Super post. Refreshing to see some broad coverage of the underlying issue and what it means to us.
Yes it brings back memories in regards to BMELs and OA. Dr Felson has done a fair amount of work and research on this topic. I do also remember that it is very hard to disassociate presence of BMEL's and OA and this also works in our favour. A potential competitor would have to go out of their way to prove there is no presence of BMELs in the application of their solution. The alternative pathway to approval for a bio similar if not impossible as Dungiven and others point out, is onerous to say the least.
Its come up a number of times but due to the patents we have had successfully submitted and approved and more importantly in my mind, the excellent strong relationship we have from a supply point of view, this area is adequately covered off regardless of the outcome in June.
Patents are good and important but its the high complexity of manufacture, absolute batch to batch audited (FDA) consistency and long time supplying to various markets that is testimony to Bene that forms another complete layer of protection for us.
DYOR
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