Replies to post #7128 on Momenta Pharmaceuticals, Inc. (MNTA)

[iwfal]

Bypassing of patents -

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.

[investorgold2002]

FOB speculation

the "FOB platform" patents that MNTA has (Eg: Host cell line selection) could block competition(biogeneric type) in a NUMBER OF BIOLOGICS and not just 1 biologic.

Is this an extreme assumption ? If the above is true, there should be a beeline of Big Pharma wanting to partner with Momenta. Of course this is after FDA announces the official pathway for biogenerics

[tekcor_atnm]

Investorgold,

If that is so, I am not sure how FDA's bio pathway will address "biosimilar/generic legislation the intent of which was to reduce drug cost and bring affordability.

I disagree. First, the pathway needed to be defined to allow competition to the branded drugs in the first place. Secondly, you are assuming that there's only one way (in the case of a duopoly like the current state of Lovenox) of proving sameness. (Hmmm, if there is only one way to prove sameness in many drugs and MNTA has the capabilities, wow, buy as much MNTA as you can Monday and just wait 5 - 10 years!).

I understand duopoly is better than monopoly. But there will not be significant cost reduction like how it is happening in non-biologics.

Again, I disagree. Now let me make an assumption that there might be more than one way to prove sameness. If this were the case, there will likely be many situations in the future where licensing of patents will occur. For example, let's say that MNTA feels that there might be another way to prove sameness -or- a way to get around it's patents, then they might choose to license their patents (after some period of sole generic status) giving an entry to more competitors to the marketplace. A steady revenue stream from licensing is usually desirable for any product facing margin pressures (possible competitors, new drugs, etc.). At the right time, licensing can also disincentivize others from continuing to develop other methods.