Apotex is arguing that no one has exclusivity based on the technicality that PFE’s ‘303’ patent dies from natural causes on 3/25/07 (this Sunday) and hence the only thing the patent litigation was able to accomplish was to knock out PFE’s six-month pediatric extension.
The pediatric-extension law was adopted by Congress subsequent to the H-W Act and it is not explicitly addressed in the H-W text you cited.
If my interpretation is correct, there will be an announcement in the near future of a deal between Apotex and Mylan resolving all outstanding issues so that both of them can launch. Regards, Dew
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