Biotech Values

[DewDiligence]

Is there a reason why FDA does this [excludes process patents from the Orange Book]?

This decision was part of the give and take that went into crafting the Hatch-Waxman bill in the 1980s. It was felt that allowing process patents in the Orange Book would impede generic drugs from coming to market by allowing branded-drug companies to tweak their processes for the sole purpose of delaying competition.