For branded biopharmaceuticals that proceed from conception to commercialization quickly, the original patent on the drug may still extend beyond 12 years at the time of market launch. In such cases, the 12 years of ‘marketing exclusivity’ in the proposed bill becomes moot except to the degree that it precludes the branded company from having to defend its patent during that period.
Where the 12-year provision in the bill becomes relevant is for branded drugs that take a longer time to navigate the R&D phase. In these cases, the original patent may be expired or close to expiring upon market launch.
It would be helpful to know the probability distribution of the elapsed time from patent to launch for all FDA-approved biopharmaceuticals. I don’t have such data, but perhaps someone reading this does :-)
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