Replies to post #127039 on Biotech Values

[DewDiligence]

Process patents are not permitted in the FDA’s Orange Book, so there is no way other than an injunction or a settlement for such a patent to prevent a company from launching.

[zipjet]

I'm not personally aware of a case where a process patent prevented a generic company from launch (not to say there isn't an example though).

The other side of that issue is that we have entered an era of much more complex generics where the reverse-engineering and proving sameness may be more likely to offer patenting opportunities.

At the end of the day, I think a not unlikely outcome is that MNTA gets a couple percent royalty on sales by Amphastar and Teva if the latter ever get approval.

Perhaps, one of the patent attorneys can enlighten us as to the criteria that the courts will apply in deciding whether a patent that is infringed will be allowed to block or simply be awarded a royalty.

It should be an interesting line to draw where the infringement was essential and yet a small part of the accomplishment.

ij

PS - Unrelated. Today the 30yr T yield dropped under 3% as I said it would. (The 10yr dropped under 2% quite some time ago.)

[mcbio]

At the end of the day, I think a not unlikely outcome is that MNTA gets a couple percent royalty on sales by Amphastar and Teva if the latter ever get approval.

What are the driving factors behind just receiving a couple percent royalty on sales versus an outright permanent injunction of the competitor's generic? With the former, it's like there's a small acknowledgement of infringement whereas in the latter it's much more clear. But, what is the fine line between these two outcomes and what drives whether one or the other is ultimately decided upon? This obviously has huge implications for MNTA because the latter outcome would validate their IP and would probably go a long way in ensuring that MNTA has the sole generic Lovenox on the market for a long time.