Saturday, October 29, 2011 8:36:16 AM
why do you think duopoly will not last for significant number of years ? take ampha litigation...take scenario both parties don;t settle and take the risk of trial judgement and say MNTA wins, Ampha cannot launch until 866 expires(2030?)
Because as I have noted before, I believe almost all patents can be worked around given time and money. E.g. in this case both 466 and 886 appear to deal with ways in which to take a manufacturing end-product and test it to ensure it is equivalent to Lovenox. But you'll note that they don't set values for every last subtype of the mixture; instead they test only some components in depth as a proxy for everything being a match. It is virtually certain IMO that there is some other fraction of the mixture that could also serve as a proxy - the only downside is the time it takes to prove it to yourself and then prove it to the FDA. Still, even with having to do the slog of proving it to the FDA I'd bet the whole process takes less than 10 years from now - and potentially quite a bit less. Note that Momenta themselves have noted that with time and incentive their patents are likely to be bypassed.
PS The normal patent period of 20 years from filing implies that 886 expires in 2023.
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