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.
“The notion that there’s a Chinese Wall between sell-side analysts and investment bankers may be the second-biggest piece of BS ever promulgated in any area of human knowledge!”
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