2 0 1 3 ▁entitled , ▁“ P aving ▁the ▁Way ▁for ▁Personal ized ▁Medicine : ▁F DA ’ s ▁role ▁in ▁a ▁New ▁Era ▁of ▁Medical ▁Product ▁Development ,” ▁in ▁which ▁they ▁out lined ▁steps ▁they ▁would ▁have ▁to ▁take ▁to ▁integrate ▁gen etic ▁and ▁bi om ark er ▁information ▁for ▁clin ical ▁use ▁and ▁drug ▁development . ▁ ▁They ▁determined ▁that ▁they ▁would ▁have ▁to ▁develop ▁specific ▁regul atory ▁science ▁standards , ▁research ▁methods , ▁reference ▁material ▁and ▁other ▁tools ▁in ▁order ▁to ▁incorpor ate ▁personal ised ▁medicine ▁into ▁their ▁current ▁regul atory ▁practices . ▁For ▁example , ▁they ▁are ▁working ▁on ▁a ▁“ gen omic ▁reference ▁library ” ▁for ▁regul atory ▁ag encies ▁to ▁compare ▁and ▁test ▁the ▁valid ity ▁of ▁different ▁sequ encing ▁platforms ▁in ▁an ▁effort ▁to ▁u ph old ▁reli ability . ▁ ▁Intel lect ual ▁property ▁rights ▁As ▁with ▁any ▁innov ation ▁in ▁medicine , ▁invest ment ▁and ▁interest ▁in ▁personal ised ▁medicine ▁is ▁influenced ▁by ▁intellectual ▁property ▁rights . ▁ ▁There ▁has ▁been ▁a ▁lot ▁of ▁controvers y ▁regarding ▁pat ent ▁protection ▁for ▁di agnostic ▁tools , ▁gen es , ▁and ▁bi om ark ers . ▁ ▁In ▁June ▁ 2 0 1 3 , ▁the ▁U . S ▁Supreme ▁Court ▁ruled ▁that ▁natural ▁occurr ing ▁gen es ▁cannot ▁be ▁pat ented , ▁while ▁“ syn th etic ▁DNA ” ▁that ▁is ▁edited ▁or ▁artificial ly - ▁created ▁can ▁still ▁be ▁pat ented . ▁The ▁Pat ent ▁Office ▁is ▁currently ▁review ing ▁a ▁number ▁of