective whilst I still haven't become a patent lawyer, I would like to point to an earlier post that from a few years ago, that may gives us an indication on this patent issue:
"As you said, it may sit with the lawyers for a while if they come to the conclusion that both products are considered "the same". And if they are, the next step would be clinical superiority. But Cynata would first need to get a trial in the US running and achieve top-line results."
https://hotcopper.com.au/threads/mst-access-values-cyp-at-2-76.6437681/page-20?post_id=57811063
And it comes back to both Mesoblast and Cynata having been granted Orphan Drug Designation for aGvHD:
https://www.aspecthuntley.com.au/asxdata/20180328/pdf/01966116.pdf
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=214805
As @Lopez used to point out when talking about Orphan Drug Designations, it comes with with a 7 year market exclusivity:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=316&showfr=1&source=govdelivery&subpartnode=21%3A5.0.1.1.6.4&utm_medium=email&utm_source=govdelivery
Mesoblast would have exclusivity once approved, no?
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/frequently-asked-questions-faq-about-designating-orphan-product
That's at least how I would read Jacobus’s NDA review mentioned in my earlier post and the statement, that the wording would likely not limit it to GvHD in children, but also cover adults.
So would consider Cynata, Mesoblast and/or the FDA CYP-001 to be the "same drug"? (although granted, not a drug in that sense)
https://www.fda.gov/media/111762/download
KK's actions once FDA approves remestemcel-L (and I hope they will), will he abandon CYP-001's P2 trial in aGvHD? If he agrees that this is the "same drug", you would think that he'd rather preserve the cash left and pursue other targets once he gets in touch with Mesoblast to acquire a license in an indication MSB does not wish to pursue, right?
But if he believes in what he preaches (and he has been on MSB's payroll before, is familiar with the product) and it is in fact "same same but different" and has a pair of cojones grown out of stem cells using a different process that is of course not in breach with any patents owned by MSB, it will be business as usual and the trial will continue.
If the results warrant pursuing this indication, it will come down to the FDA having to make a decision on this topic at some stage down the road (after a P3 as I see no way of approval after a P2 trial in the US).
It definitely won't matter what you or I think and post, and definitely won't matter what @Lopez cuts and pastes... sorry, I mean thinks, to anyone really.
Also, @Bazsa, I checked and the nick @BIASza is still available. You are welcome.
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