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Alias Born | 03/03/2011 |
Saturday, November 05, 2011 11:15:40 AM
1. No TEVA's process patents would be infringed by MNTA including the test reaction - Non-infringement of process
2. MNTA probably has provided evidence under seal that 9-24KDA mol weight copaxone(MNTA's formulation) is NO more toxic than 5-9kda copaxone doing rodent studies. Maybe MNTA has also shown that 9-24KDA has same effect on biomarkers (cytokines) as 5-9kda- Patent on lower m.w copaxone is deemed Invalid.
Maybe the judge will also take in to consideration the 2 prior human clinical studies on higher m.w copaxone where TEVA itself concluded it was safe.
The judge will probably ask for FULL data on rodent studies done by TEVA where they concluded higher m.w copaxone was more toxic. was there any cherry picking of data by teva?
Hard to say what will happen on this point.
Hoping Judge jones will deliver verdict before xmas. It appears all filings have been made by both parties as of 11/01.
Is it possible that there could be settlement discussions between the 2 parties now ? For example, if TEVA believes the case is 50:50 it may want to settle with MNTA for a launch in 2013?
TEVA for one does not believe that generic copaxone will not be approved by FDA...
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