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mcbio

12/23/10 6:35 PM

#111413 RE: DewDiligence #107893

I think an at-risk Copaxone launch is very unlikely without a favorable ruling from the District Court. If NVS/MNTA (and now MYL) prevail against Teva in the District Court, NVS/MNTA might decide to launch before a decision is rendered by the appellate court (assuming that they had FDA approval by then).

I was about to post on this topic as I didn't think we had discussed it but I just saw your prior exchange. One question I'll add is: what are the penalties for launching at-risk when one doesn't prevail in patent litigation? Surely the penalties are much harsher than just having to re-pay revenues derived during the at-risk period. But, how harsh are these penalties normally and what are they based on? Some multiple of revenues earned by the maker of the generic during the at-risk period?