Momenta Pharmaceuticals, Inc. (MNTA)

[pollyvonwog]

Mouton will probably provide a better idea of this, but I'll give it my best.

During the CAFC review the panel unanimously (all 3 judges) found the 2015 patent invalid. TEVA then asked for an en banc review which was denied. Usually in these kinds of cases that should do it, but alas that did not happen as we all know.

Moving on there was a recent 6-4 en banc hearing regarding a case called Lightning Ballast that had to do with de novo review of claims construction where the CAFC hears the case from scratch. Lightning upheld the de novo of the CAFC, but since it was a close decision apparently SCOTUS felt that they should get involved and it just happened that the MNTA/TEVA case tackled the same subject matter at the same time so they took it.

So basically this case is about the CAFCs ability to rule on the district court's claims constructions, which as you can imagine was quite the blind side to MNTA/NVS.

MNTA believes it very unlikely that SCOTUS will consider the CAFC ruling invalid and that this is really about procedure more than anything else, but there is still that possibility that SCOTUS rules the CAFC invalid which is why MNTA set up the ATM and plans to sideline copax revs. MYL has come out and said that they don't even consider a launch to be "at-risk" to show their confidence on what will happen.

Hopefully Mouton chimes in to give a better picture!