Haha, googala beat me ! ... although I think I posted this link...

Haha, googala beat me ! ... although I think I posted this link many months ago ?
https://www.sec.gov/Archives/edgar/data/1345099/000156459018022521/meso-ex421_530.htm

From memory, I recall hearing that up to 15 patents were alleged to have been infringed. This settlement , resulted in a global patent licence being entered into which meant tiered royalties, averaging 6%, needed to be PAID to Mesoblast, to settle the dispute in question ( royalty details are redacted on the SEC filed document as commercially sensitive). A further requirement was that Tigenix had to make a milestone payments of up to US $ 24m to Mesoblast , including, I believe , US$ 12m on European authorisation for Alofisel ( darvadstrocel ) or CX601 as previously referred to .

I also believe that when” push comes to shove” Cynata may also need to have some interesting discussions with Mesoblast over Mechanism of Action patents before they commercialise their products... and yes I am aware of that Cynata has an exclusive license from WARF ( Wisconsin Alumni Research Foundation) which has some very old established patents , arising from work done in this area by James Thomson in the 1990’s. This is my opinion, rightly or wrongly. I should stress I have no legal training and have largely relied upon the expert opinion of someone who has a clear vested interest in MSB. I have no intention of expanding any further on this point ... so please don’t bother asking because I will not reply.
I believe Mesoblast also has some amazing IP , especially in relation to the commercial harvesting of MSCs which is far more critical than people understand. Being able to multiply stem cells in a cost efficient manner without affecting potency or consistency is essential, not only to receiving FDA approval, but also to allow a low manufacturing cost of goods. This is a very big important differentiator between the allogenic approach and autologous therapies . Many CART-T therapies may be limited by high cost of care as referenced in the link below from the Journal of Medical Economics:

https://www.tandfonline.com/doi/full/10.1080/13696998.2019.1582059

I have been told MSB decision to acquire the stem cell assets of Osiris was to a large extent to be sure they could withstand any patent challenge. This can be shown by acquisition statement which said the IP portfolio is “highly complimentary and additive to Mesoblast’s existing patent estate.” At the time Osiris transferred to MSB, 110 granted patents globally, 48 in the US, 21 in Europe and 9 in Japan. The press release stated granted patents “ covered composition of matter, uses and method claims to 2025. Additional patent applications, if granted will extend patent protection to 2031.”
Many people forget that Osiris still has an earnout on sales of acquired products ranging from low single digit to a 10% cap on annual sales in excess of $ 750m . I should point out however that Osiris IP, applied in Remestemcel, is first generation . Mesoblast’s most valuable therapies, such as CHF , utilise second generation methodologies, which are based on its own IP ( Rexlemestrocel-L) , for which no royalty payments to Osiris would be required. Indeed, should the FDA allow Mesoblast to substitute formulations at a later date post approval ( if Rexlemestrocel-L is shown to having higher efficacy) even those potential royalties payments would be unnecessary and this might further extend patent life.


Please do not rely on the opinions expressed above when making an investment decision. It goes without saying that the ultimate arbiter of patent enforcement is the court system which is the only “opinion” that really matters. Both WARF and Mesoblast have successfully defended parts of their IP against legal challenge.