Replies to post #156872 on Biotech Values

[DewDiligence]

Perhaps FDA disclosed no trade secrets, only patented methods [in the reply to SNY’s Lovenox CP]

That may have been part of the FDA’s thinking with respect to its Lovenox disclosures, although the response to SNY’s CP clearly went beyond the contents of MNTA’s Lovenox patents. However, the more consequential impetus for the FDA’s Lovenox disclosures was that the CAFC ruling in the Amphastar case hadn’t yet happened.

The problem for Momenta is that so much of their IP is protected by process patents versus trade secrets. This seems to include Copaxone…

Agreed that MNTA’s patents have left MNTA somewhat exposed on the technology for generic Copaxone, and hence there will probably be other generics approved in due course. (Fortunately, MNTA earns a 50% profit split on NVS’ Copaxone sales regardless of the number of generic players in the market.)

Where trade secrets will carry the day for MNTA, IMO, is in the FoB programs partnered with BAX, where relatively little has been patented on how MNTA hopes to achieve interchangeability with the branded drugs.

[pollyvonwog]

I hope you're right, though one wonders why Momenta hasn't sued the FDA for just such a disclosure, in that case.

This could be a possibility if the SCOTUS does not take up MNTAs case.

[DewDiligence]

Re: FDA disclosure policy on ANDA/351(k) trade secrets

I noticed this thread while updating the MNTA ‘ReadMeFirst’ today; looks like my 2013 post in #msg-84501925 was correct. Regards, Dew