Replies to post #128032 on Biotech Values

[mouton29]

Here is the proposed TRO submitted by MNTA (Item 36 in the docket)

[PROPOSED] ORDER GRANTING LIMITED
TEMPORARY RESTRAINING ORDER
In consideration of the Plaintiffs’ Motion for a Temporary Restraining Order and the
arguments raised during oral argument held on October 7, 2011, it is hereby ORDERED that for a
period of fourteen days the Defendants shall not advertise, offer for sale, or sell a generic
enoxaparin product in the United States.
This Order shall expire on October 21, 2011, or such other time as may be set by further
order of this Court.

[iwfal]

Plaintiffs' patent infringement claims ... relate to testing, not to themanufacture of enoxaparin

Well, that would seem to be close to an admission that they do actually use those methods of ensuring manufacturing is creating the product per spec.

PS I'll say again I believe that the crux of the matter is that the FDA is requiring certain product quality via rigorous testing. And Momenta staked out that ground in patents. To the extent that the FDA allows different proof of manufacturing goodness Momenta's patents become, IMO, worth a lot less.