,,ii #aag? ,,congress #b;d ,session ,s4 #ddcj ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #af1 #bjbb,mr4 ,durb9 7= himself1 ,mr4 ,tillis1 & ,mr4 ,grassley7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to am5d title #ce1 ,unit$ ,/ates ,code1 to e/abli% an int]ag5cy task =ce betwe5 ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice & ! ,food & ,drug ,adm9i/ration = purposes ( %>+ in=mation & provid+ te*nical assi/ance ) respect to pat5ts1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,int]ag5cy ,pat5t ,coord9ation & ,improvem5t ,act ( #bjbb4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,decisions by ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice relat+ to pat5ts may implicate1 or h relevance to1 in=mation h\s$ at or involv+ o!r ,f$]al ag5cies4 7#b7 ,entities submitt+ pat5t applications to ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice may also submit in=mation to1 or %>e in=mation )1 o!r ,f$]al ag5cies1 necessitat+ accuracy & consi/5cy 9 ^? repres5tations4 7#c7 ,rese>* has %[n t pat5t exam9]s may b5efit f additional in=mation t is h\s$ at1 or is available to1 ,f$]al ag5cies o!r ?an ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice 9 ord] to assess prior art & ! /ate ( sci5ce & te*nology4 7#d7 ,! ,"u ,secret>y ( ,comm]ce = ,intellectual ,prop]ty & ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice is enc\rag$ to "w ) o!r ,f$]al ag5cies4 #c4 ,report by ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,"u ,secret>y ( ,comm]ce = ,intellectual ,prop]ty & ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice %all submit to ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives a report t conta9s-- 7#a7 a description ( ! frequ5cy ) :i*-- 7,a7 in=mation is provid$ by ! ,food & ,drug ,adm9i/ration to ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice ?r\gh ! ,int]ag5cy ,task ,=ce on ,pat5ts e/abli%$ "u section #ae ( title #ce1 ,unit$ ,/ates ,code1 z add$ by section #d7;a7 ( ?is ,act1 or "u processes e/abli%$ by t ,task ,=ce2 & 7,b7 ! in=mation describ$ 9 subp>agraph 7,a7 is us$ 9 pat5t exam9ations2 7#b7 an id5tification ( :i* me?ods ( provid+ in=mation1 z describ$ 9 p>agraph 7#a77;,a71 & types ( in=mation s %>$1 are mo/ useful to pat5t exam9]s2 7#c7 any recomm5dations = *anges to be made by ,congress to ! m&ate1 fund+1 or op]ations ( ! ,task ,=ce describ$ 9 p>agraph 7#a77;,a72 & 7#d7 an id5tification ( o!r ,f$]al ag5cies ) :i* ! ,"u ,secret>y ( ,comm]ce = ,intellectual ,prop]ty & ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice %\ld explore opportunities = coord9ation t are simil> to ^? und]tak5 ) ! ,food & ,drug ,adm9i/ration ?r\gh ! activities ( ! ,task ,=ce describ$ 9 p>agraph 7#a77;,a74 #d4 ,int]ag5cy ,task ,=ce on ,pat5ts 7a7 ,9 g5]al ,*apt] #a ( title #ce1 ,unit$ ,/ates ,code1 is am5d$-- 7#a7 9 section #b7;c71 by add+ at ! end ! foll[+3 7#f7 7,a7 ,9 ex]cis+ ! ,director's p[]s & duties "u ?is section relat+ to pat5ts1 & decisions or actions involv+ pat5ts1 = human drugs & biological products1 ! ,director %all1 ?r\gh ! ,int]ag5cy ,task ,=ce on ,pat5ts e/abli%$ "u section #ae1 consult ) ! ,commission] ( ,food & ,drugs 9 ! mann] describ$ 9 t section4 7,b7 ,= purposes ( subp>agraph 7,a71 ! t]m decisions or actions involv+ pat5ts means decisions or actions tak5 ) respect to pat5ts "u ?is title4 2 & 7#b7 by add+ at ! end ! foll[+3 #ae4 ,int]ag5cy ,task ,=ce on ,pat5ts 7a7 ,e/abli%m5t ,!re is e/abli%$ an int]ag5cy task =ce1 to be kn[n z ! ,int]ag5cy ,task ,=ce on ,pat5ts 7ref]r$ to 9 ?is section z ! task =ce71 to coord9ate ef=ts betwe5 ! ,director & ! ,commission] ( ,food & ,drugs 7ref]r$ to 9 ?is section z ! ,commission]7 reg>d+ communication ab\t1 evaluation (1 & effective implem5tation ( ! activities ( ! ,(fice & ! ,food & ,drug ,adm9i/ration ) respect to pat5ts1 & decisions or actions involv+ pat5ts 7z def9$ 9 section #b7;c77#f77;,b771 = human drugs & biological products4 7b7 ,memor&um ( und]/&+ ,! ,director & ! ,commission] %all ent] into a memor&um ( und]/&+1 or update an exi/+ memor&um ( und]/&+1 = ! purposes ( implem5t+ & c>ry+ out ! duties ( ! task =ce4 7c7 ,memb]%ip ,! task =ce %all be compris$ ( employees ( ! ,(fice1 :o %all be appo9t$ by ! ,director1 & employees ( ! ,food & ,drug ,adm9i/ration1 :o %all be appo9t$ by ! ,commission]1 :o h appropriate exp]tise & decision-mak+ au?ority reg>d+ op]ational1 adm9i/rative1 te*nical1 m$ical1 ph>macological1 cl9ical1 & sci5tific matt]s to c>ry out ! functions ( ! task =ce4 7d7 ,activities ,! task =ce %all c>ry out ! foll[+ functions reg>d+ int]ag5cy coord9ation to promote reciprocal access ( in=mation3 7#a7 ,%>+ in=mation on ! g5]al processes ( ! ,(fice & ! ,food & ,drug ,adm9i/ration1 :at ea* su* ag5cy consid]s 9 its respective review ( applications1 & h[ ea* su* ag5cy evaluates ^? applications1 :i* may be und]tak5 ?r\gh r\t9e & ongo+ meet+s1 work%ops1 & tra9+ sessions4 7#b7 ,%>+ in=mation on new approvals ( pat5ts1 human drugs & biological products1 new te*nologies & prior art 7z appropriate on a case-by-case basis71 & sci5tific tr5ds & developm5ts4 7#c7 ,e/abli%+ a process t requires-- 7,a7 ! ,director to reque/ f ! ,commission] 7& ! ,commission] to provide to ! ,director1 ^u receiv+ su* a reque/7-- 7i7 appropriate in=mation = use by employees ( ! ,(fice ) responsibility to exam9e pat5t applications "u section #aca 7ref]r$ to 9 ?is section z pat5t exam9]s7 reg>d+ :5 c]ta9 in=mation relat+ to a human drug or biological product approval1 :i* may include updates to a label or newly approv$ indications1 is made publicly available1 includ+ :5 su* in=mation is po/$ onl9e2 & 7ii7 appropriate access = pat5t exam9]s to relevant s\rces ( product application1 approval1 pat5t1 & label+ in=mation or communications betwe5 ! ,food & ,drug ,adm9i/ration & ! prescription drug or biological product sponsors t may n curr5tly be subject to public disclosure1 z appropriate & only to ! ext5t necess>y = ! ,(fice to c>ry out ! responsibilities ( ! ,(fice1 includ+ ensur+ accurate repres5tations & ! en=cem5t ( ! limitation on grant+ a pat5t because ! claim$ inv5tion t w\ld be ! subject ( ! pat5t 0 on sale be=e ! effective fil+ date ( ! claim$ inv5tion1 z describ$ 9 section #ajb7;a77#a72 & 7,b7 ! ,(fice to assi/ ! ,food & ,drug ,adm9i/ration 9 its m9i/]ial role ( li/+ appropriate & accurate descriptions ( pat5ts4 7#d7 ,e/abli%+ a process to ensure t1 9 appropriate circum/ances1 at ! reque/ ( ! ,director1 ! ,commission] %all consult ) or o!rwise furni% specific1 available in=mation to ! ,(fice ) respect to c]ta9 applications1 responses1 or affidavits aft] rejections 9 ord] to assi/ pat5t exam9]s 9 c>ry+ out ! duties ( ^? pat5t exam9]s4 7e7 ,rule ( con/ruction ,no?+ 9 subsection 7d77#c77;,b7 %all be con/ru$ z-- 7#a7 direct+ ! ,(fice to int]f]e ) or delay ! m9i/]ial function ( ! ,food & ,drug ,adm9i/ration ( li/+ pat5ts2 or 7#b7 indicat+ ! position ( ! ,(fice reg>d+ ! ability to ass]t a pat5t 9 infr+em5t litigation4 7f7 ,confid5tiality 7#a7 ,9 g5]al ,! task =ce %all e/abli% appropriate protocols to safegu>d confid5tiality & prev5t ! inappropriate disclosure ( in=mation :5 %>+ in=mation betwe5 ! ,(fice & ! ,food & ,drug ,adm9i/ration4 7#b7 ,pot5tial rem$ies ,9 e/abli%+ protocols "u p>agraph 7#a71 ! task =ce %all id5tify appropriate rem$ies = any pot5tial injury suff]$ :5 confid5tial in=mation is made available1 includ+ inadv]t5tly1 ?r\gh ! %>+ ( in=mation describ$ 9 t p>agraph4 4 7b7 ,te*nical & con=m+ am5dm5t ,! table ( sections = *apt] #a ( title #ce1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 #ae4 ,int]ag5cy ,task ,=ce on ,pat5ts4 4 7c7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to ! ,"u ,secret>y ( ,comm]ce = ,intellectual ,prop]ty & ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice & ! ,commission] ( ,food & ,drugs su* sums z may be necess>y = ! purposes ( c>ry+ out ! functions ( ! ,int]ag5cy ,task ,=ce on ,pat5ts e/abli%$ "u section #ae ( title #ce1 ,unit$ ,/ates ,code1 z add$ by subsection 7a74