C. taxi drivers and Uber services, or the decade-old spat between cable operators and telco-based video providers, understands that when regulators can no longer provider monopolyprotection to an incumbent, their basis for imposing monopoly-related fees or obligations washes away.
The orphan drug act only gives them eight years of exclusivity, but it does set a precedent for giving companies an extension of their monopoly that is not based on patent protection.