Contenu connexe
Plus de SterneKessler (20)
SKGF_Advisory_Therapeutic Antibodies Top Three Intellectual Property Issues_2008
- 1. 7KHUDSHXWLF $QWLERGLHV 7RS 7KUHH ,QWHOOHFWXDO 3URSHUW ,VVXHV
7KHUDSHXWLF DQWLERGLHV KDYH EHFRPH ELJ EXVLQHVV 7ZHQW RQH DQWLERGLHV DUH QRZ DSSURYHG E WKH )'$ IRU
PDUNHWLQJ DQG DQQXDO VDOHV KDYH UHDFKHG ZHOO SDVW WKH ELOOLRQ GROODU PDUN &RPSDQLHV RSHUDWLQJ LQ WKLV
VSDFH PXVW SD FDUHIXO DWWHQWLRQ WR LQWHOOHFWXDO SURSHUW LVVXHV ZKLFK FDQ GUDPDWLFDOO DIIHFW SRWHQWLDO
GHYHORSPHQW DQG SURILWDELOLW 7KH 7RS 7KUHH ,3 LVVXHV DUH IUHHGRP WR RSHUDWH SDWHQW OLIHFFOH
PDQDJHPHQW DQG WKH FKDQJLQJ OHJDO ODQGVFDSH
)UHHGRP WR 2SHUDWH
$ SDWHQW GRHV QRW JUDQW WKH SDWHQW KROGHU WKH DIILUPDWLYH ULJKW WR SUDFWLFH WKH SDWHQWHG WHFKQRORJ ± D SDWHQW
FRQYHV RQO WKH ULJKW WR H[FOXGH RWKHUV IURP SUDFWLFLQJ WKDW WHFKQRORJ ,W LV D UHDO SRVVLELOLW WKDW LQ PDNLQJ
XVLQJ RU VHOOLQJ SDWHQWHG WHFKQRORJ FRPSDQLHV PD XQZLWWLQJO LQIULQJH D VHSDUDWH SDWHQW RI D WKLUG SDUW
,Q IDFW WKH WUHPHQGRXV JURZWK LQ WKH WKHUDSHXWLF DQWLERG PDUNHW KDV FUHDWHG D PLQHILHOG RI WKLUG SDUW
SDWHQWV ZKLFK PXVW EH FDUHIXOO QDYLJDWHG DV D FRPSDQ VHHNV WR FRPPHUFLDOL]H LWV SURSULHWDU DQWLERG
WHFKQRORJLHV
,I D FRPSDQ SURFHHGV ZLWK FRPPHUFLDOL]LQJ LWV RZQ DQWLERG WHFKQRORJ LQ EOLQG GLVUHJDUG WR RU HYHQ
LJQRUDQFH RI SRWHQWLDOO GRPLQDWLQJ WKLUG SDUW SDWHQWV WKDW FRPSDQ PD ZLQG XS LQ WKH XQHQYLDEOH SRVLWLRQ
RI EHLQJ IRUFHG WR DFFHSW RQHURXV WKLUG SDUW OLFHQVHV RU EHLQJ NHSW RII PDUNHW RQ WKH HYH RI FRPPHUFLDO
ODXQFK
$YRLG RU PLQLPL]H WKH OLNHOLKRRG RI WKLV VFHQDULR E FRQGXFWLQJ DQ DSSURSULDWH IUHHGRP WR RSHUDWH VHDUFK RI
WKLUG SDUW SDWHQWV HDUO LQ WKH GHYHORSPHQW SURFHVV &ULWLFDO IRU DQ DQWLERG FRPSDQ UHJDUGOHVV RI VL]H
PDQ YHQWXUH FDSLWDOLVWV QRZ YLHZ IUHHGRP WR RSHUDWH DV LPSRUWDQW DV D VWURQJ SDWHQW SRUWIROLR ZKHQ
DVVHVVLQJ WKH IXWXUH RI DQ HDUO VWDJH FRPSDQ
,W LV IDU EHWWHU WR DGGUHVV ZKDW KDV EHHQ FDOOHG WKH PRQRFORQDO PD]H HDUO RQ ZLWK D SURSHU IUHHGRP WR
RSHUDWH DQDOVLV LQ KDQG WR JXLGH GHFLVLRQV WKDQ WR EOLQGO PRYH IRUZDUG DQG UXQ WKH ULVN ODWHU RI EHLQJ VKXW
GRZQ RU KDYLQJ WR DFFHSW RQHURXV OLFHQVHV GXH WR WKLUG SDUW SDWHQW LVVXHV
3DWHQW /LIH &FOH 0DQDJHPHQW
0DQ RI WKH WKHUDSHXWLF DQWLERGLHV ODXQFKHG LQ UHFHQW HDUV DUH WKH UHVXOW RI JURXQGEUHDNLQJ WHFKQRORJLHV
ILUVW GHYHORSHG D GHFDGH RU PRUH DJR $QWLERG KXPDQL]DWLRQ WHFKQLTXHV WKH SKDJH GLVSOD WHFKQRORJLHV
DQG WKH WHFKQRORJ IRU SURGXFLQJ IXOO KXPDQ DQWLERGLHV LQ PLFH ZHUH DOO FULWLFDO WR PDNLQJ WKHUDSHXWLF
DQWLERGLHV WKH PXOWLELOOLRQ GROODU EXVLQHVV LW LV WRGD
+RZHYHU DV WKH XVH RI WKHVH WHFKQRORJLHV EHFRPHV PRUH FRPPRQ DQG WKHLU EURDG DSSOLFDELOLW EHFRPHV
LQFUHDVLQJO DSSDUHQW WKH DUH QR ORQJHU FRQVLGHUHG JURXQGEUHDNLQJ ± WKHLU XVH EHFRPHV PRUH RI DQ
LQGXVWU QRUP &RQVHTXHQWO WKH DUJXPHQW IRU SDWHQWDELOLW RI WKH SURGXFWV RI WKHVH WHFKQRORJLHV KDV
EHFRPH PRUH GLIILFXOW ,Q D VHQVH FRPSDQLHV WKDW GHYHORS WKHVH WHFKQRORJLHV FDQ EH WKH YLFWLP RI WKHLU RZQ
VXFFHVV
6WHUQH .HVVOHU *ROGVWHLQ )R[ 3 / / & 1HZ <RUN $YHQXH 1: :DVKLQJWRQ '& ZZZ VNJI FRP
- 2. &RPSDQLHV FDQ DGGUHVV WKLV E DGRSWLQJ D ZHOO SODQQHG ILOLQJ VWUDWHJ WKDW VHHNV WR WLPH WKH ILOLQJV RI QHZ
DSSOLFDWLRQV VR DV WR PLQLPL]H WKH WKUHDW SRVHG E WKHLU RZQ SULRU SDWHQWV ZKLOH DW WKH VDPH WLPH PD[LPL]LQJ
SDWHQW WHUP IRU SRWHQWLDOO EORFNEXVWHU SURGXFWV &RPSDQLHV VKRXOG DOVR FRQWLQXH WR LQQRYDWH GXULQJ WKH
SURGXFW GHYHORSPHQW DQG FOLQLFDO WULDO SKDVHV ,QVLJKWV ZKLFK ZHUH QRW DSSDUHQW HDUO RQ FDQ RIWHQ UHVXOW LQ
SDWHQWV WR QRYHO SKDUPDFHXWLFDO IRUPXODWLRQV GRVDJH UHJLPHQV PHWKRGV RI DGPLQLVWUDWLRQ FRPELQDWLRQ
WKHUDSLHV HWF WKDW DGG WR WKH SDWHQW SURWHFWLRQ IRU WKH FRUH DQWLERG DQG H[WHQG WKH SDWHQW SURWHFWLRQ FORVHU
WR WKH FRPPHUFLDO OLIH RI WKH WKHUDSHXWLF SURGXFW % FUDIWLQJ D FDUHIXO SDWHQW OLIH FFOH PDQDJHPHQW VWUDWHJ
FRPSDQLHV FDQ FRQWLQXH WR REWDLQ SDWHQWV WR QHZ LQQRYDWLRQV VXUURXQGLQJ D YDOXDEOH DQWLERG SURGXFW
&KDQJLQJ /HJDO /DQGVFDSH
7KH OHJDO ODQGVFDSH LQ ZKLFK DQWLERG SDWHQWV DUH SURFXUHG DQG HQIRUFHG LV FRQVWDQWO EHLQJ UHVKDSHG E
&RQJUHVV DQG WKH FRXUWV ,Q SDUWLFXODU VHYHUDO UHFHQW GHFLVLRQV E WKH 8 6 6XSUHPH &RXUW PD DIIHFW WKH
SDWHQWDELOLW RI UHFRPELQDQW DQWLERGLHV DV ZHOO DV WKH YHU ULJKW RI SDWHQW KROGHUV WR HIIHFWLYHO OLFHQVH WKHLU
WHFKQRORJLHV RU WR H[FOXGH RWKHUV IURP SUDFWLFLQJ WKHP 7KHVH LQFOXGH
x .65 Y 7HOHIOH[ ± ,Q WKLV FDVH WKH 8 6 6XSUHPH &RXUW FODULILHG WKH VWDQGDUG IRU GHWHUPLQLQJ
ZKHQ DQ LQYHQWLRQ LV QRQREYLRXV 8QGHU WKH QHZ VWDQGDUG D SDWHQW H[DPLQHU PD XWLOL]H D
UHDVRQDEOH GHJUHH RI FRPPRQ VHQVH LQ DSSOLQJ ZKDW LV ZHOO NQRZQ LQ WKH DUW LQVWHDG RI D ULJLG WHVW
0RVW UHOHYDQW WR WKH UHFRPELQDQW DQWLERG LQGXVWU DQ LQYHQWLRQ PD EH FRQVLGHUHG REYLRXV LI LW LV WKH
PHUH UHVXOW RI DSSOLQJ D NQRZQ WHFKQLTXH WR D NQRZQ VWDUWLQJ PDWHULDO UHDG IRU LPSURYHPHQW WR LHOG
SUHGLFWDEOH UHVXOWV ,W LV FXUUHQWO XQFOHDU KRZ WKH .65 GHFLVLRQ ZLOO LPSDFW WKH SDWHQWDELOLW RI QRYHO
KXPDQL]HG $EV SURGXFHG IURP PXULQH DQWLERGLHV DFFRUGLQJ WR NQRZQ KXPDQL]DWLRQ PHWKRGV
x H%D ,QF Y 0HUF([FKDQJH ± &RQFHUQLQJ XVLQJ SDWHQWV WR SUHYHQW RWKHUV IURP HQWHULQJ WKH
PDUNHWSODFH WKH 6XSUHPH &RXUW DSSOLHG DQ HTXLWDEOH EDODQFLQJ WHVW IRU GHWHUPLQLQJ ZKHQ LQMXQFWLRQV
DUH DSSURSULDWH LQ WKLV GHFLVLRQ 6XEVHTXHQW ORZHU FRXUW GHFLVLRQV KDYH JHQHUDOO HVWDEOLVKHG
WKDW LQIULQJHUV LQ GLUHFW FRPSHWLWLRQ ZLWK WKH SDWHQWHH XSRQ HQWU LQWR WKH PDUNHWSODFH DUH PRUH OLNHO
WR EH HQMRLQHG WKDW DUH LQIULQJHUV ZKR DUH VXHG E D QRQ SUDFWLFLQJ SDWHQWHH 7KH GHFLVLRQV KDYH DOVR
HVWDEOLVKHG WKDW SXEOLF LQWHUHVW FRQFHUQV DUH GHHPHG UHOHYDQW E FRXUWV ZKHQ GHFLGLQJ WKH LQMXQFWLRQ
LVVXH LQ FDVHV LPSDFWLQJ WKH SXEOLF KHDOWK
x 0HG,PPXQH Y *HQHQWHFK ± ,Q WKLV FDVH WKH 6XSUHPH &RXUW KHOG WKDW D OLFHQVHH ZKR KDV QRW
EUHDFKHG WKH OLFHQVLQJ DJUHHPHQW QRQHWKHOHVV KDV VWDQGLQJ WR EULQJ D GHFODUDWRU MXGJPHQW DFWLRQ D
ODZVXLW EURXJKW E D SRWHQWLDO GHIHQGDQW VHHNLQJ D GHFODUDWLRQ WKDW D SDWHQW LV LQYDOLG DQG RU QRW
LQIULQJHG DJDLQVW WKH SDWHQWHH SURYLGHG WKDW DQ DFWXDO FRQWURYHUV RWKHUZLVH H[LVWV EHWZHHQ WKH
SDUWLHV /DWHU WKDW HDU WKH &RXUW RI $SSHDOV IRU WKH )HGHUDO &LUFXLW DSSOLHG WKH 0HG,PPXQH VWDQGDUG
WR WKH SUH DJUHHPHQW OLFHQVLQJ QHJRWLDWLRQ SURFHVV LQ 6DQ'LVN &RUS Y 670LFURHOHFWURQLFV ,QF
ZKHUH D SRWHQWLDO OLFHQVHH ZDV GHHPHG WR KDYH VWDQGLQJ WR EULQJ D GHFODUDWRU MXGJPHQW DFWLRQ LQ D
VLWXDWLRQ ZKHUH WKH SDWHQWHH KDG SUHVHQWHG D GHWDLOHG LQIULQJHPHQW DQDOVLV GXULQJ PHHWLQJV HYHQ
WKRXJK WKH SDWHQWHH KDG SURYLGHG DVVXUDQFHV WKDW LW KDG QR LQWHQW WR ILOH D VXLW IRU SDWHQW LQIULQJHPHQW
'XH WR WKHVH ORRVHQHG VWDQGDUGV FRPSDQLHV QRZ PXVW ZDON D ILQH OLQH LQ WKHLU QHJRWLDWLRQV ZLWK
SRWHQWLDO LQIULQJHUV
6WHUQH .HVVOHU *ROGVWHLQ )R[ 3 / / & 1HZ <RUN $YHQXH 1: :DVKLQJWRQ '& ZZZ VNJI FRP
‹ $OO ULJKWV UHVHUYHG