>>If the patent is overturned within a few months (likely) and no generics are approved within 6 months of that(also likely imo), does the 6 month exclusivity period expire? mnta has stated this is the case.
The exclusivity period proved to be a very effective "carrot" for the comparatively simple drugs. It built the entire generics industry. It was critical BECAUSE many companies could qualify and launch the same drug in short order. So six months without competition, other than the branded, for a company that had not spent hundreds of millions of dollars on development studies produced huge economic profits. In this context, the statute allowing the exclusivity period to start running from patent invalidation (at the appellate level) made good policy sense.
In the era of complex glycosolated mixtures and biologics that are difficult to duplicate and get qualified, the exclusivity period is unlikely to have the same significance. Thus the need for new legislation that addresses this new era.
Bottom line is that MNTA's assertion that the exclusivity period will start to run on the patent invalidation makes sense to me.
Of course, lawyers can and will contest that if there is any advantage perceived or real. But that should not keep SNY from launching.
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)
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